Access to Medicines in India: The Strategy of Pre-grant oppositions

1. Access to Medicines in India: The Strategy of Pre-grant oppositions Anand Grover, Lawyers Collective HIV/AIDS Unit, India aidslaw@lawyerscollective.org Lawyers Collective HIV/AIDS Unit

2. Indian Patents Act 1970 • No product patent for drugs or chemicals • Process patents only protected • Protection only for only seven years • Result: No monopoly in products • Enabled competition • More than one manufacturer • Drugs in India available at the lowest prices in the world • Provisions to tackle abuse of monopoly like Compulsory Licenses existed to facilitate availability & accessibility Lawyers Collective HIV/AIDS Unit

3. TRIPS Patent Regime • Patentable: Invention which is new, involve an inventive step and capable of industrial application, Excludes patenting of plants and animals, except microorganisms and varieties of plants • Type of Protection: For Products and Processes • Period of Protection: Minimum 20 years for both • Interim period 1995 to 2004: Provides for Exclusive Marketing Rights • Minimum conditions for granting of compulsory license: Consent, Judicial Review, Limiting Period provided for • Compulsory License: Consent not required in cases of national emergency, extreme urgency, non-commercial public use, anti-competitive practices • Which Drugs: Applies to drugs which are invented in the world on or after 1.1.1995 Lawyers Collective HIV/AIDS Unit

4. Patents (Amendment) Act 2005 • In March 2005 India enacted a TRIPS compliant law with full product-patent protection for 20 years with the following significnant provisions: • § 2 (j) – “invention” means a new product or process involving an inventive step and capable of industrial application; • § 2 (j a) – “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 Lawyers Collective HIV/AIDS Unit

5. Patents (Amendment) Act 2005 § 3 Not an invention (Specific to Indian law) • 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, mere discovery of any new property or new use for a known substance ” • [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 substances shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy.” • 3(e):a substance obtained by mere admixture resulting only in aggregation of properties Lawyers Collective HIV/AIDS Unit

6. Accessibility and affordability:Options Under Patent Law: • Pre-Grant Oppositions • Post-Grant Opposition Voluntary licensing • Revocation (by interested person or Central Government on a petition to the Appellate Board or in an infringement suit by a counterclaim, s 64) • Compulsory Licensing • Non-commercial public use Under Drug Price Control Order • Minimum Turnover: Rs 10crores (USD 2 million) • Cannot control imported drugs. • Government is seeking to linking to grant of patent Lawyers Collective HIV/AIDS Unit

7. Patents (Amendment) Act 2005 – Patent Oppositions, pre and post-grant: § 25 (1): “Where an application for a patent has been published but a patent has not been granted, any person may, in writing, represent by way of opposition to the Controller against the grant of the patent…” involves summary hearing § 25 (2): “At any time after the grant of patent but before the expiry of a period of one year from the date of publication of grant of a patent, any person interested may give notice of opposition to the Controller…”involves leading of evidence and trial • Identical grounds provided in 25 (1) and (2) Lawyers Collective HIV/AIDS Unit

8. Pre–Grant Oppositions :Gleevec • In December 2003, Novartis was granted exclusive marketing right on Gleevec – a crucial treatment for chronic myeloid leukemia in India • Novartis’s price – Rs 120,000 (USD 2700) per month; Indian generics’ price – Rs 8500 (USD 200) per month. • Cancer Patients Aid Association (CPAA) opposed the grant of patent for Gleevec Lawyers Collective HIV/AIDS Unit

9. Pre–Grant Oppositions :Gleevec Novartis’s application for grant patent for Gleevec was in respect of about a particular crystalline form of salt, imatinib mesylate, of an already known and drug (imatinib); Novartis argued • the crystalline form it “invented” was efficacious • It had already been granted a patent in 35 other countries. Lawyers Collective HIV/AIDS Unit

10. Pre–Grant Oppositions :Gleevec CPAA argued: • That the salt form of the drug was not new • That the salt form of the drug was an obvious improvement of an existing drug; • The crystalline form was just a new form of a known substance • There was no significant difference in properties regarding to efficacy [sec 3(d)] • Other countries laws are totally irrelevant and India Patent law was not subject to their law Lawyers Collective HIV/AIDS Unit

11. Pre–Grant Oppositions :Gleevec • In January 2006, Patent Office rejected Novartis’s application for grant of patent for Gleevec Now in August 2006 Novartis have filed • Petition challenging the order of the Patent Controller challenging the rejecting the patent application • petitions in the Madras High Court challenging the order of the Patent Controller and constitutional validity of Section 3 (d) Lawyers Collective HIV/AIDS Unit

12. Pre–Grant Oppositions :Others • PLHA groups have also filed a number of pre-grant oppositons against the grant of the patents in case of the following:- • Combivir • TDF • Abacavir • Atazanavir • Valganciclovir • Amprenavir • PLWHA groups are fully involved and in the process of developing capacity on issues relating to patents Lawyers Collective HIV/AIDS Unit

13. Pre–Grant Oppositions :Others Most of the oppositions take the following grounds:- • The alleged invention is not new; • The alleged invention is obvious; • The drug is a “new use” for a known substance and is not patentable under 3(d); • The combination is a “new form” of a known substance and is not patentable under sec. 3(d); • The combination is a “mere admixture” of its component parts and thus not patentable under 3(e); • The patent applicant has not disclosed the full details of the other applications that they are pursuing Lawyers Collective HIV/AIDS Unit

14. ARV Rollout in India Estimate of the umber of PLWHA: 52 lacs Estimate of the number needing ARV: 5-7.5 lacs No of persons actually on 1st Line ARVs: 20,000 on the ARV Rollout, 20,000 on other Government or private sector That is 8% or 5.3% of the actual requirement This is against the global figure of 21.6% The target ultimately is to have 188,000 by 2010, that is 37.6% or 25% of the present requirement This is the position when drugs are cheapest in India Lawyers Collective HIV/AIDS Unit

15. ARV Rollout in Danger 1st line drugs provided in Rollout • Stavudine + Lamivudine +Nevirapine (3TC/NVP) • Zidovudine + Lamividine + Nevirapine (AZT/3TC/NVP) • stavudine / Lamivudine + Efavirenz (d4T/3TC + EFV) This first line drugs are available at about Rs 500 per month With patents being granted there is a danger that even first line drugs will not be available at such prices Second and third line will become even more expensive Lawyers Collective HIV/AIDS Unit