Pharma & Biotech Strategies for Patent Prosecution, Hatch-Waxman, Litigation and Licensing
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 various Hatch-Waxman drug exclusivities, 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, and pending legislation on biosimilars may fundamentally change the life cycle management of biomolecule pharmaceuticals. Against this backdrop, biotechnology and pharmaceutical patent law 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 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 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 cycles 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 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, 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 for the increasingly common situation in which an organism’s genome has been published, and the invention focuses on a single gene. Other important topics include patenting screening assays, methods of treatment, polymorphs, transgenic animals, antibodies, RNAi, single nucleotide polymorphisms (SNPs), reach-through claims, and inventions in the burgeoning field of bioinformatics. 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.
Each attendee will receive a massive, 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 US 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. You will receive a book of printed lecture slides when you arrive at the course.
Click here for the course syllabus. The course will generally follow this syllabus, though the lecturers reserve the option of altering the stated subject matter to incorporate important new topics. The course is updated every time it is taught.
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.