ipr - a primer on intellectual property rights-dr krishnasarmapathy

A Primer on Intellectual Property Rights

ByDr Pathy.Krishna Sarma

Dr.krishnasarma Pathy

Contents Types of Intellectual Property What is a Patent , its requirements &

specification Patent claims Criteria for claiming inventors Types of patents Infringement & validity of patent Indian patent scenario Patent Cooperation Treaty (PCT) Differences in patent Laws Patent ResourcesDr.krishnasarma Pathy

Types of Intellectual Property

Copyrights Trademark Designs Patents Semiconductor integrated circuit layout

design Geographical indications Trade Secrets


What is a patent?

A right to exclude others from making , using or selling what is claimed in the patent for the life of the patent.

It is NOT a right to make , use or sell your own invention.


Why do patents have value?

Protection for a competitive advantage.

Barrier to entry for deterring competitors.

Licensing can generate revenue on product that are not important to the patent owner’s business.


Patentable Subject Matter

Product Process Machine Article of Manufacture Composition of Matter


Requirements for a patent

Novelty

Non Obviousness / Inventive Step

Utility (Usefulness / Industrial applicability)


The “Novelty” Requirement

Novelty

• The invention was not known or used (region specific) by others prior to the date of filing of first application (EU & others) / date of invention (US).

• The invention was not patented or described in a printed publication any where prior to the date of filing of first application (EU & others) / date of invention (US).


The Novelty Requirement (Cont)

Unpatentable for lack of Novelty• Product or process is expressly

described in a single prior art reference (Anticipation).

• Product or process is inherently present in a single prior art reference (Inherent anticipation).


The ‘ Non obviousness ’ Requirement

An easy-to-use Non obviousness Analysis

• A different plus An advantage can Demonstrate Non obviousness


The ‘ Non obviousness ’ Requirement (Cont)

The Claimed Invention A compound of the

structural formula

Where in R is a lower alkyl radical containing more than one and less than five carbon atoms.

The prior Art A journal publication

described a compound of the structural formula

Where in R is methyl

N

N

O

O

R

R

CN

NR

H N

N

O

O

R

R

CN

NR

H


The ‘ Non obviousness ’ Requirement (Cont)

Analysis of the Non obviousness Issue

• The prior art compound required the R substituent to be methyl (one carbon atom); the claimed compounds required the R substituents to have two , three or four carbon atoms.

• Prior art compound had essentially no anti inflammatory properties; only the claimed compound possessed anti-inflammatory properties.

• The claimed compounds were not obvious in view of the prior art compound because their properties could not have been predicted by a person with ordinary skill in the art based on the structural differences.

• A compound and its properties are inseparable.Dr.krishnasarma Pathy

The ‘ Usefulness ’ Requirement

Usefulness

• Any practical utility• Utility must be expressly stated


Patents are country specific

Almost every country has its own patent low and a person desiring a patent in a particular country must make an application for patent in that country , in accordance with that country’s requirements.

E.g. the rights granted under a United States patent extend only throughout the territory of the United States and have no effect in other countries.


Who can obtain a Patent?

An inventor or any other person/company assigned by the inventor can obtain the patent over his invention.


Details of Patent Specification

Title Field of the invention Background of the invention Summary Detailed description of the invention Claims Abstract Drawing


What is a Patent claim?

A patent claim is a single sentence that clearly explain the “metes and bounds” of the invention.


Metes & Bounds

A patent claim measures the boundaries of Intellectual property like a survey measures the boundaries of real property.


Typical Patent Claims for Chemical Compound

A compound of the general formula I

A compound as claimed above which is N-[2-[[[5-(dimethylamino)methyl-2-furanyl]methyl]thio]ethyl]-N’-methyl-2-nitro-1,1-ethenediamine.

(CH2)nX(CH2)mNHCNHR3Alk-N

R1

R2Y


Claims

Independent Dependent Multiple dependent It is claims and not the patent

which are infringed.


Claims (Cont.)

Claim 1.A method of testing the purity of a sample of lamotrigine or a pharmaceutical dosage form comprising lamotrigine , which method comprises assaying the said sample for the presence of N-[5-amino-6-(2,3-dichlorophenyl)-1,2,4-triazin-3-yl]-2,3-dichlorobenzamide. [Independent claim].

Claim 5.Asmaple of a compound as claimed in claim 1 which is in substantially pure from [dependent claim].

Claim 6.A sample according to claim 1 and 5 which has a purity level of 90% or above [Multiple dependent claim]. Dr.krishnasarma Pathy

Criteria for Naming Inventors in an Application

for Patent

All persons who contribute towards development

of patentable features of an invention should be named inventor(s).

All persons who have made intellectual contribution in achieving the final results of the

research work leading to a patent should be named inventor(s).

A person who has not contributed intellectually in the development of an invention is not entitled to be included as an inventor.


Criteria for Naming Inventors in an Application

for Patent (Cont)

A person who provides ideas needed to produce the important features of the invention need not himself/herself carry out the experiments , construct the apparatus with his/her own hands or make the drawings himself/herself. The person may take the help of others. Such person who helped in conducting the experiments , constructing apparatus or making the drawing or models without providing any intellectual input are not entitled to be named inventors.


Criteria for Naming Inventors in an Application for Patent

(Cont)

Quite often difficulties are experienced in deciding the names of inventors. To avoid such a situation, it is very essential that all scientists engaged in research should keep factual , clear and accurate records of daily work done by them in the form of diary/journals/note book. The pages in the diary should be consecutively numbered and the entries made be signed both by the scientist and the concerned leader.


If two or more persons work together to make an invention to whom will

the patent be granted?

If each had a share in the ideas forming the invention as defined in the claims-even if only as to one claim, they are joint inventors and a patent will be issued to them jointly on the basis of a proper patent application. If, on the other hand , one of these persons has provided all of the ideas of the invention , and the other has only followed instructions in making it, the person who contributed the ideas is the sole inventor and the patent application and patent shall be in his/her name alone. Dr.krishnasarma Pathy

Time period to obtain patent

No fixed time and generally not predictable

However, the period of time which the patent office usually requires to review and grant the patent varies from about 1.5 to 3 years.


Types of patents Design patent Plant varieties patent Utility patent• Generic patent• Specific patent• Method of use patent• Composition patent Formulation patent Platform technology patentDr.krishnasarma Pathy

Generic patent Specific patent

Examples Benzimidazole

compounds. Alpha adrenergic

blocking agents. Compound of

formula I

Examples Omeprazole Omeprazole

magnesium Omeprazole Form

B


Method of use patents Composition patents

Examples

Method of treating anxiety

Method of treating gastrointestinal disorders…..

Examples

Formulation comprising atorvastatin and basifying agent

Osmotic composition comprising…..


Patent Filing

Provisional specification To be filed to protect the Intellectual

property and claim the earlier property dates.

Complete specification To be filed within 12 month from the

priority date if provisional application is filed. Dr.krishnasarma Pathy

Infringement and Validity of Patent


Types of Infringement

Literal Infringement Infringement under doctrine of

equivalence Induced Infringement Contributory Infringement


Literal Infringement

If patent claims methanol for crystallization and infringer uses methanol to crystallize , there is Literal Infringement of the patented invention.


Infringement under doctrine of equivalence

If patent claims methanol for crystallization and infringer uses ethanol to crystallize , there is no literal infringement of the patented invention , however there is Infringement under doctrine of equivalence.


Duty of patent Holder

It is the sole duty/responsibility of the patentee to see that his patent is not being infringed upon by someone else. It is the patentee’s duty to file a suit of infringement against the infringer.


Invalidation/Opposition

Patents are not enforceable if obtained through inequitable conduct.

Patents can be challenged in court and invalidated.

One , all or different claims of patent can be subjected to invalidity challenges at one time.


India 2005

Understanding the present Scenario


India in the WTO context

India is a signatory to the WTO resolution on TRIPS agreement.

India was thus committed to recognizing product patents by amending the Indian Patent Act , 1970.


A Historical Perspective Indian patent act,

1970 In force since

20.4.72 A first step towards

recognizing intellectual property in India

Act only recognized process patents

This led to generic version of patented drugs , sold at very low prices

Indian companies have pushed up their market share since 1970 from under 30% to 72%.Growing at over 20% a year. Indian pharma sector is the third largest in the world in volume but much lower down in value of output because of the low prices.


IPA (1970) Amended in March 1999

The patents (Second Amendment)

Amendment Bill 1999 Application for

product patents to be accepted

Application will be processed after 2005

Exclusive Marketing Rights for product

-Till grant of patent or

-For five years Exclusive marketing

right only for drugs for which patent application filed after 1 Jan 1995


Patent Act 2005

Product patent allowed. Mere admixture not patentable. Mere discovery of new use not

patentable. Polymorphs and other forms like

enantiomers, salt, ester, combinations etc. not patentable unless significant enhancement in efficacy is shown.


Cost of patent Filing in India

Individual Legal Entity Form No

Filing 1000 4000 1 Examination 2500 10000 18Grant Request 1500 6000 12Opposition 1500 6000 7Revocation 1500 6000 19


Maintenance of Patent Individual Legal Entity

0-6 years 500*4=2000 2000*4=80007-10 years 1500*4=6000 6000*4=2400011-15 years 3000*5=15000 12000*5=6000016-20 years 5000*5=25000

20000*5=100000

Total Rs.48000 Rs.1,92,000


Patent Cooperation Treaty (PCT)

Patent Cooperation Treaty (PCT)-1970(Amended in 1979 & 1984)


PCT Application It is NOT a world patent. PCT offers a provision for

centralized process of patent filings. The application are designated as

WOXXXXXX. These application do not have any

exclusive rights to the Assignee/Applicant.


Differences in Patent Laws

India USA Europe

First to file First to invent First to file$20 year term #17/20 year term 20 year

term *Extension? Extension possible Extension

possible **Grace period 1 year 1 year No grace

period


Differences in Patent Laws (Cont)

*It is not yet clear whether such provisions of extension would be granted in India in future.

** Allowable period during which applicants own publication / use/ presentation is not considered as prior art for his own patent application.

$ The term is calculated from date of filing of earliest application. For PCT application it is considered as date of filing of PCT application.

# For the application filed on or before 08-june-1995 the term is 17 year from publication or 20 years for earliest filing whichever is greater. For all application filed after 80-june-1995 the term is 20 years from date of earliest filing date.


Differences in Patent Laws India USA Europe

OppositionPre/post grant Under consideration ** third party observation/post

grant Damages*From publication From grant From grant

#Cost of patent 2,12000 Rs. 9080$= 9245 Euro= about 4 Lakh Rs. about 4.6 Lakh Rs.


Differences in Patent Laws (Cont)

*However any such damages from date of publication can only be claimed after the patent grant.

** Third party observation is sort of pre grant opposition with slight difference in procedural aspect and conditions of hearing by the party during the opposition period.

# Shown for legal entity only.Dr.krishnasarma Pathy

Differences in Patent Laws

India USA Europe

Second use claims No Yes * YesMere admixture No Yes Yes Polymorphs # No Yes Yes Combination of Drugs # No Yes

Yes

*Allowable if written as composition of matter claims (Swiss claims).

#Allowed if significant enhancement in efficacy is shown.


Patent Resources

Free patent search resources European patent office: http:/ep.espacenet.com/ US patent office: www.uspto.gov Delphion patent search: www.delphion.com Patent offices worldwide http://www.bl.uk/collections/patents/polinks.html Patent firms http:/www.ipmenu.com/patentattornevlistings.htm British Library patent collection: http:/www.bl.uk/collections/patents/keylinks.html


Conclusion

Beginning today, do not overlook any potential patentable inventions that you create. A patent can be valuable intellectual property that can be used to exclude the competition or to generate financial returns.


THANK YOU


ipr - a primer on intellectual property rights-dr krishnasarmapathy

Documents