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 13, 2017
Recorded event now available

This CLE webinar will provide guidance to 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.


A drug label may play an important role in Hatch-Waxman patent litigation, particularly in relation 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 instructions and information in a drug label.

In addition, according to the Supreme Court in Limelight Networks Inc. v. Akamai Techs. Inc. (Akamai III), 134 S. Ct. 2111 (2014), liability for inducement requires a finding of direct infringement. On remand, the Federal Circuit concluded that a single entity is responsible for the performance of method steps when that entity “directs or controls others’ performance,” or when “the actors form a joint enterprise.”

Although the Federal Circuit explained that the type of conduct sufficient to amount to the required “direction or control” is something that is to be decided on a case-by-case basis, directing or controlling others’ performance includes circumstances in which an alleged infringer (1) “conditions participation in an activity or receipt of a benefit upon performance of a step or steps of a patented method,” and (2) “establishes the manner or timing of that performance.” Akamai Technologies Inc. v. Limelight Networks Inc. (Akamai V), 797 F.3d 1020 (Fed. Cir. 2015) (en banc) (per curiam).

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., __ F.3d __ (Fed. Cir. Jan. 12, 2017), the Federal Circuit found direct infringement attributable to physicians and held defendants liable for inducing that infringement because the “evidence that the product labeling that Defendants seek would inevitably lead some physicians to infringe establishe[d] the requisite intent for inducement.”

Listen as our authoritative panel of patent attorneys discuss the implications of Lilly and label language for induced infringement. The Orange Book listed patent’s label may be written 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.


  1. Implications of Lilly for induced infringement
  2. Other Federal Circuit induced infringement decisions post-Commil
    1. Takeda Pharma U.S.A. v. Hikma Am Inc. (Fed. Cir. May 6, 2015)
    2. Braintree Labs Inc. v. Breckenridge Pharm. Inc. (Fed. Cir. May 5, 2017).
  3. How do Novo v. Caraco and use codes fit in?
  4. Strategic considerations of label language for induced infringement


The panel will review these and other key issues:

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


Thomas L. Irving, Partner
Finnegan Henderson Farabow Garrett & Dunner, Washington, D.C.

Mr. Irving has 35 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.

Barbara R. Rudolph, Ph.D., Partner
Finnegan Henderson Farabow Garrett & Dunner, Washington, D.C.

Dr. Rudolph has successfully litigated complex Hatch-Waxman Paragraph IV Abbreviated New Drug Application and biotechnology cases over the past twenty years. She serves as lead counsel in pharmaceutical and biotechnology disputes and has extensive litigation experience in federal courts. She has argued before the U.S. Court of Appeals for the Federal Circuit and authored an amicus brief submitted to the U.S. Supreme Court in a landmark biotechnology patent case. She devises strategies to protect clients' valuable intellectual property involving sophisticated technologies in the pharmaceutical and biotechnology industries.


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Patent Law Advisory Board

Charles S. Baker


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David S. Bloch


Winston & Strawn

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David Segal

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Mark P. Wine



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