The Association of Accessible Medicines (AAM) and the BioSimilars Council (a Division of AAM) released a statement of support (here) for a legislative fix to provide a safe harbor for generic / biosimilar label carve-outs. The issue is the potential threat of litigation for inducement to infringe, a problem that could bankrupt a generic or biosimilar company just for saying their product is the “generic of” or the “generic equivalent of” or is bioequivalent to the brand name product. The AAM letter (at the link above) explains in detail the problem and “supports the statutory safe harbor for carve-outs proposed by the Food and Drug Administration in its fiscal year (FY) 2024 budget and urges its adoption.”

The letter notes that “[D]espite this well-established practice, a recent decision from the U.S. Court of Appeals for the Federal Circuit threatens to undermine Hatch-Waxman’s carve-out process. That decision, GSK v. Teva, holds that a generic can be liable for infringing the brand’s patented method that the generic carved-out from its label, based on arguments that the carve-out was supposedly not broad enough, and that the generic publicly described its product as the equivalent of the brand product—something that is true of every generic. Although the federal government filed a brief to the Supreme Court explaining that the Federal Circuit’s decision was wrong, the Supreme Court has declined to review the decision at this time” (as we covered in a previous blog post here), and hence, a legislative fix is likely the only way to continue to assure that generic and biosimilar products that contain a label carve out of a patented use can come to market without delay without the fear of losing their company.

We have written extensively about this issue here, here, here, here, here, here, here, here, here, and here. This is an important issue for FDA as well as industry. Let’s see if this becomes the path forward for the skinny label’s required protected status.