Ever since November 24, 1984, the effective date of the Drug Price Competition and Patent Term Restoration Act (aka Hatch-Waxman) which created the unique and delicate balance between innovation and safe and effective high quality generic copies of brand name products, the use of the “skinny label” has been a touchstone of that balance. Rather than repeat a lot of what was in my November 2020 post that captures the relevance of the so called “little viii” statement that can lead to a skinny label, I will just refer you to that post here.
Time moves on, and now we understand that Teva is seeking an en banc (full appears court panel) review of the case. While awaiting that decision, it might be noteworthy that anyone in industry or any consumers who have an interest in this situation of “inducement to infringe” (and by the way, you all do unless you want to see further monopoly pricing from the brand name drug companies) should keep their eyes wide open and be prepared to speak to your congressmen (and congresswomen) and senators. Failure to engage could be costly and could open a new “evergreening” pathway that could keep generics off the market in some instances almost indefinitely.
So, I am sounding the alarm again because after the en banc appeal, if the decision is not reversed, it will likely be onto the Supreme Court. So, fasten your seat belts – the generic pharmaceutical industry is being taken for a ride for its life!