atPharmexcil, Chennai24th August, 2012

by Dr. Gopakumar G. NairAdvisor to Pharmexcil, IndiaGopakumar Nair AssociatesUrl: www.gnaipr.netEmail: gopanair@gnaipr.net

Product Patents In IndiaProduct Patents In India

Patents Act, 1970Patents Act, 1970

Abolished Product Patents for

substances intended for use as

Food, Drugs And Agrochemicals

Came into force on 20th April, 1972

Patents (Amendment) Act, Patents (Amendment) Act, 19991999

Came into force retrospectively from 1st January, 1995

Provided for filing of Product Patent

Applns in the field of Food, Drugs &

Agrochemicals

u/s 5 (2) of the Patents Act, but,

no Grant, only EMR

Patents (Amendment) Act, Patents (Amendment) Act, 20022002

Insertion of Section 3(j)Exception: Microorganisms &

Microbiological processes made Patentable

Came into force on 20th May, 2003

Deletion of Section 3(g)Method of Testing during

manufacture made Patentable

Extension of Term of Patent from 5/7 years to 20 years across all fields of technology.

Deletion of License of Right (Automatic CL)

Patents (Amendment) Act, Patents (Amendment) Act, 20052005

Filing and Grant of Product Patent across

all fields of technology including

Food, Drugs & Agrochemicals

Came into force on 1st January, 2005

1st Product Patent Granted in India for Pharma,

IN198952 granted for Pegasus (Peinterferon

apha-2a) to

F. Hoffmann-la Roche AG on 21st February,

2006 Currently, under Opposition at IPAB,

Chennai

Deletion of Section 5(2)

TRIPS – Article 27TRIPS – Article 27Patentable Subject Matter

1. Subject to the provisions of paragraphs 2 and 3, patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application.

[1] Subject to paragraph 4 of Article 65, paragraph 8 of Article 70 and paragraph 3 of this Article, patents shall be available and patent rights enjoyable without discrimination as to the place of invention, the field of technology and whether products are imported or locally produced.

2. Members may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by their law.

TRIPS – Article 27TRIPS – Article 27

Patentable Subject Matter

3. Members may also exclude from patentability:(a) diagnostic, therapeutic and surgical methods for the

treatment of humans or animals;(b) plants and animals other than micro-organisms, and

essentially biological processes for the production of plants or animals other than non-biological and microbiological processes. However, Members shall provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof. The provisions of this subparagraph shall be reviewed four years after the date of entry into force of the WTO Agreement.

[1] For the purposes of this Article, the terms "inventive step" and "capable of industrial application" may be deemed by a Member to be synonymous with the terms "non-obvious" and "useful" respectively.8

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Three Statutory Pillars of Three Statutory Pillars of

PATENTABILITY PATENTABILITY

1. Novelty (new)

2. Inventive Step (non-obvious) (Sec

2(1)(ja))

3. Industrial Applicability (utility) (Sec 2(1)(ac))

Must not be covered by Sec. 3 or Sec.

4

Patent - PatentabilityPatent - Patentability

An invention can be patented if it is

NOVEL: Must be New, Must DISTINGUISH from “State of the

Art” (PRIOR ART)

Must have INVENTIVE STEPNon-obvious to a person “Skilled in the

Art”

Must have INDUSTRIAL APPLICATIONMust be UsefulMust have Utility

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InventionInvention

Section 2(1)(j)

“invention” means a new product or

process involving an inventive

step and capable of industrial

application.

Discovery adds to the human knowledge

by disclosing something, not seen

before, whereas,

Invention adds to human

knowledge by suggesting

an act to do which

results in a new product or

new process.

Invention vs. DiscoveryInvention vs. Discovery

NoveltyNovelty

Must not be Anticipated by Prior Publication Prior Claiming Prior Public Use Prior Public Knowledge

The anticipatory disclosure must be entirely contained within a single document (no Mosaicing). If more than one document is cited, each must stand on its own. The cumulative effect of the disclosures cannot be taken into consideration nor can the lack of novelty be established by forming a mosaic of elements taken from several documents. This may be done only when arguing obviousness. (Ammonia's Application, 49 RPC 409).

Inventive StepInventive StepSection 2(1)(ja):

"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.14

Non-ObviousNon-Obvious

THE DIFFERENCES BETWEEN THE

CLAIMED INVENTION and the PRIOR ART

are such that the subject matter as a

whole WOULD NOT HAVE BEEN

OBVIOUS at the time the invention was

made to a PERSON SKILLED IN THE ART,

to which the subject matter pertains.

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Utility / Industrial ApplicationUtility / Industrial Application

• Be Useful

• Must work / be workable

• At least one recognized,

verifiable and practical end-use

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Test of Utility: Whether the invention will work and whether it will do what is claimed for it.

Lakhapati Rai & Ors. v. Srikissen Dass & Ors. (1917)

Patentability FilterPatentability Filter

Prior use/ prior publication/ prior disclosure

Industrial applicability Novelty Non-obviousness: inventiveness Sec. 3 - Not patentable Written description / enablement

requirements Application/ specification/ claims Patent prosecution Maintenance / Defense after grant

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NCE/NME API Product Patent Process Patent ‘Me too’ derivatives – Imatinib,

Erlotinib Formulation Dosage Forms – Tablet, Capsule, etc Release Profile – Controlled, Slow etc. NDDS – ex. Transdermal Patches,

Transmucosal Drug Delivery. New Use – Aspirin (analgesic & blood

thinner)

Famotidine

Tiotidine

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Inventions Not Inventions Not PatentablePatentable

Section 3 . What are not inventions.-3(a) Frivolous Or Obviously Contrary

To Well Established Natural Laws; A machine purporting to produce perpetual

motion. A machine allegedly giving 100% performance.

3(b) Contrary To Public Order Or Morality, Prejudice To Human, Animal Or Plant Life Or Health Or To The Environment;

Device, method for committing theft/burglary Biological warfare material

Inventions Not PatentableInventions Not Patentable3(c) Mere Discovery Of Scientific Principle,

Abstract Theory, Living Thing Or Non- living Substances

Discovery of any living thing, micro-organism, naturally occurring material.

3(d)Mere Discovery Of New Form, New Property, New Use Of A Known Process, Machine Or Apparatus (EFFICACY)

Explanation: salts, esters, ethers, etc. New use of Aspirin in heart ailments

Inventions Not PatentableInventions Not Patentable

3(e) Mere Admixture (SYNERGY) mixture of sugar and some colorants in

water to produce a soft drink.

3(f) Mere Arrangement, Re-arrangement, Duplication of known devices.

Umbrella cum Torch

3(g) Omitted (Testing Methods)

3(h) Method Of Agriculture Or Horticulture

method of producing mushroom plant. method of producing improved soil

Inventions Not Inventions Not PatentablePatentable

3(i) Method Of Treatment. Treatment of malignant tumour cellsHowever, Patent can be obtained for

surgical, therapeutic or diagnostic instrument or apparatus.

3(j)Plants, Animals, Including Seeds Varieties, Species, Biological Processes. Exception: Microorganisms

Protection of Plant Varieties & Farmers’ Rights Act, 2002.

Inventions Not PatentableInventions Not Patentable3(k) Mathematical Or Business Method

Or A Computer Program Per Se Or Algorithms;

3(l) Literary, Dramatic, Musical Or Artistic Work, Other Aesthetic Work

Copyright Act, 1957.

3(m) Mere Scheme, Rule, Method Of Performing Mental Act, Playing Game;

Method of learning a language.Method of playing chess.

Inventions Not PatentableInventions Not Patentable

3(n) A Presentation Of Information;Method of expressing information.Business methods

3(o) Topography Of Integrated Circuits;

Semiconductor Integrated Circuit Lay-out Designs Act, 2000

3(p) Traditional KnowledgePesticidal / insecticidal

properties of neem.

Inventions Not PatentableInventions Not Patentable

Section 4: “No Patent shall be granted in

respect of an INVENTION RELATING TO

ATOMIC ENERGY falling within

subsection (1) of section 20 of the

Atomic Energy Act, 1962 (33 of 1962)”

Radioactive Substances or Radioactive

Material

Nuclear Materials, Nuclear-related other

Materials.

Distinguishing Distinguishing Indian Patentability vis-à-vis Indian Patentability vis-à-vis

US & EUUS & EUIndia US EU

Method of Treatment

Swiss Claim(New Use of Known Subs)

?

Composition of Matter ? ?

Product by Process ?

Plant Patents PVPFA Both

Research & Other Exemptions (?) (?)

Biological Matter (other than Micro-organisms)

(?)

Stem Cells / Cloning (?) (?)

Compulsory LicenseCompulsory License

India’s 1st CL granted, u/s 84 of the

Patents Act, 1970, to Natco Ltd. for

Sorafenib (Nexavar®) by Former

Controller General of Patents, Trademarks

and Design, Mr. P. H. Kurian vide order

dated 9th March, 2012.

http://ipindia.nic.in/ipoNew/compulsory_License_12032012.pdf

……..contd..contd

Grounds for Grant of CL

1.Reasonable Requirements of the Public were not satisfied,– Drug was accessible to only 2% of Patients

2.Patented invention was not available to the public at a reasonably affordable price,– Rs.2,80,428/- per month

ØPatented invention was not worked in India.

1.Mere importation of the drug into India.

Section 3(d)Section 3(d)

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.

Explanation:- For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy.

Section 3(d)Section 3(d)Gleevec (Gleevec (Imatinib Mesylate)Imatinib Mesylate)

……..contd..contd

Hearing re-scheduled for 22nd August , 2012

Madras High Court order dtd Madras High Court order dtd 06/08/200706/08/2007…..if the discovery of a new form of a known

substance must be treated as an invention, then the Patent applicant should show that the substance so discovered has a better therapeutic effect - enhanced efficacy …..

all derivatives of a known substance would be deemed to be the same substance unless it differ significantly in properties with regard to efficacy.

the Patent applicant should show the discovery has resulted in the enhancement of the known efficacy of that substance and if the discovery is nothing other than the derivative of a known substance, then, it must be shown that the properties in the derivatives differ significantly with regard to efficacy.

Landmark Indian Cases Landmark Indian Cases Related to PharmaceuticalsRelated to Pharmaceuticals

1) Patent Linkage(a) Bayer Corp vs. UOI (Sorafenib) 2008 to 2010

Division Bench & Supreme Court upheld decision of Single Bench that Patents Act and the Drugs & Cosmetic Act are distinct and separate. Attempt to establish a linkage was not permitted.

(b) BMS Company vs. Hetero (Dasatinib) in 2008Justice Rajiv Sahai Endlaw prevented the Drug Controller General of India in allowing marketing approval of generic drug in view of a granted Patent.

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…….. contd.. contd

3) Public Interest & Temporary Injunction (Erlotinib)

F. Hoffmann-La Roche Ltd. v Cipla Ltd. in

2008Justice S. Ravindra Bhat while rejecting application for ad-interim injunction held that the injury to the public which would be deprived of the defendant’s product, which may lead to shortening of lives of several unknown persons, who are not parties to the suit, and which damage cannot be restituted in monetary terms, is not only uncompensatable, it is irreparable.

Exemptions In Indian Patents Exemptions In Indian Patents Act, 1970Act, 1970

Relevant to Pharma PatentsSec. 3(d), Sec. 3(e), Sec. 3(i), Sec. 3(p).Sec. 47(3), Sec. 47(4), etc.Sec. 84 to Sec. 90: Compulsory Licence

(CL)Sec. 92-A: CL for Export of Patented

Pharma productsSec.107(A)(a): Research for Regulatory

Exemption.Sec. 107(A)(b): Parallel Import Exemption.

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