Dr. Shahid A SaacheDept. of Pharmacology

BJGMC, PunePG Guide- Dr. S. A. Divhare

Intellectual Property Litigations: A Case Study of Novartis

Anticancer Drug Glivec in India

Definition

Intellectual property is an intangible creation of human mind, usually expressed or translated into a tangible form that is assigned certain

rights of property.

Constitutional aspect

The US. Constitution authorizes Congress to protect patents (Art. 1, Sec. 8, clause 8):

“Congress shall have the power to promote the progress of science and useful arts, by securing for

limited times to Inventors the exclusive right to their discoveries"

Indian constitution

No mention of IP but just the word "property"

Article 19 - Freedom to acquire, hold and dispose off propertyArticle 31 - Protection from deprivation of property Article 32 - Property could be possessed or acquired for public purpose only by law and only on payment of compensation

Major Types of IP

Functional & Technical Inventions

Patents Act, 1970 Amended

in 1999 & 2005

Purely Artistic works

Copyright Act,1957

Amended in1982,1984, 1992,

1994 & 1999

A symbol, logo, word, sound, color, design, etc.

TrademarkAct, 1999Amended in 1994,1996 & 2000

Copyright The term original in the copyright law means that the

work originated with the author There is no requirement for novelty or uniqueness as

there is in patent law Copyright law protects the expression of an idea

not the idea itself

What is covered by copyright?

Literary Films Dramatic

Musical Sound RecordingArtistic

What is not covered by copyright?

Ideas Facts Recipes Works lacking originality

(e.g. The phone book) Names, titles or short

phrases

Registration Procedure

Register a copyright by completing a simple application form, along with appropriate fee

Need not send a copy of your work It may appear with the same title, but if each work

has been created independently, each will have its own copyright protection

Duration of Copyright

Copyright lasts for- Author’s lifetime + 50 years from the end of calendar

year in which the author dies 50 years for films & sound recordings 25 years for typographical arrangements of a

published edition Copyright protection always expires on December 31

of the last calendar year of protection

PATENTS Word “Patent”- “litterae patentes” meaning an open

letter Covered under the Act called the Patents Act, 1970

[Amended by Patents Act, 2005]

Invention patentable if... New (novel) Useful Not obvious Pertains to patentable subject matter

Life & Duration Term of the patent is 20 years from the date of filling

for all types of inventions The date of patent is the date of filing the application

for patent The term of the patent is counted from this date

Fees For Filing Patent The Government fee for filing a patent application in

India is Rs.1600/- for individuals and Rs.8,000/- for legal entities

No fee for 1st and 2nd year Renewal fee, on yearly basis, is required to be paid

for 3rd to 20th for keeping the patent in force. Patent lapses if renewal fee is not paid within the

prescribed period

Salient features of Indian Patent law

The object: The object of patent law is to encourage scientific research, new technology, industrial progressInventive step: The fundamental principle of Patent law is that a patent is granted only for an invention which must have novelty & utilityUseful: should be useful to the communityImprovement: In order to be patentable, it must satisfy the test of invention or an inventive step

What Does a Patent look Like?

Trademark It is covered under the Act called the Trade Marks Act,

1999 --- came into effect on Sept 15, 2003 It replaced the Trade and Merchandise Marks Act, 1958

™ Intent to use application filed for productSM Intent to use application filed for services

® Registered trademark

Registration Procedure Application for search Application for registration Examination of trademark Advertisement of trademark Filing of opposition Certificate issued

DURATION & FEES OF TRADEMARK

• Trademark is valid for 10 years from the date of application which may be renewed for further period of 10 years on payment of prescribed fees.

• Service mark Rights are reserved exclusively for owners for 17 year & it can also be renewed.

• The Govt. fees

The case of Novartis

Anticancer drug Glivec in India

Novartis International AG is swiss MNC based in Basel, Switzerland is 3rd largest beneficiary of registered patents in India.

Generic pharmaceutical manufacturers dominate the Indian pharmaceutical market, accounting for up to 90% of product sales

Given its capacity to produce large quantities of drugs at cheap, affordable prices, India is known to many as the “Pharmacy of the Developing World”

India now supplies 80% of the 6 million people receiving treatment for HIV/AIDS in the developing world today

India and TRIPS agreement

For well over 30 years, the Indian government did not allow product patents for pharmaceutical inventions, paving the way for Indian generics companies to

“freely produce medicines created by foreign drug companies at a fraction of the cost”.

• In 1995, India became a member of WTO & was compelled to revise its patent laws following a 10-year transition period.

• India’s adjusted laws had to comply with the TRIPS Agreement i.e. WTO’s minimum standards for intellectual property protection.

Process patents, on the other hand, were recognized as they were seen as an incentive for domestic manufacturers to develop “cheaper methods of making expensive patented products”, and a way for the Indian government to keep drug prices low

India’s domestic patent provisions have been contested by the international research-based pharmaceutical industry

provisions in its domestic law that ban ‘EVERGREENING’

Criteria for ‘Compulsory licensing’ a clause permissible under the TRIPS Agreement, which under extenuating circumstances, permits a country to “force a firm to license a patented drug to a generic company”

History of case

Filing of patent by Novartis: Novartis filed an application at Chennai patent office

in 1997 to grant a patent on Glivec At that time India did not yet grant patents on

medicines In Nov. 10, 2003 Novartis able to get EMR (Exclusive

Marketing Rights) for a period of 5 years based on previous provision of Indian patent act

Granting EMR was a TRIPS obligation for countries like India which do not give patent on pharmaceutical products

After 2005 , Indian Patent Office began to review pharma product patent applications EMR are either given patent or are rejected

If rejected EMR rights also ends EMR works like a patent monopoly which prevents

other pharma companies to manufacture of sell generic products of Imatinib Mesylate

Pre-grant opposition of patent Cancer patient aid association (CPAA) has filed an

opposition on behalf of cancer patients in the Chennai patent office

Pre grant opposition of Glivec1. Claims show that patent is granted not on the

compound in its free form but also for the salt form of Imatinib Mesylate

2. There is no inventive step, specifications do not show any inventive step in making salt from free base of Imatinib Mesylate & the process described is too obvious for the person skilled in art

1. Crystal salt form does not allow to invention2. Patent application does not claim any therapeutic

efficacy- sec 3(d)3. At the time of filing the patent application in 1998

Switzerland is not recognized as convention country in India

Moreover to these grounds Glivec costs Rs.1,20,000 per patient per month which is not affordable in comparison to cost of generic medicines which is Rs. 8000 per month per person

This is beneficial for public health in developing countries like India

Also India is the main market of medicine for developing countries, so low cost medicines are needed

Issuing of patent will effect such requirements

Novartis’ patent application rejected by Patent Controller

In January 2006, the Patent Controller in Chennai, refused to grant Novartis a patent, agreeing, amongst others, with the contentions of the CPAA and generic companies that the subject application lacked novelty, was obvious, was not patentable under section 3(d)

Sec 3(d) of Indian Patents (amendment) act, 2005

“the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant”

In June 2006, Novartis AG & its Indian subsidiary, Novartis India, filed a series of writ petitions against the Government of India, CPAA and 4 Indian generic manufacturers before the Madras High Court

In April 2007 the Government of India notified the IPAB to hear appeals relating to patents

Consequently, Novartis’ appeals were transferred to the IPAB- a specialist tribunal on matters relating to intellectual property

Constitutional validity of section 3(d) upheld by Madras High Court

In August 2007, Madras High Court issued its decision rejecting Novartis’ writ petitions challenging the validity of section 3(d)

Novartis’ primary contention in its challenge to the constitutional validity of section 3(d) was that the use of the term “efficacy” in section 3(d) is vague and ambiguous, and therefore violates the equality provision (Article 14) of the Indian Constitution

During the arguments, while conceding that the meaning of the term “efficacy” is known, Novartis contended that because there was no clarity as to what constituted “enhancement of efficacy” and “significant enhancement of efficacy” as required by section 3(d), the law was vague and lent itself to arbitrary decisions by the Patent Controller

The Government of India, CPAA and generic companies argued that section 3(d) is not in violation of the equality provision of the Indian Constitution as the concept of efficacy is well-known to persons in the pharmaceutical industry and it is impossible to lay down a “one size fits all” standard to determine what constitutes a significant enhancement of efficacy

Dismissing the petition, the Madras High Court held that section 3(d) was not vague or arbitrary and therefore did not violate the Indian Constitution

The term “efficacy” was known in the pharmaceutical field to mean “therapeutic efficacy”

Madras HC states- “We have borne in mind the object which the Amending Act wanted to achieve namely, to prevent evergreening; to provide easy access to the citizens of this country to life saving drugs and to discharge their Constitutional obligation of providing good health care to it’s citizens.”

Appeal on merits rejected on the ground of section 3(d)Commenced before the IPAB: After a series of litigation in which Novartis contested

the constitution of the IPAB, Novartis’ appeal challenging the patent controller’s order was finally heard by a specially constituted bench of the IPAB

In its decision issued in june 2009, the IPAB overturned the patent controller’s findings on novelty and inventive step and held that the beta-crystalline form of imatinib mesylate was new and involved an inventive step

However, the IPAB held that Novartis’ alleged invention did not satisfy the test of section 3(d) in as much as Novartis did not provide data to show that the beta-crystalline form of imatinib mesylate exhibited significantly enhanced therapeutic efficacy over imatinib mesylate, the known substance

In the appeals, the IPAB reversed the Patent Controller order on two grounds, and held that the claimed invention was novel and inventive

However, it agreed with the Patent Controller that it was hit by Section 3(d) & rejected the patent application

Subsequently in 2009, Novartis appealed directly before the Supreme Court through a special leave petition under Article 136 of the Indian constitution

Rejection by Supreme court

Chief contentions of Novartis were as follows1. Company had met the required criteria of novelty &

inventive step 2. Compound in its β-crystalline form had enhanced

efficacy over other variants of the same compound such as imatinib or imatinib mesylate and thereby all requirements of the section 3(d) of the Indian patents act, 1970 stands fulfilled

3. Sufficient research was carried out to selectively prepare beta crystalline form of imatinib mesylate & it was worthy of being granted patent rights

The contentions made by the Additional Solicitor General of India are as follows β-crystalline form of the compound is neither novel

nor non-obvious owing to publications about it in the ‘Cancer Research and Nature’ in 1996, and various other disclosures in Zimmerman patents & by FDA

Requirement of efficacy as stated in section 3(d) of the Act should be held to be interpreted on lines of therapeutic efficacy and not merely one of physical efficacy

Taking into consideration the contentions of the parties, the Supreme court held that Novartis failed to meet the requirement of novelty

And also thereby failing to qualify for the test of invention as provided for under in section 2(1)(j) and section 2(1)(ja) of the Patents Act, 1970 as a result of the various publications and disclosures already made about the beta crystalline form of the compound, Imatinib Mesylate

Section 2(1)(j) in The Patents Act, 1970 “Invention" means a new product or process

involving an inventive step & capable of industrial application

“Inventive step" means a feature of an invention that involves technical advance as compared to the existing knowledge or having economic significance or both and that makes the invention not obvious to a person skilled in the art

Further the court decided to interpret efficacy as laid down in section 3(d) of the Act of lines of therapeutic efficacy and not merely physical efficacy

Though physical efficacy of imatinib mesylate in beta crystalline form is enhanced in comparison to other forms, but since there was no substantive and conclusive material and evidence to prove that beta crystalline form of imatinib mesylate will produce an enhanced or superior therapeutic efficacy, Novartis failed to meet the requirements under section 3(d) of the act

On these grounds Supreme court also rejected the patent application on April 2013

Case summary

September 2012: Hearing began in the Supreme Court.

August 2009: Novartis approached the Supreme Court of India.

June 2009: The Intellectual Property Appellate Board rejected a fresh appeal.

August 2007: The Madras High Court ruled against Novartis's case.

May 2006: Novartis challenged the Indian government and four other companies in the Madras High Court.

January 2006: The Patent Controller in Chennai denied Novartis a patent.

2005: India introduced the Indian Patent Act preventing frivolous patents.

1997: Novartis filed a patent application in India for its drug Glivec.

Thank you