Patenting the Product Label

When the U.S. Food and Drug Administration (FDA) 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 (i.e., a generic or biosimilar pharmaceutical company) is required to package its product with a product label. The generic product label is required to be substantially similar to the brand product label.

Litigation involving pharmaceutical-related patents typically occurs prior to the launch of a generic or biosimilar product. So infringement by the generic or biosimilar pharmaceutical company is based upon the product or product label proposed to the FDA to be approved.

A generic or biosimilar pharmaceutical company rarely performs a step recited in a method of use patent, such as “treating a patient.” Therefore, to establish patent infringement, a patentee must demonstrate the generic pharmaceutical company induces a third party (e.g., the doctor or patient) to perform a claimed method, such as “treating a patient.”

Overview of Inducement as Applied in the Pharmaceutical Context

• A party “causes, urges, encourages, or aids” a direct infringement by another party.
• It must establish that the alleged infringer (e.g., a generic or biosimilar pharmaceutical company) knowingly induces infringement and has a specific intent to encourage the third party to infringe the patent.
• A generic or biosimilar 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.
• Draft claims directed to new indications and patient subpopulations, especially if there is a difference in efficacy in a particular patient subpopulation.
• Draft claims directed to combination therapies, especially if the combination impacts the safety and efficacy of the original patient population.
• Draft claims with claims directed to the pharmacokinetic parameters (e.g., Cmax, Tmax, and AUC) included on the product label.
• If you 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.

This article appeared in the 2025 Life Sciences IP Tool Kit.