Amarin is a biopharmaceutical company whose lead product since 2008 is Vascepa® (AMR-101) (“Vascepa”), a prescription grade ultra-pure omega-3 fatty acid derived from fish oil. In July 2012, the U.S. Food and Drug Administration (“FDA”) first approved Vascepa to treat patients with very high levels of triglycerides (“TG”), a type of fat found in blood, and in December 2019, expanded the label to include the reduction of cardiovascular disease events, including heart attack, stroke and cardiovascular death, in high-risk patients.
In order to protect its market share, Amarin sought and obtained dozens of U.S. patents in connection with Vascepa, including for its formulation and method of use. Indeed, going into the Class Period, Vascepa stood to have patent protection until 2030, when the last patent was set to expire. At the same time, Amarin was engaged in patent litigation against applicants who submitted Abbreviated New Drug Applications (“ANDA”) for generic drug products of Vascepa – exposing the Company to real risks related to the validity and scope of coverage in its patent portfolio.
Throughout the Class Period, Defendants made false and misleading statements and/or failed to disclose that: (i) there was an increasingly high risk that certain of Amarin’s patents would be invalidated; (ii) once the District Court invalidated certain of Amarin’s patents, there was little to no chance of reversing that ruling; (iii) the Company’s litigation was preventing it from effectuating a successful takeover; (iv) Defendants were downplaying the true threat the ongoing ANDA litigation posed to the Company’s business and future prospects; and (v) as a result, the Company’s public statements were materially false and misleading at all relevant times.