1. at Pharmexcil, Chennai 24 th August, 2012 by Dr. Gopakumar G. Nair Advisor to Pharmexcil, India Gopakumar Nair Associates Url: www.gnaipr.netwww.gnaipr.net Email: gopanair@gnaipr.netgopanair@gnaipr.net

2. Product Patents In India

3. Patents Act, 1970 Abolished Product Patents for substances intended for use as Food, Drugs And Agrochemicals Came into force on 20 th April, 1972

4. Patents (Amendment) Act, 1999 Came into force retrospectively from 1 st 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

5. Patents (Amendment) Act, 2002 Insertion of Section 3(j) Exception: Microorganisms & Microbiological processes made Patentable Came into force on 20 th 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)

6. Patents (Amendment) Act, 2005 Filing and Grant of Product Patent across all fields of technology including Food, Drugs & Agrochemicals Came into force on 1 st 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)

7. TRIPS – Article 27 Patentable 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.

8. TRIPS – 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][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

9. 9 Three Statutory Pillars of 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

10. Patent - 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 STEP Non-obvious to a person “Skilled in the Art”  Must have INDUSTRIAL APPLICATION Must be Useful Must have Utility 10

11. Invention Section 2(1)(j) “invention” means a new product or process involving an inventive step and capable of industrial application.

12. 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. Discovery

13. Novelty 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).

14. Inventive Step Section 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

15. Non-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. 15

16. Utility / Industrial Application Be Useful Must work / be workable At least one recognized, verifiable and practical end-use 16 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)

17. Patentability 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 17

18.  NCE/NME  API  Product Patent  Process Patent  ‘Me too’ derivatives – Imati nib, Erloti nib  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 18

19. Inventions Not Patentable 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

20. Inventions Not Patentable 3(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

21. Inventions 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

22. Inventions Not Patentable 3(i) Method Of Treatment.  Treatment of malignant tumour cells  However, 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.

23. Inventions Not Patentable 3(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.

24. Inventions 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 Knowledge  Pesticidal / insecticidal properties of neem.

25. Inventions 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.

26. Distinguishing Indian Patentability vis-à-vis US & EU IndiaUSEU Method of Treatment  Swiss Claim (New Use of Known Subs)  ? Composition of Matter? ? Product by Process? Plant PatentsPVPFA Both Research & Other Exemptions (?) Biological Matter (other than Micro-organisms)  (?) Stem Cells / Cloning(?) 

27. Compulsory License India’s 1 st 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 9 th March, 2012. http://ipindia.nic.in/ipoNew/compulsory_Licens e_12032012.pdf

28. …..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 3.Patented invention was not worked in India. – Mere importation of the drug into India.

29. 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.

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

31. …..contd Hearing re-scheduled for 22 nd August, 2012

32. Madras High Court order dtd 06/08/2007 …..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.

33. Landmark Indian Cases Related 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 2008 Justice Rajiv Sahai Endlaw prevented the Drug Controller General of India in allowing marketing approval of generic drug in view of a granted Patent. 33

34. ….. contd 3) Public Interest & Temporary Injunction (Erlotinib) F. Hoffmann-La Roche Ltd. v Cipla Ltd. in 2008 Justice 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.

35. Exemptions In Indian Patents Act, 1970 Relevant to Pharma Patents  Sec. 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 products  Sec.107(A)(a): Research for Regulatory Exemption.  Sec. 107(A)(b): Parallel Import Exemption. 35