In the latest development in the carvedilol skinny label odyssey, the US Court of Appeals for the Federal Circuit dismissed Teva’s petition for a rehearing before all the judges of the Court.
In the United States, brand drug companies link patents to drug products through the Orange Book. Brand companies submit information about patents linked to their products, including which uses of the products are covered by the patents.
Legislation requires generic companies to address patents listed in the Orange Book in a limited number of ways. One such way is that a generic company may remove from its product label the use identified by the brand company as being covered by a patent. If a generic company uses this “carve out” and seeks approval based on a “skinny” product label, the brand company cannot assert the patent to prevent the generic company from obtaining regulatory approval for its product.
GlaxoSmithKline sells carvedilol in the United States under the brand name Coreg. GSK listed the 069 Patent in the Orange Book with respect to the use of Coreg to treat congestive heart failure. The 069 Patent was later reissued as the 000 Patent. Teva sought approval for its generic carvedilol product using a skinny label that carved out the use of the drug to treat CHF. Teva’s carvedilol product was approved by the FDA in 2007 with the skinny label.
GSK sued Teva in 2014 for infringement of the 000 Patent despite its use of a skinny label. A jury found that Teva induced infringement of the 000 Patent and awarded GSK over $235 million in damages.
Teva then brought a motion to set aside the jury verdict on the basis that the jury did not have a sufficient evidentiary basis to find in favour of GSK. Justice Stark granted the motion, noting that factors other than Teva’s skinny label caused physicians to prescribe carvedilol for CHF and the lack of evidence that doctors are affected by Teva’s label. A copy of Justice Stark’s decision may be found here.
GSK appealed the decision to the CAFC. In 2020, a 3 member panel of the CAFC reinstated the jury verdict in GSK’s favour. The majority of the CAFC held that the jury had sufficient evidence to conclude that Teva induced infringement of the 000 Patent. This evidence was Teva’s skinny label, as well as Teva’s press releases noting that its product was equivalent to Coreg and indicated for heart failure. In dissent, Justice Prost held that there was no evidence of inducement and that the jury verdict effectively nullified the legislative provisions that allowed the use of skinny labels. A copy of the CAFC’s 2020 decision may be found here.
The CAFC vacated its 2020 decision following a request for rehearing by Teva that was supported by several third parties. In a decision issued in 2021, the majority of the panel again reinstated the jury verdict in GSK’s favour, this time noting that Teva’s skinny label did not successfully carve out the patented use because it was possible that the use of carvedilol to treat another condition in patients with heart failure may result in infringement of the 000 Patent. Justice Prost in dissent held that Teva could not induce infringement because its skinny label and press releases were insufficient to establish intent to infringe. A copy of the CAFC’s 2021 decision may be found here.
Teva petitioned for a rehearing before the entirety of the CAFC. Its request was denied by a vote of 6-3.
The majority opinion of Justice Moore characterized Teva’s argument as one of estoppel: GSK could not assert the use of carvedilol for another indication in patients with heart failure as an infringement of the 000 Patent because GSK did not identify that use as infringing the 000 Patent when listing the 000 Patent in the Orange Book. The majority held that this estoppel defence was not raised in the lower court and that it was inappropriate for the defence to be addressed for the first time by the CAFC. The majority therefore remanded the decision back to the District Court.
Justice Prost in dissent focused on the uncertainty caused by the possibility that a generic manufacturer could be exposed to liability for patent infringement despite abiding by all regulations to obtain approval for a product with a skinny label. Justices Dyk and Reyna also provided brief reasons concurring in the dissent.
A copy of the CAFC’s decision denying the request for an en banc hearing may be found here. Teva has indicated that it will appeal this decision to the Supreme Court.