Novartis Pharmaceuticals Corporation v. Accord Healthcare, Inc., Appeal No. 2021-1070 (Fed. Cir. Jan. 3, 2022)

In this week’s Case of the Week, the Federal Circuit affirmed a district court’s bench trial finding that claims of a pharmaceutical patent were supported by adequate written description under 35 U.S.C. § 112(a).  This is the latest in a series of recent precedential opinions addressing written description issues associated with claimed dosages and dosage ranges, such as we reported on here and here.

In this case, appellee Novartis’s patent claimed a method of treating relapsing remitting multiple sclerosis (RRMS) with a daily dose of 0.5 mg of the compound fingolimod, without an immediately preceding loading dose regimen.  HEC Pharm Co., Ltd. and HEC Pharm USA Inc. (HEC) appealed the district court’s determination that the 0.5 mg daily dosage and the negative limitation excluding a loading dose were adequately supported by the specification.

The district court found that both the patent at issue and the British application, to which it claimed priority, described an animal study in which a 0.3 mg/kg weekly dose of fingolimod effectively reduced RRMS-like symptoms in lab rats, as well as a “Prophetic Trial” in which human RRMS patients would receive 0.5, 1.25, or 2.5 mg daily dosages of the class of compounds including fingolimod did too.  In addition to the express recitation of the 0.5 mg daily dose in the description of the prophetic clinical trial, the court also credited expert testimony that a person of skill in the art would have understood the 0.3 mg/kg weekly dose in lab rats to translate to about a 0.5 mg daily dose for humans, which in both instances was about 60% lower than the lowest known effective dose in the prior art.

The Federal Circuit agreed that these disclosures were adequate to demonstrate to a skilled artisan that the inventors had possession of a 0.5 mg daily dose at the time of the invention.  The Federal Circuit court rejected HEC’s argument that the specification did not contain “blaze marks” directing a skilled artisan to this particular dosage among many possibilities, noting that such indicia were unnecessary where an artisan would recognize the claimed dosage as expressly disclosed among a small number of embodiments.  This stands in contrast to the court’s recent decision in Biogen Int’l GMBH v. Mylan Pharms Inc. (our write-up here), in which the Federal Circuit found a specific dosage inadequately supported where it was described in the specification only as one end of a dosage range among several disclosed possible ranges.

Regarding the “no loading dose” negative limitation, the patent’s specification notably did not contain any mention of a loading dose at all.  (A “loading dose” is a dose that is typically higher than subsequent daily dosages, administered initially to help elevate the amount of medication in the patient to therapeutic levels.)  Loading doses were well-known in the prior art, and the district court credited expert testimony that the daily dosages were described as being administered “initially,” and that there were several points where a skilled artisan would have expected a loading dose to be recited if it was to be used in the claimed dosing regimen.

The Federal Circuit reviewed relevant precedent concerning written description support for negative limitations and expressly declined to adopt a bright-line rule that a specification’s silence as to a limitation’s presence is insufficient to support a negative limitation in the claims.  The court agreed with the district court that in this context and given the knowledge of persons skilled in the art, the specification adequately described a treatment regimen with no loading dose.  Chief Circuit Judge Moore dissented on this point, arguing that the negative limitation was added during prosecution to overcome an obviousness rejection; the specification did not clearly provide any reason to exclude a loading dose; and the majority was “relegating the legal determination of a term’s meaning to the backseat of an expert’s post-hoc rationalization.”  The majority opined that written description support was a factual question reviewed for clear error and that Judge Moore’s dissent attempted to substitute the district court’s factual findings with her own.

Because the majority discerned no clear error in the district court’s finding of written description support, the decision was affirmed.

The opinion can be found here.

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