Induced Infringement in Pharma Litigation: Lessons From Amarin v. Hikma, Guidance for Use of Skinny Labels

Course Details
- smart_display Format
On-Demand
- signal_cellular_alt Difficulty Level
Intermediate
- work Practice Area
Patent
- event Date
Thursday, August 29, 2024
- schedule Time
1:00 p.m. ET./10:00 a.m. PT
- timer Program Length
90 minutes
-
This 90-minute webinar is eligible in most states for 1.5 CLE credits.
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.
Faculty

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.

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.

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.
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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.

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.
Description
In Amarin Pharma Inc. v. Hikma Pharmaceuticals USA Inc. (Fed. Cir. June 25, 2024), the Federal Circuit revived the litigation, reversing the district court's grant of Hikma's motion to dismiss the induced infringement case. Amarin accused generic drugmaker Hikma of infringing its patents on the branded drug. The case draws attention to the challenges facing generics with skinny labels and induced infringement.
The Federal Circuit concluded Amarin plausibly pleaded that Hikma had induced infringement of the asserted patents. The court noted that the theory of induced infringement is not based solely on the label but is based on the label in combination with Hikma's public statements and marketing materials.
The Amarin decision provides some guidance for generics wanting to use skinny labels, emphasizing the importance of being careful when issuing statements, whether in press releases or promotional materials, to minimize the likelihood of infringement.
Listen as our authoritative panel of patent attorneys discusses the Federal Circuit's recent Amarin v. Hikma decision, and any other relevant pharmaceutical litigation, and the implications for induced infringement cases. 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?
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