INTERESTING ARTICLE (sorry if this was already uploaded here) - I read that this was posted on Investor Village yesterday:
Justices Urged To Fix Fed. Circ. 'Paradox' In Heart Drug Case
Law360 (February 24, 2021, 7:44 PM EST) -- Inventor group U.S. Inventor is asking the U.S. Supreme Court to take up Amarin Pharma's appeal of the Federal Circuit's decision to strike down six patents on its heart drug Vascepa, saying the appeals court has created a "jurisprudential paradox" in how it analyzes obviousness.
The group filed an amicus brief Tuesday supporting the pharmaceutical company, which argued in a Feb. 11 certiorari petition that the Federal Circuit didn't properly take into account some secondary evidence of non-obviousness when it invalidated six of Amarin's patents covering Vascepa, which is used to treat high levels of triglycerides in the blood.
U.S. Inventor said the appeals court has "consistently overlooked" such evidence — including whether a product satisfied a long-felt need — even though it found that an ordinarily skilled person would have been motivated to modify prior art to get the claimed invention. To the group, this was a "jurisprudential paradox" that could not be squared with the law.
"The Federal Circuit created this preposterous and unstable legal landscape," the group wrote. "The paradox materializes as a one-way ratchet that only operates against patent owners."
Counsel for the parties did not immediately return requests for comment Wednesday.
Since Vascepa is Amarin's only marketed drug, it accounts for all of the company's revenue, according to the company. Amarin reported in regulatory filings that Vascepa had $427.4 million in sales in 2019, predominantly in the U.S. The patents were set to expire in 2030 before the invalidity decision cleared a path for potential generic competition.
The case began when Amarin sued Hikma Pharmaceuticals plc and Dr. Reddy's Laboratories Inc. over their planned generic versions of Vascepa. U.S. District Judge Miranda M. Du, however, ruled in March 2020 that the drug's patents were obvious in light of earlier treatments.
Judge Du said her finding of obviousness was not outweighed by Amarin's argument that there was a long-standing need for a treatment that, unlike earlier ones, didn't cause a dangerous surge in bad cholesterol, and that the industry was skeptical of Amarin's approach.
The Federal Circuit in September summarily affirmed that decision, leading Amarin to lodge a petition for rehearing that urged the court to prevent certain evidence of non-obviousness from being treated as "second-class citizens."
The full Federal Circuit in November denied Amarin's rehearing petition.
Hikma said after the appeals court's ruling that it had received approval from the U.S. Food and Drug Administration for its generic version of Vascepa and was working toward launching it. On Tuesday, the company waived its right to respond to Amarin's certiorari petition, filings show.
The patents-in-suit are U.S. Patent Nos. 8,293,728; 8,318,715; 8,357,677; 8,367,652; 8,431,560; and 8,518,929.
Amarin is represented by Mark C. Fleming, Amy R. Pearlman, Jonathan E. Singer, Seth P. Waxman and Claire H. Chung of WilmerHale.
Hikma is represented by Charles Klein of Winston & Strawn LLP.
US Inventor is represented by Robert Greenspoon of Flachsbart & Greenspoon LLC.
The case is Amarin Pharma Inc. et al. v. Hikma Pharmaceuticals USA Inc. et al., case number 20-1119, before the U.S. Supreme Court.
