AAM urges federal judge to reject challenges to “skinny label”

Regulatory NewsRegulatory News | 23 August 2021 |  By 

In an amicus brief filed on 19 August, the Association for Accessible Medicines (AAM) has urged a federal judge to challenge the attacks on the so-called “skinny label” which allow generic drugs to be approved for non-patented indications, permitting their entry to the market before patent for other indications expire.
The amicus brief challenges a magistrate judge’s report and recommendations to allow the continuation of Amarin Pharmaceuticals’ suit alleging that Hikma Pharmaceuticals is infringing on its patents for Vascepta, a cardiovascular drug. The suit is being heard in the US District Court for the District of Delaware.
Specifically, the judge “found that Hikma’s product labeling, website and press releases touting the drug’s equivalence to Vascepta made it plausible that Hikma intended to induce others to infringe three Amarin patents on the branded drug,” according to Law360.
If the suit proceeds, generic drug companies will be deterred from seeking more approvals for skinny labeling, resulting in higher drug prices, according to AAM. “If a generic manufacturer knows that it will face a jury trial just for bringing a skinny label generic to market with the statements the law permits and requires, then it will not bring that generic to market, and patients will ultimately pay higher brand prices for longer,” according to the amicus brief.  
Skinny labeling was enacted under the 1984 Hatch-Waxman Act and allows generic companies to enter the market without having to wait for all patents on a particular brand-name drug to expire.
The nine-page brief, which has yet to be posted online, said that “the claims in this case threaten to make a dead letter out of the ‘skinny label’ regime that Congress enacted to help ensure patient access to low-cost generic and biosimilar medicines. The ultimate victim of these misguided claims will be the American public, which will face higher prices for branded medicines that Congress intended to be available at a lower cost.”
The amicus brief follows a controversial October 2020 split decision in the US Court of Appeals for the Federal Circuit October in the case GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc. That decision reinstated a jury’s verdict that Teva infringed on GSK’s patent for its Coreg drug product, even though Teva’s product was launched with a skinny label.
Skinny labeling is a common practice used by the generic drug industry to get approval for an indication on a brand name drug where all the patents have not yet expired. Of 56 brand-name drugs that became available as generics from 2015 to 2019, 43% were launched with skinny labels, according to a study conducted by researchers at Brigham and Women’s Health Hospital and Harvard Medical School.
The study, published in May 2021 in JAMA Internal Medicine, asserted that “without skinny labeling, our findings suggest that generic drug entry for susceptible brand-name drugs could be delayed by multiple years.”


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