(Updated for KEI’s corrected brief).
On Wednesday December 16, 2020, Knowledge Ecology International (KEI) filed an amicus curiae brief in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc. (“GSK”, “Teva”). The case concerns secondary indications of medicines, and whether Teva induced infringement of GSK’s product, Coreg, though Teva’s product was initially approved for the older indication Coreg addressed (which was off-patent). The Federal Circuit reinstated the jury’s verdict that Teva had induced infringement in a 2-1 opinion. KEI filed its amici in Teva’s appeal of that decision. (KEI filed a corrected version of the brief on December 28, 2020.)
In KEI’s brief, we note the court’s challenge in trying to balance both patent protections and access to medicines for the public, when trying to decide cases concerning possible infringement by pharmaceutical companies. In the dissent, it indicates that the decision may have been motivated by a desire to incentivize companies to undertake research on new uses of medical products that have previously been approved by the US FDA for other indications.
KEI’s brief seeks to lay out for the court that while patents provide an incentive for investments in research on new uses, the patent system is poorly designed for such a purpose, and may provide either excessive or inadequate protection for new uses. Further, the enforcement of patents on new uses is only one of many mechanisms that are available to directly fund, subsidize or reward such investments, and not the most efficient, in this case creating a deep and consequential conflict between innovation incentives on the one hand, and affordability and access to unpatented inventions on the other.
Therefore, if the court is motivating its decision in this case through the lens of seeking to incentivize R&D in new uses of existing treatments, there are many other policy mechanisms and proposals that address that issue, and it should not be the motivating factor of this decision regarding infringement.
KEI’s amicus brief is available here: KEI-GSKvTeva-28Dec2020
For more information on the GSK v. Teva case, see:
- https://patentlyo.com/patent/2020/10/inducing-infringement-available.html
- https://www.cooley.com/news/insight/2020/2020-10-06-gsk-v-teva-induced-infringement-liability-despite-skinny-label
- https://www.fiercepharma.com/pharma/gsk-scores-appeals-as-court-orders-teva-to-pay-235m-for-induced-infringement
The court has received amicus briefs from the following:
- Novartis Pharmaceuticals Corporation and Sandoz Inc.,
- Fifty-Seven Law, Economics, Business, Health, and Medicine Professors,
- Apotex Inc.,
- The R Street Institute,
- Association for Accessible Medicines,
- Mylan Pharmaceuticals,
- Former Congressman Henry A. Waxman, Waxman Consulting, Inc.
- Knowledge Ecology International (KEI) and James Packard Love