47 working the other invention efficiently or the best advantage

possible.

Chapter XX PENATLIES

106. Power of court to grant relief in cases of groundless threats of infringem~nt proceedings.-

(1) Where any person (whether entitled to or interested in a

patent or an application for patent or not) threatens any

other person by circulars or advertisements or by

communications, oral or in writing addressed to that or

any other person, with proceedings for infringement of a

patent, any person aggrieved thereby may bring a suit

against him praying for the following reliefs, that is to

say-

(a) a declaration to the effect that the threats are

unjustifiable;

(b) an injunction against the continuance of the

thre<1ts; and

(c) such damages, if any, as he has sustained

thereby.

(2) Unless in such suit the defendant proves that the' acts in·

respect oJ which the proceedings were threatened

constitute or, if done, would constitute, an infringement

of a patent or of rights arising from the publication of a

complete specification in respect of a claim of the

specification not shown by the plaintiff to be invalid the

court may grant to the plaintiff all or any of the reliefs

prayed for.

Explanation.- A mere notification of the existence of a

patent does not constitute a threat of proceeding within

the meaning of this section.

108. Relief in suit for infringement.-

;.j;i·. ~ ...

(1) The reliefs which a court may grant in any suit for

infringement include an injunction (subject to such

terms, if any, as the court thinks fit) and, at the option of

the plaintiff, either damages or an account of profits.

(2) The court may also order that the goods which are found

to be infringing and materials and implements, the

predominant use of which is in the creation of infringing

goods shall be seized, forfeited or destroyed, as the court

deems fit under the circumstances of the case without

payment of any compensation.

109. Right of exclusive licensee to take proceedings against infringement.-

(1) The holder of an·· exclusive licence shall have the like

right as the patentee to institute a suit in respect of any

·infringement of the patent committed after the date of

the licence, and in awarding damages or an account of

profits or granting any other relief in any such suit the

court shall take into consideration any· loss suffered or

likely to be suffered by the exclusive licensee as such or,

as the case may be, the profits earned by means of the .

infringement so far as it constitutes an infringement of

the rights of the exclusive licensee as such.

(2) In any suit for ~fringement of a patent by the holder of

an exclusive licence under sub-section (1), the patentee

shall, unless he has joined as a plaintiff in the suit, be

added as a defendant, but a patentee so added as

defendant shall not be liable for any costs unless he

enters an appearance and takes part in the proceedings.

--/. 122. ~efusal or failure to supply information.-

(J) If any person refuses or fails to furnish-

49 (a) to the Central Government any information which

he is reqvired to furnish under S'lib-section (5) of

section 100;

(b) to the Controller any information or statement •-· • • .· ____ ........ ,,_ ,_.-,~~,.,-.......-·-- ••••~-"""•'-'-' ........ -''_...,.~7>"'-"'<'..,;""'·'"""<·.,._,,_,,. ·-""-'ob'-..w ,_,..,_ •

which he is required to furnish by or u11ger section . - . .-· . -.. -· . .- ... - ' .. . '..:..'··---~-~-.

146, ~;he shall be punishable with fine which may

.extend ~rupees. ~ If any person, being required to furnish any such

information as is referred to in sub-section (1), furnishes

information or statement which is false, and which he

either knows or has reason to believe to be false or does

not believe to be true, he shall be punishable with

imprisonment which may extend to six months, or with

fine, or with both.

Chapter XXIII Miscellaneous

146. Power of Controller to call for information from • patentees.-

(1) The Controller may, at any time during the continuance

of the patent, by notice in writing, require a patentee or a

licensee, exclusive or otherwise, to furnish to him within .

two months from the date of such notice or within such

/ (2)

further time as the Controller may allow, such

information or such periodical statements as to the

extent to which the patented invention has been

commercially worked in India as may be specified in the

notice.

Without prejudice to the provisions of sub- section (1),

every patentee and every licensee (whether exclusive or

otherwise) shall furnish in such manner and form and at

such intervals (not being less than six months) as may be

prescribed statements as to the extent to which the

patented invention has been worked on a commercial

scale in India.

li:·:f;j)"·ii<'""'"""'~-·""""-"'""'""'.........,""'"""'""'"""""""'-~""-""'"""''·<••>o•''"'""'"'"-"'"'"""'"'"''-"'""'''''""<'"'"''·'''''''"·'R''~•n»•ti"""-~'"""'~"""~"~~.·~><0'·'""'-'''~~·~

50 (3) The Controller may publish the information received by

him under sub- section (1) or sub- sedion (2) in such

manner as may be prescribed.

II. PATENTS RULES, 2003

131. Form and manner in which statements required under section 146(2) to be furnished.-

..;/ (2)

The statement shall be furnis.hed by every patentee and

every licensee under sub-section (2) of section 146 in '

Form 27 which shall be duly verified by the patentee or ·'

the licensee or his authorized agent.

The statement referred to in sub-rule (1) shall be

furnished in respect of every calendar year within three

months of the end.of each year.

vy/ (3) The Controller may publish the information received by

~ him under sub-section (1) or sub-section (2) of section

~ 146 in the Official Gazette and in such other manner as

~f~ he may deem fit.

~;

51

APPENDIX-B

FORM27

THE PATENTS ACT, 1970 (39 of 1970) &

The Patents Rules, 2003

STATEMENT REGARDING THE WORKING OF THE PATENTED INVENTION ON COMMERCIAL SCALE IN INDIA

[See section 146(2) and rule 131(1)]

1. Insert name, address and nationality.

2. State the year to which the statement relates

3. Give whatever details are available.

4. To be signed by person(s) giving the statement

In the matter of Patent No ........... of ............. . IIWe ..................................................... :

The patentee(s) or licencee(s) under Patent No ............... hereby furnish the following statement regarding the working of the patented invention referred to above on a commercial scale in India for the year

i. The patented invention:

} Worked { } Not Worked [Tick (...f) mark the relevant box]

(a) if not worked: reasons for not working and steps being taken for working of the invention

(b) If worked: quantum and value (in Rupees), of the patented product: i) manufactured in India. ii) imported from other countries. (give

counh-y wise details)

ii. the licences and sub-licences granted during the year;

iii. state whether public requirement has been met partly I adequately I to the fullest extent at reasonable price.

To

Signature

The Controller of Patents, The Patent Office, at .............................. .

>:

C:J

52

ANNEXURE P-1 SHAMNAD BASHEER

Managing Trustee, IDIA Charitable Trust C/o. Spire

No.45, 2nd Floor, Jubilee Building Museum Road, Bangalore 560 025

(shamnad@gmail.com: 9818825148)

DPhil (PhD): University of Oxford (2013) MPhil: University of Oxford (2004-2005) BCL (distinction): University of Oxford (2002-2003)

BALLB (Hons.): National Law School of India University (NLSIU), India (South

Asia's leading law school)

• Founder and Managing Trustee, IDIA (Increasing Diversity by Increasing Access to Legal Education) (2010 onwards)

• Visiting Professor, Masters in Public Policy Programme, National Law School of India University, Bangalore: (2015 onwards)

• Associate, Oxford IP Research Center (OIPRC), Univ of Oxford: (2004 onwards)

• Founder, SpicyiP, a blog dedicated to Indian IP (rated by MIP as one of 50 most influential IP personalities)

• Founder, Promoting Public Interest Lawyering (P-PIL), a forum to leverage synergies between legal academia and practice to achieve shared public interest goals.

•

• •

• •

•

• • • • • • •

Member, Expert Committee on Access and Benefit Sharing, National Biodiversity Authority (NBA): (2012 onwards) Research Affiliate, IP Osgoode, Canada: (2008 onwards) Founder, Lex Biosjs, a collaborative initiative between lawyers and law students to enhance clinical learning Founder, CLAM, an online platform for collaborative policy making Editorial Board, Journal of Intellectual Property Rights GIPR): (2011 onwards) Advis~ry Panel Member, Indian Journal of Intellectual Property Law: (2008 onwards) Editorial Board Member, India Business Law Journal: (2007 onwards) Editorial Board Member, Christ College Law Review Editor: PharmAsia (Portal dealing with pharmaceutical news from Asia) Founder member of EDIP, an online intellectual property database Apex Member, Patent Facilitating Cenh·e, TIFAC Member, Academic Council, NUALS, Cochin Member, Academic Council, University of Allahabad

• Ministry of HRD Chaired Professor in Intellectual Property Law, West Bengal National University of Juridical Sciences (NUJS), Kolkata, India: (November 2008-Feb 2014) •

• Frank H. Marks Visiting Associate Professor of Intellectual Property Law, George Washington University, Washington, US: (2008-2009)

• Visiting Scholar, University of Washington School of Law, April-May 2012 • Expert, Global Advisory Council (IP), World Economic Forum (2011-2013) • Visiting Faculty, Munich IP Law ~er, (May-July 2007)

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~

53 • Member, India Project, GW University: (2006-2007) • Visiting Faculty, LSE Sununer School in IP law: (May-June 2006) • Visiting Scholar, University of Illinois at Urbana Champaign, illinois:

(September 2005-January 2006) • Invited Research Fellow, Institute of Intellectual Property (liP), Japan:

(2003-2004) • Tutor, Sarah Lawrence Program, Wadham College, University of Oxford

(Tutorials on Patent Law): 2003-2004 • Visiting Sch<;>lar, CUSAT, Cochin, 2012-2013 • Visiting Faculty,. Indian Law Institute, New Delhi: 2000-2002 • Editor: Oxford Co1.11Irfonwealth Law Journal (2003-04)

Anand and Anand - Leading Indian Intellectual Property Law Firm, Delhi q

Period : January 2000-end of 2002. Position : Was a Senior Associate and Head of Technology and Media Law Division. Practice Areas : Intellectual Property Litigation, Advisory and Transactional (dealing with technology transfers, licensing agreements etc).

Intellectual Property Consultancy/Other Assignments:

~·1

1. Consultant, Innovate Legal, London (Jan 2008-present): advising on aspects of Indian pharmaceutical patent law.

2. Ongoing consultancy to various IP stakeholders (government, inter­government agertcies,law firms, NGO's and policy think tanks) on various aspects of Indian intellectual property

2015: Infosys Award for research excellence in humanities (law), selected by jury headed by Nobel laureate, Prof Amartya Sen.

2014: 2014:

2012:

Award for Excellence in IP Education (by LegalEra) SpicyiP, a blog I founded was rated by MIP as one of 50 most influential IP personalities for 2014.(and earlier for 2011) Amicus-Academic Intervenor in the Novartis vs UOI landmark patent case at the Indian Supi·eme Court. Made submissions to the court and argued

for two days. 2012: Cited by the Controller General of Patents in his decision granting India's

first compulsory licensing decision (Natco vs Bayer) 2011: Selected to be on the Global Advisory Council for IP on the World

Economic ·F9rum (WEF) 2011: Rated as one amongst the top 10 patent academics whose works are

downloaded the most from SSRN in 2011 (the only non US academic from the ten member list).

2010: Selected for the European Union Visitors Programme (EUVP) for year 2011 (a programme that facilitates dialogue between EUVP Fellows andEU Policy Makers)

2007: Awarded the first place in a writing contest held by A TRIP for an article dealing with the Novartis-Gleevec patent case in India.

2004: Awarded the second prize in a writing contest held by the Stanford

Technology Law Review for an article on biotechnology and patent law in

India.

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2004: Awarded the MS Lin Scholarship to attend the Inter Pacific Bar Association (IPBA) conference in Seoul.

2003: Awarded the Wellcome Trust studentship prize and th~ Clarendon Scholarship for the Mphil/Dphil at Oxford.

2003: Awarded a distinction on the BCL at Oxford.

2003: Awarded the IBA (International Bar Association) scholarship.

54

2002: Awarded the.Shell Centenary-British Chevening Scholarship for the BCL

at Oxford. 2001: Awarded the second best prize by the Institute of Company Secretaries of

India (ICSI) for an article on "Internet and Intellectual Property Rights".

2005: Solicitor, UK 2002: Patent agent, registered with the Patent Office, India 1999: Advocate, Bar Council of India (called to the Bar in August 1999)

2008: Member of GLG (Gerson Lehrman Group) Council: group of experts/ consultants in various disciplines

2002: International Bar Association (IBA) 2002: Inter Pacific Bar Association '(IPBA) 2001: Computer Law Association (CLA)

Rated as one of the leading technology lawyers il1 India by the IFLR 1000 guide (a Euromoney publication) in 2002.

Books:

Published:

1. When Intellectual Properh; Rights Overlap (co-edited with Neil Wilkof),OUP 2012.

(Indian edition of book with Indian inh·oductory chapter, OUP India 2013).

Forthcoming:

1. Patent Law and Poliet; in India: A Developmental Perspective (forthcoming book by OUP: expected date: 2016)

2. Copyright Amendment Act (2012): A Fair Balance (forthcoming edited.book by EBC: expected date: 2016)

Book Chapters:

1. Pharmaceutical Patent Enforcement: A Developmental Perspective "Patent Law in Global Perspective" Bagley and Okediji (ed), OUP, 2014

2. The WIPO Development Agenda: Factoring in the "Technologically Proficient" Developing Countries 11Implementing WIPO's Development Agenda11

DeBeer (ed), (Wilfred Laurier University Press/Centre for International Governance Innovation/International Development Research Centre, Waterloo, Ontario, 2009).

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55 3. Trademark Issues on the Internet: Domain Name Dispute Resolution,

"Information Technology Law in India" (Indian Law Institute, New Delhi~ 2004).

4. Media Laws in India 'Investing in India' (Asia Law and Practice, Euromoney Publications (Jersey) Limited, 2002).

5. £-commerce in India: An E-volving £-jurisprudence 'Asian E-volution' (Asia Law & Practice, Euromoney Publications (Jersey) Limited, 2001).

Reports:

1. Was part of a team of international experts that prepared a WIPO Report on the Informal Economy and Intellectual Property (2014)

2. Led the team -that prepared a WHO report on Intellectual Property and Public Health (2014).

3. Undertook a commissioned report for WIPO (Standing Committee on Patents) on exceptions/limitations to patents, as part of a team led by Professor Lionel Bentley.

4. Prepared a report on the state of IP infrastructure in India for the EU as part of the EU TIDP Project (2006).

5. Undertook an extensive survey of Indian Patent Law and prepared reports on the compulsory licensing regime, experimental use provisions and patent pooling in India on behalf of the Institute of Intellectual Property (liP), Tokyo and Japanese Patent Office (JPO) in 2004.

6. Authored reports for the Intellectual Property Institute (IPI) on pharmaceutical patents and regulatory data protection.

Papers (Refereed):

1. Alternative Incentives for Pharmaceutical Innovation, 27 Intellectual Property Journal (IPJ) 13, 2014.

2. The Invention of an Investment Incentive for Pharmaceutical Innovation, Journal of World Intellectual Property, (2012) Vol. 00, no. 00, pp. 1-60

3. How to Achieve International Action on Falsified and Substandard Medicines, British Medical Journal (BMJ), 2012;345:e7381 (with Amir Attaran et al)

4. The Doctrine of Equivalents in Various Patent Regimes: Does Anybody Have it Right?, 11 Yale J.L. & Tech. 261, 2009 [co-authored with 7 others, including The Hon. Sir Nicholas Purnfrey, Justice Meirbeck and Prof Adelman]).

5. Exhausting Copyrights and Promoting Access to Education: An Empirical Take Journal o! :(ntellec·tual Property Rights, Vol 17, July 2012, pp 335-347 (coauthored with Khettry, Nandy and Mitra)

6. The Experimental Use Exception: A Developmental Perspective, IDEA Volume 50, Number 4, 2010, page 831-873 (with Prashant Reddy)

7. Outsourcing "Bayh Dole" to India: Lost in Transplantation, Columbia Journal of Asian Law, Volume 23, Number 2, Spring 2010

8. Turning TRIPS On Its Head: An IP "Cross Retaliation" MaCiel for Developing Countries, Law and Development Review, Berkeley Press, Volume 1, 2010.

9. Section 377 and the 'Order of Nature': Nurturing 'Indeterminae1j' in the Law?, NUJS Law Review, Vol.2, No.3, 2009

10. The "Efficacy" of Indian Patent Law: Ironing out the Creases in Section 3(d), Volume 5, Issue 2, Script-ed, August 2008. (co-authored with Prashant Reddy)

11. 'Ducking' TRIPS in India: A Saga Involving Novartis and the Legality of Section 3(d) National Law School of India Review, Vol. 20, No.2, pp. 131-155, 2008.

12. TRIPS, Patents and Parallel Imports: A Pmposal for Amendment, Indian Journal of Intellectual Property Law, Vol. 2, pp. 63-86, 2009 (with M Kochu pillai)

13. Exhausting' Patent Rights in India: Parallel Imports and TRIPS Compliance, Journal of Intellectual Pmperty Rights, Vol. 13, pp. 486-497, September 2008 (with Mrinalini Kochupillai).

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56 14. Popping Patented Pills: Europe and a Decade's Dose of TRIPs EIPR Volume 28

Issue 4 (May 2006). (with David Vaver) (in French translation as "Overdose de medicaments brevets: l'Europe dans uri iTRIPS' depuis dix ans". in Bernard Remiche & Jorge Kors (eds.), L'Accord ADPIC: dix ans apres (:Eds. Larder, Brussels, 2007) 129; (reprinted inN. Sudarshan (ed.), Public Health and Law (ICFAI University, Law Books Division, Hyderabad, 2008).

15. India's New Patent Regime: Aiding Access or Abetting Genericide International Journal of Biotechnology, 8 (5) 2006. .

16. Taming of the Flu: Working Through the Tamifiu Patents in India Journal of Intellectual Property Rights 11(2)(2006) 113-124 (with Tahir Amin)

17. India's Tryst with TRIPS: The Patents (Amendment) Act 2005 1 Indian J. L. & Tech. 15 (2005). (reprinted in in Edson Beas Rodrigues Jr. and Fabricio Polido (ed), Propriedade Intelectual (Rio de Janeiro, Elsevier, 2007) and inN. Sudarshan (ed.), Public Health and Law (ICFAI University, Law Books Division, Hyderabad, 2008).

18. Policy Sh;le Reasoning at the Indian Patent Office Intellectual Property Quarterly (IPQ), 2005, 3, 309-323 (paper based on BCL thesis submitted at Univ of Oxford that was the winner of second prize in a contest by Stanford Technology Law Review (STLR)).

19. Block Me Not: Genes as Essential Facilities? Journal of Law, Technology and Policy (2005) Issue No 2, 55. (reprinted in Journal of Intellectual Property Rights, September 2006, 11(5) 309-390).

Other Papers:

1. Indian Legal Education: Some Thoughts for Reform, Concept Note Prepared for committee headed by Gopal Subramanium, SG, India. available at < http:// papers.ssrn.com/ sol3 / papers.cfm?abstract_id=1584037 >

2. The "Glivec" Patent Saga: A 3-d perspective on Indian patent policy and TRIPS Compliance, A TRIP, 2007 <www.atrip.org/uploadjfilesjessays/Shamnad%20Basheer%20Glivec%2 0Patent%20S'aga.doc> (Best Paper Award by A TRIP)

3. Block Me Not: Genes as Essential Facilities: liP, International Collaboration on Intellectual Property, Tokyo, 2003.

4. Regulaton; Data Protection under Article 39.3 of TRIPS: Towards a Compensaton; Liabilihj'Standard, India Paper No 108, Intellectual Property Institute (IPI), London (Commissioned by the IPI and available at. <http:/ I WV\rvv.ip-institu te.org.uk/pu b.html>)

5. TRIPS CompatibilihJ Review of the Patents Amendment Act 2005, India Paper No 106, Intellectual Property Institute (IPI), London (Commissioned bhy the IPI and available at <http:/ jwww.ip-institute.org.uk/pub.html>).

6. The Patents Amendment Act, 2005: Implications In and Outside India, 62 liP 43 (with Mrinalini Kochupillai).

7. Unleashing the True Potential of Convergence: Will the Law be a Damp Squib, 'Computer and Telecommunications Law Review' (Sweet and Maxwell, London November 2002).

8. IP Owners Win Indian World Cup Contest 'Managing Intellectual Property' (Sweet and Maxwell, London, August 2002).

9. India Liberalizes Domain Name Policy 'International Internet Law Review' (Sweet and Maxwell, London, Feb 2001).

10. Patenting Genes and Gene Sequences: The Next El Dorado (EDIP [Electronic Database of Intellectual Property], Oxford, January 2001)

11. ConfidentialihJ of Genetic Information: Need for Legislation 5 Law & Medicine 101 (1999)

12. Cash in on Gena-Dollars 'Science Express' May 2000 13. Internet and Intellectual ProperhJ Rights 30 (8) Chartered Secretary (August

2000). 14. Establishing Rights/Legitimate Interests in a Domain Name: Cyber squatters Get

Creative 'Computer and Telecommunications Law Review' (Sweet and Maxwell, London, January 2001). rv/

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57 15. CompulsonJ Licensing Under Competition Law: the Concept of Essentialihj

Know IP- Stockholm Network Monthly Bulletin on IPRS, Vol2, Issue 1, February 2006. o

Newspaper Editorials:

1. These Rancid Rankings, Indian Express, Feb 10, 2015 (critiquing IP rankings for their flawed methodology).

2. Patented Price Gouging and the Fndurir}g Enigma of Drug Costs, LiveMint, D~cember 17, 2014 (advocating that drug makers be forced to disclosed individual R&D costs for drugs)

3. Fixing the Tribunal Mess, Financial Express, Oct 10, 2014 (analyzing the SC decision striking down the National Tax Tribunal as Unconstitutional)

4. New Drug Era, Indian Express, September 27, 2014, (highlighting the erosion of the innovator:generic divide)

5. Judging a Democratic Deficit, Indian Express, September 9, 2014 (advocating that there be public consultation in all Indian law /policy making)

6. Paten!:lv Positive, Financial Express, June 20, 2014 (arguing that Indian IP law is not biased and protective of IP owners too)

7. Innovation that lncludes, Indian Express, April 26, 2014 (discussing the need to democratize the innovation ecosystem and make it "inclusive")

8. From Ambedkar to Doniger: Can Co~:_;.~Iight La~;v Rescue Books at Risk, Firstpost, March 28, 2014 (discussing compulsory licensing, copyright and free speech). ·

9. Patent Error, Indian Express, Feb 20, 2014 (critiquing the US industry ranking of Indian IP)

10. When Fair is FouL and Foul is Fair, Hindu, December 30, 2013 (discussing the Khobrogade scandal and sexual harassment controversies in India and why a strict legal view is not the answer)

11. Patent Lies ~1nd Convenient Truths, Hindu, September 4, 2013 (discussing the hypocrisy of the US in the international IP dialogues)

12. VVhv Students Need the Rig;ht to Cor-v, Hindu, April 26, 2013 (discussing the OUP copyright case against Delhi University pertaining to student photocopying).

13. Patent v,rith a Purpose, Indian Express, April 3, 2013 (analyzing the Novar~s decision in the larger context of Pharma Innovation Policy).

14. Publishers vs Students, Indian Express, August 30, 2012 (discussing the copyright photocopying controversy between Delhi University and book publishers)

15. Set the Bar Higher, Indian Express, May 2012 (discussing the future of legal education reform in India)

16. CLAT: A Question of Aptihtde, Times of India, April 9, 2012 (discussing CLAT and strategies for preparation) ' .1

17. A Life Saver, Indian Express, March 15, 2012 (discussing India's first compulsory licensing order)

18. Let's Bridge the Democratic Deficit, Times of India (Crest Edition), 16 April 2011 (advocating ~r opening up the policy making process in the wake· of Hazare agitation)

19. Govt for Legali~i_t!]g_ Parallel lm}Xl£.L.<.2L~2)Tight Worksj Publishers Oppose, Economic Times 17 March 2011 (dealing with parallel imports and access to education)

20. Rernainders of the Dav: A Case for ParaLlel Imports (dealing with parallel imports of books), Mint, 25 Feb 2011.

21. Build Palen! l~cginu· 011 Forli{i'ed Law, Economic Times, 7 October 2010 (with Prashant Reddy: discussing the unconstitutionality of the present compulsory licensing scheme)

22. In Ihc Service of Pri-r>acv, Times of India (Crest Edition), 7 August 2010 (advocating for a privacy legislation)

23. Sold f(Jr a Song, Indian Express, 16 July 2010 (advocating for better remuneration and royalties for copyright artists, lyricists and musicians.

rv/ TRUE COPY

,_: ~:

58 24. Don't Burn the Digilial Books, Indian Express, Feb 11, 2010 (dealing with

copyright issues in the context of the Coogle Book Search project) 25. '3 Idiots' and the Moralitv of Numbers, Indian Express, Jan 7, 2010

(dealing with the copyright conh·oversy involving Chetan Bhagat and the movie 3 Idiots)

26. SaJiDg No to th<~ Wron~; Drug1i, Indian Express, September 24, 2009 (dealing with definition of spurious drugs)

27. f,ncol-!.!1!:.';;il1g Drug lnmm,;rlion, Mint, August 27, 2009 (dealing with the revised Mashelkar Conunittee Report)

28. The Law, Smoke <md Mirrors, Mint, March 12, 2009 (dealing with a ban on the advertising of "smoking")

29. ~reating Inform.al IP Norms, Mint, December 23, 2008 30. A J\1ethod to the /VIminess, Mint, November 5, 2008 (discussing software

patents in India). 31. indian Patent Bill: Let's Not he too f-!asl~tl, Sci-Dev, 10 Sept 2008 (Bayh Dole

Bill). 32. !vlake that 13argain Equitahle, Mint, August 26, 2008 (discussing WTO-TRIPS

and cross retaliation). 33. The Polenclt c~f a Midtlle Pnl"h, Mint, July 9, 2008 (discussing patents and

drug regulation). 34. Brenk with Tradition, Indian Express, July 5, 2008 (discussing the Kerala TK

protection model) 35. J~rmlnrxv-Daiiclli Merger: f\11 Ernerging J\rd/mnrislmvzr lvlodel? DNA, July 10,

2008. 36. The l~heloric o[Polenl Busling1.Indian Express, April12, 2008 (discussing the

Roche vs Cipla (Tarceva) litigation 37. Patent Problem DNA, August 29, 2007 (discussing the pharma vs generic

wars( 38. fJ!wnun /VINC::; 13ullyj}J_g Covt with China Sword? Economic Times, 14 August"

2007. 39. EwptvAllegalions, DNA, Feb 25,2007 (discussing the Mashelkar

Committee Report Controversy) 40. Baazee, Bajaj, and Bailing out the Law, Economic Times, February 5, 2005 41. 0{ Generics, Plumnaceutical Pate11ts nnd tile Cm.1nldmPn to 2005: A Note to

Policy .Makers, Economic Times, 26th September 2004 (dealing with,pharma mailbox applications).

Interviews:

1. How to Secme Creative Capital, India Today (Aspire), April2015. 2. Maverick l·:Iolistic Lawvers Career 360, 9th Jan, 2015 3. Novartis Verdict will Help Genuine Drug Innovalion, The Hindu, 6 April

2013 4. ·The Current Pat(:~nt Svstem is Deeplv Flaw~ Frontline (May 2012),

Volume 29, Issue 8. 5. Law and Behold, The Hindu 7th Jan 2011 (on the Common Law Admission

Test [CLAT]) 6. ~han!;emakers, Times of India, 2nd November 2011 (on legal education) 7. IDJA, Bar and Bench, May 5, 2010 (discussing IDIA project and access to

education) 8. Access to Education, India Law Journal, June 2010 (discussing access to

legal education) 9. Encourrzge lmurm.tion 7Pith Holistic Approach The Hindu (13 October 2008) 10. The Nouarlis Saga - Prescription f(Jr Patent Stmtegv in India, The Hindu

Business-Line (Sept 5, 2007) 11. vVe need Lo evolz>c our ow11 set o[ disU11cfiPe illtelfectual propertv norms' The

Hindu Business Line (Feb 24, 2007) 12. In Perso11lnteruiew, Journal of Intellectual Property Law & Practice (2009) 4 (6):

447-448.

TRUE~OPY

59

{

1. IP and Biodiversity, Kerala Biodiversity Congress, March 2015. 2. A Tale of Two Patents, Conference by Univ of Washington and ISIL, New

Delhi, Jan 2015 3. India and Trade Secrecy, WTO Public Forum on Trade Secrecy, Geneva, 1

October 2013 4. Indian IP and Innovation, "India as a Pioneer of Innovation", University of

Pennsylvania Conference, November 15, 2013. 5. Opening India; Open Access and Research Conference, Queensland

University of Technology (QUT), Aush·alia, 31 October 2013, 6. IP and Biodiversity: NBA Asean Workshop, 5th September 2012 7. Globalising Legal Education: Whither Access and Diversity? GLEE

Conference, Harvard Law School, 13 April2012. 8. Data Protection or Investment Protection? Conference by University of

Pennsylvania law school and NLS, Bangalore, 17th July 2012. 9. Patents and Compulsory Licensing: A Middle Path Solution? Paper

Presented at University of Washington School of Law, 30 April2012. 10. Pharmaceutical Patent Injunctions: A Developmental Perspective, MHRD

Conference at NLU Jodhpur, 17 April 2012. 11. Pharmaceutical Patents and Public Health: Paper Presented at Special

Lecture Series organized by University of Kerala, 6 July 2012. 12. Towards a Paid Innovation Commons, WIPO:WTO Teachers Colloquium,

Geneva, June 2011. 13. Compulsory licensing: Presertt Framework and Future Prospects,

presentation at the CUSAT workshop on "Rethinking Intellectual Property Rights", January 2012.

14. Traditional Knowledge: From Reductionism to Holism, A TRIP Conference, Stockholm, Sweden, July 2010

15. Pharmaceutical Patent Enforcement in India: Some Thoughts for Reform, "New Spaces, New Actors and the Institutional Turn in Contemporary Intellectual Property Law", Kyushu University, Japan, February 13 and 14, 2010

16. A TK Model for India, "FICPI Indian Symposium", New Delhi, December 9-12, 2009

17. Romanticising Innovation, 5"' International Forum on Creativitt; & Inventions­A Better Future for Humanity in the 21st Century", WIPO FICCI Conference, New Delhi, November 11-13,2009

18. Indian IP: A Holistic View, "International Bioforum", Tokyo, July 3, 2009 19. Indian IP: An Ex.tra Legal P,erspective "IPBC Forum", Chicago, June 22, 2009 20. Indian IP: Judicial Enforcement "Training for Indian Judges", National

Judicial Academy, Bhopal, September 5, 2009 21. Patent Enforcement as a Trade Barrier, "International Trade Barriers for

Indian Generics", Pharmexcil, Mumbai, August 21, 2009 22. The Indian "Bayh Dole": Injection of "Public Interest", Conference by NUJS IP

Chair, NUJS, Kolkata, Sept 12, 2009 23. The Drug-Patent Linkage Issue: A Transparency Solution, "Pharmaceuticals

2014: Will India Leap Forward" FICCI, Mumbai, March 18,2009. 24. Accessing patented knowledge: Compulsory license under Competition law,

"Patents and Platform Technologies: R&D in Malaria and Tuberculosis", Centad, New Delhi, September 9, 2009

25.' FOSS: Decoding the Law, IOTA Free Technology Convention, Science Auditorium, Kolkata, 27th January 2009.

26. Collaborative Innovation in IP Polictj Making, "Collaborative Innovation for Development: Enlarging the Global Commons" (Knowledge Commons, New Delhi, 6th December 2008)

27. Indian Patent Law and TRIPS: From Gripping to Tripping, "1st Annual National Law School of India Review Symposium on Challenges to India's Patent Regime" (National Law School of India University, Bangalore 12 April 2008).

rvJ TRUE COPY

'. ·•·

60 28. "From Faith Based IP to Fdct Based IP", Symposium on Intellectual Property

Rights (IPR) to celebrate World Intellectual Property Day, (OPPI, New Delhi, April 25th 2008).

29. Indian Patent Law and its Tn;st with TRIPS, EGA 4th legal Forum (Brussels, Jan 30, 2008)

30. "Mobilizing Governments for A2K", Moderator, Access to Knowledge (A2K) Conference (Yale Law School, April 2007).

31. Impact of US Patent Reform on Indian Firms, USIACC panel on Patent Law Reform (Washington, 5 September 2007)

32. Patents and Innovation in India, National Academy of Sciences (Washington DC, 24 Sept 2007)

33. Histon; of the Indian Patent System, "Patent Rights in India & China", (IPO Education Foundation, June 11,2007, Washington)

34. Are Pharmaceutical Inventions a Special Class: Invited Speaker by the University of Augsburg (Germany, 20 July 2007)

35. Factoring in the Technologically Proficient Developing Countries, Strategies to Implement a WIPO Development Agenda, EDGE Network, (Vancouver 15 October 2007)

36. India's New Patent Regime: TRIPS Implications, First speaker at IP Speaker Serief? organised by PIJIP (Program on Information Justice and Intellectual Prop~rty) (American University, Washington, April 19th, 2007).

37. Schizophrenia in Indian IP Policy? Invited Speaker to panel on "India, IP Developments and ImPS" at the 15th Annual Fordham Conference on Intellectual Property Law Policy (Fordham, New York, April12, 2007).

38. Indian Generics: Future IP Strategies "US-India Partnerships in Drug Discovery and Generics" (Asia Society: Observer Foundation, New York, 20 November 2007).

39. Bridging IP Disputes: Towards a "Middle Path" Conference to Commemorate World IP Day (IPI, Washington, 26 April2007)

40. Enforcement of Patents in India: The Likely Scenario, American Society of International Law event on IP (GW, Washington, 27 March 2007)

41. Patents and Access to Medicines Invited panelist by UNDP to workshop titled' Access to Treatment for HIV I AIDS in Arab States (Cairo, 17 November 2005).

42. Impact of India's Patent Amendment on the Pharmaceutical Industn; 'Invited Speaker to a workshop by SIPLA at Franklin Pierce Law Centre (Concorde, 20 October 2005).

43. Unblocking Gene Patents: An Antitrust Approach Invited speaker by the Shandong University of Technology (Zibo, China 24 September 2005) ..

44. Genes as Essential Facilities: An Antitrust Approach, 'CLASF Conference' (London September 2004).

45. CreativihJ and Human Societt; 'Queen Mary ESRC Research Seminar Series' 29-30 November 2004, London (Invited Panelist)

46. Block Me Not: Genes as Essential Facilities 'Fifth Asian Bioethics Conference (ABC5Y.(Tsukuba, Japan 13-16 February 2004).

47. Patenting Research Tools in Human Genome Studies: View from a Technologically Proficient Developing Country (Joint Presentation with Ms. Sivaramjani Thambisetti, University of Cambridge April2003).

48. IT laws: A Practitioner's Perspective 'Indian Institute of Management (liM)' (Bangalore 14 December 2001).

49. Convergence: Legal Issues 'International Conference on International Law in the New Millennium: Problems and Challenges ahead' Organised by Indian Society of Intemational Law (New Delhi 4-7 October 2001).

50. Copyright Issues on the Internet 'National Seminar on Copyrights and Related Rights' Organised by the Copyright Office, Ministry of Human Resource Development (Kottayam, Kerala 12 February, 2001).

51. Dispute Resolution Mechanism in Cyberspace 'National Seminar on Challenges of Internet Law' Organised by the Indian law Institute (Vigyan Bhawan1 New Delhi 4 March 2001).

rvJ TRUE COPY

61

1. Organised a Workshop on IP Teaching Methodology along with University of Washington School of Law and NLU Delhi: Jan 2014, March 2013 and March 2012

2. Organised several IP conferences at WB NUJS (themes include 2012 copyright amendments (November 2012) and Indian "Bayh Dole" Bill (September. 2009)).

3. Organised an International Conference on "Innovation, Creativity and IP Policy" with the Max Planck Institute, Munich: November 19-20,2010

Public Interest Cases (Illustrative list)

1. Filed a Public Interest Litigation before the Delhi High Court in July 2014 arguing that the RTI must be given pre-eminence over all other statutes when it comes to information dispensation to the public.

2. Intervened in a copyright law suit as part of a group of academics (SPEAK) interested in furthering access to education. This law suit was filed by OUP and other leading publishers against Delhi University for copyright infringement in creating course packs.

3. Filed a Wlit Petition .. before the Gujarat High Court on behalf of an underprivileged student who was denied admission to GNLU on an arbitrary ground.

4. Represented Missing Seamen on Board an Iranian Ship. 5. Filed a Writ Petition Against the Government of India, challenging the

constitutionality of the Intellectual Property Appellate Board (IPAB). Court ruled in our favour sh·iking down key aspects of IP AB selection process.

6. Was academic intervenor cum amicus before Supreme Court in landmark patent case, Novartis vs Union of India, where court relied significantly on arguments advanced in 1ts final decision.

7. Investigated the extent of working of pharmaceutical patents in India Filed RTI's to determine the extent of "working" of pharmaceutical patents in India. ,Compiled report and presented to Conh·oller General Kurian. As a result of this investigation, the government has now made all working statements publicly available.

Parliamentary Depositions (Illustrative list)

1. Was invited as an expert wih1ess before Parliamentary Standing Committee dealing the Indian "Bayh Dole" Bill (appeared before them twice in March 2010)

2. Was · invited as an expert witness before Parliamentary Standing Committee dealing witl1 Indian Copyright Act (Amendment) Bill (appeared before them in May 2010)

Government Advisory

Advising various govermnent agencies from time to time on intellectual property advisory issues, such as the Minish·y of Commerce (DIPP), HRD Ministry (copyright office), the National Biodiversity Authority, Department of Science and Technology. In particular, was part of a team that helped revamp the Indian

Patent Agent Exam. ~

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REPORT

RTI APPLICATIONS AND "WORKING" OF FOREIGN DRUGS IN INDIA?

APRIL2011

f::~ SpicylP Report prepared by Professor Shamnad Basheer (Founder ofSpicy!P and MHRD Prof of -J:~)

IPLaw, NUJS), with the assistance ofSai Vinod N (SpicyiP Blogger and NUJS Student)

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TABLE OF CONTENTS

PART I INTRODUCTION: WORKING & COMPULSORY LICENSING IN INDIA .................................. ; ..... 2

PART II FORM 27 & SPICYIP RTI's ................................................................................................. 3

PART III SPICYTP FINDINGS ............................................................................................................. 5

ANNEXURE A FORM 27 ......................................... : ........................................................................ 12

ANNEXURE B ................................................................................................................................. 14

ANNEXURE C RTI PROCESS & IMPORTANT DATES ........................................................................ 17

ANNEXURE 0 ........................................................ : ......................................................................... 20

ANNEXURE E CONTENTIOUS PROCEEDINGS INVOLVING THE ABOVE DRUGS ................................ 21

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PART I

INTRODUCTION: WORKING & COMPULSORY LICENSING IN INDIA

The Indian patent regime places significant importance on the "working" of a patent. Indeed,

section 84 goes to the extent of stipulating that any patent that has not been worked for 3 years in

India after the date of grant of a patent can be subject to a compulsory license (CL). 1 There is

some debate around wh~ther or not "importing" a drug into India amounts to "working". Owing

to section 83, which explicitly states that a patent cannot be obtained for the mere purpose of

impotiing, it is clear that a patented drug that is not being manufactured in India, but is only being

imp01ted into India can be subject to a CL.2 Further, the scheme of the Act reveals at several places

that the term "working" and the term "importing" are distinct and different.

In view of the above provisions, the vast majority of all registered drug patents in India are

potentially subject to the risk of a compulsory license, since they belong to multinational firms that

merely imp01t the drug into India.

Section 146 states that information relating to the "working" of a registered patent is to be

periodically submitted to the Controller in a form prescribed by the rules. 3 Rule 131 ofthe Patent

1 Patents Act, 1970, §84(l)(c), reads as follows: "84. Compulsory licenses- (1) At any time after the expiration of three year .from the date of the grant of a patent, any person interested may make an application to the Controller for grant of compulsory license on patent on any of the following grounds, namely:- ·

(c) that the patented invention is not worked in the territory of India .. , (emphasis added)

2 Patents Act, 1970, §83(b ), reads as follows: "83. General Principles applicable to working of patented inventions Without prejudice to the other provisions contained in this Act, in exercising the powers conferred by this chapter, regard shall be had to the.following general considerations, namely, -

(b) tlzat tlzey are not granted merely to enable patentees to e1~;oy a monopo(v for-the importation of the patented article; ·· (emphasis added)

3 Patents Act, 1970, §146, reads as follows: "146. Power of Controller to call for information from patentees (I) The Controller may, at any time during the continuance of the patent, by notice in writing, require a patentee or a iicensee, exclusive or othenvise, to furnish to him within two months from the date of such notice or within such jitrther time as the Controller may allow, such information or such periodical statements as to tlze extent to whiclz the patented invention has been commercially worked in India as may be specified in the notice.

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RTI APPLICATIONS & "WORKING" OF FOREIGN DRUGS IN INDIA?

Rules stipulates that information required under Section 146 shall be submitted in a form outlined

in Form 27.4 Form 27 is appended as Annexure A and asks questions such as whether the

patented product is imported or manufactured, and if so, the quantity and the value. It also asks

queries on whether or not the patent has been licensed and details thereof.

Importantly, Section 122 of the Patents Act, 1970 penalises any non-compliance with section 146

and Form 27, including t~e omission of any critical information required by Form 27.5

The above scheme makes it amply clear that "working" information is of critical importance to the

functioning of the Indian patent regime and cannot be taken lightly.

PART II

FORM.27 & SPICYIP RTI's

SpicyiP is a blog/website that was initiated in the year 2005 as a means of engendering more

transparency in the Indian IP system. Its very genesis was rooted in the fact that IP information in

India was largely "hidden" and this opacity impacted the quality of IP laws and policies and

fostered corruption at the various Indian IP offices.

(2) Without prejudice to the provisions of sub-section (I), evety patentee and every licensee (whether exclusive or otherwise) shall furnish in such manner and form and at such intervals (not being less than six months) as may be prescribed statements as to the extent to which the patented invention has been worlwd on a commercial scale in India. (3) The Controller may publish the information received by him under sub-section (I) or sub-section (2) in such manner as may be prescribed'' (i!mphasis added)

4 Patent Rules, 2003, Rule 13I, reads as follows: "13 I. Form and manner in which statements required under Section 146(2) to be furnished-(I) The statements shall be furnished by eve1y patentee and eve1y licencee under sub-section (2) of section 146 in Form 29 which shall be duly verified by the patentee or the licencee or his authorized agent. (2) The statements referred to in sub-rule (I) shall be furnished in respect of every calendar year within three months of the end of each year. ~ (3) The Controller may publish the information received by him under sub-section (I) or sub-section (2) of section I 46 in the Official Gazette and in such other manner as he may deem fit."

5 Patents Act, I 970, §122, reads as follows: "Refusal or failure to supply information- (I) if any person refuses or fails to furnish-

(b) to the Controller any information or statement which is required to furnish by or under Section 146, he shall be punishable with fine which may extend to ten lakh rupees." (emphasis added).

3

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RTI APPLICATIONS & "WORKING" OF FOREIGN DRUGS IN INDIA?

Its aim therefore is to help evolve optimal IP policies by increasing transparency around IP

institutions and laws.

In the last 6 years, it has taken up the "transparency" cudgel wherever it could, and owing to

numerous articles that were written by its bloggers and several petitions sent to the government,

including to the Prime Ministers Office, it was able to play a small role in helping release a

significant amount of "patent" information to the pubic. Of course, the pro-active role of the

present Controller General, Mr PH Kurian helped a Jot in this regard.

In furtherance of its transparency mission, SpicyiP (through Prof Shamnad Basheer) filed RTI's

to determine the level of compliance with providing patent working information, as mandated by

Section 146 and Form 27.

The information was sought in relation to the "working" or "non working" of a small basket of top

selling drugs in India. 4 of these drugs were anti cancer drugs and the remaining 3 were drugs

catering to Hepatitis ailments. The drugs are listed as under:

Cancer Drugs:

1. Nexavar (Bayer): Treats Kidney Cancer

2. Dasatinib (BMS): Chronic Myeloid Cancer

3. Tarceva (Roche & OSI): Non-small cell lung cancer (NSCL)

4. Sutent (Pfizer): Kidney Cancer

~ Hepatitis Drugs:

1 Pegasus (Roche) - Hepatitis C

2 Viraferonpeg (Schering)- Hepatitis C

3 Entecavir (BMS)- Hepatits B

Each of the drugs selected are either the subject matter of litigation before the Delhi High court or

were subject to patent office oppositions.

4

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RTI APPLICATIONS & "WORKING" OF FOREIGN DRUGS IN INDIA?

The RTI process was a very arduous one, with the patent office refusing information or claiming

missing files in some cases. We had to resort to the appellate procedure in almost all cases. And

in one case, both the CPIO (Delhi office) and the appellate authority refused to provide

information. We had to then take the matter up directly with Controller General PH Kurian who

immediately ordered that the infonnation be provided. This information was provided only

yesterday (41h of April 2011). The information obtained thus far (as of 4th April, 2011) from the

Patent Office is tabulated in Annexure B.

PART III

SPICYIP FINDINGS

The Non-Working of the "Working" 'Disclosure Norm!

I. All the pharmaceutical firms that we studied are in breach of section 146 norms. They have

either not filed Form 27s for some years or have filed incomplete information.

Illustratively, a company such as Roche, which otherwise has filed comprehensive Form

27 information for the year 2009'-201 0 did not bother filing any form at all for 2008-2009.

Further, firms such as Schering Corp. and Sugen have not bothered listing out their sales

figures for India. They merely mention that they are importing their drug from Ireland.

Sugen Inc (which owns the patent over Sutent) has only filed the quantum of imports and ~

not the value. On the other side, BMS list out only the value of imports, without mentioning

the quantum (in relation to its drug, Entecavir). In fact, we found that none of the

pharmaceutical firms that we studied have provided full and complete Form 27

information. We can only conclude that none of these firms take the Form 27 and section

146 working requirement seriously. We also found that firms have been careless with their

filings. Illustratively, Bayer filed two forms for the same drug (Nexavar), and with

different information. (See attachments of their filings in this regard annexed as

Annexure D)

5

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RTI APPLICATIONS & "WORKING" OF FOREIGN DRUGS IN INDIA?

FLAGRANT VIOLATION OF NORMS

2. No firm has provided complete Form 27 infonnation. In some cases, Fonn 27 has not been

filed at all. And in others, the information provided is woefully inadequate. This indicates

that firms are not taking this disclosure requirement seriously at all! That Fonn 27

disclosure is serious business is evident from the fact that Section 122 of the Patents Act,

1970 permits the ~ontroller to take those who file incomplete infonnation to task and fine

them Rs. 10 lakhs. SpicyiP urges the Controller to do so in order that an example might be

set. And if this fining process begins, the Patent Office stands to earn at least Rs. 70 lakhs

from the erring parties. This money could be used to enhance the transparency mission of

the Patent Office, a mission that the present Controller General has already been pursuing

quite passionately.

Injunction Despite Non Working

3. It is interesting to note that the Delhi High Court granted Bristol Myers Squibbs (BMS) an

ex-patie interim injunction against Hetero Drugs (an Indian generic company) in

December, 2008 in C.S. (O.S) No. 2680 of2008, in relation to the Dasatinib patent, despite

the fact that BMS itself conceded in the Form 27, that it was not even working the patent

in question (by manufacture or import of the drug) at that point in time.6 The law on

temporary injunctions (as followed by Indian coutis) is very clear in that a temporary

injunction cannot be granted when the patent is not worked in India.7

Similarly, in the highly controversial patent linkage case, as per its own Fonn 27

information, Bayer was not even selling "Nexavar" in India at the time that it sought to

prevent the approval of Cipla's generic version by the DCGI.

6 See generally Shamnad Basheer, Court orders Indian Drug Controller to "Police,. patents, SpicyiP (January 06, 2009) available at http://spicyipindia.blogspot.com/2009/0l/breaking-news-court-orders-indian-drug.html.

7 See Franz Xaver Huemer v. New Yash Engineers, AIR 1997 Delhi 79.

6

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RTI APPLICATIONS & "WORKING" OF FOREIGN DRUGS IN INDIA?

Mere Importation and Compulsory Licensing

4. None of the drugs mentioned in Annexure B are being manufactured in India. Therefore,

they are all subject to compulsory licenses under section 84 of the Indian Patents Act. As

mentioned earlier, section 83(b) clearly mandates that patents cannot be granted for the

mere purpose of importation.8 All the drugs mentioned in Annexure B (for which Form

27's have been filed) are being imported into India. As such, they are all subject to

compulsory licenses under section 84, which stipulates that if a patent that has not been

commercially w0rked in India even after 3 years have elapsed from the date of grant of the

patent, it is susceptible to a compulsory licensing application, that can be filed by any

generic company interested in manufacturing the drug.

5. Even assuming that "importatiop~' does amount to working, it is clear that drugs such as

Scherings' Viraferonpeg can be subjected to a compulsory license, since they have not

bothered to file any "import" information in Form 27. As mentioned earlier, Schering

merely states that they are importing the drug from Ireland, without providing any details

ofthe quantum and value ofimp01t.

Since Schering's drug is excessively priced in India, generic manufacturers may wish to

apply for such licenses and sell at cheaper prices.9 Given that a determination of what

constitutes "excessive pricing" may be complex and time consuming, an Indian generic

manufacturer could easily apply for a license on the ground that the patent is not being

worked in India. 10 Given Schering's failure to file critical information in Form 27, the

8 Patents Act, 1970, §83(b ), reads as follows: "83. General Principles applicable to working of patented inventions

Without prejudice to the other provisions contained in this Act, in exercising the powers conferred by this chapter, regard shall be had to the following general considerations, namely, -

(b) that they are not granted merely to enable patentees to enjoy a monopoly for the importation of the patented article;''

9 Leena Menghaney, HIV/HCVCO-INFECTION: PLANNING THE WAY FORWARD, JSl SOUTH AND SOUTHEAST ASIA REGIONAL COMMUNITY MEETING 3 (June 22-23, 2101) available at http://www. ttag. info/pdf/Finai%20Report _Regional%20HCV%20meeting-l . pdf

10 Section 84(5) authorizes the Controller on being satisfied that the invention is not available at a reasonable price, to grant a license. Patents Act, 1970, §84(5), reads as follows:

"84. Compulsory licences.

7

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RTI APPLICATIONS & "WORKING" OF FOREIGN DRUGS IN INDIA?

patent office and courts have no choice but to presume that the drug is not being worked in

India or even imported into India.

6. Further, on analysing the information in the Form 27s against the number of patients for . .

various cancer and hepatitis ailments, the Controller General of Patents and the Health

Ministry can easily determine whether the reasonable requirements of the Indian

population are being satisfied with respect to these drugs. In other words, are the drugs .,

being supplied in adequate quantities and are they priced reasonably? If it is found that

these drugs are not being manufactured in adequate numbers for the Indian population or

at an unreasonable price, the Central Government can issue compulsory licences for these

patents on these separate grounds as well under section 84 of the Patents Act.

Drug Sales and Revenues in India:

7. Most pharmaceutical firms appear to have healthy sales in India. As can be seen from

Annexure B, all the drugs, for which Form 27 information has been provided, make more

than Rs ten crores a year (USD 2.2 million). The highest revenue grosses is Roche's

Pegasus which made Rs. 42 crores (approximately USD 9 million) in a single year! The

information in encapsulated in a bit more detail below:

a. The Dastinib patent which is currently under challenge by Natco and Hetero, earns

BMS an estimated Rs. 16.02 crores on a yearly basis. The company has however . not revealed the quantum of sales for that year. With another estimated ten years

left on this patent, BMS is poised to pull in another Rs. 160 crores on this patent.

b. The Pegasus patent earns Roche a substantial Rs. 42 crores every year. With another

6 years left before the patent expires, Pegasus will earn Roche at least another Rs.

300 crores. The figures for the financial year 2007-08 are unavailable since

according tb the Patent Office Roche did not file its Form 27 for that year.

c. The Entecavir patent earns BMS Rs 23 crores every year. With another 11 years

left on the Entecavir patent, BMS will earn atleast another Rs. 253-270 crores

(5) The Controller, if satisfied that the reasonable requirements of the public with respect to the patented invention have not been satisfied or that the patented invention is not available to the public at a reasonable price, may order the patentee to grant a licence upon such terms as he may deem fit." (emphasis added).

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RTI APPLICATIONS & "WORKING" OF FOREIGN DRUGS IN INDIA?

before the patent expires. Once again BMS does not reveal the quantum of its yearly

sales. Last year, the Delhi High Court refused BMS an interim injunction against

Ranbaxy which markets a generic version of the BMS drug.

d. The 'Tarceva' patent though filed in the name of OSI and Pfizer is licensed to

Roche, In. the year 2010-11, it earned Rs. 12.38 crores. At the present average,

Tarceva should earn another Rs. 60 crores for Roche before it expires in 2016. .

e. The 'Sutent' patent though filed in the name of Sugen and another company, may

actually be licensed to Pfizer. During the compulsory licensing attempt by Natco in

2008 it was reported in the media that this patent actually belonged to Pfizer. This

is yet to be confirmed as Sugen has failed to provide its licensing detailsoon the one

Fonn 27 that it has filed before the Patent Office. The E-Register facility on the

Patent Office indicates that the licensing details have not been entered into the

Patent Office register. If there is a licence in place and not registered in the Patent

Register it would be in violation of Section 68 and 69 of the Patent Act, 1970. The

only infonnation provided on the Form 27 is that 7000 units were imported in one

year.

Tortuous RTI Process!

8. As mentioned earlier, the R TI process has been a tortuous one. Section 146 mentions that

the Controller may publish ''working" information.'' The Patent Office has taken several

laudable steps in the past to foster more transparency in the patent process and has made

an entire range of information available. We therefore urge the Patent Controller, Mr PH

Kurian and the Department of Industrial Policy and Promotion (DIPP), the nodal

government agency in charge of IP affairs, to ensure that patent "working" information be

published on a timely basis. As mentioned earlier, the scheme of the patent regime makes

it amply clear that "working" is a very important requirement and the public as well as

11 Patents Act, I 970, §146(3) reads as follows: '· 146. Power of Controller to call for information from patentees

(3) The Controller may publish the information received by lzim under sub-section (1) or sub-section (2) in suclz manner as may be prescribed'' (emphasis added)

9

.:II

( .,..~·~· M IP ,.::/.l ~v(_) RTI APPLICATIONS & "WORKING" OF FOREIGN DRUGS IN INDIA?

competitors have a right to access this information in a timely manner, without undue

hurdles. Our RTI process reveals just how difficult it is to procure this information. And if

we, being lawyers and self styled patent expe11s are faced with this degree of difficulty, we

shudder to think what it might be like for the aam aadmi (common man) who wishes to

procure this information as an interested member of the public!

9. While we underst.aii.d the constraints of the patent office in taking the trouble of locating

Form 27 information and providing it to us, we were pmiicularly troubled by the sudden

volte-face executed by the Delhi Patent Office in releasing information pertaining to the

drugs, Erlotinib and Stutent. As noted in Annexure C detailing our rather arduous RTI

process, the Delhi patent office did not initially object to the substance of our request.

Rather the Public Information Officer as well as the appellate authority, Mr DPS Parmar

merely made out a technical point against us, namely that we failed them to pay them the

kingly sum ofRs 4 (USD 0.8)!

And while we ran around and organized a good Rs I 0 (USD 0.2) for them, they then turned

around and objected, stating that the information is "third party" information. There is no

provision in the RTI Act, which prohibits a Public Information Officer from disclosing

"third pmiy" information. In fact, all information required from the government through

regular RTI process is "third party" information. What the RTI Act prohibits (through

Section II) is only "third party" 'confidential' information. 12 In the present case, it is clear

12 Right to Information Act, 2005, §!!,reads as follows:

"I I. Third party information- (I) Where a Central Public Information Officer or a State Public Information Qfficer, as the case may be, intends to disclose any information or record, or part thereof on a request made under this Act, which relates to or has been supplied by a third par(v and has been treated as confidential by that third party, the Central Public Information Officer or State Public Information Officer, as the case may be, shall, within five days from the receipt of the request, give a written notice to such third party of the request and of the fact that the Central Public Information Officer or State Public Information Officer, as the case may be, intends to disclose the information or record, or part thereof, and invite the third party to make a submission in writing or orally, regarding whether the information should be disclosed, and such submission of the third party shall be kepi in view while taking a decision about disclosure of information:

Provided that except in the case of trade or commercial secrets protected by law, disclosure may be a/lo}l!ed if the public interest in disclosure outweighs in importance any possible harm or injury to the interests of such third party.·

(2) Where a notice is served by the Central Public Information Officer or State Public Information Officer, as the case may be, under sub-section {I) to a third party in respect of any information or record or part

10

,·:.r·

'I

\ .. , ..

s-p\tt) IP RTI APPLICATIONS & "WORKING" OF FOREIGN DRUGS IN INDIA?

that Form 27s cannot be considered to be 'confidential', especially since Section 146 of

the Patent Act allows for such information to be published by the Patent Office.

Moreover this reply contradicts the CPIO's earlier reply, which stated that he would release

the information on the payment of the essential amount. Particularly when the same

information as regards other firms and drugs have been provided to us by the very same

patent office and under instructions of the very same appellate authority, Mr DPS Parmar!

Interestingly, one of these drugs, Erlotinib, is involved in a big-ticket patent litigation 13 and

both of them were the subject of a compulsory licensing applications by Natco back in

2008. 14

We brought this case to the attention of the Controller General, PH Kurian who

immediately ordered that the information be released. Yesterday (41h Apri12011), we were

sent this information by the Delhi patent office.

Caveats: In places where the patent office did not provide us with any Form 27 (as filed for a certain yew· for a certain drug), we assume that the said Form 27 was not filed by the patentee for that year.

LIST OF ANNEXURE(S)

ANNEXURE A Form 27 (Statement Regarding the Working of the Patented Invention on

Commercial Scale in India)

ANNEXUREB Table containing Form 27 infmmation relating to certain drugs for the years

2008 & 2009

ANNEXUREC RTI Process and Important Dates

ANNEXURED Form 27 Statements submitted by the Patentees of the drugs mentioned Ill

Annexure B.

ANNEXUREE Contentious proceedings relating to the drugs mentioned in Annexure B

thereof, the third party shall, within ten days from the date o.f receipt of such notice, be given the opportunity

to make representation against the proposed disclosure." (emphasis added).

13 F. Hoffman La Roche Ltd. v. Cipla Ltd., C.S.(O.S.) No. 89 of2008.

14 Shamnad Basheer, India 'sfirst 'Doha· case: Natco, Pfizer and Roche will be heard soon .... , SpicyiP, (February 24, 2008) available at http://spicyipindia.blogspot.com/2008/02/indias-first-doha-case-natco-pfizer-and.html.

II

2

S,1)fc,:.,11'P ! 'i\ u

RTI APPLICATIONS & "WORKING" OF FOREIGN DRUGS IN INDIA?

ANNEXURE A

FORM27

FORM27

THE PATENTS ACT, 1970 (39 of 1970)

& The Patents Rules, 2003

STATEMENT REGARDING THE WORKING OF THE PATENTED INVENTION ON COMMERCIAL SCALE IN INDIA

[See section 146(2) and rule 131(1)]

Inse1i name, address and nationality.

State the year to which the statement relates

In the matter of Patent No ................. of ............ . I/We 1

•••••••••••••••••••••••••••••••••••••••••••••••••••••••

The patentee(s) or licencee(s) under Patent No............... herebyfurnish the following statement regarding the working of the patented invention referred to above on a commercial scale in India for the year2

................ ..

3 Give whatever details are available.

(i) The patented invention: { } Worked { } Not worked [Tick (..J) mark the relevant box]

(a) if not worked: reasons for not working and steps being taken for working of the invention.

(b) If worked: quantum and-value (in Rupees), of the patented product: i) manufactured in India. ii) imported from other countries. (give

country wise details) (ii) the licences and sub-licences granted during the year; (iii) state whether public requirement has been met

12

'1r~-~~ ~ , r.-o "" .' · .. r: ··'""'····':

'·

, I

4

!-·, .. •

3'

~·~ s -,.':i .~, c, v.' I 'P

' "'\ ,.

RTI APPLICATIONS & "WORKING" OF FOREIGN DRUGS IN INDIA?

To be signed by the person(s) giving the statement.

Note: (a) Strike out whichever is not

partly/adequately/to the fullest extent at reasonable price.

The facts and matters stated above are true to the best of my/our knowledge, information and belief.

Dated this ................ day of ............. 20 .. .

Signature 4 ..

To The Controller of Patents, The Patent Office, At ................................... ..

applicable

13

. ··~·· ······. .. ~- ~· ... ;

' ~~.

s·p\ct) I"P RTI APPLICATIONS & "WORKING" OF FOREIGN DRUGS IN INDIA?

ANNEXUREB

Note:

(i) The RTI Applications had requested for Form 27 information from the years 2007 to 2010. In all cases where the Patent

Office has not provided Form 27 information for a particular year we have presumed that no such information was filed by

the patentee in the first place.

(ii) The Form 27s are filed for each financial year. Therefore if the table states '2008', this is information for the Financial Year

2008-09.

REGISTERED OWNER, APP. WORKING OF PATENT

PATENT No., PRODUCT NAME, DATE OF VALUE APPROX.REVENUE

No INDICATION & YEAR OF GRANT YEAR STATUS QUANTUM (ROUNDED BY END OF PATENT EXPIRY OFF) TERM

2007 N.F N.F N.F N.F

Bristol Myers Squibbs Co. IN/PCT/2001/01138/MUM 2008

Not 29th: January,

203937 PRODUCT NAME: Dasatinib worked I

INDICATION: CML 2007. Rs. 16.02 ·

PATENT EXPIRY: 2021 2009 Worked Not provided crores Rs. 160 crores

(US$ 3.5 US $ 35-40 million million)

215758 Bayer Corporation 2008 Not Worked

213457

198952

207233

196774

.s-p\_ctj IP RTI APPLICATIONS & "WORKING" OF FOREIGN DRUGS IN INDIA?

IN/PCT/200 l/00799/MUM PRODUCT NAME: Nexavar 271h March,

INDICATION: Kidney Cancer 2008. PATENT EXPIRY: 2021

Bristol Myers Squibbs Co. IN/PCT /2002/00891/MUM

17th January, PRODUCT NAME: Entecavir

2008. INDICATION: Hepatitis B PATENT EXPIRY: 2022

Hoffman La Roche AG l 032/MAS/ 1997

19th May, PRODUCT NAME: Pegasus

2006. INDICATION: Hepatitis C PATENT EXPIRY: 2017

..

Schering Corporation IN/PCT/2000/434

5th June, PRODUCT NAME: Viraferonpeg

2007. INDICATION: Hepatitis C PATENT EXPIRY: 2020

2009 Worked

2008 Not Worked

2009 Worked

2007 Not Filed

2008 Not Filed

2009 Worked

2007 Not filed

2008 Worked

2009 Not Filed

2007 Not Filed

15

Tp_.1 ,,._ I '- ;·. • (~- ,.-•• t") \1

" I. - .• 1

4,665 packs were imported but only 1,679 packs sold)

Not provided

Not Filed Not Filed

Imported: 47574 packs

Sold in India: 44432 packs

Not filed

Not Provided

Not Filed

Not Filed

I

Rs. 16.5 Rs. 165 - Rs. 180 crores in crores

sales US $ 40-45 million

Rs. 23 Rs. 253-270 crores

crores m US $ 50-60 million

saies

Not Filed Not Filed

Not Filed Not Filed

Imported: Rs. 45 crores

Rs. 290 - 300 crores Sold in US$ 62-66 million India: Rs.42 crores

Not Filed Not Filed

Not Provided

Not Provided

Not Filed Not Filed

Not filed Not filed

'

209251

.s~\Gd I'P RTI APPLICATIONS & "WORKING" OF FOREIGN DRUGS IN INDIA?

OSI Pharmaceuticals Inc. & Pfizer Products Inc.) (Licensed

to Roche but licensing details

have not been provided on the

Form 27) February,

537/DEL/1996 2007.

PRODUCT NAME: Tarceva

INDICATION: Non-Small Cell

Lung Cancer

PATENT EXPIRY: 2016

Sugen Inc., USA & Pharmacia

& UpJohn Company (Licensing

details have not been provided

on the Form 27) October,

IN/PCT/2002/00785/DEL 2007

PRODUCT NAME: Sutent

INDICATION: Kidney Cancer PATENT EXPIRY: 2022 - ..

:.:,• ''·' :.

.... ·.'

2008

2009

2010

2007

2008

2009

Worked

Worked

Worked

Not Filed

Not Filed

Worked

16 1 cJ-1

(a) 100 mg tablets-

504 packs (Rs. 2.5

crores)

(b)150 mg tablets-

1287 packs (Rs. 7.9

crores)

4357 packs

5814 packs

Not Filed

Not Filed

7000 packs

Rs. 10.4

crores

12 x 5 = Rs. 60

crores

(USD 13 million)

Rs. 13.68

crores

Rs. 12.38

crores

Not filed Not available

Not Filed

Not

Provided

. .... .' ·.· ':,;, .· ... '•

s~~CVji"P I~(./ R TI APPLICATIONS & "WORKING" OF FOREIGN DRUGS IN INDIA?

ANNEXUREC

RTI PROCESS & IMPORT ANT DATES

1. The first rounds-of RTI applications were filed on the 21st of September, 2010.

2. The Chennai Patent Office replied on 7th October, 2010 informing us that they had the

Form 27 statements of working for Patent no: 198952 (Pegasus) and Patent no: 207233

(Viraferonpeg) for the year 2009. However for reasons unexplained, the Chennai Patent

Office did not send us photocopies of these Form 27 statements that were clearly in their

possession.

3. The Mumbai Patent Office replied on the 13th October, 20 I 0 providing us with the Form

27 statements of working for Patent number 215758 (Nexavar). However, as regards

Patent no. 213457 (Entecavir), the Patent Office told us that the Form 27 was 'not

traceable'. We found, much to our surprise, that Form 27 for this patent was in fact very

much attached to the Patent Office's reply. Instead the Form 27 for patent no: 203937

(Dasatnib) was not attached and we presume that the patent office meant to say that the

form 27 for patent no: 203937 was not traceable.

4. On 12th Nov~mber, 2010 appeals were filed to the First Appellate Authority within the

Patent Office.

5. As no replies were received from the Appellate Authority, fresh applications were filed on

the 161h of Dbcember, 2010 with the Chennai and Mumbai Patent Offices with clear

instructions to provide us with actual photocopies.

6. On the 28th of December, 20 l 0 the First Appellate Authority at the Patent Office, New

Delhi passed orders allowing the appeal dated the 121h ofNovember. Both the Chennai and

the Mumbai patent offices were directed to provide the required information.

7. On the lOth of January, 2011 the Mumbai Patent Office sent to us the Fonn 27s for patent

number 215578 (Nexavar) and patent numbers 213457. As regards Form 27 for patent

number 203937 (Dasatinib), which was earlier 'untraceable', the Patent Office finally

managed to trace the Form 27 for the year 2008. With regard to the same form for the year

2009 we were informed that the same 'was filed but not traceable' and that a copy of the

17

/~··; ; ...

\,

, I

.s-p(qj I"P RTI APPLICATIONS & "WORKING" OF FOREIGN DRUGS IN INDIA?

same would be supplied to us 'as soon as possible'. On the l41h of January, 2011 the

Mumbai Patent Office sent us another letter informing that the Form 27 for the year 2009

had finally been traced and dispatched to us.

8. On the 121h of January, 2011 the Chennai Patent Office sent us the Form 27s for patent for

patent numbers 198952 (Pegasus) and 207233 (Viraferonpeg) for the year 2009. There

was no explanation provided for the missing Form 27s for both drugs for the year 2008.

APPEALS AGAINST THE DELHI PATENT OFFICE ..

I. In response to the first RTI Application on 21st September, asking for the Form 27s of

patent numbers I 96774 (Tarceva) and 209251 (Sutent), the CPIO (Central Public

Information Officer) replied requesting Rs. 4 to cover the photocopying charges of

these forms.

2. An appeal was filed, against the above reply, along with replies received from the

Chennai and Mumbai patent offices, which showed that these offices were happy to

give us the information without insisting on Rs 4 ... an amount that the government had

anyway spent in despatching their first response (letter) to us, suggesting that we pay

this magnificent sum of Rs 4!

3. The Appellate Authority ruled that the CPIO, Delhi was within the law to ask for Rs. 4

towards photocopying charges.

4. In the meanwhile, on the 161h ofDecember, 2010, a new RTI application, this time with

Rs. 30, was filed with the CPIO Delhi office requesting the same information.

5. On the 251h of January, 2011 the CPIO, Delhi Patent Office did a sudden volte face! He

refused to provide us the same information which he had agreed to earlier provide us

with, since it was allegedly 'third-party information'. The exact reply of the CPIO is

reproduced as follows: 'With reference to your letter dated 22/12/2010 seeking

information under RTI Act, 2005, I am to inform you that Form-27 have been filed

against both Patent Nos. 196774 & 209251. Photocopies ofform-27 cannot be supplied

to a third party'.

18

~

'"1::,(1 ·'I),,._, .~~- \).v~-~ r I • U

RTI APPLICATIONS & "WORKING" OF FOREIGN DRUGS IN INDIA?

What is even more egregious is the fact that he got the law completely wrong (section

I I prohibits "third party" confidential information, and not "third party" information)

and that he did not bother to offer any other reasons for this sudden volta face.

6. We were aghast at this sudden change of heart at the patent office. We immediately

sent an appeal on the 29th of January, 2011 to the First Appellate Authority against the

above reply by the CPIO. To this appeal we attached photocopies of Mr. Parmar's

previous orders to the Mumbai and Chennai Patent Offices ordering them to release

Form 27 Information to us.

7. On the 25th of February, 2011 Mr. Pannar replies to us stating that the Central Public

Information Officer, Delhi had provided us with the requisite information in his reply.

This makes no sense at all b~cause the CPIO, Delhi had not provided us with any

information. Either the authorities frave failed to appreciate our letters penned in plain

English or there is something more deeper and mysterious going on here.

8. A clarification letter sent to Mr. Parmar subsequently by has not yet been replied to. In

the meantime, we complained to Controller General PH Kurian who ordered the

immediate release of this information. We got this from the Delhi patent office on 41h

April, 2011.

19

s-p(ttj I'P RTI APPLICATIONS & "WORKING" OF FOREIGN DRUGS IN INDIA?

ANNEXURED

Form 27 Statements filed by the Patentees of the following drugs are attached below:

S.No PATENT NO. NAME OF THE DRUG YEAR

I 203937 Dasatinib 2008

2 203937 Dasatinib 2009 ~

3 2I5758 ' Nexavar 2008 ··• .. :

4 215758 Nexavar 2009

5 2I5758 Nexavar 2009

6 2I3457 Entecavir 2008

7 2I3457 Entecavir 2009

8 I98952 Pegasus 2009

9 207233 Viraferonpeg 2008

10 196774 Tarceva 2008

I I I96774 Tarceva 2009

12 196774 Tarceva 20IO

13 209251 Sutent 2009

20

.. ,

I :

sp\c,81'P RTI APPLICATIONS & "WORKING" OF FOREIGN DRUGS IN INDIA?

ANNEXUREE

CONTENTIOUS PROCEEDINGS INVOLVING THE ABOVE DRUGS

PRODUCT CAUSE TITLE

NATURE OF REGISTERED OWNER PATENT APP. No

NAME FORUM

PROCEEDING

.~; Bristol-Myers Squibb

'2. BRISTOL MYERS SQUIBBS Co. IN/PCT/2001101138 Dasatinib

Company v. Dr. BPS Reddy High Court of Patent /MUM (Hetero Drugs) C.S. (O.S) No. Delhi infringement suit

2680 of2008.

IN/PCT/200 1/00799 Bayer Corporation Anr. v. High Court of Patent

BAYER CORPORATION /MUM Nexavar Cipla Ltd C.S. (O.S) No. 523 Delhi infringement suit . of2010

Bristol-Myers Squibb . IN/PCT/2002/00891 Company v. Ramesh Adige & High Court of

Patent BRISTOL MYERS SQUIBBS Co. Entecavir Infringement

/MUM Anr (Ranbaxy) C.S. (O.S) No. Delhi 534 of2010

Suit

1 032/MAS/ 1997 0 • .. Patent Office, Post-Grant

HOFFMAN LA ROCHE AG Pegasus Wockhardt v. Roche Chennai Opposition

IN/PCT/2000/434 Patent Office Pre-Grant &

SCHERING CORPORATION Viraferonpeg Cadi/a v. Schering Chennai

Post-Grant Opposition

.. 21

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~ ~ it

~ ~ :~~ ~...:

~

I ;,~

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f ('

f;: ~-~ ~-.

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b

£\

OSI PHARMACEUTICALS INC.

& PFIZER PRODUCTS INC.

SUGEN INC., USA &

PHARMACIA & UP JOHN

COMPANY

s-p\ct) IP RTI APPLICATIONS & "WORKING" OF FOREIGN DRUGS IN INDIA?

537/DEL/1996

IN/PCT /2002/00785

/DEL

Tarceva

Sutent

Hoffman La Roche v. Cipla C.S.(O.S.) No. 89 of2008

There are three more pending

suits in the Delhi High Court

involving the same patent,

against Dr. Reddy's, Glenmark

and Natco. Additionally there is

one more infringement suit

pending before the Madras

High Court, against Matrix

Laboratories.

Natco v. Pfizer

rr"":D\r . . I

22

High Court of

Delhi

Patent Office,

Delhi

Patent

Infringement

Suit

Compulsory

Licensing

Proceedings

_ .. - "'-- __ _:: ··'-·· ~-- ..• :-·.:._:· __ •. ·.··- J.. . ._._, ~· _, : .. •.:0. •. ·~·.::.:,._.__),!::. '·, • .:. • .:.;• ___ :\.'.:.'..;~,.:..t:..l.

t!l•• •.. I. .

j\'lNTEL. LECTUAL , -~ PROPERTY INDIA

PATENTS I DESIGNS I TRADE Mfl.RKS I GEOGRAPHIC.i!.L INDICATIONS

,·· :. ·_.:... '_ ................ :.•.':.-~' · .. _., ~~- ' ... : . .:...'.:.."·:·. "'. ·, . ' ·-·- - .

~~ GOVERNMENT OF INDIA

810 P-a

Controller General of Patents. Designs and Trademarks Department of Industrial Policy and Promotion

Ministry of Commerce and Industry

PUBLICATION OF INFORMATION RECEIVED FROM PATENTEES REGARDING WORKING OF PATENTED INVENTIONS ON COMMERCIAL SCALE IN INDIA U/S 146 OF THE PATENTS ACT 1970 FOR YEAR 2012/2013

Patent Number/Application Number/Name Of Patentee Search Criteria , Search

Fonnat:-

Application Number: XXXX/DELIYYY'{ or XXXX/DELNP/YYY'/ or IN/PCTiYY'r'Y/XXX/DEL(whne, XXXX is running serial numberofapplication & YY'{Y is Year of application DEL corresponds to Ordin<1ry I Convention applications. DELNP and lN/PCT co1Tesponds to PCT Nation<11 phase ~~pplications)

Patent number NNNNNN (:six digit Numeric Patent serial no_)

Examp ks: !\ ppl icatJon number:' 144/D LL/200 l' or· 123/DELN P/2006' or 'IN/PCT/2000/00314/DEL' Patent number 2! 5657

NOTE:

I_ The data corresponds to the information received from paientces in Form-27 for the year 2012. Data which is still under processing may not appear in the list and \.vill be made available at the earliest

2_ Any discrepancy may be notified to delhi-patent@nic_mumbai-patent@nic.in,chennai-patent:JZ].nicin or kolkata-patcnt(L_i~nic.in as per applicable jurisdiction in with a copy to cgofficc-mh(ll;nicin

AS ON

ANNEXURE P-4 '

A COMPREHENSIVE LIST OF PATENTS SURVEYED

I. PHARMACEUTICAL SECTOR

A. Allergan Inc.

PRODUCT PATENT NO. GRANT DATE Ganfort, Combigan 212695 12.12.2007 Ganfort, Combigan 219504 07.05.2008

B. Astrazenca AB

Zoladex 198149 13.01.2006 (~~·~ ;.·:,:~

Ires sa 199501 08.12.2006

Brilinta 200897 05.06.2006

Crestor 205788 10.04.2007

Faslodex 206639 03.05.2007

Brilinta 209907 11.09.2007

Ires sa 217528 27.03.2008

Brilinta 238424 04.02.2010 Iressa 239083 04.03.2010

Iressa 240234 04.04.2010

Brilinta 247984 08.06.2011

Brilinta 252484 17.05.2012

Brilinta 253995 12.09.2012

C. Bayer Corporation

Xarelto 211300 24.10.2007 • 1?:: Nexavar 215758 03.03.2008

Avelox 215998 05.03.2008

D. Bristol-Myers Squibb

Dasatinib 203937 16.11.2006

Onglyza 206543 30.04.2007

Baraclude 213457 17.01.2008

Oren cia 214214 07.02.2008

Ixempra 223589 16.09.2008

Ixempra 224075 29.09.2008

Ixempra 234024 29.04.2009

E. F. Hoffmann-LA-Roche AG

Tarceva* 196774 Feb.2007

·Pegasys 198952 21.02.2006

Mircera 206891 15.05.2007

i-rl

TRUE COPY

Valcyte 207232 01.06.2007 Bonviva 208718 p7.08.2007 Dilatrend 209504 04.09.2007 Invirase 227217 05.01.2009

F. Genentech Inc.

Xolair 205534 05.04.2007 Xolairt 235206 04.07.2012

G. Glaxo Group Limited

Tykerb 221017 11.06.2008 Tykerb 221171 18.06.2008

t;~~ H. IRBM Science Part S. p.A

_,t·<~¥

Isentresst 212400 03.12.2007

I. Janssen Pharmaceutica N.V.

Intelence 204028 19.09.2006 Sirturo 236811 23.11.2009

J. Merck Sharp & Dohme Corp. (formerly as Schering Corporation)

Noxafil 202128 13.10.2006 ViraferonPeg 207233 05.06.2007 Janumet, Januvia 209816 06.09.2007 Isentresst 212400 03.12.2007 Janumet, fanuvia 235426 02.07.2009

(';!;\.,. 'i'&

K. N ovartis AG

Afinitor, Certican 202379 04.10.2006 Xolair* 205534 05.04.2007 Galvus, Galvus Met 212815 17.12.2007 Myfortic 221674 07.07.2008 Onbrez 222346 05.08.2008 Vildagliptin 229761 20.02.2009 Diovan, Co-diovan 237273 14.12.2009 Aclasta 237596 29.12.2009

L. Pfizer Inc.

Tarceva 196774 Feb.2007 ~ :

Chantix 204091 26.12.2006 Selzentn; 204132 05.01.2007 Chantix 210325 27.09.2007

rr-v TRUE COPY

M.Pharmacia & Upjohn Company

Sutent 209251 23.08.2007 Detro[ LA 211539 05.11.2007

Depo-Provera 224279 10.10.2008

II. TELECOMMUNICATION SECTOR

·:' N. Apple Inc.

TITLE OF INVENTION PATENT NO. GRANT DATE

A method of performing motion 223889 23.09.2008 estimation in a digital video system

~'·:, Unlocking a device by performing 263108 07.10.2014

.... -.·v gestures on an unlock image

List scrolling in response to moving 263125 08.10.2014 contact over list of index symbols

Illuminated touchpad 264414 29.12.2014

0. Ericsson Inc.

Linear predictive analysis-by-synthesis 203034 19.10.2006 encoding method and encoder (AMR)

Apparatus of producing from an 203036 29.11.2006 original speech singal a plurality of parameters (AMR)

Method and system for alternating 203686 29.12.2006

.... , (~~~ transmission of codec mode information (AMR)

Quadriphase spreading codes in code 204085 26.12.2006 division multiple access communications (3GPP Standard)

Method and apparatus for generating 213723 10.01.2008 comfort noise in a speech decoder (AMR)

.. Multi-service handling by a single 229632 19.02.2009 •'· mobile station (3G Standard) ' .. ,_.

A method of endocidng/decoding multi- 234157 07.05.2009 code book fixed bitrate celp signal block (AMR)

: ...

A mobile radio for use in a mobile 240471 12.05.2010 · communications system (3G Standard) r! ' !'

TRUE COPY ,.

A transceiving unit for block automatic retransmission request (EDGE)

· P. Motorola Mobility

A selective call receiver

A telecommunication network (3GPP Standard)

A method for adapting an access probability for a multimedia broadcast multicast service for a communication system (3GPP Standard)

Method and apparatus for presenting graphic messages in a data communication receiver

Method of validating communication in a wireless communication on de.vice (3GPP L TE Standard)

A communication system for transmitting to a remote unit for locating the remote unit (IS-95, IS-2000 Standards)

Emergency call placement method

Q. Nokia Corporation

A method of transmitting information from a sender to a. receiver in a communications system

A method and system for selecting an access point in a wireless communication system

Method and apparatus for transmission between stations of a communication system

Arrangement for generating service­oriented call-charge data in a communication network

Supporting in a communication system a request for information on a mobile device

A data communication apparatus for communication between a mobile

241747

188578

199910

224757

231920

239197

241931

247777

208450

220016

225833

226420

227155

231889

rvJ TRUE COPY

~:

22.07.2010

25.07.2003

02.02.2007.

22.10.2008

13.03.2009

10.03.2010

31.07.2010

18.05.2011

31.07.2007

15.05.2008

01.12.2008

17.12.2008

05.01.2009

13.03.2009

station and base station

Sessions in a communication system 239847 06.04.2010

A method of transmitting complex 240592 19.05.2010 symbols using a transmission code matrix

An lpc-hjpe speech synthesiser and a 241026 16.06.2010 post-processing method for enhancing lpc-synthesised speech

Symbol interleaving 242227 19.08.2010

Method for sub-pixel value 252965 12.06.2012 interpolation

.W, R. Qualcomm Corporation J-l·~~:

Video encoding method, video decoding 235997 11.09.2009 method, video encoder & video decoder thereof

A method operational in a mobile user 242591 02.09.2010 device for authentication

Power control based on an overlapping 244450 07.12.2010 factor in a quasi-orthogonal ofdm system

A channel estimation method and a 249353 18.10.2011 receiver to estimate a channel

Method and apparatus for phase 250318 22.12.2011 matching frames in vocoders

~j,

® Method and apparatus for performing 251398 12.03.2012 timing synchronization with base stations

Ciphering and re- ordering packets in a 251810 07.04.2012 wireless communication system

Method and apparatus for list sphere 251876 12.04.2012 decoding

Multiplexing and feedback support for 252127 27.04.2012 wireless communication systems

s. Research In Motion Ltd.

System and method for queuing and 243876 10.11.2010 moderating group talk

An apparatus for a radio 234045 01.05.2009 communication system rvV

TRUE COPY

...... 1

Apparatus & associated method for 248123 20.06.2011 facilitating network selection at a mobile node utilizing a network selection list maintained threat

System and method for secure control of 249536 25.10.2011 resources of wireless mobile communication device

Method for providing.network 249790 11.11.2011 information to a wirele~s device in a wireless local area network

An always-on wireless internet protocol 250891 06.02.2012 network

~'. Method for adjusting presentation of 252447 16.05.2012 ;;i..J

text, images and moving images of an electronic device according to an orientation of the device

T. Samsung Electronics Co.

A test device for testing a plurality of 191620 25.06.2004 DSP ICS under the finish product state in a digital video apparatus

Method for retransmitting data 197686 28.09.2007 according to radio link protocol in

.,,,

mobile communication system ·' ::

An ATM switching system configured 199194 05.05.2006 to serve an N-ISDN traffic imd a

~) method for controlling the same

A cartridge for an information 242433 26.08.2010 recording medium

Method for operating plural 244009 15.11.2010 applications between portable storage device and digital device, portable storage device, and digital device

III. PUBLIC FUNDED RESERCH UNITS

u. Council for Scientific and Industrial Research (CSIR)

An improved process for the synthesis 192966 20.01.2006 of 5-(2-jluorophenyl)-lH-tgetrazole

An improved process for the 192519 14.10.2005 preparation of raw vegetables having exposed shelf-life

A device useful for continual forming 194692 17.02.2006

TRur'coPY

q~

and disensing of doughnut shapped batter for making traditional vada

An improved process for prepration of 194697 17.02.2006 1, 1, 1,-trichloro-trifluoroethane

An eco-friendly method of preparation 196712 21.06.2006 of high purity tetrabromobisphenol-A

An improved process for the production 196947 11.08.2006 of high grade synthetic rutile

An improved process for the 197048 14.07.2006 preparation of poly(ester-carbonate)s

A process for the preparation of 199735 22.12.2006 nutritious instant pudding mix with

.;-,,\ - r:~.~ enhanced shelf life

. :.1

An improved process for the prepration 208858 13.08.2007 of 1-[2-dimethyllamino-( 4-methoxy phenyel)-ethyl] cyclohexanol

:·::·

A process for the preparation of high·. 218313 31.03.2008 grade synthetic rutile from ilmenites and pigiron as a by-product

A process for preparation of compound 231500 05.03.2009 1,1 - { [ (bisalkane-1,n-diyl) piperazine] dioxy} bis (llas)-7- methoxy-1,2,3,11

... ·'i a-tetrahydro-5h-pyrrolo[2,1-c] [1,4] benzodiazepin-5-one

:··=-i

.'I A process of isolating camptothecin 238011 18.01.2010 and/or camptothecinioids (CPT) from

. I ~::}

novel endophytic fungal strain

An improved process for recovering 254692 06.12.2012 cobalt from roast-reduced sea nodules

v. Department of Bibtechnology, Government of India

An anti HIV-1 active bacterial and 226541 18.12.2008 bactulovirus recombinant EP AP-1

An improved process for oak tasar 236242 13.10.2009 cocoon cooking using pineapple' extract

A device for collecting air borne dust 241684 20.07.2010 generated by moving vehicles

Novel primers for a PCR-RELP assay 242073 ,

09.08.2010

~- ., ... for identification of pathogenic mycobacteria

Dimmer of Phenazine-1-Carboxylic 243949 11.11.2010 acid and to the process of preparation rvl

TRUE COPY

·· .. ,,

:•;.

thereof

A method for preservation of human hematopoietic stem or progenitor cells

Process of extracting anti-white spot syndrome virus molecules from mangrove plants

W. Indian Institute of Science (liSe)

A method for the manufacture of aqueous solution of metal complexes and a method of manufaCturing high temperature coloured vitreous glass­ceramic tiles

A process for manufacture of ceria­supported platinum as hydrogen­oxygen recombinant catalyst in sealed batteries

A novel gelled-electrolyte-AGM­hybrid-VRLA battery

A novel vaccine formulation consisting of DNA vaccine and inactivated virus

Fuel efficient biomass stove and a method of operating the stove

A metal ionic catalyst composition and a process thereof

A peptide and a method thereof

246982

254984

197957

198047

201330

207234

229283

237260

254638

X. Indian Institute of Technology (IITs) (collectively)

A method of making a supported fluid 197755 separation membrane of nanopore structure

A process of wastewater renovation 203744

Freeze concentratzon system 204956

Highly porous ceramic or metallic 206908 material and simple environment friendly process for fabrication of the same

Strength enhancing insert assemblies 211354

Three-dimensional core holder for 225118 performance evaluation of oil well.

cv--1 TRUE COPY

23.03.2011

10.01.2013

07.04.2006

24.01.2006

25.06.2006

01.06.2007

16.02.2009

11.12.2009

29.11.2012

09.01.2006

15.11.2006

12.03.2007

16.05.2007

26.10.2007

31.10.2008

'

.. - .• ~. d .,. '·

configurations

A combined capacitive and electromagnetic voltage transformer

A method for magnetic abrasive finishing using a pulsating flexible magnetic abrasive brush

An abrasive flow finishing device

A method and apparatus for the formation of patterns on surfaces and an assembly and alignment of the structure thereof

TRUE COPY

239070

255664

255847

258688

04.03.2010

13.03.2013

26.03.2013

31.01.2014

FORM NO. lOCCE

[See mle 19AD]

Certificate under sub-section (2) of section 80RRB for Patentees in receipt of royalty income, etc.

PART A

(To be filled in by the assessee)

I. Details of the patent: (i) Patent registration number

( ii) Date of registration of patent (iii) Title of patent (iv) Whether the patent IS m the native of patent of

addition (Yes/No) (v) If reply to (iv) is yes, the title and registration number

of original patent 2. Details of pa:tentee:

(i) Name and address of the patentee(s), (ii) Whether the patentee is the tme and first inventor of

the invention (Yes/No) . (iii) Date on which the name of pateiltee was entered on

the patent register (iv) Whether the name of the patentee was revoked or

excluded from the patent register in respect of patent mentioned at item number (i) (Yes/No)

(v) If reply to (i) is yes, the date from which such revocation or exclusion took place

3. Name, address of the person paying the royalty incomefrom patent:

4. Details of royalty agreement: (a) The nature of royalty (mark./, where applicable)

(i) tninsfer of all or any rights (including the granting of a licence) in respect of the patent (ii) imparting of any information conceming the working of, or the use of, the patent (iii) lise of the patent (iv) rendering of any services in connection with the activities referred to in sub-clauses (i) to (iii) (v) ·consideration for sale of products manufactured with the use of patented process or the patented article for commercial use

(b) Period for which the agreement is applicable (c) Amount of royalty income payable for the previous

year (in Indian mpees) 5. Details of payments:

(i) Payment received in Indianmpees (ii) Payment received in foreign currency (value 111

Indian mpees) (iii) Total payment received

Printedfrom www.taxmann.com

~-. :_ . . . -..;-.!:. ' \.._.} -~'·:

.:.:

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(iv) If in foreign currency, details of payment m the following proforma :-

Total amount payable during the year

6. Verification :

Amount actually paid Date o.f payment

,,

Mode of payment

This is to verify that 1/we, s/o having PAN No is/are the patentee, being tme and first inventor of the invention, in respect of the patent titled entered in the patent register maintained by the patent office at under the Patents Act, 1970.

This is to further verify that during the previous year, I/we have received payment in the nature of royalty income from such patent from Shri/Smt.!Ms. which is entitled for deduction under section 80_RJ{B of the Income-tax Act, 1961.

Signature and name of the assessee Date:

Place: Address:

PARTE

(To be filled in by the prescribed authority)

Certification

This 1s to certify that ' the information furnished by the assessee named in items Number and 1 and 2 of Part A is correct as per the patent register maintained by us.

This is to further certify that a compulsory license has/has not (strike off whichever is not applicable) been issued by the Controller in respect of the patent mentioned at item number 1 of Part A, and the royalty income settled in terms of any compulsory license, pertaining to the period starting from 1st April, and ending at 31st March, is rupees (not to be filled in if no compulsory license is issued).

Name, designation and signature of the Controller

Date:

Place: Address:

Printed from www.taxmann.com

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AN~'IO~&- P-' ( (ott.. V)

<l> 022-24132735 022-24132393

q:,-.

e>l!!:a •• ;;" INTELLECTUAL PROPERTY INDIA

Fax No.022-241223322 022-24172288 022-24156392

Patents/Oesigns!Trademark GEOGRAPHICAL INDICATIONS

~cr~

GOVERNMENT OF INDIA

Office of the Controller General Patents, Designs and Trademarks

Boudhik Sampada Bhawan S.M.Road, Antop Hill, Mumbai-400037,1ndia.

E-mail : cgoffice-mh@nic. in Website: http://ipindia.nic.in

No.CG/PG/2009/ I ':J-'7 Date:- :l-4 _, 12.2009

P U B L I C N 0 T I CE

All Patentees and Licensees are required to furnish information in Form No.27 on working of patents as prescribed under Section 146 of the Patents Act (as amended) read with Rule 131 of the Patents Rules 2003 (as amended). Attention of the Patentees/Licensees are also invited to provisions of Section 122 of the Patents Act, 1970 (as amended) wherein penalty is prescribed for non-submission of such information.

Therefore all Patentees and Licensees are hereby called upon to comply with the abo~ pi;~T~io~by filing the information in Form 27 before 31 51 March 2010.

(P .H. Kurian) Controller General of Patents, Designs and Trade Marks.

: ... ~.· ~..... ~ ' ...

t)l!t.. •• ~ INTELLECTUAL PROPERTY INDIA PATENTS/DESIGNS/

TRADE MARKS/ GEOGRAPHICAL

INDICATIONS.

I ~~

Government of India Office of The Controller General, Patents, Designs & Trade Marks,

Boud.hik Sampada Bhavan, S.M. Road, Antop Hill,

Mumbai-400 037 (India)

No. CO !Public Notice/20 13/ ':) :)

PUBLIC_ NOTI._CE

(Tel): a 022-24132735 022-24123388

(Fax): ~ 022-24123322 (Email): cgoffice-mb@nic.in (Website): www.ipindia.nic.in

)2-Date: ..l-1-;02.20 13

ln accordance with the provisions contained in sub-section (2) of section 146 of the Patents Act, 1970 read with rule 131 of the Patents Rules, 2003, all Patentees and Licensees (whether exclusive or 'otherwise) are required to furnish infonnation in Form-27 in respect of each calendar year, within three months of the end of each year.

All the Patentees and ~icensces are hereby called upon to comply with the above provisions. Attenuon IS also invited to the provisions contained in section 122 ofthe Patents Act, 1970.

The Patent Office appeals to all that c-filing service available on the official website \.VW\V.ipindia.nic.in may be used for this purpose, as far as possible.

(ChW~~~ Controll~r General of Patents, Designs & Trade Marks

I'~

-------

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---·-·--------·--- -------- ----- ------ ' ---------·

\:)·1!!:. Ill• INTELLECTUAL PROPERTY INDIA

PATENTS/DESIGNS/ TRADE MARKS/ GEOGRAPHICAL

INDICATIONS.

I ~~

Government or India Office of The Controller General, Patents, Designs & Trade Marks,

Boudhik Sampada Bhavan, S.f\1. Road, Antop Hill,

Mumbai-400 037 (India)

(Tel): · a 022-24132735 022-24123388

(Fax): ai .022-24123322 (EmaU): cgoffice-mh@nlc.in (Website): www.lpfndla.ol(.fn

q:Y/Publlc Notlcc/2015/ ~ b Dated: 12.01.201~ ·/}

PUBLIC NOTICE

In accordance with the::provisions ·contained in sub-section (2).of section 146 or the Patents Act, 1970 read with rule 131 of the Patents Rules, 2003, all Patentees and Licensees (whether exclusive or otherwise) are,.required to furnish information in Fonn-27 in respect of each calendar year, within three months of the end of. each year.

Ail the ~entees and Licensees are hereby catted upon to comply with the above \ --provisions. Attention is also invited to the provisions contained in section 122 of the Patents . . Act, t 970.

The Patent Office appeals to all that e-filing ser\lice available on the officiaJ website www.ipindia.nic.in may be used for this purpose, as far as possible.

!i . ~"l-/th.ow;-

<Chaitanya rlalad} Controller General of Patents, Designs & Trade Marks

THE OFFICE OF THE CONTROllER GENERAL OF PATENTS, DESIGNS, TRADEMARKS AND

GEOGRAPHICAL INDICATIONS

p .. ~ LOQ

ChapiPr I

Chapter II

Ch<1pter IV

Chapter V

Chapt~r VI

CONTENTS PAGE NO.

OVERVIEW ............................................................................. 3

TRENDS IN IPR- 1\T A GLANCE .............................................. ::,

PlH\IIC SfRVICf fXIIVERY -ITFICif-NCY ,<:.,_ ...

TRANSPt\RENCY . ........ :1:!.

1-'AII:NI) ............................................................................... lb

OESICi'-JS ............................................................................ 3'8

TRADEiviARKS ............................................... _ ...................... 44

Chapter VII GEOGRAPHICAL II\.DICATIONS .......................................... 57

Cb1ptcr VIII I'IS 8.. Nlll'i\1 .......................................................................... 67

01<rp1er IX TRAINING PROGR!\,\·1S & OL TREt\CH ,-\CTIVITIES ....... ..... .7'!

Chapter X IIU.rvi.A.I\ RESOURCES ........................................................... S2

02 I OlfiCo cf tho CQnlroll<>rGoncral arPa:onL•. Dosigos, Tmdomarka ard GoographL..,IIndic:alians

, . .'

ANi\U1\:

CHAPTER-I

"l •:'_!' l.i_'\.. ',

··, ' ' .::.u ;,

Overview

Intellectual Property fuels th: er.gine of :>rosperity, fosters invention and ;,nov~ lion. and

is an intangible asset tl>at plays a vital role in the socio-economic ecosystem. Its creation

<~ruJ IJIUlecliurr i::; e::;::;..,nlial fur Lire ::;u::;!<J·rlatle·\lruwlll ur lli~ rraliun. lrrlellec;lual Pru!Jerly

Rights (lPRs) provide protection to the creators and inventors for their intellectual assets in

contom1itywith the public policy objectives of a country.lpRs are essential for the promotion

of creation of new technologies, their protection. transfers. enforcement an.d dissemination.

The "commodific<Jtion of knowledge" has transformed the different tPRregimes <~cross the

world. Knowledge has become a "strategic asset" and its appropriate use can 9enerate

tremendous weallh. Properly designed tPRs, C2librated to the social priorities. therefore,

~ct os CJ driving for·~e of t~re industrial development of a nation.

Over the past decade. tnd'a has shown re11arkab!e a biLly in various f,etds of technology

such as pharmaceuticals. irforr1ation technology, biotechnology, nanotechnology, etc. India is gradually metamorphosing into an "inn·Jvation factory· by exploiting its "human

ca;:~ital". 11\~~th this rapid growth in technology competency. India is predicted to emerge as a loader in the world economy.

Commensurate to this development, IPR Offices in India ha'le been modsrnized by

inle!lration of modern infrast·u-:ture. mobilization or ~.umar reso·;rces. user friendly and

simplified filing procedures, and use of state-of-the art technclogies. The process of

modernization is continuously behg reviewed and renewec to ac~ieve U1e maximum quality

of service delivery by these Offices.

The Offir.e of the Controller GenP.rill ofPi!ti?.nls, Des•gns. TrnriP. Mflrks flnrl Geogr;=.f:hicill

lndica:ions is a subordinate office oithe Department of lnd~strial Policy & Promo:ion (DIPP)

under the Min'stry of Ccn·rnerce & fndLstry, Governr1ent cf India. Patents, Designs, Trade

Maries & G:ographicat lndicmions laws are being administered by the Office of the

Comroller General. It administers tile IP laws u~der its control in an effective manner to

create an enviwnrnenl or jusl arrd balanced IP eco-system in the countty. Mo•·eover, lhe

Patent Information System (PIS) and the Rajiv Gandhi Nabonat Institute of Intellectual

Prorert}· ManagemP-nl [Nil PM) at Nagpur are also under thP. administrativP. control of the

ComrotterGenerat of Patents, Designs. Trade Marks and Geographical Indications.

OlfiC(J of tllt) Controller Ganoral of Patents, Oo.signs, Tr.:r.::k.-marks anc Goographic.-1.1 bldiet.tions 1. 03

;.. . . "::,·,. : .. ·

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.·.• ~·-~~:,_-,,.;_· .: ' .. ~~: . .:.. ·;.:. ..• :.: ... .' ..• • : .. > ,_ -- '--'~-.' •.• : . .:..'.:.::---. • ·,J ••.• -· ··- -··-- - -·~ ....

CHAPTER-IV Patents

1. INTRODUCTION:

This chapter presents the 41st report, under section 155 of the Patents Act 1970, about the activities performed by the Patent Off;ce during the year 2012-13. The Patent Office is geographically divided and located at Kolkata. Chennai, Mumbai & Delhi whereas Patent Office, Koikata is the Head Office. The Patent Office administers the law concerning protection of inventions in the country by way of grant of limited monopoly rights to the inventors or their assignees or legal SUCCCS50r5. The Patents A:::l1970 governs the grant of patents. The paragraphs given beiO'N provide an outline of the major activities of the Patent office as executed under the Patents Act and Ru:es.

2. PATENT APPLICATIONS:

ThP. numhP.r of nflfllic<Jticns for [JniP.nts fiiP.o in 2012- B wns 43,674whiiP. in 2011-12 thP. figure was 43197, which is an increase of aboLt 1.10%. The filing of apotications in Chemical. Drug, Food, Mechanica·, Computer/Electronics. Biotechnology fields show a modest growth, whereas in the Electrical field. a downward trend i;; ncticed. The details of figures ofthetrend in applications, segreqatec in different fields, are shown in Appendix- E.

{a) Applications filed by Indian Applicants

Out of the total number of 43674 a:Jplications, the number of applications filed by Indian applican:s was 9911, which sho•.vs about 11% growth compared to the previous year, wl·,ereinthe corresponding nu:nber was 8921. However, the nu:nber of applications filed by foreign applicants filed during the year (33763) has shown a decrease of 1.5% as compared to the 342?G applicatior.s filed du~ing 2011-12. The number of applications filed by Indian Ap:Jlicants was about 22.69 % of the total nurr.ber of applications filed during the reporting yc<>ras compared to 20 .65°!0 during 2011-12.

Out of !he applications filed by Indian applicants, Maharashtra continued to lead the filing this year as well and ac::ounted for the maxi,1Ur'1 number, fallowed by Tamil Nadu, Ka~nataka, Delhi, Andhra Pradesh. Gujarat, Uttar Pradesh, West Bengal etc. The State/ Union Territory wise l;reak-up is cr~ shown irr brackets: Maharashlm (2540), Tarrril Ncrllu (1212). Knrn<Jtak:'l (1167), Delhi (890). Ancfhra PradP.!ih (1\44), Gujnrat (645), Uttnr Prncfesh (478), West Bengal (441), Haryana (287), Kerala (257), J<larkhand {115). Madhya Pradesh (111), Punjab (107). Rajasthan (78), Assam (67). Uttaranchal {50). Bihar (46), Orissa (44). llirn;;~chal Pradesh(40j, etc.

16 I Orrico cf lho Ccnrmllnr General or Po!<lnts, Q,"ISiQns. Tradom""'" ar.d Googrnphi::al lndicalions

Ordinary Applications (State-wise)

.'

• Mallarashtra

• Tamill\<>du

f-' Kanataka

•Delhi

Ill A1Chra Pradesh

~::Gujarat

11 Uttar Pradesh

11 West Bengal

'~ Haryana

• Kerala

ltl Jharkhand

l

(b) Top 5 Indian applicants for patents in tha fiald of Information Tachnotogy

St. No. Name of Companies I Applications filed

1. lATA CONSULTANCY SERVICES L MITED I 162

2 SAMSUNG INDIA SOFTWARE OPERATIONS I 13!i FRIV;\TE Llfi.·IITED

--···-- ---- ··--------~-··-----· ··------···--·- -~~·- ~--·--·--·· .. j--' ------- -T• 0 ·--·--3. INFOSYS 81

'--~

4. TEJAS NETWORKS LIMITED I 40

5. HCL TECHNOLOGIES LIMITED I 36 ·---

In the fietc cr lnformmion technology. TCS has cccupied the top place in tile reponing year, while INFOSYS occupied the top place during lhe previous )'ear, Samsung l~dia continued to occu;:Jy the second pta:e In the table this year too.

OffiCe: of Uw Controller Gane:al of P~~onts, Ons:gns, Tr~-d~mmlcs anc Gooqmphict::J hd~ticJns. .I 17

1102-

'··-,- . . - .- . . . . '"'···· .. _,, .. ······""'----'-----~ .. -'·'·~----'- ·-.

Top 10 Indian Applicants for Patents from Scientific and Research & Development Organizations.

Sl. No. l 1

2 i

Name of Scientific and Research & Development Org3nization$.

COUNCIL OF SCIENTIFIC & INDUSTRIAL R=SEARCH

DEFENCE RESEARCH 6. DEVELOPM::NT OI<GANISAfiON

App.lications I filed

202

13 :

3 : IND AN COUNCIL OF AGRICL;LTUR.'\L RESEARCH I f--- !

------------+-----65 1 621 ·l i HETERO RESEARCH FOUNDATION

5 DEPAR7MENT OF BIOTECHNOLOGY. GOVERNMEt\ T OF INDIA

6 AlRCR.I>.FT UPGRADE RESEARCH & DESIGN CENTRE (AIJRDC)

7 ' NNIONAL INSTITUTE OF PH!\RI\·IACEUTICAL i EDUCAliON AND RESEARCH (NIPER) l

B i IND AN SPACE fiESE.II.RCH CRGANISATION

~~----L IND•AN COUNCIL OF MED I_CAL RES-EARCH __ _

10 i INTERNATIONAL ADVANCED RESEARCH CENTRE ! FOR Pm'\'DER 1>1ETALLURGY AND NEVJ i MATERIALS (ARCI)

2!\

23

15

I

In this category, CSIR continued to occupy the top position with marginal increase in the number of applications. However, DRDO, which occupied the 3rd place in the previous year, shm'led an upward tre1c and occupied 2nd position this year. whereas ICAR which occupied 2nd position last ycor slipped to 3rd position in the reporting yeilr.

Top 10 Indian Applicants for Patents from Institutes and Universllies

Sl. No. l Name of lnstitutes/Unive.rsiiies

;-----: lNDIA \1 INSTlTUTEOFTECHtJOLOGY (Cc;llecti~-;)···-·--_ App~alion~!_i_~e~J

205 :

2 ' AMITY UNIVERSFY 140 ! ; 3 ! INDIA \I INSTITUTE OF SCIENCE 31 I

4 i TAMIL NADU AGRICULTU~AL UNIV::RSITY 16

5 I NATIONAL 1\ISTITUTE OF PHARMACEUTICAL 15

I EDUCATION AND RESEARCH (NIPER)

5 M S RAMAIAH SCHOOL OF ADVANCED STUDIES· 1"3

7 NATIONAL INSTITUTE OF IMMUNOLOGY 12

7 • PARUL INSTITUTE OF ENGINEERING AND 12 TECHNOlOGY

7 THE ENERGY AND RESOURCES INSTITUTE (TERI} 12

1 A I omca cf tho Cc-ntrollor Gt.Jneml orPato'ltS.. Dosigrts. Tmdemilrlt.s arid Gcographi::allodit:atlons

8 f--. y

9 1-c--9

9

10 r--10

10

'---- -

I CENTRAL POWER RESEARCH INSTITdTE I I I NAIIONAL INS Ill U II:'- Of- I ECHNULOGY ((.;ollective)

! G.H.R. LABS AND RESEARCH CENT~E

l AMRITA VISW/\VIDYAP:OETH,\M UNIVERSITY I CENTRE FOR MATERIALS FOR ELECTRONI:::S I I TECHNOLOGY

j NATIONAL INSTITUTE OF OCEAN TECHNOL03Y

-i lJNIV~RSITY OF CALC:UTTA

I J.I\WAHARLAL NEHRU CENT~E FORADVAN~ED I SCiENTIFIC RESEARCH

-

11

10

10 1

10

10

9

9 I I

____ __fl_ __ . _ __j

This year too, the IITs and Al'v11TY University cont·nued to occupy the first t,vo positicns. However, Amity University recorded about 237'o growth in filing as compared lo p·evious year. whereas there was only a marginal growth of around 2% for IITs as compared to the previous year. However, the Indian lnstilLle of Scie~ce has shown a remarkable growth lhis year. L<::sl year, the Institute filed only 14 applications wnereas this year. it has flied 31 appliC':'ations, thereby showing an upward trend of 121.42% and it occupied 3rd position in ranking ofi[lslitutes and uni'lersities.

(e) Applications filed by foreign applicants

I. Convention Applications

~·lun·ber of convention applications filed was 4215, showing a minor decrease as compar~d to previOll~ year's <!295.

ii. PCT National Phase Applications:

The majorit): of foreign applications were filed thrcugh the PCT National Phase route. The number of such applications 7iled during the repcrting year was 28435, 111l1ich is a minor decrease in comparison with tre previous year {28965). The United States of /\meri~ led wich the maximum numbec of applications followed by Japan, Germany, france, Switzerland, Netherlands, Republic cf China, United Kingdo.111, Sweden, Republic of Korea etc. Tne country wise break-up of figures was as shown in brackets: USA (8745), Japan (4939), Germany (3364), France (1390), Sv..itzerland (1380), Netherlands (1148), United Kingdom (991}, Repul.Jiic of China (957), Sweden (885), Repul.ilic uf Korea (584), !lilly (534), Canada (438), Denmark (335). Australia (325}, Belgium (321), Finland (321), Israel (285),Austria (252). Spain {20·3), No!Way(136), etc .

Offil:c.l ofUlO Contrc.llor Geoora.l or Pa~. OllS.ign~. Trc.r(l'f:mrHis anc Goo;:;raphic.-'11 ~)dic;;tions ~ 19

103

.:::.;:.:..~.;·-:.;,,_, __ ._:;_:._. __ .. :; ... ,_ .·.· .. . -~ · ... :::·. ·- . -- --' .

Top ten applicants for PCT National Phase Applications (Country-wise)

France, 1300

----------------------------~

Trend of PCT National Phase Filing

2008.()9 2009-10 2010-11 2011-12 2012-13

· 20 I Offica cf lho Cc-ntrollor Gon~::rnl or Patants. Oosigns. Tradcnmrks ard Goographi::allndi~tlons

'·.: .... ·' · .. -···~---- ...... --~------·. '.

TREND OF CONVENTION APPLICATIONS FOR LAST FEW YEARS

sooo 4~00

400ll

3500

JUUIJ i · · Z500 -;----·-· -· ----·---- ·- · ---------····

i ZOOO '

1500 ! 100u

50:)

>)

2oos-o6 200G-07 2007-0S 2:1os-o~ 2009-10 2010-11 2011-12 2012-:>

iii. Top 10 foreign resident applicants

The following table provides a list of top 10 foreign resident applicants 'Nho filed patent appll-:ations during 2012-~ 3. It is observed that Qualcomm tncorpcrated tcpped the list followed by Koninklijke Phili;:>s Electrcnics N.V., Sony Corporation and TELEFONAKTIEBOLAGET LM ERICSSON etc.

Top 10 Foreign Residents Applicants

St Np. 1 Na.me of Organisation Number of Applications

1 I QUALCOMM INCORPOR'<TED 1034 -2 ----T KoNINi<LiJK'E-P~Iili'Psi:LEc=rR"ciNics-N:v~---- ··---·-------- ··---··

647 I

3 I TELEFONAKTIEBOLAGET LM ERICSSON 413 1---- '

4 i BASFSE 343

5 GENERAL ELECTRIC CCMPAI\Y 342

6 SIEMENS AKTIENGESELLSCHAFT 318

7 ROBERT BOSCH GMBH 207

8 SONY CORPORATION 276

9 SHARP KABUSHIKI KAISHA 260 10 PANASONIC CORPORATION 251

Offioo of d~o Conttoll\~r Genaml of Pe"J~Onl.G. Dosgns, T~dtimartcs an:: Goographic.-'lllndic;:tion::; .I 21

TRUF rnpv

. ~

Filing detai'S of applications for patents curing 2012-13, received through vari:>us rcutes and classified according to the country and slate of origin, are shown in Appendix 'B'.

The number of applications for patents received from Indian residents and non· residents through various routes. during the period from 2003-2004 to 2012-13 is shown in Appendix 'C'.

A tahle showino thP. d ist rihution of :-1 rr>lir.<~ lions filed suhjec:t wise in Chemic.!:! I, Fler:tric:al. Mechanical, General fields e:c. during the period from 2000-09 to 2012-13 is shown in Appendix- 'E' (and 'Et'for 2012-13forotherfields).

3. PATENTS GRANTED AND PATENTS IN FORCE

Total number of patents granted during the year was 4126 out of which 716 were gran led to Indian applicants. The number of patents in force was 43920 as on 31st March 20 t 3, out of which 8308 patents belonged to Indians. Out of the total granted patents, 749 patents were granted on spplications relaling lo Mechanical, 1289 to Chemicals, 344 to Drugs or M<::dit:ines, 228 to El<::drical <mc.t 37 to Fuou. •

ThE'! number of applications filed, number of requesls for examinaiion received, applications deemed to t1ave been abar.doned and applications on which patents were grc;nted ar.d the number cf patents in force from the year 2002-03 to 2012-13 is shawl' in Appendix ·o·.

Number of Patents granted dunng the last five years i.e. from 2008-2009 to 2012-13 under various fields of in·,entions are shown in Appendix 'F' and 'F1 '.

4. PCTINTERNATIONALAPPLICATIONS FILED BY INDIAN APPLICANTS

During the repor:irg year. the total m1mber of international applications filed by Indian applicams using PCT system in Patent office as Receiving Office was 1042, which has shown a substantial increase of 32% in filing as compared to 873 in the previous year. This shows a remarkably high usc of international System under Patent Cooperotion Treaty (PCT) by Indian applicantsi1nventors to protect their inventions abroad. Statistics of filin~ of PCT international applications for the last five years is givon below (these applications. do not include international .applications that are directly filed by Indian applicants in the International Bureau ofWJ?O):

,...--. Year Individual Legal Entity Total

2008-2009 232 655 887

2009·2010 • 231 521 752 •

2010·2011 243 628 871

2011-2012 254 519 873

2012-2013 252 790 1042 :

22 I OfrJCO cf lho: Cc-n.trollor Goneml or Pmants. Oosigrls. Tradcm.'lf'l{f; ar1~i GG:ographi:':al Indications

i ! ......

} { '{: .l ( .. \/ l.

Trend of International applications for the last five years

---790 ~s_---...,sz..-r---6-~~

231 2:43 254 252

2008-2009 2009-2010 2010-2011 2011-2012 2012-13

OL!Pot .. ~

Major contributors towards the PCT international applications during the yaar were Hetero Research Foundation. lneda Systems Pvt. Limited, Mylan Laboratories Limited. TVS Motors Company Limited, Tata Ste<'!l Limited, Tega Industries Limited, Natco Pharma Limited. anc Dr. Reddys Laboratory L·mited.

5. Miscellaneous proceedings under the Patents Act & Rules

(a) Inventions in the field of Atomic Energy: 78 e1pplications were referred to the Depi'lrtmentof l>.tomic Energy during the period ror review under sec~ on 4 of I he Patents Act 1970. out of which 42 applicatio% were allowed to proceed under the normal course of officia action during the year, 29 applications are still pending with the Department of Atomic Ene~gy for its opinion and 7 applications were refused :Jy the De;Jartment of A:omic Energy and hence attracted Section 4 of Patents Act. 1970.

(b) Publication of Patent applications under section 11A: During the year, 26159 applications were published uls 11A. Including 1413 applications rorearty publication.

The yearwise defai's regarding the number or patent applications published are given below:

()f(ioo of lhGCor.ttollor Gon(lra! of P.iJ1.ants. Dos;gn~. Tr;;dcmarks anc GoogrtJphical kldicdions I 23

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l.l. )013

Year 2008-09 2009-10 1 2010-11 2011-12 2012-13 i Total

Publication uls 11 A 39821 33328 I 32213 26~22 2'17~6 I 131784 I '

Early Public3tion 928 977 I 1153 1331 14':3 ' 4389 i Total 40749 343os 1 33366 27753 26159 I 136173 I I

(c) Pre-grant Opposition [under Section 25(1 )]: During the year, 262 oppositions by way of representations were received ur:der this section. Out of these, 34 pre-grant oppositions wore disposed off during the y·:::ar.

(d).Post-grant Opposition [under Section 25{2)): 1 ~post-grant oppositions we~e filed during tile year. 07 post-grant oppositions were disposed off d~ling the year and 162 post gre-nl oppositions remained pending for disposal.

(e) Secrecy direction (under Section 35}: During the year, 33 piltent applications were referred :o DRDO. 12 applications remained pending with DR06 and 21 applications were cleared by the Ministryo: Defence to proceed in the normal course of action.

(f) Pernffssion (under Section 39): 3690 ap:~lications requesling permission for filing <Jpplications o1.1tsice lndi<J were filed, out of wh:ch 3681 were ail owed.

(g) Restoration of lapsed Patents (under Section 60): 342 applications fer restoration of patents were received and 181 applications were

(h) Assignment, mortgage, license and 69): 2098 received for regiscration of . out of which 1685 were dispo,sed off during tile reporting year.

of Patents (Under Section 146): The ratent Office received 27946 the reporting year. of which !:i:!01 were s'lown to be working.

-----·---- -·---- ---------· i 2012-13] 2009-10 2010-11 2011-12

Patents in force 3f334 39:>t•4 399d!J I 43920 1

Form ·27 received 24009 34112 27825 I 27946 1

Reported as working 4189 6777 7431 I 6201 \

24 I Offico cf tho CcntrollorGcnGml orPatcn;s, (A)sig'ls.lmdornarks and GfJt"sgraphL-:-allndil~tiortS

.··:.._::·

Ul Compulsory license (under Section 84, Section 92 & 92-A): One application for coo1pulsory license ·.vas rec3ived during the reporting year.

(k) Revocation of patent (under Section 66): In exercise of the powers under section 66 of the Act, the Central G~\·ernment rev·Jked Patent No. 252093 granted to M/s Avesthagen L:miled under se:tion 66 of the Pate_nts Act. 1970 as the same was fourd to be prejudic•al to the public.

(I) Information (Under Section 153): The Patent Office recei·ted 541 recuests during the year for st.:pply of information relating to pater1ts under various provisions of tre Act. as provided in rule 134oftfle Patents Rules 2003.

(m) Duplicat<: Patents (Under Section 154): 16 rcquosts were received .:~nd <lll16 were disposed off.

(n) Registration of Patent agents: Number of new registrations during the year was 05. Total number of registered patent agents as on 31st Man:h, 2013 was 1584.

6. Revenue ·and Expenditure

The Pa!ent Ofiice generated a revenue of Rs. 170.48 crore b\' way oifees on 'larious proceedings under the Act and Rules. During the year. the corresponding cxpcnditum (inclurJirg Design Administration) was Rs. 25.33 Crores. The details of revenue hy way of co'leclion of fees on patents are shown in APPENDIX-G.

7. G!!neral information

Tic?. Sr.iP.ntific II. TP.r.hnie-'!1 Lihrnrie1': of the Patent Offir.P. nt l<nlknl<~ r.nd its hr-'lnr.hes <~I Mumbai, Delhi and Chennai provided facilities to the publi:; 'o:· consultation and rsference work. rt·e inventors of different research and industrial organizations and ct~er members of the public as well as the research scholars of different universities increasingly availed the 1acilit1es.

Pr~sently, the Patent Office, 111 addition to CD-KOMS, Books and Journals, sLbscnbes to sciontific and technical e- journals. About3,347 persons visited the libraries of tho Patent Office to conduct sea·ches through the patent specifications and other publications of the Patent Offices in India and a:Jroad. The search rooms and libraries of these o:fices were also appropriately utilit.ed I.Jy the scientists/technologist:> etc.

Members ofthe public also availed the free online internet search facility provided by the Pateni Office.

OffiC(J of U1o Contronor Gonor!\1 ofPa'.ents. Oosgns., T~de:marks a.nc Googmphicallndic.::ti(Jns .J 25

COPY

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