The U.S. Supreme Court’s denial of Teva Pharmaceuticals’ appeal could have broad ramifications for the wider generics industry, for which “skinny labeling” is a common and accepted practice.
Pictured: Supreme Court building/Courtesy Adobe Stock, philip
The U.S. Supreme Court has denied Teva Pharmaceuticals a hearing for its appeal of a 2020 appellate court ruling over a patent dispute with GlaxoSmithKline, according to a High Court order form released Monday.
With the denial, the Israel biotech will continue to owe a $235 million payout to the British drugmaker after the U.S. Federal Circuit Court of Appeals ruled in October 2020 that Teva persuaded doctors to prescribe its generic version of GSK’s beta-blocker Coreg (carvedilol). Coreg patent protections expired in 2015; Teva’s alleged infringement started in 2007.
At the heart of the lawsuit is “skinny labeling,” which refers to the standard industry practice of securing regulatory approvals for generic medications in indications not covered by the label of their branded counterparts. This practice is an exception to the FDA’s requirement that generic labeling be identical to the brand-name drug’s labeling.
The Supreme Court’s decision “provides validation to our previous arguments that Teva did not adhere to patent law when it marketed carvedilol,” said a GSK spokesperson in an emailed statement to BioSpace. “GSK is a staunch supporter of increasing access to generic medicines and reducing barriers to generic drug development. However, we firmly believe that intellectual property is critical for spurring the innovation necessary for developing future medicines and vaccines,” the spokesperson said.
The legal salvo started in June 2014 when GSK filed a lawsuit against Teva, alleging that the latter violated patent protections for Coreg in 2007 when it started marketing its generic drug with a skinny label that covered hypertension and left ventricular dysfunction. Coreg is approved for treating these two conditions, along with congestive heart failure.
In 2011, the FDA asked Teva also to include the third indication to the generic’s label. This gave GSK legal standing to file a lawsuit, in 2017 culminating in a $234.1 million ruling against Teva to make up for GSK’s lost profit and an additional $1.4 million to cover royalties.
A year later, in March 2018, a federal court overturned this initial verdict and the approximately $235 million payment for GSK.
In the appellate court ruling that favored GSK, Circuit Judge Pauline Newman found enough evidence to support Teva’s “induced infringement” of Coreg’s patent protection, including the generic’s product catalogs, press releases and other promotional materials.
Chief Judge Sharon Prost disagreed with the court’s decision, saying that going after the skinny label practice the ruling “undermines” Congress’ thrust to lower drug costs by empowering generics drugmakers.
Monday’s Supreme Court denial could compound Prost’s concerns and those of the Biden administration. In 2022, the Supreme Court asked for the Department of Justice’s opinion. Solicitor General Elizabeth Prelogar wrote back, indicating that if Teva’s generic drug constitutes its intent to induce infringement, the skinny label “pathway will be seriously jeopardized.”
Tristan Manalac is an independent science writer based in metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
