“This narrow, case-specific review of substantial evidence does not upset the careful balance struck by the Hatch-Waxman Act regarding section viii carve-outs.”- CAFC
The U.S. Court of Appeals for the Federal Circuit (CAFC) on Thursday underscored its October 2020 ruling that generic company, Teva Pharmaceuticals, was liable for induced infringement of GlaxoSmithKline’s (GSK’s) patent directed to a method of treating Congestive Heart Failure (CHF) using carvedilol. The court clarified, however, that its ruling should apply only narrowly to the facts of this particular case. Judge Prost again dissented.
The case relates to GSK’s United States Patent No. 4,503,067 (the ’067 patent), which expired on March 5, 2007 and United States Patent No. 5,760,069 (the ’069 patent), which was directed to a method of treating CHF using a combination of carvedilol and “one or more of an angiotensin-converting enzyme (ACE) inhibitor, a diuretic, and digoxin.” The ’069 patent was listed in the FDA’s Orange Book for “decreasing mortality caused by congestive heart failure” and the claimed combination was approved under the name Coreg® in 2003 “for use by patients suffering from left ventricular dysfunction following a myocardial infarction.”
All in the Label
Teva applied for Food and Drug Administration (FDA) approval of “its generic carvedilol, certifying in the Abbreviated New Drug Application (ANDA) under Paragraph III of the Hatch- Waxman Act that its product would not be launched until the ’067 patent expired in March 2007.” In the application for approval, Teva certified that the ’069 patent was “invalid, unenforceable, or not infringed” and, particularly stated that the claims of the ’069 patent were invalid for anticipation or obviousness. The FDA tentatively approved Teva’s ANDA “for treatment of heart failure and hypertension.” Subsequently in 2003, GSK filed an application to reissue the ’069 patent, for the purposes of adding the following limitation to the claims: “wherein the administering comprises administering to said patient daily maintenance dosages for a maintenance period to decrease a risk of mortality caused by congestive heart failure, and said maintenance period is greater than six months.” The reissue application issued as Reissue Patent No. RE40,000 (the ‘000 patent).
In 2014, GSK filed a suit against Teva and Glenmark Pharmaceuticals USA. A jury found that Teva induced infringement of claims 1-3 of from the issue date of the ‘000 patent because Teva “continued to take an action that began before the ’000 patent issued, after the ‘000 patent was issued on January 8, 2008, intending to cause the physicians to directly infringe by administering Teva’s carvedilol product.” Specifically, Teva encouraged physicians to use carvedilol for an infringing purpose during the full label period via marketing materials that promoted the use of carvedilol in an infringing manner.
The CAFC ultimately agreed, ruling last year that the “precedent makes clear that when the provider of an identical product knows of and markets the same product for intended direct infringing activity, the criteria of induced infringement are met.”
Substantial Evidence Supports
Teva petitioned for en banc rehearing and the CAFC granted a panel rehearing in February 2021. Teva argued that the 2020 decision “could be broadly read to impose liability on ANDA filers that carve out patented uses under [21 U.S. Code § 355] section viii when seeking approval to market generic drug products, in direct contravention of the Hatch-Waxman Act.” Amici also chimed in to say that the decision could “upset the careful balance struck with section viii carve-outs.” But in Thursday’s decision, the court explained that “the facts of this case place it clearly outside the boundaries of the concerns expressed by amici.” The court continued:
As this record reflects, in both time periods, substantial evidence supports that Teva actively induced by marketing a drug with a label encouraging a patented therapeutic use. They did not “omit all patented indications” or “merely note (without mention-ing any infringing uses) that FDA had rated a product as therapeutically equivalent to a brand-name drug.” Novartis Br. at 1–2. This is a case in which substantial evidence supports a jury finding that the patented use was on the generic label at all relevant times and that, therefore, Teva failed to carve out all patented indications. This narrow, case-specific review of substantial evidence does not upset the careful balance struck by the Hatch-Waxman Act regarding section viii carve-outs.
The court thus vacated the district court’s grant of judgment as a matter of law and remanded the case for further proceedings. Judge Prost again dissented, saying that the majority’s second flawed ruling signals that “our law on this issue has gone awry.” She added:
The majority creates confusion for generics, leaving them in the dark about what might expose them to liability. These missteps throw a wrench into Congress’s design for enabling quick public access to generic versions of unpatented drugs with unpatented uses.
The ruling restores a $235 million verdict for GSK.