After all these years of skinny-label suits, the issue is finally going to be adjudicated through the top court in the land. Remember that the Supreme Court previously refused to review a skinny label case (here). We’ve written ad nauseum (search the Lachman blog here for hours of reading) about the skinny label, which permits FDA approval of a generic version of a brand-name drug if the generic’s label does not include a patented use or exclusivity protected feature of the Reference Listed Drug (RLD) product’s approved label.
The case headed to the Supreme Court is no. 24-889, Hikma Pharmaceuticals USA Inc. et al. v. Amarin Pharma Inc. et al. Even the administration has asked the court to take the case under review, reported by Law360 (here, subscription required), as U.S. Solicitor General D. John Sauer said, “the Federal Circuit’s ruling puts the availability of lower-cost generic drugs at risk.”
In the instant case, it appears that the label of the generic drug clearly does not claim the patented use of the drug; however, Amarin argues that because Hikma advertises the generic as an AB-rated equivalent to the RLD, and, thus, therapeutically equivalent and substitutable, it induces infringement. While there is a bit more to the case (i.e., Amarin also sued a health insurer claiming that the plan placed the Hikma drug in a lower tier for reimbursement purposes, which reduced copays), the Supreme Court’s review could be the defining moment in the skinny label’s struggle for survival. In my opinion, the essence of the case is the fact that, in order to approve a generic of a brand-name product, the FDA must decide that the drug product is both therapeutically equivalent and bioequivalent to the RLD upon which it bases its application; this is both the statutory and FDA regulatory definition of the AB rating and therapeutic equivalence. Because the FDA will not approve a generic equivalent of a drug product that differs from the listed drug, the product, by definition, is AB-rated.
The statute permits labeling to be different in several specific instances and, in this instance, it permits generic “carve outs” of a patent- or exclusivity protected use. Will this be the final chapter to the skinny label issue? Let’s hope so, and let’s hope the Supreme Court’s decision aligns with the FDA’s statutory and regulatory interpretation, which has been, in effect, the basis of the skinny-label provisions since the 1984 passage of the Drug Price Competition and Patent Term Restoration Act, known familiarly as Hatch-Waxman.
