Please note that the faculty members listed for this course are subject to change prior to the actual course date.
Course Faculty • The faculty, all senior principals in Fish & Richardson’s vaunted life sciences group, has many decades of experience counseling pharmaceutical and biotech companies in patent prosecution, litigation, and Hatch-Waxman strategies. They teach these topics in the same way they approach them for their clients – as a seamless whole.
Why Should You Take This Course?
In an industry where billions of dollars often hinge on the viability of a single patent claim, you can't afford to make mistakes. Brush up on the skills needed to prosecute, evaluate, and enforce pharmaceutical and biotech claims in an ever-changing legal and economic climate. Learn cutting-edge techniques for putting the Hatch-Waxman laws to work for your company's benefit. This highly regarded course is taught by an experienced team who puts it all together for you.
Discovering and developing new pharmaceuticals – whether biomolecules or traditional small molecules – entails extraordinary R&D costs (some estimate nearly $1B per drug) with no guarantee of success. Likewise, biotech companies invest enormous resources in identifying and validating the targets and creating platform technologies that are becoming more and more essential for the drug discovery process. Without the protection afforded by patents and the various market exclusivities provided by Hatch-Waxman and the 2009 Biologic Price Competition and Innovation Act, the pharmaceutical and biotech industries as we know them would not exist. At the same time, patents on research tools and drug discovery targets can frustrate the early-stage research efforts of competitors seeking to discover novel drugs. In addition, the generic industry is increasingly aggressive in challenging patents covering FDA-approved drugs, the boundaries of the Hatch-Waxman Safe Harbor are shifting, FDA reforms have limited the Orange Book as a weapon for pioneers, gene patenting is under serious challenge, and the 2010 legislation authorizing an approval pathway for biosimilars may fundamentally change the life cycle management of biomolecule pharmaceuticals. Against this backdrop, biotechnology and pharmaceutical patent law in particular continues to evolve rapidly – perhaps faster than patent law in any other field – with numerous abrupt shifts and reversals of policy just in the last decade.
The course conveys both fundamentals and advanced legal strategies in three major, interrelated areas: (1) Biotech and Pharma Patent Prosecution; (2) Hatch-Waxman and Biosimilars strategies; and (3) Pharmaceutical and Biotech Patent Enforcement. These topics are taught as a seamless whole by four principals from Fish & Richardson PC, who utilize frequent cross-references to highlight the interplay among all the topics. For example, relevant patent case law (including the most recent biotech and pharma cases) is discussed from different viewpoints in the context of prosecution and enforcement. An expert on the Hatch-Waxman and biosimilars laws will provide a coherent overview of these complex provisions; another lecturer will explain these laws’ critical importance to patent enforcement in the pharmaceutical and biotech fields; and others will show how these laws inform strategy in prosecution. Strategies for managing the life cycle of patented drugs is a theme that echoes throughout the course. This course provides valuable, practical information for the patent practitioner, whether in-house or in private practice, to use in maximizing protection of biotechnology and pharmaceutical inventions. The litigator will come away with a comprehensive understanding of the pertinent case law and concepts necessary to enforce pharmaceutical and biotechnology patents, or to recognize the weaknesses in improvidently granted patents. Company executives tasked with making strategic decisions based on their own company’s patent portfolio as well as those of their competitors will benefit immeasurably from the broad understanding of biotech and pharmaceutical patent and Hatch-Waxman law gleaned from this course.
A key feature of the course is its coverage of biotechnology patent law, including both established principles and current developments (such as the recently enacted overhaul of the US patent statute) in this rapidly changing area of the law. In addition, the course highlights patent issues that crop up frequently in the pharmaceutical arts where biotech and small molecule drugs overlap: issues such as enablement, written description, obviousness post-KSR, inherent anticipation, patent-eligible subject matter, inventorship, overbreadth, functional limitations, claim construction, infringement based on in vivo conversion, and infringement under the doctrine of equivalents. The course will present claim strategies that address the Supreme Court's landmark holding in the Myriad case regarding gene patents, including repercussions for other types of biomolecules. Other important topics include screening and diagnostic assays, methods of treatment, personalized medicine, polymorphs, transgenic animals, antibodies, RNAi, single nucleotide polymorphisms (SNPs), and reach-through claims. Concepts such as impractical claims (claims difficult or impossible to enforce) are illuminated with real and hypothetical examples. The increasing importance of the pharmaceutical label as a way to extend the life cycle of an approved drug is explored and specific strategies proposed. Since another PRG course (Chemical Patent Practice) ably covers the fundamentals of chemical prosecution in great detail, the present course instead focuses on issues that concern biotechnology and pharmaceutical inventions in particular.
Each attendee will receive an over-1000-page, two-volume set of course materials. Fondly known as the “Purple Book” for reasons that will be apparent once you receive yours, these materials are updated by Fish & Richardson each year to keep them current with new cases, new U.S. Patent and Trademark Office directives, and evolving technology. They cover many more topics, and in more depth, than the course itself. The Purple Book is an invaluable resource – a very practical “how-to” manual you will use every day.