Pharmaceutical Medicine, Biotechnology and European Law

References

• For a technical treatment of the law, business, and regulation of biotechnology, see MICHAEL J. MALINOWSKI, BIOTECHNOLOGY: LAW, BUSINESS, AND REGULAUON (1999 & Supps. 2001, 2002). See also PHILIP W. GRUBB, PATENTS FOR CHEMICALS, PHARMACEUTICALS AND BIOTECHNOLOGY: FUNDAMENTALS OF GLOBAL LAW, PRACTKE AND STRATEGY (1999) (a comprehensive treatment of patent criteria and procedure in the European Union and United States, written by a seasoned European patent attorney).
   Google Scholar
• See Juan Enriquez & Ray A. Goldberg, Transforming Life, Transforming Business: The Life-Science Revolution, HARV. Bus. REV., Mar.-Apr. 2000, at 95. See generally CYNTHIA ROBBINS-ROTH, FROM ALCHEMY TO IPO: THE BUSINESS OF BIOTECHNOLOGY (2000).
   Google Scholar
• As stated by Dr. Francis Collins, "the gene-based approach to medicine will revolutionize how we diagnose and treat disease and genetic testing will be a critical tool in the health care provider's arsenal." Statement on Genetic Testing in the New Millennium: Advances, Standards, Implications Before the H.R. Subcommittee on Technology, Committee on Science, 106th Cong., Apr. 21, 1999. For discussion of how bioinformatics is accelerating drug development, see ROBBINS-ROTH, supra note 2, at 73-81 & table B.I. The emerging scientific disciplines centered on genetic profiling and the law and regulatory environment s surroundin g this technology are addressed in Michael J. Malinowski, Separating Predictive Genetic Testing from Snake Oil: Regulation, Liabilities, and Lost Opportunities, 41 JURIMETRICS 23 (2000).
   Google Scholar
• This has been the mantra of the Ethical, Legal, and Social Implications (ELSI) program of the Human Genome Project. From 1990 through 1997, the federal government expended more than $50 million for ELSI studies and projects. D.H. Kaye, Respecting Genetic Privacy: The ASU-SB Conference on Law, Science, and Technology, 40 JURIMETRICS 1, 5 n.22 (1999).
   Google Scholar
• See generally RKHARD W. OLIVER, THE COMING BWTECH AGE: THE BUSINESS OF BIOMATERIALS (1999); ROBBINS-ROTH, supra note 2; Enriquez & Goldberg, supra note 2.
   Google Scholar
• On June 26,2000, an international team of scientists, led by Francis Collins of the United States National Institutes of Health, and a privately funded team of scientists, led by Craig Venter, Chief Science Officer of Celera Genomics, a biotechnology company located in Gaithersburg, Maryland, announced jointly that they had completed a rough map of the human genome. See What's News World Wide, WALL ST. J. EUR., June 27, 2000, available at 2000 WL-WSJE 21064884; Inside the Industry--Cetera: After Genome Announcement, Future Uncertain, AM. POL. NETWORK, AM. HEALIH LINE, June 28,2000.
   Google Scholar
• With a map of the human genome in hand, scientists now are working to decipher the intricacies of gene and protein function. See Francis S. Collins et al., New Goals for the U.S. Human Genome Project: 1998-2003,282 Sci. 682, 683 (1998).
   Google Scholar
• The contemporary biotechnology sector is unusual in that it represents an entanglement of academi a and industry, small companies and multinational pharmaceutical giants, commercial applications ranging from medicines for human health to biomaterials and agriculture, and, in spite of its youth, is as global as any other. For information about the sector, visit the Web site of the Biotechnology Industry Organization, the world's largest biotechnology trade organization, at www.bio.org (visited Dec. 6,2001 ). See generally ERNST & YOUNG, CONVERGENCE: THE BIOTECHNOLOGY INDUSTRY REPORT, MILLENNIUM EDITION (2000), available at www.ey.com (visited Dec. 6, 2001); MALINOWSKI, supra note 1.
   Google Scholar
• See generally William Cornish, The Free Movement of Goods I: Pharmaceuticals, Patents and Parallel Trade, in PHARMACEUTICAL MEDICINE, BIOTECHNOLOGY, AMD EUROPEAN LAW 11 (Richard Goldberg & Julian Lonbay eds. 2000).
   Google Scholar
• See generally Belinda Isaac, The Free Movement of Goods H: Pharmaceuticals, Trademarks and Parallel Trade, in PHARMACEUTICAL MEDICINE, supra note 9, at 25.
   Google Scholar
• See generally Leigh Mancher, EC Competition Law, Pharmaceutical s and Intellectual Property: Recent Developments, in PHARMACEUTICAL MEDICINE, supra note 9, at 76.
   Google Scholar
• See generally Julian Lonbay, The Free Movement cf Health Care Professionals in the European Community, in PHARMACEUTICAL MEDICINE, supra note 9, at 45.
   Google Scholar
• See generally Ian Dodds-Smith, Data Protection and Abridged Applications for Marketing Authorizations in the Pharmaceutical Industry, in PHARMACEUTICAL MEDICINE, supra note 9, at 93.
   Google Scholar
• See generally Antoine Cuvillier, The Role of the European Medicines Evaluation Agency in the Harmonization of Pharmaceutical Regulation, in PHARMACEUTICAL MEDICINE, supra note 9, at 137.
   Google Scholar
• See generally Deryck Beyleveld et al., The Morality Clauses of the Directive on the Legal Protection of Biotechnological Inventions: Conflict, Compromise and the Patent Community, in PHARMACEUTICAL MEDICINE, supra note 9, at 157.
   Google Scholar
• See generally Richard Goldberg, The Development Risk Defence and the European Court of Justice; Increased Injury Costs and the Supplementary Protection Certificate, in PHARMACEUTICAL MEDICINE, supra note 9, at 185.
   Google Scholar
• See generally Jonathan Harris, Transnational Health Care Litigation and the Private International Law (Miscellaneous Provisions) Act 1995, Part III, in PHARMACEUTICAL MEDICINE, supra note 9, at 205.
   Google Scholar
• See generally ROBBINS-ROTH, supra note 2; CONVERGENCE, supra note 8. See also Michael J. Malinowski, Institutional Conflicts and Responsibilities in an Age of Academic-Industry Alliances, 8 WIDENEER L.SYMP. J. 47, 47-49 (2001). This pressure also is evident in the advancement of harmonization initiatives among the United States, Europe, and Japan in recent years via the International Conferences on Harmonisation (ICH) and the role that establishment of the European Agency for the Evaluation of Medicinal Products played in the success s and comprehensivens s of initiatives to modernize the Food and Drug Administration (FDA). See GRUBB, supra note 1, at 30-33 (addressing the General Agreement on Tariffs and Trade and the Agreement on Trade Related Aspects of Intellectual Property Rights); MALINOWSKI, supra note 1, §§ 11.02[A][S], 11.07 (addressing modernization of the FDA and ICH).
   Google Scholar
• As observed by Professor Cornish: "It is very difficult to show with any exactness how far the patent system produces the effects for which it is designed.... One indication of its value lies in the fact that, for all the doubting and criticism, the degree of its use around the world continues to grow." Cornish, supra note 9, at 14. For a technical treatment of the relative importance of intellectual property rights for R&D in pharmaceutical s and biotechnology, see generally GRUBB, supra note 1. See also Michael J. Malinowski, The Commodity of Intellectual Property in the Risky Business of Life Science, 41 JURIMETRICS 409 (2001) (reviewing GRUBB, supra note 1). The most recent, major advance in global patent law is the Patent Law Treaty, which is addressed in MALINOWSKI, supra note 1, § 2.03[B][3].
   Google Scholar
• See Michael J. Malinowski, Foreword, Conflicts of Interest in Clinical Research: Legal and Ethical Issues, 8 WIDENER L. SYMP. J. ii, n.l (2001); Michael J. Malinowski, Institutional Conflicts and Responsibilities in an Age of Academic-Industry Alliances, 8 WIDENER L. SYMP. J. 53 (Part II, captioned "The Metamorphosis of Clinical Research").
   Google Scholar