The Indian Scenario: Generics, Biosimilars and the Law

2. Outline Brief Overview of Patent Law in India Patentability Exclusions in the context of Pharma and Biotech. Biosimilars in India Patent Linkage in India Data Protection / Exclusivity in India Relevant Case Laws

3. Brief Overview of Patent Law Governed by Patent Act, 1970 and Patent Rules, 2003 India follows a first-to-file system In compliance with TRIPS obligations Product patent allowed from 2005 Judicious borrowing of patent jurisprudence from EU/UK

4. Patent Applications Filed in India

5. Non-Patentable Subject-Matter All fields of technology are patentable Section 3 and 4: What are not inventions Section 3(b): Contrary to public order and morality Section 3(c) � discovery of living things Section 3(d) � new forms of a known substance Section 3(e) � composition-mere admixture Section 3(i) � method of treatment of animals and humans Section 3(j) � plants, animals and parts thereof and Essentially Biological Processes Section 3(k) � computer programs per se

6. 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 �. 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 to Section 3(d).�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.

7. Novartis v. UoI Novartis attempted to patent beta crystalline form of imatinib mesylate, already known in prior art Controller rejects as not new, obvious and not patentable under section 3(d) Declared Constitutional by the Madras High Court Efficacy is the therapeutic effect in healing a disease of having a good effect on the body. Mere increase in bio-availability does not indicate that there has been an enhancement in the efficacy. Hence, barred by Section 3(d). Section 3(d): Cases

8. Novartis v. Cipla (December 2009) Section 3(d) is not applicable to NCEs. Ind Swift v. Cadila (Review Petition � August 2010) Original decision of Deputy controller in January 2009 Patent application on crystalline Clopidogrel besylate; known substance was Clopidogrel bisulphate salt and solvated forms of Clopidogrel besylate Deputy Controller overruled Section 3(d) on the basis that the invention is more stable, has increased shelf life, is more free flowing and less cardiotoxic. This was upheld on Review. Roche v. Cipla (August 2010) Section 3(d) does not apply to process A pharmaceutical composition of two known substances � Section 3(d) not attracted. Section 3(d): Cases

9. Section 3(i) Method of Treatment �any process for the medicinal, surgical, curative, prophylactic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products� Treatment of disease required Treatment of plants patentable Diagnostic kits patentable Cosmetic enhancement?

10. Section 3(j) Section 3(j) � plants, animals & parts thereof �plants and animals in whole or any part thereof other than microorganisms but including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals; Microorganisms Patentable Genes & Antibodies Patentable Stem Cells/Plant Cells?

11. Inventive Step KSR v teleflex � persuasive Implied admission of �obvious to try� Routine experimentation and verification of data is not inventive even when time and money is spent on it (CO:3598/ DELNP/ 2004) Converting API to polymorphs using known techniques with reasonable expectation of success will amount to obvious efforts (CO:3598/ DELNP/ 2004) Issues regarding Selection Patents

12. Loss of Revenue to major Pharma companies due to expiration of patents

13. List of major drugs whose patents are expiring and for which para IV filing have been filed

19. Regulatory Process Drug Controller General of India. May involve other regulatory bodies Genetic Engineering Approval Council (GEAC) Recombinant DNA Advisory Committee (RDAC), Review Committee on Genetic Manipulation (RCGM), Institutional Biosafety Committee (IBSC) No separate approval process No Exclusive Guidelines; applied on a Case-to-Case by Indian Pharmacopoeia Commission (IPC) in collaboration with National Institute of Biologicals (NIB) Since 2004 � plans and discussions for exclusive guidelines on biosimilars Biosimilars in India: Approval Process

20. No statutory provision Satwant Reddy Report of 2007 Article 39.3 of TRIPS does not �require data exclusivity� May not be in India's national interest to grant �data exclusivity� to pharmaceutical drug data Recommended fixed 3 years data protection for agro-chemicals The Pesticides Management Bill, 2008 Pharmaceuticals Prevent unauthorized disclosure of data. In the long-term , fixed period of 5 years � the drug regulatory authorities would not rely on originator�s data. Government Notifications of 30th October, 2007 and 18th February, 2008, under Insecticides Act, 1968 Limited 3 year data exclusivity Validity questionable � (Sygenta v. UOI � 2009 Del HC) Data Exclusivity

21. Recent Case Laws Roche v. Cipla, (2009, Del HC) Product: Erlotinib � Tarceva (TM name) Decision: Injunction denied Reason: Between the public interest in granting an injunction to affirm a patent during the pendency of an infringement action, as opposed to the public interest in access for the people to a life saving drug, the balance has to be tilted in favor of the latter. Reduced price of the generic drug was a major consideration in not granting any injunction.

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