In Short
The Situation: The Hatch-Waxman Act allows generic drug companies to omit from their labeling approved indications that are covered by the innovator's patents. While these "skinny labels" can be used to support a noninfringement defense, in
The Result: On
Looking Ahead: Although this decision is unlikely to impact the analysis of "skinny labels" in a pre-marketing context, once a generic drug is launched, innovator companies should pay attention to how the generic advertises and markets the product, as this evidence-including any statements regarding therapeutic equivalency to the innovator product-may be sufficient to establish induced infringement even with a Section viii carve-out
Background
On
The case involved so-called "skinny labels," also known as Section viii carve-outs-a reference to the provision of the Hatch-Waxman Act that allows a generic company to vary the label of its products from that of the reference listed drug in order to exclude one or more indications that are patented by the innovator. In this case, Teva sought and obtained FDA approval of a generic version of GSK's COREG® product but carved out of its label the approved indication for treatment of heart failure, in order to avoid a GSK patent claiming this use.
Years after the product was launched with the "skinny label," the FDA ordered Teva to add the heart failure indication back into its label. GSK brought a suit for patent infringement, claiming that Teva was liable for inducing infringement of its patent even during the time period when Teva's label omitted the heart failure indication. GSK argued that Teva's label was ambiguous, and further that Teva's conduct in the actual marketing and advertising of its generic drug was sufficient to establish inducement under 35 U.S.C. § 271(b).
The jury agreed with GSK, but the trial judge granted Teva's motion for JMOL, finding as a matter of law that Teva could not have induced infringement because it had specifically availed itself of the Section viii carve-out procedure and had removed the patented indication from its label. GSK appealed, and in
In
Opinion of
In a 2-1 opinion, the panel again concluded that the "narrow, case-specific review of substantial evidence" supported the jury's verdict of induced infringement by Teva.
Similar to its
Unlike the
The court agreed with GSK. It said Teva failed to challenge the testimony of GSK's expert, and even Teva's own expert admitted some overlap did exist. The court also clarified that infringement via overlapping indications was a factual issue for the jury to decide, not a legal one for the district court to review de novo.
Recap
This case highlights the unsettled and contentious nature of infringement in the skinny-label context. The decision indicates that the use of a skinny label is not a dispositive noninfringement argument, at least after the product has been launched; courts can consider all evidence, including the label, expert testimony, and marketing and promotional materials to assess infringement. This was a post-marketing case, so questions remain concerning how it will be applied to "standard" Hatch-Waxman cases where infringement issues are addressed prior to FDA approval and launch of a generic.
Three Key Takeaways
- Using Hatch-Waxman's Section viii carve-out procedure alone may not be enough to avoid a finding of infringement, at least in the post-marketing context.
- Indications on a generic's label coupled with marketing materials and press releases advertising the generic's drug as the AB-rated equivalent of the brand can be sufficient to show infringement.
-
The court's decision to vacate its
October 2020 opinion and reissue a new opinion reaching the same conclusion suggests an attempt to narrow its holding to the unique facts of this case.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
NY 10281
Tel: 2165863939
Fax: 2165790212
E-mail: info@JonesDay.com
URL: www.jonesday.com
© Mondaq Ltd, 2021 - Tel. +44 (0)20 8544 8300 - http://www.mondaq.com, source