I’ve been blogging about the chilling and hugely negative impact that the court decisions in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., No. 18‑1976, have on the delicate balance between the generic and brand‑name industries struck by the Drug Price Competition and Patent Term Restoration Act of 1984 (better known as the Hatch-Waxman Act). I won’t recount the issues of the case or the implications if the current court decisions stand; instead, I will refer you back to our March 10, 2023 post (here), which provides all the information you need to know and contains links to all the previous posts we’ve published on the skinny‑label issue.
Well, then, what’s the point of this post? To let you know that the generic industry is picking up further support from not only the Association for Accessible Medicines and other generic companies but also, we learned today from the reporting of David Wallace at the Generics Bulletin, that “Teva has seen its chances of success in a long‑running U.S. legal battle over ‘skinny-label’ generics given a major boost, after the U.S. solicitor general emphatically supported the firm’s position as it seeks a Supreme Court review of litigation over induced-infringement claims made by GlaxoSmithKline.”
Because of the significance of this issue to the generics industry and possibly to the survival of the skinny label provisions of the Act, a reversal of the negative lower court decisions and a clear position from the Supreme Court will hopefully enshrine the FDA’s long‑time position regarding how to apply this provision. In the Lachman post cited above, there is a brief discussion of how the Agency is also seeking legislative relief in the form of a “safe harbor” provision for the so‑called skinny label.
The bottom line is that the skinny‑label provision, as current applied by the FDA, allows generic drugs to market years before they might otherwise be available to consumers. Let’s hope the U.S. solicitor general can help the cause.
