BarbriSFCourseDetails

Course Details

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

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

  1. Skinny labels and inducement
  2. Recent court treatment
  3. Implications of Amarin v. Hikma
  4. Demonstrating liability
  5. 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?