Hatch-Waxman and Biosimilars:
A Total Immersion Course Encompassing Strategies for Prosecution, FDA Regulation, Post-Grant Challenge, Litigation and Appeal
Course Schedule: 8:15 – 11:30; 1:30 – 4:15 (Days 1-3)
Projected CLE Credit: 16.5
The course starts with a broad survey of the Hatch-Waxman and BPCIA legislation provisions that underpin the strategies to be discussed throughout the course. The course then conveys both fundamentals and advanced legal strategies in three major areas: (1) pharmaceutical and biotech patent prosecution; (2) litigation and appeal; and (3) post-grant challenges such as inter-partes review and post-grant review. These topics are taught as a seamless whole by four principals from Fish & Richardson P.C., 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 and post-grant challenges. 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 with an eye to possible future enforcement and post-grant validity challenges. The litigator will come away with a comprehensive understanding of the pertinent case law and concepts necessary to enforce pharmaceutical and biotechnology patents, to recognize the weaknesses in improvidently granted patents, and to weigh strategic considerations. 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 immersion course.
A key feature of the course is the immersion aspect, intended to convey an overall understanding of the various parts of the Hatch-Waxman Act, as well as strategies for obtaining strong patent claims or for challenging or enforcing patents under that regime. In an industry where billions of dollars often hinge on the viability of a single patent claim, the economic risks of getting it wrong can be enormous. Discovering and developing new pharmaceuticals – whether biomolecules or traditional small molecules – entails extraordinary R&D costs (some estimate over $28 per drug) with no guarantee of success. Without the protections afforded by patents and the various regulatory exclusivities provided by the Hatch-Waxman Act and the 2009 Biologic Price Competition and Innovation Act (BPCIA), the pharmaceutical and biotech industries as we know them would not exist. Generic manufacturers aggressively challenge the patents covering FDA-approved drugs, the boundaries of the Hatch-Waxman Safe Harbor continue to shift, FDA reforms have limited the Orange Book as a weapon for brand dominance, and the BPCIA legislation authorizing a new approval pathway for biosimilars may fundamentally change the life cycle management of biomolecule drugs.
Against this backdrop, biotechnology and pharmaceutical patent law continues to evolve rapidly, with numerous abrupt shifts and reversals of policy just in the last decade. Recent Supreme Court decisions regarding patent-eligible subject matter and inducement have the potential to exclude broad categories of pharmaceutical and biotech inventions from patenting and to make enforcement of method claims essentially impossible where multiple parties carry out the claimed method.
Topics covered by the course include ideas for addressing the new challenge of patenting compositions derived from nature, for ensuring that your claims will survive validity challenges, and for obtaining patents on inventions (such as side effects) discovered after the product is on the market. The lecturers will explain what to expect in a Hatch-Waxman litigation or in the “patent dance” required by the BPCIA, considerations to take into account when settling such a litigation, and strategies for successfully challenging a patent (or surviving a challenge) under the various types of post-grant procedures. 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.
Each attendee will receive a detailed set of slides covering all of the topics included in this intensive immersion course.