We have written extensively about the attack on the section viii label carve-out that is permitted under the Hatch-Waxman Act (H-W); this carve-out allows certain changes to a generic drug’s labeling to avoid patent infringement or certain exclusivity protection (here, here, here, here, and here). This so-called section viii label carve-out was part of the delicate balance struck between the generic and innovator industries during negotiations of H-W to permit patent term restorations, patent listings, a 30-month stay in certain situations, and certain exclusivity in exchange for generic sponsors’ ability to rely on innovators’ safety and efficacy data to support approval of generic applications.
As the saga continues, in a post today written by Sara W. Koblitz on Hyman, Phelps & McNamara’s FDA Law Blog (here), the author artfully addresses the latest challenge, in which an innovator company has asked the “District Court for a Temporary Restraining Order [TRO] enjoining FDA’s approval of a generic version” of its drug. The TRO request comes after the FDA denied a citizen petition, the resultant suit filed against the FDA, and approval of a generic for the product. This case has some very interesting twists and turns, especially and in light of the Supreme Court shooting down the Chevron decision (see post here), which could have further implications for the Agency.
