Get 40% Off
👀 👁 🧿 All eyes on Biogen, up +4,56% after posting earnings. Our AI picked it in March 2024.
Which stocks will surge next?
Unlock AI-picked Stocks

U.S. Supreme Court to hear Amgen bid to revive cholesterol drug patents

Published 11/04/2022, 02:09 PM
Updated 11/04/2022, 04:38 PM
© Reuters. FILE PHOTO: An Amgen sign is seen at the company's office in South San Francisco, California October 21, 2013  REUTERS/Robert Galbraith/Files

By Blake Brittain

WASHINGTON (Reuters) -The U.S. Supreme Court on Friday agreed to hear Amgen Inc (NASDAQ:AMGN)'s bid to revive patents on its cholesterol drug Repatha that were invalidated due to a legal challenge by rivals Regeneron Pharmaceuticals Inc (NASDAQ:REGN) and Sanofi (NASDAQ:SNY) SA.

The justices took up Amgen's appeal of the lower court ruling that threw out the Repatha patents. Amgen and other drugmakers have called the case a test of their ability to earn and defend patents for important drugs.

Amgen first sued Regeneron and Sanofi in 2014 over their rival drug Praluent, which works by a similar mechanism as Repatha. The two monoclonal antibody drugs won U.S. approval weeks apart in 2015.

An Amgen spokesperson said the company was encouraged by the decision and "firmly believes in the validity of its patents."

"Amgen believes that patent protection is essential, 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 said.

A spokesperson for Regeneron said it is the company's "longstanding belief" that Amgen's patents are invalid, and it expects a decision from the high court by the end of June 2023.

Representatives for Sanofi did not immediately respond to a request for comment.

Thousand Oaks, California-based Amgen sold more than $1.1 billion worth of Repatha worldwide last year.

The two drugs, which lower "bad" LDL cholesterol by blocking a protein called PCSK9 that prevents its removal from the blood, can reduce the risk of heart attacks and strokes in people with heart disease.

3rd party Ad. Not an offer or recommendation by Investing.com. See disclosure here or remove ads .

Amgen sued French drugmaker Sanofi and Tarrytown, New York-based partner Regeneron shortly after they sought regulatory approval for Praluent.

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 in 2019 threw out a jury verdict in favor of Amgen after finding the patents invalid. The U.S. Court of Appeals for the Federal Circuit, which focuses on patent law, agreed with the lower court 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 (NASDAQ:BIIB), Bristol Myers (NYSE:BMY) Squibb Co and Merck & Co 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."

The Biden administration said in a September court brief that the high court should decline to review the case.

Latest comments

Risk Disclosure: Trading in financial instruments and/or cryptocurrencies involves high risks including the risk of losing some, or all, of your investment amount, and may not be suitable for all investors. Prices of cryptocurrencies are extremely volatile and may be affected by external factors such as financial, regulatory or political events. Trading on margin increases the financial risks.
Before deciding to trade in financial instrument or cryptocurrencies you should be fully informed of the risks and costs associated with trading the financial markets, carefully consider your investment objectives, level of experience, and risk appetite, and seek professional advice where needed.
Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. The data and prices on the website are not necessarily provided by any market or exchange, but may be provided by market makers, and so prices may not be accurate and may differ from the actual price at any given market, meaning prices are indicative and not appropriate for trading purposes. Fusion Media and any provider of the data contained in this website will not accept liability for any loss or damage as a result of your trading, or your reliance on the information contained within this website.
It is prohibited to use, store, reproduce, display, modify, transmit or distribute the data contained in this website without the explicit prior written permission of Fusion Media and/or the data provider. All intellectual property rights are reserved by the providers and/or the exchange providing the data contained in this website.
Fusion Media may be compensated by the advertisers that appear on the website, based on your interaction with the advertisements or advertisers.
© 2007-2024 - Fusion Media Limited. All Rights Reserved.