Induced Infringement in Pharma Litigation: Lessons From Amarin v. Hikma, Guidance for Use of Skinny Labels
Recording of a 90-minute premium CLE video webinar with Q&A
This CLE course will guide patent counsel on issues of inducement in pharmaceutical patent litigation following the Federal Circuit's decision in Amarin Pharma v. Hikma Pharm. The panel will also discuss strategies and tactics regarding claim language and label language, as well as types of evidence to adduce to prove inducement of infringement.
Outline
- Skinny labels and inducement
- Recent court treatment
- Implications of Amarin v. Hikma
- Demonstrating liability
- Best practices
Benefits
The panel will review these and other key issues:
- What impact will the court's decision in Amarin v. Hikma have on proving induced infringement?
- What impact will recent decisions have on claim drafting?
- What strategic considerations should patent owners keep in mind when labeling FDA-approved drugs?
Faculty
Joanna T. Brougher, Esq., MPH
Owner & Principal
BioPharma Law Group
Ms. Brougher is a patent attorney who focuses on all aspects of services related to patents in the areas of... | Read More
Ms. Brougher is a patent attorney who focuses on all aspects of services related to patents in the areas of biotechnology, pharmaceuticals and medical devices, including patentability opinions, due diligence, patent drafting, domestic and foreign patent prosecution, development and management of patent portfolios, and general client counseling during all phases of a product’s lifecycle, from concept to commercialization.
Her patent experience covers a variety of complex and innovative inventions involving small molecule drugs, biologics, cell-based technologies, compositions, drug formulations and drug delivery systems, immunotherapeutics, medical devices, diagnostic tests, nanotechnology, and immunology, particularly vaccines and antibodies. Ms. Brougher also has experience counseling clients on the Hatch-Waxman Act and is monitoring developments involving biosimilars under the Biologics Price Competition and Innovation Act.
Sarah Hooson
Director, Legal
Merck Sharp & Dohme
Ms. Hooson is director in the Intellectual Property Group at Merck in Rahway, NJ. Her present responsibilities include... | Read More
Ms. Hooson is director in the Intellectual Property Group at Merck in Rahway, NJ. Her present responsibilities include patent preparation, prosecution, and due diligence support for small molecule, vaccine, and antibody programs in human and animal health. She gained her initial legal patent experience while working at GlaxoSmithKline (GSK). She received her bachelor’s degree in Biomedical Engineering from Georgia Institute of Technology, and her J.D. from Delaware Law School - Widener University. She gained considerable bio-pharmaceutical research and development and vaccine process development experience while working as an engineer at Merck, GSK, and MedImmune.
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Thomas L. Irving
Partner
The Marbury Law Group
Mr. Irving has 47 years of experience in the field of IP law. His practice includes due diligence, patent prosecution,... | Read More
Mr. Irving has 47 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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Michelle E. O'Brien
Partner
The Marbury Law Group
Ms. O’Brien has more than 20 years of experience representing domestic and foreign clients of all sizes in... | Read More
Ms. O’Brien has more than 20 years of experience representing domestic and foreign clients of all sizes in patent procurement, litigation, and client counseling, with a particular emphasis on chemical, biochemical, and pharmaceutical technologies. Exemplary areas of her technical expertise include polymer chemistry; ceramics; glass; food chemistry; cosmetics; paper products; adhesives; and pharmaceutical products, including new chemical entities and formulations and novel solid forms, including polymorphs, cocrystals, and amorphous forms of compounds.
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