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25 August 2022Big PharmaSarah Speight

GSK presses court to deny Teva’s ‘skinny label’ petition

Teva’s petition relies on a “blatantly misleading” question, argues GSK | Case presents “no new issues” that haven’t already been decided.

GlaxoSmithKline (GSK) has hit back at Teva Pharmaceuticals by urging the US Supreme Court (SCOTUS) to reject its petition for a writ of certiorari over ‘skinny labelling’ of the heart drug Coreg (Carvedilol).

‘Skinny labelling’ is a commonplace practice adopted under the Hatch-Waxman Act of 1984, in which generic drug makers omit patent-protected indications from generic labels, in a process called ‘carving-out’.

This enables them to enter the market before the brand-name drug’s patent for other indications expire. But many brand-name manufacturers oppose the practice because it reduces the prices of drugs overall.

Generics firm Teva filed its petition in July this year, urging SCOTUS to overturn a precedential $235-million verdict handed down by the US Court of Appeals for the Federal Circuit in August 2021.

That verdict ordered the reinstatement of the decision against Teva after a 2-1 majority found that Teva’s version of the drug had infringed GSK’s by failing to carve out a patent-protected use of the drug on its generic label.

The decision, alleged Teva, had “blown a hole in the carefully calibrated regime governing the modern prescription-drug marketplace”.

A split US Court of Appeals for the Federal Circuit subsequently declined to rehear the dispute in February this year, based on a “sense of fairness” among the dissenting judges. “They [the judges] believe Teva’s partial label cannot be evidence of the intent required for active encouragement when Teva ‘play[ed] by the skinny-label rules.’,” wrote Chief Circuit Judge Kimberly Moore at the time.

Competition ‘block’

The question presented by Teva in its July petition was: “If a generic drug’s FDA-approved label carves out all of the language that the brand manufacturer has identified as covering its patented uses, can the generic manufacturer be held liable on a theory that its label still intentionally encourages infringement of those carved-out uses?”

It went on to say that the court’s August 2021 decision, if upheld, would result in allowing “a narrow patent on one way of using a drug to completely block any generic competition, potentially for years—precisely the opposite of what Congress prescribed”.

GSK rejected Teva in its opposition this month with the question: “When a generic drug is doubly indicated for a patented use, and there is strong record evidence of intent and inducing conduct, can the generic manufacturer evade liability for induced patent infringement merely because it did not include on its label (ie, ‘carved out’) one of the two indications corresponding to the patented use?”

It pointed out that the court has considered the issue of induced infringement “at least four times over the last approximately 15 years”, quoting Commil USA v Cisco Systems (2015) and Limelight Networks v Akamai Technologies (2014), among others.

“This fact-bound case presents no new issues in those areas of law, and was properly decided by the appellate court under those authorities,” argued GSK’s defence lawyers. “Certiorari should be denied.”

GSK filed its patent for Coreg in 1998, which expired in 2015. The biopharma company argued that Teva began to sell and market the drug “years before GSK’s patent on the use of carvedilol to treat heart failure had expired, and without taking appropriate steps to ensure its generic drug was approved only for non-patented uses.”

“Instead, Teva left one of Coreg’s two approved heart failure uses on its generic label and launched its product.

“Simply put, Teva sold a generic drug with a patented use on its label and marketed the drug, with the intent to capture the sales for that patented use. Liability here under the law of induced patent infringement is clear.”

GSK argued that “for all of Teva’s complaints, it is telling that it resorts to a blatantly misleading ‘question presented’ that relies on a premise—that Teva’s label ‘carved out’ the patented use—rejected by the jury and the Federal Circuit”.

“Teva also fails to mention that the ‘skinny-label’ issue impacts less than 30% of the damages. After launching with a ‘carve-out’ label, four years later, Teva went to a full label and never notified GSK, as required by law.

“In short, this case presents no novel issues under the law and concerns the liability of a party whose problems are of its own making. It presents no threat to generic companies who operate properly under the law of induced infringement as applied to generic drug labels—’skinny’ or not.”

Teva launched its generic version of Coreg in 2007, which GSK initially received approval for in 1995. The drug is used for treating hypertension, congestive heart failure (CHF), and left ventricular dysfunction (LVD).

When asked by LSIPR for comments, GSK declined, while Teva did not respond immediately.

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