India’s Patent Path. Srividhya Ragavan Associate Professor of Law University of Oklahoma College of Law

Historical Background Pre-1970: Process patents for food, pharmaceutical and chemical innovation.  Compulsory licensing after 3 years of grant Indian Patent Act, (post-1995):  Two statutory amendments  Two amendments using Presidential Ordinance

Requirements for Patentability (post-’95): (j) 'invention' means a new product or process involving an inventive step and capable of industrial application; “new invention" (novelty) means any invention or technology which has not been anticipated by publication in any document or used in the country or elsewhere in the world before the date of filing ….  Note: definition is broader than 35 USC 102 (restricts knowledge & use to US activities). Patentability

(ja) 'inventive step' - synonymous to nonobviousness (ja) 'inventive step' … invention not obvious to a person skilled in the art;‘ (amended again in 2005) "inventive step" … 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;  Re: 35 USC 103 – Graham, Hybertech standard Industrial application: utility

Patent Litigation & Implications The Novartis Dispute Novartis, in 1993, invented imatinib. Novartis has a patent on the free base of imatinib. Imatinib mesylate – a salt of imatinib- was used to treat leukemia.  Imatinib mesylate is the polymorphic form of salt that results when imatinib is treated with methanesulfonic acid.  Mail-box application on July 17, 1998 on the polymorph

The Novartis Question Generic drug companies opposed as lacking the efficacy requirement of sec. 3(d)  India has pre & post-grant opposition (allowed within the first year after grant) Novartis filed a writ in MDS High Court and asserted:  Patent validity  Unconstitutionality of §3(d)

§3(d) outlines exclusions from patentability: d) the mere discovery of a new form of a known substance which does not result in increased 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 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.

Meanwhile, in Madison Place, Washington D.C.,: Pfizer v. Apotex : Pfizer sued Apotex for infringing the patent on Norvasc - besylate form of amlodipine.  Norvasc is used to treat hypertension and forms of angina. Apotex alleged that Pfizer’s earlier ‘909 patent over amlodipine anticipated the patent over amlodipine besylates – (salt form of amlodipine). Federal Circuit agreed with Apotex on the grounds that the besylate form lacked enhanced utility from the base compound.  The Federal Circuit reiterated an established principle that salts of known compounds are deemed obvious unless there is an unexpected utility or improvement or efficacy!!

Roche v. Cipla Roche patented erlotinib (2007) and sold as Tarceva at Rs.4,800 ($120) a tablet.  Tarceva covered by US Pat (1996 filing date) Cipla sold a low-cost version at Rs1,600 ($ 40). Cipla asserted invalidity  Tarceva (Erlotinib) is not efficacious than an earlier known compound (Gefatinib).

Patent v. Patient CIPLA could continue producing generic versions of Erlotinib. Case established: 1. Price as a criterion to determine access 2. Statutory CL Bottom Line: To market a pharmaceutical product in India, price consciousness is required

Price as a determinative factor DPCO in India Price control decisions of the US  PhRMA v. Maine  Biotechnology Industry Organization v. District of Columbia (2005) Excessive Pricing Act preempted by federal patent statute

Statutory CL v. Judicial CL in India Statute:  § 84 of Patents Act, 1970 (§ 92A)  3 years from grant After Roche v. CIPLA: Patentee is not entitled to an injunction if a generic manufacturer can prove:  Patented drug is priced more than the generic, and  not locally manufactured (about 90% of MNC drugs would qualify)  Generic is already manufacturing the drug(?)

Judicial CL in the US? Amgen v. Roche (March, 2008) Validity of Amgen’s patent on epogen questioned Roche manufactured cheaper generic- Mircera Amgen’s patent held valid by a Federal Dist. jury (Boston) But, Judge refused permanent injunction based on eBay factors  Mircera ("follow on" biologic version of Epogen) requires less-dosing and hence, tips the "public interest" balance Roche agreed to the Judge’s suggestion of a 22.5% royalty on sale of Mircera on Amgen.

Temporary Injunctions in India Temporary injunctions seemingly not automatic when the counterclaim is invalidity (Roche, Bilcare, Star Plough from MDS)  Exception 1: More than 6 years of grant – possibility of injunctions  Exceptions 2: Exhaustion of opposition rights. Eg: Telemecanique v. Schneider But, once infringement is established, injunction would not be refused (Telemecanique v. Schneider)  Possibly different from eBay: injunctions need not follow infringement

Other practice issues No presumption of validity of patents in India (§ 13(4))  Bilcare v. M/S Amartara (ND HC) & Bilcare v. Supreme Industries (ND Dist)

The End