This article is a collaboration between MedPage Today and:
A jury's decision last week in a patent case might possibly lead to the removal of one of the new PCSK9 inhibitor cholesterol lowering drugs from the U.S. market, according to a Wall Street analyst who has been closely following the case.
Amgen, which manufactures Repatha (evolocumab), scored a court victory last week when a federal jury upheld two of its patents in Amgen's case against Regeneron and Sanofi, which manufacture Praluent (alirocumab); previously the latter two companies had acknowledged that their drug infringes Amgen's patents as written, but argued that those patents shouldn't have been granted.
The two sides have been locked in an intense battle over the currently small but potentially enormous market for this new class of cholesterol lowering drugs.
Most observers think that in the end the decision will not lead to Praluent being pulled from the market. Instead they think Sanofi and Regeneron will probably have to pay a penalty and royalties to Amgen. But Chardan's Gbola Amusa reports that "it is reasonably likely that Praluent will be removed from the U.S. market in 2016."
A hearing is being held this week in which the judge in the case will rule on Amgen's request to halt Praluent sales. Sanofi and Regeneron could still reach a settlement with Amgen. Without a settlement, hearings and appeals could stretch out for another 12 to 18 months, according to a report in BidnessEtc -- and even longer if the case is sent back to the district court for reconsideration.
A Sanofi representative sent the following comment: "We do not believe that Amgen's patents are valid, and we are confident that the law and the facts support our invalidity position."
Since their approval last summer, sales of the drugs have been quite modest by all accounts. The high price of the drugs (with a retail price at $14,000 a year, though most companies have negotiated discounts) and payer resistance have played a strong role in their slow uptake. Another important factor has been physician reluctance to prescribe the drugs in the absence of data showing improvement in cardiovascular outcomes. That could change by the end of this year when the results of the first large cardiovascular outcomes trial are expected to be presented.