Warner-Lambert Company LLC v. Actavis Group PTC EHF

Swiss-form second medical use patent — defining sufficiency and infringement boundaries in the pregabalin (Lyrica) case.

Short Description :

Warner-Lambert owned a Swiss-form patent for pregabalin’s use in treating pain, after its original patent for epilepsy and anxiety expired. Actavis launched a generic version for non-pain indications using a “skinny label.” Warner-Lambert sued, claiming that Actavis’ product would inevitably be used for pain treatment. The case focused on (1) validity of the patent and (2) what evidence is required to prove infringement under Swiss-form claims.

Facts

• Warner-Lambert’s original pregabalin patent expired in 2013. A later Swiss-form patent covered use of pregabalin for treating pain.

• Actavis obtained approval for a generic pregabalin with labeling limited to epilepsy and general anxiety disorder — excluding pain treatment.

• Warner-Lambert feared that pharmacists and doctors would still prescribe the generic for pain and sought an injunction to prevent its sale.

• Key issue: Whether Actavis’ generic indirectly infringed the Swiss-form patent, and whether Warner-Lambert’s patent disclosure was sufficient.

Findings

Court of Appeal (28 May 2015)

- Refused to grant interim injunction.- Held that Warner-Lambert lacked evidence that Actavis was targeting pain treatment.- Mere foreseeability that some off-label use might occur was not enough for infringement.

Patents Court (10 September 2015)

- Claims 1 (all pain) and 3 (neuropathic pain) were invalid due to insufficiency.- Specification only supported inflammatory pain, not neuropathic pain.- Attempt to amend patent late in proceedings was disallowed.

Supreme Court (14 November 2018)

Validity:- Majority: Claims invalid; no plausible technical evidence for neuropathic pain.- Dissenting judges: Minimal data was sufficient.Infringement:- Even if valid, Actavis did not infringe.- Foreseeability alone was insufficient.- Split opinion: some required subjective intent, others outward labeling.

Suggestions

• Draft patents with clear, specific data to show plausibility for each claimed indication.

• Consider using 'compound for use' format instead of Swiss-form wording for easier enforcement.

• Generics should use clear labeling and communication to avoid indirect infringement claims.

• Innovator companies should gather evidence of active promotion for off-label use before suing.

Judgment Dates

Court	Date
Court of Appeal	28 May 2015
Patents Court	10 Sep 2015
Supreme Court	14 Nov 2018