Patent Docs provides two reviews for the price of one as Kevin Noonan and Donald Zuhn each discuss the second edition of Martin Voet's book "The Generic Challenge: Understanding Patents, FDA & Pharmaceutical Life-Cycle Management."
By Kevin Noonan --
Martin A. Voet, Senior Vice President and Chief Intellectual Property Counsel at Allergan, Inc., has published the second addition of his helpful primer, "The Generic Challenge: Understanding Patents, FDA & Pharmaceutical Life-Cycle Management" (Brown Walker Press: Boca Raton, FL; 183 pp., $28.95). And primer it is: Mr. Voet gives the reader a comprehensive, up-to-date tour of the issues facing innovator drug companies in the current patent and regulatory climate.
The subtitle presages the structure of how Mr. Voet sets out the topics in the book. The first three chapters are about patents (Overview of Patents; Patent Enforcement and Infringement; and Pharmaceutical, Biological and Medical Device Patents). Next come the chapters on regulation (Overview of FDA; Drug Product Exclusivity; and Hatch Waxman Act). The book wraps up with chapters entitled Putting it All Together: Product Life Cycle Management and Conclusions and Final Thoughts.
The book is intended to be comprehensive but not exhaustive, and accordingly, the essentials of each topic are highlighted without the kind of in-depth coverage that would have doubled (at least) the length of the book and decreased its easy accessibility. Mr. Voet is thorough, however, and a reader knowledgeable in the topics is left with few quibbles regarding what he has included and what he has left to others (preferably, as he notes in his Disclaimer, a legal professional; the book is not intended to be a substitute for formal legal advice) to explain.
One big advantage of the second edition is that it brings many topics up-to-date in view of the changes (occasioned principally by court cases) that have occurred in these topics since the 2004 first edition. Thus, Mr. Voet discusses the Supreme Court's KSR Int'l Co. v. Teleflex Inc. decision, as well as how the Federal Circuit has adapted to it (including a mention of the contrasting decisions in its Lexapro® and Altace® cases). He discusses the difficulties for innovator pharmaceutical companies caused by the Supreme Court's eBay Inc. v. MercExchange, L.L.C. decision, particularly with regard to the uncertainties created for investors when the ability to keep a competitor off the market cannot be counted upon. In re Seagate is mentioned in his discussion of patent litigation and the changes in risk assessment as a result of this decision. He includes Medimmune, Inc. v. Genentech, Inc. and Merck KGaA v. Integra Lifesciences I, Ltd. as cases affecting (at different decision points) how generic companies may behave with regard to ANDA activities, particularly noting that the Medimmune case should permit a generic company to sue an innovator who does not file suit with 45 days of receiving statutory notice of an ANDA filing; using the Supreme Court's logic, the generic company should not have to launch "at risk" in order to ask a District Court to find invalid the innovator's Orange Book listed patent(s).
In addition to the situation in the U.S., Mr. Voet touches on the patent and regulatory situation abroad, specifically in Europe, Japan and Canada. While less detailed than his treatment of U.S. law and regulation, the book provides a succinct comparison among the different countries, noting areas where the consequences for innovators are better, or worse, than they are in this country.
The second edition of "The Generic Challenge" is much like the first: an easy, enjoyable read that touches all the high points and is comprehensive enough to alert the reader to the issues in drug product life cycle management. It should prove useful for executives and in-house counsel, as well as the interested general reader who would like an appreciation of the issues facing new drug development that goes beyond the inadequate treatment found in the popular press.
By Donald Zuhn --
Martin A. Voet, the Senior Vice President and Chief Intellectual Property Counsel at Allergan, Inc., recently provided Patent Docs with a copy of the second edition of his book "The Generic Challenge: Understanding Patents, FDA & Pharmaceutical Life-Cycle Management." It is a book that any patent attorney or regulatory attorney should consider adding to his or her library. Despite dealing with two topics that could (and do) fill multi-volume treatises, Mr. Voet provides a thorough yet light and interesting discussion of both patent law and regulatory law.
The 183-page book is divided into eight chapters. The first three chapters (Overview of Patents; Patent Enforcement and Infringement; and Pharmaceutical, Biological and Medical Device Patents) relate to patents, the fourth and fifth chapters (Overview of FDA and Drug Product Exclusivity) address regulatory matters, the sixth chapter (Hatch Waxman Act) presents what Mr. Voet describes as the "final piece of the puzzle," the seventh chapter (Putting It All Together: Product Life-Cycle Management) synthesizes the first six chapters, and the final chapter (Conclusions and Final Thoughts) provides some closing thoughts.
Mr. Voet offers that "The Generic Challenge" might be helpful to the regulatory lawyer or patent lawyer "who wishes he or she had a better understanding of the interaction of patent law with regulatory law so that they can better see the bigger picture and help achieve the goal of successful pharmaceutical product life-cycle management." As a patent attorney, I found the chapters on regulatory matters to be quite informative, and believe that regulatory lawyers would find the patent chapters to be equally informative. Mr. Voet suggests that patent and regulatory attorneys might want to save time by skipping the chapters in their own specialty, but the book is such an easy read that there is really no need to skip anything. For example, the first three chapters provide as thorough and up-to-date an overview of patent law as I imagine one can get less than 100 pages, and I suspect that regulatory attorneys would say the same about chapters four through six.
In the introduction to his book, Mr. Voet states that "[i]f the generic industry is not kept in check, the balance between the goals of low-priced currently available drugs and innovative, life-saving and life-enhancing future drugs will not be maintained, and while we may have cheap, old drugs, we will have no new, innovative drugs." Coming as it does from the Chief IP Counsel for a brand pharmaceutical company, this is perhaps not a surprising sentiment. However, Mr. Voet understands the importance of both innovator and generic drug companies, and in the last chapter of his book, he advocates for a system in which innovative pharmaceutical companies are encouraged to innovate, generic drug companies are allowed to offer low-cost medicines to people who need them, and the law is crafted "to maintain the delicate balance between fostering new innovative drugs and providing good quality, inexpensive generic drugs." Mr. Voet recognizes -- and addresses in his book -- the reality that the U.S. pharmaceutical industry will soon have to deal with a follow-on biologics regulatory pathway, and as Congress begins to debate the issues of exclusivity and bioequivalence, members of the Senate and House would be wise to keep the above goal in mind.
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