On February 19th, 2009, the international conference on “Biotech Medicines Innovations in Developing Countries: Intellectual Property Protection and Regulations for Safety and Efficacy” was held at National Graduate Institute for Policy Studies. This international conference was organized by GRIPS and supported by Ministry of Foreign Affairs, Microsoft Corporation, Japan Pharmaceutical Manufacturers Association (JPMA), Japan Health Science Foundation, Japan Bioindustry Association.
There were about 200 attendees and it was very successful conference.
Here is the programme and presentations.

Hiroko Yamane (Professor, National Graduate Institute for Policy Studies)

Main point of the conference

For the development of biotech medicines, synergy between pure science, clinical research, and the organization of clinical trials is essential. The advent of genomics, genetics, and proteomics has posed a massive challenge to university researchers, pharmaceutical companies, and regulators alike. It requires not only sophisticated investments, but also further education in science, basic research, and biotechnology. For companies, a massive increase in regulatory requirements both in the pre- and post-launch periods resulted in significant changes in risks and benefits. For regulators, the need to ensure non-toxic, safe and effective drugs has led to significant delays in developing new criteria for judging whether medical inventions submitted for examination are indeed safe and effective.
Today, biotech medicines have created 4 trillion dollar markets across the world. Patent protection of major biotech medicines has started to expire and ‘biosimilar’ products are beginning to be marketed in the European Community. In Europe, Guidelines were adopted and, in Japan, the draft Guidelines are about to be adopted. In the US, the Kennedy, Hatch, Clinton, and Enzi Bill is likely to be approved in 2009. In India, Guidelines are also planned.
In India and China, manufacturing and sales of biotech medicines have increased. In December 2008, Biosimilar Guidelines were adopted in India. New compounds developed in Cuba have been licensed to pharmaceutical companies in many countries including developed countries and are now in the process of clinical trials or marketing. Such developing countries’ efforts, after having been first studied at the University of Toronto Joint Centre for Bioethics (http://www.jointcentreforbioethics.ca/), were among the subjects of discussion at the Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH) of the World Health Organization (WHO). The CIPIH report highly valued these efforts as “biomedical innovations in developing countries” (www.who.int/intellectualproperty/documents/thereport/ENPublicHealthReport.pdf).
Our symposium, planned for mid-February 2009, attempts to elucidate intellectual property and regulatory aspects of biotech medicines in general, and to understand better biotechnology innovations in developing countries in a global perspective.
While intellectual property rules are fairly global, safety regulations are national. Because there are differences in the definition and scope of biogeneric drugs and the criteria for their marketing authorization, clarification of approaches is necessary.
The purpose of this meeting is to deepen understanding on biotech drugs in developing countries, in comparison to the situation in developed countries. We would like to consider, in particular, (i) the relationship with intellectual property rights (particularly, protection of patents and clinical data filed with regulatory authorities for marketing authorisation) in the developing countries and those in other countries and the licensing status, and (ii) how their safety and efficacy are assessed. We also aim to clarify the meaning of ‘invention,’ ‘innovation,’ as well as similarities and differences of products, in biotech drug discovery, development and marketing and to compare the ways of assessing efficacy and safety of biotech drugs including biosimilars, biogenerics or biologics. With regard to developing countries, we will focus on the following questions.
(1) what role do biotech medicines play in developing countries and what incentives are provided to promote innovation (in terms of IPR, human resources development, use of information technology, financial resources, etc.);
(2) how these technologies have been commercialized;
(3) how safety and efficacy of the products are assessed; and
(4) what roles such technologies play in the global R&D and product markets. Finally, we will propose a framework for future discussions and methods for possible international cooperation in promoting R&D for safe biotech medicines globally.

Programme

Opening Remarks
Dr. Tatsuo Hatta, President, National Graduate Institute for Policy Studies

Session 1. Intellectual Property (IP) Protection of Biotech Medicines: Conditions for Patent Grant, Scope of Protection, Enforcement and Case Laws
KEYNOTE SPEECH
– “Legal Protection of Biotech Inventions and Medicines in the United States and Europe” (presentation: pdf (849kb))
Professor Dr. Dres. h.c. Joseph Straus (Marshall B. Coyne Visiting Professor of International and Comparative Law; George Washington University Law School, Washington D.C.; Max-Planck-Institute for Intellectual Property, Competition and Tax Law)
– “IP Protection of Biotech Medicines in Japan” (presentation: pdf (1,032kb))
Dr. Yuji Watanabe (President, Committee on Intellectual Property, Japan Pharmaceutical Manufacturers’ Association)

Session 2. Innovations of Biotech Medicines in Developing Countries
– “An Overview” (presentation: pdf (545kb))
Hiroshi Kato (Japan Patent Office, former Associate Professor GRIPS)
– “Biotech Medicines R&D in Cuba” (presentation: pdf (1,178kb))
Dr. Ricardo Silva Rodriguez (Centro de Ingenieria Geneticay Biotecnologia Business Development Group, Center for Genetic Engineering and Biotechnology)
– “Biotech Medicines, Convention on Biological Diversity and Protection of Clinical Data in India” (presentation: pdf (693kb))
Krishna Sarma (Corporate Law Group, New Dehli)

Session 3. Biotech Medicines and IPRs in Developing Countries
– “R&D and IP Protection of Biotech Medicines in China” (presentation.pdf (723kb))
Isshin Shirasu (Patent Attorney (Welligens))
– “The Indian Patent Act and Biotech Medicines” (presentation: pdf (544kb))
J. Suresh (Lakshmikumaran & Sridharan, Bangalore)

Session 4. Regulations for Biotech Medicines’ Safety and Efficacy
– “Regulatory Approaches and Criteria for Biotech Medicines in India” (presentation: pdf (1,012kb))
Dr. K.K. Tripathi (Adviser, Scientist-G, Member Secretary of the Review Committee on Genetic Manipulation, Department of Biotechnology, India)
‐ “Japanese approaches to Bio-follow-on Medicines” (presentation: pdf (521kb))
Dr. Teruhide Yamaguchi (Division Head, Division of Biological Chemistry and Biologicals, National Institute of Health Sciences)
– “US Regulatory Approaches to Biologicals” (presentation: pdf (483kb))
Dr. Keith Webber (Deputy Director, Office of Pharmaceutical Science, Center for Drug Evaluation and Research U.S. Food and Drug Administration)
– “EMEA Regulatory Approaches to Biosimilars and Guidelines” (presentation: pdf (958kb))
Dr. Peter Richardson (Scientific Administrator, Quality of Medicines Sector Human Unit, Pre-Authorisation, EMEA)

Session 5. Proposals for International Cooperation
‐ “Major Issues relating to Biotech Medicines” (presentation: pdf (1,575kb))
Mr. Mitsuru Miyata (Editor, Nikkei BP and Director, Centre for Biotechnology) 　
– “Analysis of Clinical Studies: International Comparison” (presentation: pdf (752 kb))
Koji Kawakami (MD, PhD, Professor and Chairman, Department of Pharmacoepidemiology, Graduate School of Medicine and Public Health, Kyoto University)

Closing Remarks
Hiroko Yamane, Professor, National Graduate Institute for Policy Studies