Teva asks SCOTUS to overturn “skinny label” verdict on GSK drug

by Stephen Riddle

Teva has asked the Supreme Court to look at a judgment in a $235 million patent dispute with GSK that it claims could undermine the ability of generic drugmakers to bring new products to market, and thereby help reduce drug prices.

The case hinges around the concept of “skinny labelling” which was introduced to stop drugmakers extending the exclusivity period for their branded medicines – through a stream of new indications or patient populations – that can be protected with so-called “use” patents.

These can extend for many years after the original substance patent of a drug has expired, an evergreening tactic that Congress sought to block by allowing generic drugmakers to seek approval for fewer indications than the brand.

Rather than waiting for all the patents to expire, they can seek approval for a truncated list of uses – the skinny label – that only includes those that are off-patent.

The case focuses on GSK’s heart drug Coreg (carvedilol), which was approved to treat high blood pressure in the 1990s, with additional indications for post-heart attack and congestive heart failure patients added later. The substance patent expired in 2007.

Teva launched its first generic in that year with a skinny label that excluded the heart failure use, as it was covered by a use patent that expired in 2015.

Things became litigious in 2017, when a Delaware court found that Teva’s label for its generic encouraged doctors to use the drug to treat heart failure in a way that infringed GSK’s RE40,000 patent, which was reissued by the Patent and Trademark Office (PTO) in 2008.

GSK claimed patent infringement, but Teva argued that the ‘000 patent should not apply as it was granted after it launched its generic.

A district court judge later overturned the first verdict, but a US appeals court in 2020 reinstated the $235 million judgment against the generics manufacturer.

Fast forward to February of this year, and the US Court of Appeals declined Teva’s request to reopen the dispute, on the grounds that it creates uncertainty for generic drugmakers and could lead to a flood of lawsuits against generics with skinny labels that have been on the market for years without challenge.

On judge who voted against that decision, Sharon Prost, said at the time that denying the petition would weaken Congress’ plans to facilitating quick access to generics to reduce drug spending.

Teva’s latest petition notes that the skinny label pathway “worked as intended for almost 40 years – until the Federal Circuit rewrote the inducement standard in this case.”

“Given the importance of this issue to patients, payors (including the federal government), and prescription-drug competition, this court should grant review,” it adds.

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