How much of the specification should be used for something that isn’t intended to be included in the claim? According to a recent Federal Circuit ruling in Novartis Pharmaceuticals v. Accord Healthcare Inc., the answer might not exist at all. The important thing, according to the decision, is that the negative limitation should not be described in the specification in a way that differs from how it is utilized in the claim.
The drug fingolimod hydrochloride, which Novartis sells under the trade name Gilenya, is used to treat Relapsing-Remitting Multiple Sclerosis (RRMS) when given “at a daily dosage of 0.5 mg, absent an immediately prior loading dose regimen,” according to the patent claims at issue in Novartis. Defendants asserted, among other things, that the patent specification lacked sufficient 35 U.S.C. § 112 written description support for the negative claim limitation “without an immediately prior loading dose regimen,” in order to get approval to commercialize a generic version of the medicine.
The parties concurred that “loading dose” refers to a dose that is larger than daily and “often provided as the first dose.” However, they couldn’t agree on the amount of information that had to be disclosed in order to satisfy the written description requirement for the specification’s negative “loading dosage” limitation. The patent specification “contains no recital of a loading dose ‘or its prospective benefits or disadvantages at all,'” according to the defendants, therefore the patentee failed to disclose the “loading dose fully.”
In response, Novartis provided expert testimony and claimed that “if a loading dose were directed, the Patent would indicate that the loading dose should be delivered “immediately”.” According to Novartis’ expert, a person of ordinary skill would read the specification to explain the absence of a loading dose because the patents did not specify an initial loading dose.
The district court sided with Novartis after a bench trial, recognizing the testimony of its expert and concluding that “although the patent provides various dosing regimens, such as “intermittent dosing,” it does not specify delivering those regimens with loading doses.” The specification thus “indicated to a person of ordinary skill that the claimed invention did not contain the delivery of a loading dose” and gave sufficient written explanations for the negative restriction, the court found.
The Federal Circuit rejected the defendants’ claim that the specification had to at least allude to the harmful restriction’s “possible advantages or disadvantages…” The Federal Circuit argued that the defendants’ stance conflicted with earlier rulings that there is no “new and heightened test for negative claim restrictions.” Although the Novartis circumstance was not directly addressed by precedent, the Federal Circuit concluded that two precedent-related ideas were especially useful.
A negative limitation cannot be “inconsistent with the disclosure,” according to the first rule, and still, satisfy the written description requirement. The second rule is that written description is sufficient where “‘the core of the original disclosure’ communicates the relevant information—regardless of how it conveys such information,” according to the Federal Circuit.
Of course, even while a negative limitation may not need to be disclosed in the specification, doing so may still be beneficial. There might not have been a disagreement at all if, for instance, the Novartis specification had simply stated, “Do not deliver a loading dose.” Detailed information on the case is available at https://www.proskauerinlifesciences.com/wp-content/uploads/sites/34/2022/02/Novartis-v.-Accord.pdf.
