Recent Developments in Patent Laws in India

1. Recent Developments in Patent Laws in India Chid S. Iyer Sughrue Mion, PLLC Washington D.C. www.sughrue.com Prepared for APLF Chicago, September 21, 2006 Sughrue Mion PLLC

2. India at a glance • Area 3,287,000 sq Km • History • One of the oldest civilizations • Most major religions took root in India • Kingdoms and Principalities until 1947 • British rule • East India Company 1600-1857 • Direct rule 1857-1947 • Independence 1947 Sughrue Mion PLLC

3. India – a giant consumer • Population 1.06 billion • Growth rate 1.5% • Life expectancy 63 yrs • Literacy 61% • Economic indications • 52 mobile phones per 1000 • 7.2 PCs per 1000 • 20 million Internet users • GDP $645 billion with a growth rate of 6.9% • Per capita income of $529 • Substantial middle class • 52 million families with incomes $2K-$25K per year • (significantly higher figures if purchasing power parity is considered) Sughrue Mion PLLC

4. India – a giant consumer • Electricity • Installed capacity of 126,000 MW • Food grain productions +200 million tons • Foreign currency assets $123 billion Sughrue Mion PLLC

5. Advantage INDIA • Over 3 million scientific & technical manpower • Over 0.8 million post graduates in science • Over 1 million graduate engineers • 0.4 million doctors and • 0.3 million graduates in agriculture and veterinary sciences. • Second only to US in English speaking scientific manpower. • Above factors provides significant advantages in • Drugs & Pharmaceuticals, • Biotechnology, • Information Technology, • Space Industry, • Speciality Chemicals and Petrochemicals, etc. Sughrue Mion PLLC

6. History of Patents in India • 1852 British Patent Act • 1911: The Indian Patents and Designs Act promulgated. • Product patent and Process patent in all fields • 1950s and 60s. MNCs dominate new formulations • 1970s: Patents Act 1970 comes into force in 1972. • Medicines, Food and Agro-chemicals removed from product patent (and put under process patent). • Term of patent -Product Patent (for items other than above) 14 years; • Process Patent 7 years. • 1980s: MNC influence declines to some extent. • 1990s: MNC influence further declines. Significant amount of indigenous production and export. Sughrue Mion PLLC

7. History of Patents • 1995: WTO – TRIPS comes into effect. • 1999-2002: TRIPS compliant laws- • the First Amendment in the Patents Act . • 2002: Second Amendment – • India’s Patents Law brought in line with TRIPs. • Patent term of 20 years for both product and process patents, change in burden of proof etc. • Medicines, Food and Agro-chemicals to continue to be under process patenting till 31 Dec 2004. • Product patent in all other areas continues • 1-1-2005: Ordnance passed introducing product patent in Medicines, Food and Agro-chemicals. • Increasing R&D activity expected in post 2005 period. Sughrue Mion PLLC

8. Position Pre - 2005 • Patents granted for Products other than medicines, agro-chemicals and food • Only process patents for the above • Mail Box provision for pharmaceutical substance • Examination from 1.1.2005 • Exclusive Marketing Rights • 5 yr Patent term for pharma and food process patents and 14 years for others Sughrue Mion PLLC 8

9. Present Position – Post 2005Amendments Patentable subject matter includes all products and processes including • Medicines • Diagnostic substances • Intermediate chemical substances for manufacture of medicine • Fertilizers, insecticides, pesticides, fungicides, weedicides Sughrue Mion PLLC

10. Important Changes • Pre-grant opposition • 20 year patent term for all categories • IP Appellate Board Setup Sughrue Mion PLLC

11. The Patents Act – Post 2005 Definitions • Any new product or process involving an inventive Step and Capable Of Industrial Application • Inventive step is a feature involving technical advancement or economic significance or a combination of above • Non obvious to a person skilled in the art Sughrue Mion PLLC

12. Definitions • Any new invention or technology not anticipated by publication anywhere in the world before filing of complete application and not anticipated by use anywhere in the world • Patentable Pharmaceutical Substance is any New (Chemical) Entity Involving one or more Inventive Step Sughrue Mion PLLC

13. Exclusions Following are not inventions: • Frivolous or contrary to natural laws • Contrary to public order, morality, harmful to humans, animals, plants and environment • Mere discovery of a scientific principle • Formulation of an abstract theory • Discovery of living things or non living substances in nature. • Method of horticulture/agriculture Sughrue Mion PLLC

14. Exclusions • Discovery - Substance freely occurring in nature • Substance in nature patentable may be patentable when isolated from its surroundings and having a technical effect Sughrue Mion PLLC

15. Exclusions • New use and forms • Method of Treatment • Plants, animals and parts thereof (micoroganisms are patentable under certain conditions) • Essentially Biological Processes • Computer Programs per se Sughrue Mion PLLC

16. New use and forms The following are not inventions: • New form of a known substance without enhancement in efficacy • Mere discovery of new property or new use of a known substance • Mere use of known process unless it results in a new product and employs at least a new reactant Sughrue Mion PLLC

17. Examples of non-patentable known substances • Salts • Esters • Ethers • Polymorphs • Metabolites • Pure form • Particle size • Isomers, • Mixtures of isomers Complexes • Combinations • Other derivatives of known substance The above considered to be same substance unless they differ significantly in properties with regard to efficacy Sughrue Mion PLLC

18. Method of Treatment • Medicinal, surgical, curative, prophylactic, diagnostic, therapeutic treatment of animals and humans not patentable • Treatment of plants patentable • Diagnostic apparatus - patentable Sughrue Mion PLLC

19. Living Organisms • Micro organisms - patentable • Isolated • Mutated • Adapted • Recombinant • Mandatory deposition required • Source needs to be disclosed Sughrue Mion PLLC

20. Dimminaco Ag Vs Controller of Patents • Patent application filed on 28.1.98 • Invention - process for preparation of infectious bursitis vaccine • Controller of Patents refused to allow application since • end product of the process resulted in living organism • process not patentable : no patent so far granted for “living organism” FACTS Sughrue Mion PLLC

21. Dimminaco Ag Vs Controller of Patents • Patent for process for preparation of infectious bursitis vaccine • Invention involved live (attenuated) vaccine • Controller of Patents refused to allow application since • end product of the process resulted in living organism • process not patentable as it was a “living organism” Sughrue Mion PLLC

22. Dimminaco Ag Vs Controller of Patents • The Court held that: • the contentions of Controller not justified • Law does not bar processes where the end-product is “living” Sughrue Mion PLLC

23. Impact of Dimminaco • Landmark decision • In consonance with world patent practice • Most processes in the biotechnology field will be patentable: irrespective of whether resultant product is living or non-living Sughrue Mion PLLC

24. Living Organisms Excluded from patentability: • Plants and animals and parts including • Whole e.g. transgenic animals • Organs • Seeds • Varieties and species • Essentially Biological Processes Sughrue Mion PLLC

25. Essentially Biological Processes UK Examination Guidelines: • To be judged on the basis of the invention • Non trivial human intervention/contribution Sughrue Mion PLLC

26. Computer Programs Non-patentable • Mathematical methods • Business methods • Algorithms Sughrue Mion PLLC

27. Patentability of Computer Programs • Similar to EP provisions • Computer programs per se not patentable • Computer programs with technical effect – patentable • No technical effect for simple interaction between hardware and software Sughrue Mion PLLC

28. Research Exemptions to Infringement • Inventions may be used for • Research • Experiments • Education and training Sughrue Mion PLLC

29. Compulsory Licensing • Provisions existed since 1911 • None granted so far • Provisions based on (compliant with) TRIPS and Doha Declaration Sughrue Mion PLLC 29

30. Compulsory Licensing • May be granted to any third person after 3 years of grant of patent • Invention is not worked in India • products not available to the public at affordable price • if reasonable requirements of the public not satisfied Sughrue Mion PLLC

31. Compulsory Licensing ... • Granted on Application by a third party showing interest • Grant is made after a hearing by the Controller of Patents Sughrue Mion PLLC

32. Compulsory Licensing ... • Factors considered • Nature of invention • Applicant’s ability & capacity • Whether Applicant has made any effort to obtain license from Patentee on reasonable term • Measures taken by the patentee or licensee Sughrue Mion PLLC

33. Compulsory Licensing ... • Compulsory licensing may also be granted for national emergency, extreme urgency and public health crisis • Patentee entitled to reasonable payment on licensing in all cases Sughrue Mion PLLC

34. Compulsory Licensing ... • Revocation of Patent after two years from grant of first compulsory license if conditions that led to the license do not change. • Patentee can apply to terminate license if condition changes Sughrue Mion PLLC

35. Summary • Patentable subject matter consistent with most major jurisdictions • Micro-organisms patentable • TRIPS compliant • Major improvement for Pharmaceutical and Biotech Industries Sughrue Mion PLLC

36. Thank You I thank Mr. Lakshmikumaran of the firm of Lakshmikumaran & Sreedharan (New Delhi, India) for helping me with the material on Indian Law Sughrue Mion PLLC