Novartis Pharmaceutical Corp. v. HEC Pharm Co. LTD:
Written Description Requirement Can Be Satisfied by Silence?
35 USC §112(a) provides “[t]he specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art…to make and use the same.” In Novartis Pharmaceutical Corp. v. HEC Pharm Co., LTD (Fed. Cir. Jan 3, 2022), the Federal Circuit considered whether a written description may be satisfied by silence.
Norvatis is an assignee of U.S. Patent No. 9.187, 405 (‘405 patent) which claims methods to treat relapsing remitting multiple sclerosis (RRMS) with fingolimod. Claim 1 of the ‘405 patent recites:
A method for reducing or preventing or alleviating relapses in Relapsing-Remitting multiple sclerosis in a subject in need thereof, comprising orally administering to said subject 2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol, in free form or in a pharmaceutically acceptable salt form, at a daily dosage of 0.5 mg, absent an immediately preceding loading dose regimen. (Emphasis added).
Novartis markets a 0.5 gm daily dose of fingolimod hydrochloride under the brand name Gilenya, to treat RRMS. HEC Pharm filed an ANDA (Abbreviated New Drug Application) with FDA, seeking approval to market a generic version of Gilenya. Novartis sued, alleging that HEC’s ANDA infringes all claims of ‘405 patent.
The district court found that HEC’s ANDA product would infringe claims 1-6 of the ‘405 patent. Then the district court turned to the validity of the ‘405 patent, and considered whether the specification provided an adequate written description of the negative limitation (“absent an immediately preceding loading dose regimen”). The expert testified that, “loading dose” (first dose that is higher-than-therapeutic level dose to get therapeutic levels up quickly) was well-known in the medical field. The court relied on the expert testimony and held that “[i]f a loading dose were directed, the Patent would say that a loading dose should be administer ‘initially’” and concluded that the patent provided sufficient written description of the negative limitation.
On appeal, HEC argued that there is no written description of the negative limitation because the ‘405 specification contains no recitation of a loading dose. HEC asserted that “it is well-settled law that silence alone cannot serve as a basis for a negative limitation. The Federal Circuit disagreed, stating that HEC “ignores a central tenet of our written description jurisprudence – that the disclosure must be read from the perspective of a person skilled in the art.” The Federal Circuit added “[i]n other words, context and the knowledge of those skilled in the art matter. And, as the Supreme Court has made clear, when assessing what the written description reveals to a skilled artisan, common sense also matters…The dissent notes that the Manual of Patent Examining Procedure (“MPEP”) states: “The mere absence of a positive recitation is not a basis for an exclusion.” MPEP §2173.05(i)…But the dissent, like HEC, ignores that it is how a skilled artisan reads a disclosure that matters. Written description may take any form, so long as a skilled artisan would read the disclosure as describing the claimed invention.” The Federal Circuit further stated, “[w]hat is critical is how a person of skill in the art would read the disclosure – not the exact words used.”
However, dissenting judge disagreed stating “[t]he majority dramatically expands a patentee’s ability to add, years after filing a patent application, negative claim limitation that have zero support in the written description. By doing so it contradicts our well-established precedent and nullifies the Patent Office’s guidance in the [MPEP]… Silence is not disclosure.”
In Novartis v. HEC, the Federal Circuit has illustrated the importance of reading the disclosure as a whole by a person of skill in the art, with his/her interpretation using common sense. After all, what matters is how a person of skill in the art would read the disclosure – not the exact words used.