Patent Prosecution Tool Kit: Patenting the Product Label

Sterne, Kessler, Goldstein & Fox P.L.L.C.

When the U.S. Food and Drug Administration approves a new drug, it also approves a package insert of the drug, known as a “product label.” A pharmaceutical company marketing a generic product is required to package their product with a product label. The generic product label is typically substantially similar to the brand product label. Rarely does a generic company perform a step recited in a method of use patent, such as “treating a patient.” Therefore, to establish patent infringement, a patentee must demonstrate the company induced a third party, e.g. the doctor or patient, to perform the claimed method.

Overview of Inducement as Applied in the Pharmaceutical Context

  • A party “causes, urges, encourages, or aids” a direct infringement by another party.
  • Must establish that the alleged infringer knowingly induced infringement and had specific intent to encourage the third party to infringe the patent.
  • Pharmaceutical company has no intent to induce infringing use if the product label does not instruct a third party to use the product in an infringing manner.

What Constitutes an “Instruction for Use” in an Infringing Manner in the Product Label?

  • It is not sufficient that the product label describes an infringing mode. The label must “recommend,” “encourage,” or “promote” the infringing use.
  • Vague label language cannot be combined with speculation about how physicians may act.

Prosecution Strategies Regarding the Product Label?

  • If possible, draft claims with the exact language included in the “Indications and Usage” and/or “Dosage and Administration” sections of the product label.
  • Draft claims to match “warnings” included in the product label.
  • File applications directed to new indications and patient subpopulations, especially if there is a difference in efficacy in a particular patient subpopulation.
  • File applications to combination therapies, especially if the combination impacts the safety and efficacy of the original patient population.
  • File applications with claims directed to the pharmacokinetic parameters e.g., Cmax, Tmax, and AUC, included on the product label.
  • If must prosecute mechanism of action claims, try to tie the mechanism of action to the approved indication.
  • Draft claims with divided infringement defense in mind. All steps must be performed by a single party or under the direction of that party.

[View full Patent Prosecution Tool Kit]

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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