On Monday, a judge ruled against patents blocking the way for generic drugmakers Hikma Pharmaceuticals and Dr. Reddy’s Laboratories to file Abbreviated New Drug Applications for Vascepa generics.
Shares of Amarin Corporation are down more than 70% in premarket trading after a judge ruled that generic companies can go ahead and seek approval of generic versions of the company’s heart disease drug, Vascepa.
On Monday, a judge from the U.S. District Court for the District of Nevada ruled against patents blocking the way for generic drugmakers Hikma Pharmaceuticals and Dr. Reddy’s Laboratories to file Abbreviated New Drug Applications (ANDA) for Vascepa generics. Fish oil-based Vascepa was the first medication green lit by the U.S. Food and Drug Administration as an adjunct to maximally tolerated statin therapy to reduce cardiovascular risk. Both Hikma and Dr. Reddy’s have filed ANDAs with the FDA for generic equivalents to Vascepa. That prompted Amarin’s lawsuit that claimed the generic medications infringed on the patents protecting Vascepa.
As reported in The Motley Fool, Hikma and Dr. Reddy’s argued that the claims made by Amarin were made invalid due to the “obvious” nature of fish-oil-based products. The judge did say that the ANDAs infringed on the patents, but the “obvious” use of fish oil, and the fact that GlaxoSmithKline has a similar product in Lovaza already on the market, the claims made by Amarin were invalidated.
In a statement issued following the ruling, Amarin said it “strongly disagrees” with the ruling and will “vigorously pursue all available remedies,” which could include an appeal of the court’s decision. Amarin Chief Executive Officer John Thero said Amarin could also seek preliminary injunction pending that appeal against any generics that could be approved by the FDA and launched prior to the day in court. Thero went on to note that the company will take all legal actions necessary to “defend and protect” the company’s intellectual property. At this time though, the company does not believe either of the two challenging companies are in a position to immediately launch a generic equivalent to Vascepa, nor have any ANDAs been approved.
“At Amarin, we have a strong balance sheet with capacity and flexibility, and we plan to fight to protect our Vascepa franchise for the benefit of our patients, physicians, the broader healthcare community and our investors. We believe we are favorably situated to obtain an injunction against generic launch pending appeal, subject to our posting a bond to secure generics’ lost profits in the event that generics prevail on appeal,” Thero said in a statement.
While Amarin plots out its legal recourse, Thero said Amarin will continue to promote Vascepa and its efficacy in treating indicated patients at high risk of cardiovascular events, such as heart attack and stroke.
