Washington University in St. Louis School of Law
January 11-15, 2010 Intersession Course

Biotechnology Law: From Patents to Food-Drug-Planting Approvals

The term "biotechnology" refers to a collection of technologies that use cellular and biomolecular processes to solve problems and make useful products. These include technologies that affect our daily lives such as food processing, animal husbandry, plant hybridization, and brewing beer. These also include cutting-edge technologies such as pharmacogenomics (personalized medicine), biosensors, whole-genome sequencing, biological defense, and even controversial techonologies such as "pharming," cloning, regenerative medicine and embryonic stem cell research. Some biotechnology research can even challenge our understanding about the very nature of life. One can imagine, then, that the entire body of "biotechnology law" that affects this patchwork of technologies is as varied and far-reaching as the underlying technologies themselves.

Although biotechnologies are said to have been first developed about 10,000 years ago with the domestication of plants and animals, the pace of modern biotechnology development has far exceeded the original pace. Therefore, biotechnology law has become a continuously adaptive body of law that evolves with the pace of biotechnology development. Because biotechnology law is also influenced by business cycles and the market, the most effective way to understand biotechnology law is by studying its evolution at the intersection of law, business and science. Legal issues at this intersection include intellectual property (especially patents), federal regulation of research through funding, FDA regulation of biomedical research, approval of products for human use, privacy issues, and international issues, among many other unique legal issues.

Before focusing on the curriculum below, I would like to thank Chuck McManis and Mike Koby of Washington University School of Law for providing the opportunity to present these materials. Special thanks also to Tom Redick of Global Environmental Ethics Counsel who established Biotechnology Law as an Intersession Course this year and who invited me to present with him. Tom is presenting materials Monday through Wednesday and I am presenting Thursday and Friday. Needless to say, five days is not enough time to review every aspect of biotechnology law, but the materials below will remain available after the course which can better be studied outside the classroom.

Biotechnology Law Curriculum: We will focus on the issues provided in highlighted boxes below. Please be prepared to discuss the following on Thursday, January 14: ACLU v. USPTO & Myriad - Complaint (May 12, 2009)Acrobat Prometheus Laboratories, Inc. v. Mayo Collaborative Services (Fed. Cir. September 16, 2009)Acrobat Please be prepared to discuss the following on Friday, January 15: In re Kubin (Fed. Cir. April 3, 2009)Acrobat Ariad v. Lilly (Vacated Opinion - Fed. Cir. April 3, 2009)Acrobat In re '318 Patent Infringement Litigation (Fed. Cir. September 25, 2009)Acrobat Many additional materials are provided below to add context to these reading materials. Reviewing the additional materials is optional for the purposes of the Intersession Course, but helpful to those interested in understanding the field of biotechnology law in greater depth. All the materials below are available electronically, so please consider the necessity of printing hard copies.

Biotechnology Law: Legal Evolution at the Intersection of Business and Science

1. Biotechnology law in context: Overview of legal issues associated with biotechnology, pharmaceutical and medical device innovation, the path to market, and post-market considerations:

• The role of intellectual property law in the field of biotechnology research and development
• International licensing issues
• Expectations of the investment community
• Regulatory considerations
• Post-market compliance, labeling, enforcement, and (where relevant) reimbursement and health care issues

A biotechnology product development timeline can be depicted to include the following:

2. Generics

• Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

3. Biosimilars

• Patient Protection and Affordable Care Act (H.R. 3590) § 7002
  (December 24, 2009)Acrobat

4. Patent Term Extension

• Patent Terms Extended Under 35 U.S.C. § 156

5. Compulsory Licensing

• TRIPS (World Trade Organization "trade-related aspects of intellectual property rights"): "National emergency," "other circumstances of extreme urgency," "public non-commercial use" and "adequate remuneration."

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Life Sciences Regulatory Compliance and Marketing:
Small Molecules, Biologics, Medical Devices and Plants

1. U.S. Food & Drug Administration - Pre-Clinical Trials, and
Clinical Trial Phases I, II, III and IV

• Drug Approvals and Databases
• Orange Book Approved drug products with therapeutic equivalence evaluations
• U.S. FDA Paragraph IV Patent Certifications Listing of drugs for which an ANDA has been submitted, and for which a legal opinion stating that the underlying drug patent is invalid or does not cover the branded product has been submitted
• U.S. FDA Medical Device Databases
• U.S. FDA 510(K) Premarket Notifications Database of notifications of intent to introduce medical devices in commerce
• U.S. FDA PMA Premarket Approval Datebase of FDA-approved medical devices

2. Reimbursement

• CMS - Centers for Medicare and Medicaid Services Information about reimbursement in the public payer system
• CMS Reimbursement Database Database of reimbursed drugs and medical devices

3. U.S. Department of Agriculture Information about regulation and compliance related to agriculture biotechnology products

4. U.S. Environmental Protection Agency Information about regulation and compliance with environmental standards (e.g., Clean Water Act, Clean Air Act, etc.)

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Intellectual Property

1. Anatomy of a Patent

Genentech Avastin® Patent		Sample Patent Application Outline

2. U.S. Constitution IP Clause and Patent StatuteAcrobat

3. Patentable Subject Matter - 35 U.S.C. § 101

• Diamond v. Chakrabarty, 447 U.S. 303 (1980)
• In re Bilski (Fed. Cir. October 30, 2008)Acrobat
• In re Bilski - U.S. Supreme Court Oral Argument Transcript (November 9, 2009)Acrobat

Are Human Genes Patentable? Association for Molecular Pathology (by way of the American Civil Liberties Union) v. United States Patent and Trademark Office ACLU v. USPTO & Myriad - Complaint (May 12, 2009)Acrobat ACLU v. USPTO & Myriad - USPTO Motion for Summary Judgment (December 23, 2009)Acrobat ACLU v. USPTO & Myriad - Myriad Motion for Summary Judgment (December 24, 2009)Acrobat Patents in Suit: U.S. Patent No. 6,033,857 (cl. 1, 2) U.S. Patent No. 5,837,492 (cl. 1, 6, 7) U.S. Patent No. 5,753,441 (cl. 1) U.S. Patent No. 5,747,282 (cl. 1, 2, 5, 6, 7, and 20) U.S. Patent No. 5,710,001 (cl. 1) U.S. Patent No. 5,709,999 (cl. 1) U.S. Patent No. 5,693,473 (cl. 1)

Are Diagnostics and Disease Treatment Methods Patentable? Prometheus Laboratories, Inc. v. Mayo Collaborative Services (Fed. Cir. September 16, 2009)Acrobat Compare: Classen Immunotherapies Inc. v. Biogen Idec (non-precedential) (Fed. Cir. December 19, 2008)Acrobat Laboratory Corp. of America Holdings v. Metabolite Laboratories, Inc. (dismissed certiorari as improvidently granted) 126 S. Ct. 2921 (2006)Acrobat Patents in Suit: Prometheus v. Mayo: U.S. Patent No. 6,355,623 (cl. 1) U.S. Patent No. 6,680,302 (cl. 1) Classen v. Biogen: U.S. Patent No. 5,723,283 (cl. 1) LabCorp v. Metabolite: U.S. Patent No. 4,940,658 (cl. 13)

4. Novelty - 35 U.S.C. § 102

5. Obviousness - 35 U.S.C. § 103

• KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007)Acrobat
• KSR v. Teleflex - U.S. Supreme Court Oral Argument Transcript (November 28, 2006)Acrobat

Post-KSR Obviousness (Biologics and Pharmaceuticals cases):

• Takeda Chemical Industries, Ltd. v. Alphapharm Pty., Ltd. (Fed. Cir. June 28, 2007)Acrobat
• Pharmastem Therapeutics, Inc. v. Viacell, Inc. (Fed. Cir. July 9, 2007)Acrobat
• Forest Laboratories v. Ivax Pharmaceuticals (Fed. Cir. September 5, 2007)Acrobat
• Aventis Pharma Deutschland GmbH v. Lupin, Ltd. (Fed. Cir. September 11, 2007)Acrobat
• Daiichi Sankyo Co., LTD (formerly known as Daiichi Pharmaceutical Co., Ltd) v. Apotex (Fed. Cir. September 12, 2007)Acrobat
• Innogenetics v. Abbott Laboratories (Fed. Cir. January 17, 2008)Acrobat
• Ortho-McNeil Pharmaceutical Inc. v. Mylan Laboratories Inc. (Fed. Cir. March 31, 2008)Acrobat
• Eisai Co. Ltd. v. Dr. Reddy's Laboratories, Inc. (Fed. Cir. July 21, 2008)Acrobat
• In re Omeprazole Patent Litigation (Fed. Cir. August 20, 2008)Acrobat
• In Re Swanson (Fed. Cir. September 4, 2008)Acrobat
• Sanofi Synthelabo v. Apotex Inc. (Fed. Cir. December 12, 2008)Acrobat

Are polynucleotide (gene) sequences obvious once the polypeptide (protein) sequences are known? In re Kubin (Fed. Cir. April 3, 2009)Acrobat Compare: In re Deuel, 51 F.3d 1552 (Fed. Cir. 1995) Patent Application on Appeal: U.S. Application Pub. No. 20080081043 (cl. 48)

• The Procter & Gamble Co. v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. May 13, 2009)Acrobat
• Altana Pharma AG v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. May 14, 2009)Acrobat
• Bayer Schering Pharma AG v. Barr Laboratories Inc. (Fed. Cir. August 5, 2009)Acrobat

6. Written Description - 35 U.S.C. § 112

• Monsanto Co. v. David (Fed. Cir. February 5, 2008)Acrobat
• Carnegie Mellon University v. Hoffmann-La Roche Inc. (Fed. Cir. September 8, 2008)Acrobat
• In re Alonso (Fed. Cir. October 30, 2008)Acrobat
• U.S. Patent & Trademark Office Written Description Training MaterialsAcrobat

Separate Written Description and Enablement Requirements? Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co. On August 21, 2009, the Federal Circuit vacated the April 3, 2009 decision and granted Ariad's petition for rehearing en banc. The court asked the parties to file new briefs addressing the following questions: 1. Whether 35 U.S.C. § 112, ¶ 1, contains a written description requirement separate from an enablement requirement? 2. If a separate written description requirement is set forth in the statute, what is the scope and purpose of the requirement? Ariad v. Lilly (Vacated Opinion - Fed. Cir. April 3, 2009) Acrobat Ariad v. Lilly - Eli Lilly Principal Brief (November 9, 2009) Acrobat Ariad v. Lilly - Ariad Reply Brief (November 30, 2009)Acrobat Ariad v. Lilly - En banc Federal Circuit Panel Oral Arguments (December 7, 2009) MP3 file Patent in Suit: U.S. Patent 6,410,516 (cl. 80, 95, 144, and 145)

7. Enablement - 35 U.S.C. § 112

• Monsanto Co. v. Syngenta Seeds, Inc. (Fed. Cir. October 4, 2007)Acrobat
• Ortho-McNeil Pharmaceutical Inc. v. Mylan Laboratories Inc. (see § 103 above)
• Impax Laboratories, Inc. v. Aventis Pharmaceuticals Inc. (Fed. Cir. October 3, 2008)Acrobat

Does a "good guess" enable one to make and use an invention? In re '318 Patent Infringement Litigation (Fed. Cir. September 25, 2009)Acrobat Patent in Suit: U.S. Patent No. 4,663,318 (all claims)

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