Petitioning the U.S. Supreme Court to reconsider a patent loss rarely pans out for drugmakers, but, in the case of Amgen and its cholesterol med Repatha, the company’s high court Hail Mary has been answered.
The Supreme Court will let Amgen argue to resurrect a pair of Repatha patents that were put on ice back in 2019. At the time, a Delaware judge sided with Sanofi and Regeneron Pharmaceuticals after a series of Amgen wins in the long-running PCSK9 feud. The U.S. Court of Appeals upheld the lower court’s decision in 2021.
A spokesperson for Regeneron said the company expects the Supreme Court to reach a decision by the end of June, Reuters reports.
The case stretches back to 2014, the year Amgen leveled its original lawsuit against Sanofi and Regeneron over alleged patent infringement by the partners’ rival PCSK9 cholesterol drug Praluent, under development at the time as alirocumab.
Praluent and Repatha won U.S. approval just weeks apart in 2015. Both medications help lower “bad” LDL cholesterol by blocking the protein PCSK9.
Amgen “firmly believes” its scrapped Repatha patents are valid, a company spokesperson told Reuters late last week. Patent protection is paramount “not only for Amgen, but also for the entire biotechnology and pharmaceutical industry to make the significant investments required to discover and develop new innovative therapeutics," the spokesperson added.
Amgen has argued that the court ought to back broader protections on antibody drugs like Repatha, suggesting that without those intellectual property bulwarks, me-too drugs can emerge with minor changes to successful meds without committing the same resources to research. Sanofi and Regeneron have countered that letting Amgen’s Repatha patents stand could allow companies to deflect entire classes of rival drugs by claiming overly broad protections.
Over the years, the litigation has captured the attention of many industry watchers and prompted other drugmakers to weigh in. Last year, Amgen ginned up the support of several of its big biopharma peers, including Biogen, Bristol Myers Squibb and Merck & Co. The companies argued in a petition that the precedent set by Amgen’s loss would “slow the pace of research and development and hinder innovation, to the detriment of patients and the public at large.”
Amgen launched its bid at the Supreme Court last November. Earlier this year, the high court called for the U.S. solicitor general’s opinion on whether it should reconsider Amgen’s loss.
In late September, the Biden administration’s top lawyer, Elizabeth Prelogar, suggested Amgen’s petition “should be denied.”
The fact that the Supreme Court has now decided to hear Amgen’s argument marks a rare turn of events on the patent litigation front. Typically, the Supreme Court takes up very few cases on petition, and that’s especially true where patent law is concerned, Barnes & Thornburg partner Ron Cahill explained in a recent interview.
Cahill made his remarks alongside a prediction the Supreme Court wouldn’t take up Teva Pharmaceuticals’ petition in a separate patent case revolving around the common generic carve-out tactic known as “skinny labeling.”