Amarin cardiovascular news

Amarin filed a response with the U.S. Patent and Trademark Office (PTO) to a November non-final rejection letter for a patent application covering the company's lead candidate, AMR101. The letter rejected some claims as being unpatentable for obviousness, which Amarin seeks to address in the amended application. Amarin amended the scope of use to "lowering triglycerides and Apolipoprotein B" ( APOB) from "treating hypertriglyceridemia," and added supporting data from the Phase III MARINE trial showing a greater than 5% reduction in APOB at week 12 of treatment vs. placebo in patients with very high triglycerides (greater than or equal to 500 mg/dL). Amarin argues that both the APOB reduction and population are "unexpected in the view of prior art" that supported approved patents. The amended application also narrows the claims to cover only a 4 g dose of AMR101 instead of 1-4 g doses (see BioCentury, Nov. 7, 2011)

Last June, PTO issued a similar non-final rejection letter rejecting some claims as being unpatentable for obviousness and double-patenting. In August, PTO issued a final rejection for the application, but Amarin filed a request for continued examination in September. Under the American Inventors Protection Act of 1999, applicants can file a request for continued examination for a fee upon receipt of a final action. There is no limit to the number of requests for continued examination an applicant can file. ...