Skinny labeling, the practice of removing infringing language from a generic label, continues to make the news. The practice is commonly referred to as a section viii certification. Rather than challenging a patent in court, subsection viii of section 505(j) of the FD&C Act allows generic drug companies to carve patented uses from their labels, and certify that their “skinny labeling” will not infringe the innovator’s patents. FDA will only reject the carve-out if the infringing language is necessary for the safe or effective use of the drug.
A generic typically is scott-free when FDA allows it to carve infringing language from its label, but cases such as GlaxoSmithKline LLC v. Teva Pharms. USA, Inc., 2017 U.S. Dist. LEXIS 39378 (D. Del. Mar. 20, 2017) (“Glaxo v. Teva”) prove that is not always the case. Glaxo v. Teva involves the blockbuster drug Coreg®, generically known as carvedilol, used to treat congestive heart failure (“CHF”).
The drug has three approved indications: (i) hypertension, (ii) CHF, and (iii) left ventricular dysfunction following myocardial infarction. The drug was first approved for hypertension but Glaxo deferred marketing the drug for hypertension while it pursued a more lucrative FDA approval for CHF. After it secured approval for CHF, Glaxo conducted additional studies in patients who had recently suffered a heart attack to secure its ventricular dysfunction indication. Those additional studies included a large number of CHF patients, and Glaxo contends in the litigation that it only secured the ventricular dysfunction indication to satisfy doctor’s concerns about whether Carvedilol could be administered to CHF patients who had recently suffered a heart attack.
The patent at issue, RE 40,000, is limited to CHF, and Teva carved out the CHF indication from its label to avoid this patent. In its motion to dismiss, Teva argued that it could not be liable for inducing infringement because the RE 40,000 was limited to CHF and any overlap between the CHF and ventricular dysfunction indications was legally insufficient to support the “intent” and “active encouragement” elements of induced infringement.
The district court held that Glaxo had sufficiently alleged both “intent” and “active encouragement,” and denied Teva’s motion to dismiss. The decision boiled down to two essential allegations in Glaxo’s complaint.
The first – that Teva’s intent to infringe could be established by press releases in which Teva referred to the entire U.S. market for Coreg®. According to Glaxo, these press releases evidenced Teva’s intention that its product be substituted Coreg® by patients using the drug for CHF.
The second – that Teva’s label actively encouraged doctors and patients to use Teva’s carvedilol for CHF because of the close relationship between CHF and the ventricular dysfunction indication which remained in Teva’s label. Glaxo allegedly only secured the ventricular dysfunction indication to satisfy doctor’s concerns whether carvedilol could be administered to CHF patients who had recently suffered a heart attack, and the trials it conducted to secure FDA approval for ventricular dysfunction enrolled a large number of CHF patient. These allegations, combined with other language in Teva’s label relevant to CHF, was sufficient to allege that Teva’s skinny label would actively encourage doctors and patients to use Teva’s carvedilol for the treatment of CHF.
The Court only determined whether Glaxo had adequately alleged a factual basis for its claim. The case is scheduled for a trial next month where a jury will determine whether Teva induced doctors and patients to use Teva’s generic version of this blockbuster drug for the treatment of CHF in violation of RE 40,000. Damages could be substantial. Coreg® sales reportedly exceeded $1.7 billion dollars per year during the infringing time frame.