Dr Suman Shrey Singh Asstt . Controller of Patents & Designs THE PATENT OFFICE GOVT OF INDIA www.ipindia.gov.in ,

1. “Patenting in Pharmaceuticals: India and Japan”(Implications of Recent Transformations)SIX- MONTHS STUDY-CUM-RESEARCH FELLOWSHIP PROGRAMUnder FRAMEWORK OF WIPO JAPAN FUNDS-IN-TRUST (INDUSTRIAL PROPERTY) April-September 2010Final Report Presented By: Dr SumanShrey Singh Asstt. Controller of Patents & Designs THE PATENT OFFICE GOVT OF INDIA www.ipindia.gov.in, www.dipp.gov.in ss.singh@nic.in, drsumans@yahoo.com Dr SumanShrey Singh Asstt. Controller of Patents & Designs THE PATENT OFFICE GOVT OF INDIA www.ipindia.gov.in, www.dipp.gov.in ss.singh@nic.in, drsumans@yahoo.com

2. Outline • Preface • Theme & Objectives • Methodology • Study and Analysis • Conclusions

3. Preface • This study-cum-research fellowship is granted by World Intellectual Property Organization (WIPO), Geneva in the framework of fellowship program financed by the Japan Funds-in-Trust arrangement (Industrial Property) to potential Govt. officials with objective to enhance the knowledge and understanding of the fellows on the topical issues in the field of industrial property, by providing them with an opportunity for independent research • There were three officials invited from India, China and Vietnam. • Duration of the fellowship was from April 2010 to September 2010. The Japan Patent Office (JPO) has assumed the responsibility for the overall program in Japan as the local organizer and has entrusted the management of this program to an affiliated organization APIC of JIII. Research facilities of the Tokyo Institute of Technology (TIT) and opportunity to have consultation and discussion with faculty member have been provided. • Throughout the fellowship period, facilities have been given to free use of the research/training facilities, including library , office space and use of personal computers by APIC-JIII. We have been invited for various training courses in the field of IPR for overseas professional organized by APIC-JIII. • Opportunities have been provided to visit industries, attorney firms, JPO-affiliated organizations and IP high court and JPO.

4. Theme & Objectives Patenting in Pharmaceuticals: India and Japan (Implications of Recent Transformations) To understand the significant provisions of the patentability and their implementation practices on both sides and their implications in overall developments in pharmaceutical industry and public health concerns. Understanding the same will further allow filling any gap to provide more strong and effective IP protection to the pharmaceutical industry both side. Hypothesis: Transformation of the national patent regime in the field of pharmaceuticals will catalyze the domestic research and development in medicine and public health care and new molecules will come-up keeping the pace for generic drug manufacturing and there will be larger scope of business relation in this field between the two countries, Japan-India.

5. Methodology • Study of Patent Legislation. • Study of Examination Guidelines and Specific Guidelines for Medical inventions. • Attending Various IP Related Training Courses and Industry Visits. • Study and Analysis of Patenting Trend for Some Significant Aspects. • Meetings with IP users and IP Authorities. • Concluding the Studies.

6. Structure of Report • Preface • Acknowledgement • Chapter I Introduction. • Chapter II Legislative Provisions – Japan. • Chapter III Legislative Provisions – India. • Chapter IV Pharmaceutical Industries – Japan. • Chapter V Pharmaceutical Industries – India. • Chapter VI Participation in Training Courses, Industry Visits and Meetings. • Chapter VII Studies on Patenting Trends: India-Japan. • Chapter VIII Conclusion and Suggestions.

7. Studies Undertaken • Comparative study in Granted Patents. • Comparative Study of Patent on same PCT Application. • Comparative Study in Published Patent Applications . • Patenting in India by Leading Japanese Pharmaceutical companies . • Statistical Analysis of Pharma Patents Granted in India.

8. Studies Undertaken • Patents granted extension of term in Japan. • Web Search for NCE introduced by Indian companies 8. Meeting with the Pharmaceutical Association: - JPMA 9. Meeting with the Pharmaceutical Industry: Daiichi Sankyo Co. Ltd 10. Patenting Trend in NDDS in India

9. Objectives of Study No. 1Comparative study in Granted Patents • The objective of this study is to understand the trend of applicants, domestic vs. foreign and the trend of the type of claims granted (product, method, composition and use) in this specific technological field of medical inventions. This study may reflect any significant difference between the two countries

10. Results of Study No. 1Comparative Study in Granted Patents JPO

11. Result of Study No. 1Comparative study in Granted Patents JPO

12. Result of Study No. 1Comparative study in Granted Patents JPO

13. Conclusion of Study No. 1Comparative study in Granted Patents • India needs for looking in to the motivation for domestic source of inventions for generating more product/basic molecules drug inventions and also maintaining the pace of composition inventions which generally lead to creation of new medicine in the form of generic medicines. There is need to assess and attend the concern of oversea applicants in India.

14. Objectives of Study No.2 “Study of Patent on same PCT Application” • The objective of this study is to understand the trend in structuring the claims of Patent granted in both the Patent Offices for substantively the same application/invention. This study is being done to extract any difference in the practice of two different Patent Offices and also the strategy of applicant in drafting claims with respect to different countries. If there is any change observed, same may be correlated with the provisions in national Legislations or any business strategy of applicants .

15. Results of Study No.2 “Study of Patent on same PCT Application”

16. Results of Study No.2 “Study of Patent on same PCT Application”

17. Results of Study No.2 “Study of Patent on same PCT Application”

18. Conclusion of Study No.2 “Study of Patent on same PCT Application” • There is no significant difference in claims structure and grant in both the country. In general structure of claims, claimed and granted in India and Japan is more or less similar except where the national provisions limit the invention. In few cases in India, it has been noted that composition claims have disclosure of percentage of constituents also. Use claims as in India are generally for single use of substance as medicine while in Japan they are related with the different use of medicine for a particular or different disease as the case may be. As usual in both the county, most case products are claimed with composition and method for preparation of such product.

19. Objectives of Study No.3 “Published Patent Application ”Synthetic compound based and Natural product based Medicines Traditional Med(IPC A61K31/00 and A61K35/00+A61K36/00) • The objective of this study is to understand the comparative trend of applicants, domestic vs. foreign in these two different specific class of medical inventions by Indian Patent Office and Japan Patent Office. This study may reflect any significant difference between the two classes of inventions in medicines.

20. Results of Study No.3 “Published Patent Application ” For India >> Applications Published as on 31st May 2010 For medical preparations containing organic ingredients, IPCA61K 31/00. For Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines. A61K 35/00,78 and 36/00

21. Results of Study No.3 “Published Patent Application ” For India >> Applications Published as on 31st May 2010 Overall ratio between filing in IPCA61K 31/00 & A61K 35/00,78 and 36/00

22. Results of Study No.3 “Published Patent Application ” For Japan >> Publication Date (20100101-20100615) For medical preparations containing organic ingredients, IPCA61K 31/?. For Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines. A61K 35/00,78 and 36/00

23. Results of Study No.3 “Published Patent Application ” For Japan >> Publication Date (20100101-20100615) Overall ratio between filing in IPCA61K 31/00 & A61K 35/00,78 and 36/00

24. Conclusion of Study No.3 “Published Patent Application ” • As such there is no difference between trend in India and Japan. • In addition to synthetic chemistry and combinatorial chemistry, India may capitalize its natural resources in order to find New Chemical Entities (NCEs) by validation of traditional medicines with the help of modern science and thus creation of inventions/patents and also research for New Biological Entity (NBEs).

25. Objectives of Study No.4“Patenting in India by Leading Japanese Companies” • The objective of this study is to understand the trend and presence of domestic industries of Japan in India.

26. Results of Study No.4 “Patenting in India by Leading Japanese Companies” Filing of Patent Application and Grant of Patent at Patent Office India: # (Since 1995) * (Including filing prior to 1995)

27. Conclusion of Study No.4 “Patenting in India by Leading Japanese Companies” • It is good to have a competitive advantage by the presence of leading Japanese pharmaceutical industries in India. Presence of foreign companies predicts possibilities for technology transfer and economic development.

28. Objective of Study No.5 “Statistical analysis of Pharma Patents Granted By India” (Post Prod Patent in Pharma) • The objective of this study is to understand the trend and kind of pharmaceutical patents granted in India as mentioned in the title of patent applications. This study is significant to have some reflections on the existing practices at Patent Office India with regard to some overseas concerns as to the application and explanations in Sec.3 (d).

29. Results of Study No.5 “Statistical analysis of Pharma Patents Granted By India” (Post Prod Patent in Pharma-2005-2010) Types of Applicants: MajorField of Inventions as mentioned in Title:

30. Results of Study No.5 “Statistical analysis of Pharma Patents Granted By India” (Post Prod Patent in Pharma-2005-2010) Various Aspect/Forms of Inventions as in Title:

31. Conclusion of Study No.5 “Statistical analysis of Pharma Patents Granted By India” (Post Prod Patent in Pharma-2005-2010) • Patents are being well granted in India on the subject matter as mentioned in Section 3 (d) for patentability of “new form of a known substance” and explanation part of section 3(d) for same substance, fulfilling the requirements of the Patent Act.

32. Objective of Study No. 6“Patents Granted Extension of Patent term in Japan” • The objective of this study is to understand the trend and utilization of the provision for extension of patent term by Japan pharmaceutical industries.

33. Result of Study No.6“Patents Granted Extension of Patent term in Japan” Data for the Year 2009 and 2010 May are given below.

34. Conclusion of Study No. 6“Patents Granted Extension of Patent term in Japan” • The extension of patent term is well in practice among Japanese Innovator Pharmaceutical Industries. • India may consider the provision for Patent Term Extension as motivation to Innovator Pharmaceutical Industries.

35. Study No 7 , 8 and 9 Title Conclusion Indian pharmaceutical industries have capability in creation NCE. There are some concern for clarification of provisions. There is lot of scope in an alternative research for NDDS • “Web search For NCE by Indian Industries”. • “Meeting with Association-JPMA”. • “Meeting with Industry-Daiichi Sankyo Co., Ltd”. • “Patenting Trend in NDDS in India”

36. Salient features Noted by MeJapan Patent Law • Patent Term Extension. [Art.67(2) ] • Preferential Examination. [Art.(46-6) ] • Mention of Employees Invention. [Art.35 ] • Provision for Refund of Fees. [Art.111, 195(9),(11)] • Flexibility in statutory timelines. “Adequate time” • Penal provisions: liability for imprisonment [Art.196-204 ]

37. Other features Japan Patent Law Practicing • Patent Prosecution Highway PPH >framework for allowing, on request by the applicant, accelerated examination in the Office of Second Filing with simplified procedures. • JP-FIRST (JP-Fast Information Release STrategy) Since April 08 >prioritizes the examination of the patent application for which the examination has been requested within 2 years from the filing date among the patent applications which are the bases for priority under the Paris Convention. • Elaborative Guidelines for Examination • Specific Guidelines for Medical Inventions >examples with explanation to reason for refusal and possible measures.

38. CONCLUSIONS • In the light of the studies of legislative provisions and analysis of various significant developments of patenting in the field of pharmaceuticals made, it can be concluded that the hypothesis made proves truth. • “The Transformation of the national patent regime in the field of pharmaceuticals has catalyzed the domestic research and development in medicine and public health care and new molecules are coming-up keeping the pace for generic drug manufacturing and there is larger scope of business relation in this field of pharmaceuticals between India and Japan.”

39. RCOMMONDATIONS • Keeping in mind the tremendous potential in this area, India needs to keep watch on striving to secure the necessary progress in the area of drug discovery and development by domestic industries/institutions. It has to be realized that drug discovery and development is a highly specialized and multidisciplinary activity and requires vigilant positive policy decisions.

40. RCOMMONDATIONS • There is a need for the data protection of information provided by the innovator company to the Govt. for approval of drug introduction in the market in India by making the necessary provisions/regulations for data protection. • There is a need for linking the marketing approval of new drugs with their patent status in India. This can be achieved by providing the patent extension term beyond the normal period in The Patent Act.

41. RCOMMONDATIONS • There is need for creating suitable IP- Networking between stakeholders, like academia and research laboratories in Public-Private Universities and highly skilled professionals and infrastructures in Public-Private Industries for economic and social development of India. This is the best way to utilize the immense potential of India to become Global Pharmaceuticals Innovator. Proposal of “The Protection and Utilization of Public Funded Intellectual Property Bill, 2008” is right step towards this goal

42. RCOMMONDATIONS • There is need to attend the concerns of oversea users of intellectual property about few provision of The Patent Act,1970 of India. In Section 3 (d) word “efficacy” and in Section 107(A)(b) word “under the law” be made more elaborative.

44. Life-time Achievement“Got bond with Nihongo” Born to Meet You SUMAN SAN NIHONGO JPO IPO 1962 2005 2010

45. / 本当に感謝しました! ARIGATO GOZAI MASU Dr SumanShrey Singh Asstt Controller of Patents & Designs THE PATENT OFFICE GOVT OF INDIA Ministry of Commerce & Industry - DIPP Plot 32 Sector-14,Dwarka-NEW Delhi-78 www.ipindia.gov.in, ss.singh@nic.in SAYONARA