Access to Medicines in Light of Patent Law Regime in India A LEGACY OF LEGISLATION OR LEASE OF THE JUDICIARY?

State of Public Health of India  Hepatitis-B: most common food or water-borne disease in India (National Center for Biotechnology Information (NCBI), USA)  Typhoid: 20, 000 people die in India every year (UNAIDS)  Malaria: Appox. 40,000 deaths per year (NCBI)  Chikungunya: 1.39 million reported cases  HIV-AIDS: 2.1 million patients (UN AIDS)  2015 statistics: overall reduction by 57% from 2.74 lakh in 2000 to 1.16 lakh in The total number is 20.9 lakh in 2011, 86% of whom were in the years age-group.

History of Patent Law in India  The Protection of Inventions Act, 1856 and 1859 and the Patents and Designs Protection Act, 1872 were consolidated into Patents Act, 1911  Law revised when did not respond to needs of the society and keeping pace with industrial development  1911 Act reviewed by Tek Chand Committee was amended in 1950, The government also introduced another amendment Bill in 1953, but was not passed.  Review of the law in 1959: for re-examination of the patent law: Ayyangar Committee appointed to recommend reforms in the law.

History of Patent Law in India  1995: Joined WTO and with it had to join TRIPS  TRIPS provisions for medicines: product patents for pharmaceuticals which India opposed to and negotiated for in-built flexibilities.  Flexibilities were added to TRIPS through Fourth Biennial Ministerial Conference in Doha: Also known as Doha Declaration on TRIPS and Public Health  developing countries which did not provide for patent protection for pharmaceuticals were given 10-year transition period to establish such protection.

TRIPS AND ITS CONSEQUENCES ON INDIAN PATENT LAW  Fulfil requirements of TRIPS until 2005: 10 year transition period  Meanwhile provide for “mail box” for applications that would be examined when 2005 amendments came into effect.  Government passed an ordinance on December 31, 2004 to comply with the deadline and bring law into force  The ordinance received widespread protests from several advocacy groups.  Globalized advocacy efforts around the bill resulted in Patents (Amendment) Act, 2005

Patents Amendment Act, 2005  Deletion of Section 5: product patents for food, drugs, medicines and chemical substances  Amendments to Section 2(1)(j), (ja)  Inclusion of Section 3(d): new form or new properties of known substances not patentable unless enhanced efficacy can be shown  Deleted Chapter IV A of the 1970 Act, dealing with EMRs: introduced by the Patents Amendment Act, 1999.

Indian Legislative and Judicial Response to TRIPS  Roche India granted product patent for Pegasys, a drug used for treatment of Hepatitis-C was the MNC to be granted product patent after the implementation of TRIPS provisions  In 2007, Wockhardt, Indian generic major and Sankalp, and NGO raised concerns with regard to the prices of the drug filed a post-grant opposition and the patent was invalidated by IPAB after six years of grant

Compulsory Licensing  India has introduced robust versions of Compulsory Licensing  Section 84(1) of the Act: grounds for grant of compulsory license  Section 90 (1) (vii): the Controller shall secure the license is granted for the primary purpose of supply in the Indian market, and the licensee may export the patented product, if need be.  Section 92A: Compulsory license may also be made available for manufacture and export of the patented pharmaceutical sector, if the country permits the importation of pharmaceuticals from India

Examples of Compulsory Licensing Cases  first case: IPO granted compulsory license to NATCO for the drug Nexavar, against the Germany-based pharmaceutical company, Bayer.  Compulsory license granted against BDR Pharmaceuticals Pvt. Ltd. Against Bristol-Myers Squibb (BMS), for manufacturing and marketing of anti- cancer pharmaceutical compound, Dastanib.  Section 92A: AP/Telegana High Court granted compulsory license to Mylan Laboratories for exporting its generic drug “Atazanavir” to Venezuela for treatment of HIV.

Section 3(d): Restrictions on Patentability for “new forms of known substances”  prohibits the patenting of new forms or new uses of known substances, if “enhanced efficacy” is not proved  Explanation: salts, esters, polymorphs, complexes, combinations and other derivatives, of known substance shall be considered to same substance  Stark contrast from the US patent law where derivatives, new properties, forms and uses are patentable  unique provision introduced to prevent ever-greening of patents

What is “Increased Efficacy”? Varied Interpretations  The enormous implications of the definition, meaning and scope of “increased efficacy” is demonstrated in the Norvartis judgment  Patent Office granted patent for ‘polymorph’ of Rixamixin, which was a known substance. The polymorph showed 100 times more absorption levels than the original levels, resulting in 100 times less toxicity, thus showing ‘enhanced efficacy’  Ajanta Pharma v. Allergan Inc. and Controller of Patents and Designs, combination derivatives showing ‘significant’ efficacy over single therapy is not ‘enhanced’ efficacy.

Recent Judicial Trends: A Balanced Approach  In Ajanta Pharma v. Allergan Inc. and Controller of Patents and Designs, Ajanta Pharma succeeded in revoking the patents for ophthalmological treatments of Allergan, a US. Based pharmaceutical company.  Novartis was granted an interim injunction against Indian generic drug company Wockhardt, thus indicating the intention of the judiciary to protect the interests of the patent rights holders.

Conclusion  Legislative action and judicial responses reveal that both the parliament and the supreme echelons of the judiciary have been careful in protecting the health care needs of the poor by promoting the generic industry through a guarded interpretation of Section 3(d) of the Patents Act,  Legislature has enacted provisions that caters to the health care needs of the society and maintaining its international obligations.  changes in the patent over the period of time largely a response to international undercurrents and developments  India has adopted cleverly the flexibilities under TRIPS