Labeling and Induced Infringement in Pharma Patent Litigation and Protecting IP Rights

Recording of a 90-minute CLE webinar with Q&A


Conducted on Thursday, July 19, 2018

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Program Materials

This CLE webinar will guide patent counsel on the implications of recent cases for labeling and discuss strategic considerations of label language. The panel will offer best practices for labeling.

Description

A drug label may prove significant in Hatch-Waxman patent litigation, particularly with respect to induced infringement of method-of-use patent claims.

35 U.S.C. §271(b) requires that the accused “actively induces infringement.” As the Supreme Court explained a few years ago in Global-Tech v. SEB (U.S. 2011), “actively induces infringement” means the accused knew of the patent and knew the induced acts were infringing. In Hatch-Waxman litigation, the first prong of Global-Tech is easily shown by the patents listed in the Orange Book and the generic manufacturer’s paragraph IV certification. The second prong of specific intent to induce infringement may be proven by the drug label instructions and information.

The Supreme Court decision in Commil USA L.L.C. v. Cisco Sys. Inc. (U.S. 2015) that a defendant’s good faith belief that a patent is invalid is not a defense to induced infringement under 35 U.S.C. § 271(b) is also relevant to the analysis. On remand, the Federal Circuit rendered a judgment of noninfringement (Commil USA L.L.C. v. Cisco Sys. Inc. (Fed. Cir. 2015).

In Eli Lilly and Co. v. Teva Parenteral Medicines Inc. (Fed. Cir. 2017), the Federal Circuit found direct infringement attributable to physicians. The court found the defendants liable for inducing that infringement due to “evidence that the product labeling that Defendants seek would inevitably lead some physicians to infringe establishe[d] the requisite intent for inducement.”

In Sanofi v. Watson (Fed. Cir. 2017), a case in which the claim tracked the label exactly, the Federal Circuit relied on the label in finding the specific intent required to encourage an infringing use. Evidence of substantial noninfringing uses was not relevant to the inducement inquiry.

Recently in Vanda Pharm. v. West-ward Pharm. Int’l (Fed. Cir. 2018), the Federal Circuit found induced infringement based on the proposed label, and explained how, in the Hatch-Waxman context, actual past direct infringement does not have to be shown. Moreover, “patentees in Hatch-Waxman litigations asserting method patents do not have to prove that prior use of the NDA-approved drug satisfies the limitations of the asserted claims.” The court also cited Sanofi when the alleged infringer tried to rely on evidence of substantial noninfringing uses.

Listen as our authoritative panel of patent attorneys discusses the implications of Lilly and label language for induced infringement. The Orange Book listed patent’s label may be written so that the generic manufacturer is more vulnerable to a finding of induced infringement. The panel will offer guidance on strategic considerations and best practices for label language.

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Outline

  1. Implications of Lilly for induced infringement
  2. Other Federal Circuit induced infringement decisions post-Commil
  3. How do Novo v. Caraco and use codes fit in?
  4. Strategic considerations of label language for induced infringement

Benefits

The panel will review these and other noteworthy issues:

  • What impact will recent decisions have on label language?
  • What impact will recent decisions have on claim drafting?
  • How do use codes fit in?
  • What strategic considerations should patent owners keep in mind when labeling drugs?

Faculty

Irving, Thomas
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

Cyr, Shana
Shana K. Cyr, Ph.D.

Partner
Finnegan Henderson Farabow Garrett & Dunner

Dr. Cyr represents clients in complex patent litigations, contentious proceedings before the USPTO, and appeals related...  |  Read More

Rudolph, Barbara
Barbara R. Rudolph, Ph.D.

Partner
Finnegan Henderson Farabow Garrett & Dunner

Dr. Rudolph has successfully litigated complex Hatch-Waxman Paragraph IV Abbreviated New Drug Application and...  |  Read More

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