Navigating Legal Issues in the Biotechnology Industry: Leading Lawyers on Staying Abreast of Supreme Court Decisions and Overcoming Challenges in Patent Filing (Inside the Minds)

Navigating Legal Issues in the Biotechnology Industry provides an authoritative, insider's perspective on protecting client inventions and intellectual property in the wake of recent legislative evolutions. Featuring experienced partners from law firms across the nation, these experts guide the reader through Supreme Court decisions affecting biotech companies and outline the impact of AIA changes on inventors and patent filing. These top lawyers offer specific advice on managing the risks involved with developing new drugs and devices, keeping abreast of potential legal challenges as a result of burgeoning technology, and navigating the complexities of US and foreign regulations for GMO-based products. From incorporating FDA requirements into product registration applications to overcoming complications in protecting biotechnology IP, these experts stress the importance of carefully drafting biotech patent applications with court decisions and PTO guidance in mind. The different niches represented and the breadth of perspectives presented enable readers to get inside some of the great legal minds of today, as these experienced lawyers offer up their thoughts on the keys to success within this complex legal field.

Inside the Minds provides readers with proven business and legal intelligence from leading C-Level executives and lawyers. Each chapter offers thought leadership and expert analysis on an industry, profession, or topic, providing a future-oriented perspective and proven strategies for success. Each author has been selected based on their experience and C-Level standing within the business and legal communities.

Chapters include:

1. Thomas M. Dunlap, Managing Partner, DunlapWeaver PLLC—"The Brave New World: Owning and Protecting Biotechnology Ideas, Inventions, and IP in a Post AIA World"
2. Cara Baer, Partner, Butler Snow LLP—"Uncertainty in Biopharmaceutical Industry Presents Challenges for Manufacturers"
3. Alan E. Schiavelli, Managing Partner, Antonelli Terry Stout & Kraus LLC—"Inter Partes Review Closing the Gap Between Biotech 510(K) and 505(B)(2) Applications: FDA-Granted Monopolies for Patent Exclusivity"
4. Susan J. Mack, Principal, Sughrue Mion PLLC—"New Political and Regulatory Issues Complicate Protecting Biotechnology Intellectual Property"
5. Brett Godfrey, Founding Partner, Godfrey Johnson PC—"Law Must Keep Pace with Increasingly Sophisticated Technology to Protect the Public Health"
6. Martha E. Marrapese and Leslie T. Krasny, Partners, Keller and Heckman LLP—"Addressing the Complexities of Regulatory Schemes for GMOs and Products Derived from Them"
7. Peter I. Bernstein, Partner, Scully Scott Murphy & Presser PC—"Biotech Patents Enter Uncharted Waters Following Recent Court Decisions"
8. James M. Francis, Member, Francis Law PLLC—"Patent Reform's Unintended Consequences in Biotech"

Appendices Include:

Appendix A: Guidance For Industry: New Chemical Entity Exclusivity Determinations for Certain Fixed-Combination Drug Products
Appendix B: Guidance For Industry: Applications Covered by Section 505(b)(2)
Appendix C: Memorandum: PTO Guidance
Appendix D: 133 S.Ct. 2107
Appendix E: 132 S.Ct. 1289
Appendix F: 134 S.Ct. 2111
Appendix G: 133 S.Ct. 1761
Appendix H: Memorandum: Association for Molecular Pathology v. Myriad Genetics, Inc.