A Close Examination of 35 U.S.C. § 112(f) as a Claiming Tool in U.S. Pharmaceutical Patents, Particularly Formulation Patents (RECORDING)
Section 112(f) reads:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
Overlooked for decades in the field of U.S. pharmaceutical patents, § 112 (f) is the focus of this webinar, presented by experts from Merck, UCB, and Eli Lilly and moderated by Tom Irving (Finnegan). Speakers will discuss how § 112 (f) can be a tool for achieving means-plus-function (MPF) claims for brand U.S. pharma applicants. By statute, the claims can cover equivalents by providing for literal infringement. The panel will also explain the need for MPF in pharma.
Manisha Desai is Associate General Patent Counsel at UCB Biopharma, in Brussels, Belgium. She has 20 years of experience as an in-house patent attorney in the pharmaceutical industry, with an emphasis on US and international patent litigation. Manisha is a co-chair of IPO’s European Practice Committee and has represented IPO and other industry organizations during multilateral negotiations at the World Intellectual Property Organization and other UN agencies.
Eli Lilly and Co.
Michelle Gao is an assistant general patent counsel at Eli Lilly and Company, providing IP support for Lilly BioMedicines assets and the Lilly Biotechnology Center in San Diego. Michelle obtained her Ph.D. in Molecular Biology from Northwestern University, and J.D. from University of Illinois. Prior to joining Eli Lilly, Michelle was a patent attorney at Novartis Institutes for BioMedical Research (NIBR) from 2015 to 2018, where she supported ImmunoOncology and Neuroscience programs. Michelle worked for Fish & Richardson as an associate in Boston from 2012 to 2015, and focused her practice on patent prosecution and litigation there.
Director of the Intellectual Property Group
Merck & Co.
Sarah Hooson is director in the Intellectual Property Group at Merck in Rahway, NJ, having gained her initial legal patent experience while working at GlaxoSmithKline (GSK). Sarah’s present responsibilities include patent preparation, prosecution, and due diligence support for small molecule, vaccine, and antibody programs in human and animal health. Sarah received her bachelor’s degree in Biomedical Engineering from Georgia Institute of Technology, and her J.D. from Widener University. Sarah gained considerable bio-pharmaceutical research and development and vaccine process development experience while working as an engineer at Merck, GSK and MedImmune.
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
Tom Irving is a partner with Finnegan. He has more than 40 years of experience in the field of intellectual property law. His practice includes America Invents Act (AIA) post-grant proceedings, due diligence, counseling, patent prosecution, and reissue and reexamination. He counsels clients on a wide range of mainly pharmaceutical matters, including pre-litigation, Orange Book listings of patents covering FDA-approved drugs, infringement issues, enforceability and validity analysis.