Last week, Judge Robinson issued on an opinion and judgment in In Re: Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litigation, C.A. No. 09-2118-SLR (D. Del. May 12, 2011) (an ANDA case). The patents-in-suit covered an extended release version of a drug that was available in the prior art. Interestingly, the Court found the patents invalid as obvious in light of four prior art references which, even when combined, did not actually disclose all of the elements of the patent. According to the Court,
[N]ot every limitation of a claimed invention need be found in the prior art in order for said invention to be obvious. The Graham factors direct the court to look to the scope and content of the prior art, the differences between the invention and the prior art, and the level of skill of one of skill in the art. . . . . While it may be easier to prove obviousness if each limitation of the claimed invention is found in the prior art, the level of skill of one of ordinary skill in the art can, at times, fill in the gap when limitations of the claimed invention are not specifically found in the prior art.
Id. at 26.
The obviousness section of the opinion included some other points of interest:
- The Court gave some weight to the fact that a person of ordinary skill would know that at least one of the elements could be “calculated by a computer program,” based on Federal Circuit precedent that “‘the discovery of an optimum value of a variable in a known process is usually obvious.'” Id. at 28 (citing Pfizer, Inc. v. Apotex, Inc. 480 F.3d 1348, 1368 (Fed. Cir. 2007)).
- In the Court’s obviousness analysis, the fact that one of four references in an obviousness combination had not been considered by the patent office was sufficient to ease the difficulty of proving invalidity: “The court notes . . . that the ‘215 patent, which claims the extended release delivery system used in the patents-in-suit, was not before the PTO during examination of the ‘793 patent. Therefore, while defendants must still prove that the patent is obvious by clear and convincing evidence, they do not have the additional burden of overcoming the presumption that is due a qualified government agency presumed to have properly done its job. Tokai Corp. v. Easton Enters., Inc., Civ. No. 2010-1057, -F.3d -, 2011 WL 308370, at *6 (Fed. Cir. Jan. 31, 2011) (citations omitted).”
- The Court held that commercial success alone is insufficient to prove the presence of a long felt need. Id. at 31.
The Court also addressed a number of other issues, including claim construction, infringement, best mode, and inequitable conduct.