Drugs

Labeling Carve-Out Court Decision Explained

In a 2-1 decision, the Federal Circuit Court of Appeals recently ruled in GSK v. Teva that ANDA and 505(b)(2) labeling carveouts induce patent infringement, rendering any generic sponsors who relied on a section viii statement for a method-of-use patent vulnerable to patent litigation. Attorney Sara Koblitz (Hyman, Phelps & McNamara) writes in her firm’s FDA Law Blog that the decision goes against years of FDA practice under the Waxman-Hatch Amendments.

The case involved GlaxoSmithKline’s Coreg (carvedilol) and a Teva ANDA. Koblitz reviewed the complicated maneuvering that both sides followed leading up to a GSK infringement suit against Teva. Teva argued that it had carved-out the treatment of congestive heart failure with a section viii statement and thus could not have infringed the applicable GSK patent. While a jury sided with GSK, Koblitz writes, finding that Teva caused doctors to prescribe general Coreg for the carved-out indication and thus willfully induced infringement, the district court granted Teva’s motion for judgment as a matter of law and overturned the jury verdict because Glaxo did not prove that Teva’s actions caused doctors to infringe. Glaxo then appealed.

The majority of the Federal Circuit three-judge panel held that “criteria of induced infringement are met” based on promotional materials, press releases, product catalogs, FDA labels, and testimony of witnesses from both sides. The appeals court judges overturned the judgment as a matter of law decision, reinstated that $235 million damages awarded by the district court jury, and remanded the matter back to the district court.

Koblitz writes that the case “highlights the delicate balance that Congress tried to walk between intellectual property rights and facilitating generic drug access when passing the Waxman-Hatch amendments, and how that balance can be upset by a single court decision.”

The article says Teva is certain to appeal the decision, either by requesting a hearing by the full appeals court or else appealing to the Supreme Court, but it may be years until generic drug companies have a clear understanding of what is safe to do in terms of carving out some labeling.

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