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Amgen Wins First Court Battle Over PCSK9 Patent Against Sanofi and Regeneron


Court Ruling

Two patents regarding the antibodies which target PCSK9 were upheld in court, but the jury did not award damages.

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March 18, 2016 | by Sarah Massey, M.Sc.

A US court jury ruled that Sanofi and Regeneron’s PCSK9 drug – sold as Praluent – infringed upon Amgen’s patent for its similar pharmaceutical, Repatha. Two patents regarding the antibodies which target PCSK9 were upheld in court, but the jury did not award damages.

A new court date is expected to be set for later this month, where Judge Sue Robinson will consider granting Amgen a permanent injunction. If this ruling is made, it could halt sales of Praluent, unless the companies are able to reach a royalty agreement.

According to a statement released by Regeneron and Sanofi, they “strongly disagree” with the jury’s verdict, and have plans to file an appeal. Both companies were also quick to point out that “this decision is the first step in this ongoing litigation and does not impact Praluent (alirocumab) Injection or our ability to deliver it to physicians and patients at this time.”

Trading of shares in Regeneron were on hold as the court ruling was announced. Some analysts estimate that Regeneron and Sanofi could be required to pay upwards of 20 percent in royalties, if Amgen wins the next court case. Other analysts are more conservative with their estimates, predicting a 5 percent royalty fee.

According to Gbola Amusa, an analyst for Chardan, if royalties are between 10 and 20 percent, Amgen could receive $750 million per year. This figure is based on an annual sales estimate of $3.9 billion for Praluent by the year 2023.

“This is a complex area of law and science, and we believe the facts and controlling law support our position. We look forward to taking our case to the Federal Circuit Court of Appeals, the U.S. appellate court that hears all biopharmaceutical patent appeals,” said Joseph LaRosa, Senior Vice President, General Counsel and Secretary, Regeneron. “Praluent was developed with Regeneron's proprietary science and technology and represents an important medical advance for patients.”

With the emerging PCSK9 market expected to bring in almost $10 billion in sales, the drug is an important asset for Regeneron and Sanofi. For Regeneron, Praluent may help diversify their offerings beyond their best-selling eye injection for macular degeneration, Eylea. Sanofi has high hopes that the drug will help keep them afloat while the company faces impending competition in the diabetes space.

Repatha and Praluent hit the market within one month of each other, making competition between the drugs strong from the outset. While some payers have signed exclusive deals with one PCSK9 drug over another, there are a few top payers who cover both drugs.

Uptake of the drugs has so far been slow – potentially due to their high price at $14,000 or more. While the drugmakers have provided clinical trials evidence that their PCSK9 products are effective at reducing LDL cholesterol, data on whether the drugs actually prevent heart attacks and stroke has yet to be released.

Keywords: Cholesterol, Drug Patent, Payer


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