Obviousness, patentability and Amarin...
The 1952 Patentability Act...The Patent Act of 1952 added 35 U.S.C. § 103,[2] which effectively codified nonobviousness as a requirement to show that an idea is suitable for patent protection. The section essentially requires a comparison of the subject matter sought to be patented and the prior art, to determine whether or not the subject matter of the patent as a whole would have been obvious, at the time of the invention, to a person having ordinary skill in the art. Clark held that the Congress, in passing the Act, intended to codify and clarify the common law surrounding the Patent Act by making explicit the requirement of nonobviousness.
Although patentability is a matter of law, the Court held that §103 required a determination of the following questions of fact to resolve the issue of obviousness:
the scope and content of the prior art;
the differences between the claimed invention and the prior art; and
the level of ordinary skill in the art.
In addition, the Court mentioned “secondary considerations” which could serve as evidence of nonobviousness. They include:
commercial success;
long felt but unsolved needs; and
failure of others.
However, the Court also recognized that these questions would likely need to be answered on a case-by-case basis, first by the United States Patent and Trademark Office (USPTO), then by the courts.
The difficulty of applying Graham to Amarin is there is an apples to oranges aspect..Graham was about a plow design and Amarin is about a complex drug interaction's actions on physiology..The lawyers might be qualified to discuss plow design but that does not mean they are qualified to discuss pathophysiology..
Graham criteria would appear to support Amarin.
Within bounds
'1) Vascepa is a commercial success (at least enough to fight over)
2) Vascepa addresses CVD event risk, a long felt but unsolved need which other drugs have failed to treat..
Then plainiff's argument and Judge Du's conclusion the Mori and Kura provide proof of prior art is ridiculous..To err might be human, but to base a legal opinion on a factual error can not possibly be the law.
Finally..The DC failed to include the role of the FDA in determining fact...Prior to the long and very expensive REDUCE-IT trial FDA specifically...approved no drugs for the Marine indication..The FDA
labeling specifically stated on the Vascepa label that Vascepa's ability to treat very high trigs is yet to be determined..In fact at that time there was no prior art accepted by the FDA...So in fact neither Mori or Kura were recognized by FDA as prior art..
":>) JL
