Patenting Pharmaceutical Drug Formulations: Withstanding Litigation and PTAB Challenges
A live 90-minute premium CLE video webinar with interactive Q&A
This CLE webinar will guide patent counsel on patenting drug formulations from drafting through patent prosecution and enforcement. The panel will examine lessons learned from the case law and offer strategies to overcome the potential challenges.
Outline
- Overview of recent treatment of pharmaceutical formulation claims
- Courts
- PTAB
- Overview of recent treatment of biosimilar formulation claims
- Courts
- PTAB
- Section 112(f)
- Ex parte Gleave, Appeal No. 2012-004973 (2014)
- Nautilus Neurosciences Inc. v. Wockhardt, United States LLC (D. N.J. 2013)
- Benefits of using means-plus-function claims
- Challenges/limits with applying means-plus-function claims
- Litigation considerations for formulation claims
Benefits
The panel will review these and other important issues:
- What steps can counsel for patentees take during drafting to avoid written description and enablement problems and withstand invalidity/unpatentability challenges based on written description and enablement?
- What steps should patent counsel take to balance showing unpredictability for nonobviousness to fulfill the enablement and written description requirements?
- How to use means-plus-function claims for pharmaceutical formulations against ANDA filers and/or 505(b)(2) filers
- What factors does counsel need to keep in mind when litigating formulation claims?
Faculty

Adriana L. Burgy
Partner
Finnegan Henderson Farabow Garrett & Dunner
Ms. Burgy focuses on opinion work, client counseling, patent prosecution and management, and litigation in the... | Read More
Ms. Burgy focuses on opinion work, client counseling, patent prosecution and management, and litigation in the chemical, pharmaceutical, and biotechnology arts. She counsels her clients on a diverse range of patent issues. She assists clients on single-patent issues as well as complex matters involving multiple patents and applications requiring ongoing advice on patent portfolio strategy and development, with an eye towards litigation. From a patent prosecution perspective, she has drafted and prosecuted numerous patent applications domestically and internationally, guided and advised clients on complex procedural and legal issues surrounding clients' patent portfolios, developed and implemented strategic prosecution in support of ongoing litigation, generated strategies for maximizing investment in patent portfolios, and facilitated the identification of high-priority applications within patent portfolios.
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Justin J. Hasford
Partner
Finnegan Henderson Farabow Garrett & Dunner
Mr. Hasford has experience in all areas of intellectual property law. His practice focuses on complex patent litigation... | Read More
Mr. Hasford has experience in all areas of intellectual property law. His practice focuses on complex patent litigation at the trial and appellate levels on behalf of pioneer pharmaceutical companies. He has particular experience with cases arising from Abbreviated New Drug Applications (ANDAs) under the Hatch-Waxman Act. Justin also has litigated antitrust cases and business method patent cases. He counsels clients on issues of infringement, validity, enforceability, unfair competition, licensing, due diligence, and IP portfolio management. He has extensive experience advising clients regarding the interplay between patent and regulatory laws, including Orange Book listing of patents for drugs approved by the FDA.
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Cora R. Holt
Partner
Finnegan Henderson Farabow Garrett & Dunner
Ms. Holt is an experienced patent litigator at both the appellate and trial levels. A former clerk at the U.S. Court of... | Read More
Ms. Holt is an experienced patent litigator at both the appellate and trial levels. A former clerk at the U.S. Court of Appeals for the Federal Circuit, she represents clients in patent disputes before the Federal Circuit, the U.S. Supreme Court, and district courts across the country. She handles cases involving a variety of technologies, with an emphasis on the biotechnology, pharmaceutical, and life sciences industries. She also assists clients in portfolio counseling matters and proceedings before the U.S. Patent and Trademark Office (USPTO).
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Thomas L. Irving
Partner
Finnegan Henderson Farabow Garrett & Dunner
Mr. Irving has 35 years of experience in the field of IP law. His practice includes due diligence, patent prosecution,... | Read More
Mr. Irving has 35 years of experience in the field of IP law. His practice includes due diligence, patent prosecution, reissue and reexamination, patent interferences, and counseling, including prelitigation, Orange Book listings of patents covering FDA-approved drugs, and infringement and validity analysis in the chemical fields, as well as litigation. He has served as lead counsel in many patent interferences.
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