United States: Patent Case Summaries | Week ending January 7, 2022
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A weekly summary of previous patent-related opinions issued by the Court of Appeals for the Federal Circuit and designated previous or informative opinions by the Patent Trial and Appeal Board.
Novartis Pharmaceuticals Corp. vs. Accord Healthcare, Inc., et al., no. 2021-1070 (Fed. Cir. (D. Del.) 3 January 2022). Opinion by O’Malley, joined by Linn. Dissenting Opinion of Moore.
Novartis markets a 0.5 mg daily dose of fingolimod hydrochloride under the brand name Gilenya, a drug used to treat relapsing-remitting multiple sclerosis (RRMS). Novartis holds a patent claiming methods of treating RRMS with fingolimod or a salt of fingolimod, such as fingolimod hydrochloride, at a daily dose of 0.5 mg without an immediately preceding loading dose. The patent claims priority over a 2006 UK patent application.
HEC has filed an Abbreviated New Drug Application (ANDA) requesting approval of a generic version of Gilenya. Novartis then filed a lawsuit, alleging that HEC’s ANDA infringes the patent. After a trial en banc, the district court found infringement and declared the patent claims not invalid for insufficient written description or anticipation. HEC appealed.
On appeal, HEC argued that the patent claims were invalid because the 2006 priority application lacked an adequate written description of the daily dose limit of 0.5 mg and the negative “no loading dose” limitation. required by the claims. The Federal Circuit disagreed and upheld, ruling that the claims had adequate written descriptive support in the priority application.
Regarding the dosage limitation, the Federal Circuit responded to HEC’s argument “that no one, including the inventors, knew that a dose of 0.5 mg/day would be effective as of the date of priority”. The court rejected this argument for two reasons. First, “efficacy is not a requirement of the claims”, as the claims “require only the administration of a dose of 0.5 mg/day for, among others, for treatment purposes.” Second, an experiment described in the application provided evidence “that the inventors knew that a 60% lower dose would be effective.”
With respect to negative limitation without loading dose, the Federal Circuit explained that “it is well established that there is no ‘new and strengthened standard for negative claim limitation’.” The court rejected HEC’s argument that “silence alone cannot serve as a basis for” a negative limitation. The Federal Circuit explained that, “as with all other limitations, the negative limitation here must be accompanied by an original disclosure that forward to a normally qualified person that the inventor was in possession of the claimed invention.” The district court in that case had “properly and fairly carefully” analyzed the specification from the perspective of a person of ordinary skill in the art, and the Federal Circuit discerned “no manifest error in the court’s analysis or conclusions.”
Justice Moore disagreed with the negative loading dose limitation, explaining that “silence is not disclosure”. Judge Moore pointed out that the written description “is silent, oddly silent” about a loading dose. In his opinion, “it was necessary to discuss loading doses to show that the inventors in fact invented this method of treatment which is not only ambivalent, but expressly excludes a loading dose. It is not a increased written description requirement; it is simply a written description requirement.”
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