An Amgen sign is seen at the company’s office in South San Francisco, California. REUTERS/Robert Galbraith
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(Reuters) – The U.S. Supreme Court on Monday asked for the federal government’s opinion in a patent case involving Amgen’s billion-dollar cholesterol drug Repatha.
The justices are considering whether to hear Amgen’s appeal of a ruling that invalidated its patents for Repatha. Major drugmakers have called the case a key test of their ability to earn and defend patents for important biologic drugs.
Amgen’s adversaries in the case, France-based Sanofi SA and Tarrytown, New York-based Regeneron Pharmaceuticals Inc, have urged the Supreme Court to reject the appeal. The high court regularly calls on the U.S. Solicitor General for the government’s views in cases in which the United States may have an interest.
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Thousand Oaks, California-based Amgen sold more than $1.1 billion worth of Repatha worldwide last year. The drug, which lowers “bad” LDL cholesterol using monoclonal antibodies to block a protein that prevents its removal, can reduce the risk of heart attacks and strokes in people with heart disease.
Amgen sued Sanofi and Regeneron in 2014 after they sought regulatory approval for their rival drug Praluent. The U.S. Food and Drug Administration approved Praluent in 2015, a month before it approved Repatha.
Regeneron sold $170 million worth of Praluent in the United States last year, and Sanofi sold over $200 million worth in the rest of the world.
A Delaware judge threw out a jury verdict for Amgen in 2019 after finding patents related to Repatha invalid. The U.S. Court of Appeals for the Federal Circuit agreed with the decision last year, finding that the patents failed to tell an ordinary person how to recreate the antibodies without “undue experimentation.”
Amgen told the Supreme Court that the type of patent “genus claims” the Federal Circuit invalidated are common in the pharmaceutical industry, and that the ruling’s impact was “devastating, particularly for critical biotech and pharmaceutical innovations.”
A brief filed in support of Amgen by companies including Biogen Inc, Bristol-Myers Squibb Co, and Merck Sharp & Dohme Corp said the Federal Circuit’s decision would “slow the pace of research and development and hinder innovation, to the detriment of patients and the public at large.”
Amgen said in a statement that it was “encouraged” by the Supreme Court’s request. A Regeneron spokesperson said that it and Sanofi remain confident that Amgen’s patents are invalid and that the Supreme Court petition is meritless.
The case is Amgen Inc v. Sanofi, U.S. Supreme Court, No. 21-757.
For Amgen: Jeffrey Lamken of MoloLamken
For Sanofi and Regeneron: George Hicks of Kirkland & Ellis, Matthew Wolf of Arnold & Porter Kaye Scholer
(NOTE: This story has been updated with comment from Amgen.)
Read more:
Amgen loses bid to revive patents for cholesterol drug Repatha
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