Patent claim limitations that are “negative”—that is, claim limitations specifying the absence of a particular element from the patent claim—can pose a dilemma in the written description context. How much of the specification should be devoted to something that is not supposed to be part of the claim? The answer may be none at all according to a recent Federal Circuit decision, Novartis Pharmaceuticals v. Accord Healthcare Inc. The key, according to the decision, is that the specification should not describe the negative limitation in a manner inconsistent with how it is used in the claim.

At issue in Novartis were patent claims directed to methods of treating relapsing remitting multiple sclerosis (“RRMS”) with fingolimod hydrochloride “at a daily dosage of 0.5 mg, absent an immediately preceding loading dose regimen”—a treatment Novartis markets under the brand name Gilenya. Defendants, seeking approval to market a generic version of the drug, argued among other things, that the patent specification lacked adequate 35 U.S.C. § 112 written description support for the negative claim limitation “absent an immediately preceding loading dose regimen.”

The parties agreed that a “loading dose” is a higher than daily dose “usually given as the first dose.” However, they disagreed regarding the level of disclosure required of the negative “loading dose” limitation in the specification for purposes of satisfying the written description requirement. Defendants argued that the patentee failed to adequately disclose the “loading dose” because the patent specification “contains no recitation of a loading dose ‘or its potential benefits or disadvantages at all.’” Novartis, in turn, offered expert testimony that “if a loading dose were directed, the Patent would say that the loading dose should be administered ‘initially.’” Because the patents did not specify an initial loading dose, according to Novartis’s expert, a person of ordinary skill would read the specification to describe the absence of a loading dose.

After a bench trial, the district court agreed with Novartis, accepting its expert’s testimony and finding that “while the patent describes alternate dosing regimens, such as ‘intermittent dosing,’ it does not describe administering those regimens with loading doses.” Thus, according to the court, the specification “indicated to a person of ordinary skill that the claimed invention did not include the administration of a loading dose,” and provided adequate written description for the negative limitation.

The Federal Circuit affirmed, rejecting Defendants’ argument that the specification must, at minimum, mention the negative limitation “or its potential benefits or disadvantages . . . .” According to the Federal Circuit, Defendants’ position was contrary to precedent establishing that there is no “new and heightened standard for negative claim limitations.” While precedent did not squarely address the situation in Novartis (where the negative limitation was completely omitted), the Federal Circuit found that two principles from its precedent were particularly instructive. The first was that a negative limitation cannot be “inconsistent with the disclosure,” and still meet the written description requirement. The second principle, according to the Federal Circuit, is that written description is satisfied where “‘the essence of the original disclosure’ conveys the necessary information—‘regardless of how it’ conveys such information.”

With these principles in mind, the Federal Circuit found no clear error in the district court’s decision. According to the Federal Circuit, the district court was correct that omitting the “loading dose” from the specification’s prophetic and working examples was consistent with the negative claim limitation because the omission conveyed to a person of ordinary skill “that the claimed invention did not include the administration of a loading dose.” Because a person of ordinary skill would read the specification as not including a loading dose, the Federal Circuit held that the manner of the disclosure (by omission) was not relevant to the outcome.

Of course, while the specification may not need to disclose a negative limitation, it may still be preferable to do so. If, for example, the specification in Novartis simply said “do not administer a loading dose,” there may have not have been a dispute over this issue at all.

The case is Novartis Pharm. v. Accord Healthcare Inc. et al., No. 21-1070, a copy of which can be found here.

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Photo of Gourdin Sirles Gourdin Sirles

Gourdin W. Sirles is an associate in the Litigation Department, where he focuses on patent and intellectual property litigations.  From large pharmaceutical litigations (including litigations related to the Biologics Price Competition and Innovation Act and Hatch-Waxman Act), to patent litigations related to electronics…

Gourdin W. Sirles is an associate in the Litigation Department, where he focuses on patent and intellectual property litigations.  From large pharmaceutical litigations (including litigations related to the Biologics Price Competition and Innovation Act and Hatch-Waxman Act), to patent litigations related to electronics, software, Microelectromechanical systems and components thereof, and financial services products, Gourdin’s intellectual property litigation experience has covered a broad variety of technologies and specialties.

Gourdin has experience in all aspects of the litigation process, including trials, Markman hearings, fact and expert discovery, depositions, case preparation and strategy, motion practice, and settlement negotiation. Gourdin is also well-versed in e-discovery, including forensic document collections, e-discovery platforms, management of contract attorney teams, document review, and production.

In addition to patent and intellectual property litigations, Gourdin’s practice has also encompassed a variety of other legal matters, including pro bono immigration matters, bankruptcy law, toxic tort, employment litigation, commercial disputes, and campaign finance compliance and other election-related laws on the state and federal level.

Photo of Siegmund Y. Gutman Siegmund Y. Gutman

Siegmund (“Sige”) Gutman is chair of the Life Sciences Patent Practice, a partner in the Litigation Department, and a member of the Patent Law and Intellectual Property Groups.

Sige is an accomplished patent litigator, frequently representing clients before trial and appellate courts, as…

Siegmund (“Sige”) Gutman is chair of the Life Sciences Patent Practice, a partner in the Litigation Department, and a member of the Patent Law and Intellectual Property Groups.

Sige is an accomplished patent litigator, frequently representing clients before trial and appellate courts, as well as arbitration panels. In the life sciences area, his practice focuses on developing and executing market exclusivity and freedom-to-operate strategies, including patent office and FDA regulatory strategies, for leading biologics, pharmaceutical, biotechnology, and medical device clients. He has extensive experience successfully litigating biologic drug patent and Hatch-Waxman cases, and has frequently spoken and written about issues relating to biosimilars and generic drugs. Sige’s background combines a graduate degree in molecular and cell biology and biophysical chemistry with more than 20 years of industry experience, including serving as senior patent litigation counsel for Amgen, the world’s largest biotechnology company.

He advises clients on patent matters involving a wide range of technologies, including therapeutic proteins such as monoclonal antibodies, antibody-drug conjugates, nucleic acids, gene therapy, stem cells, expression systems, screening methodologies, purification processes, DNA microarrays, small molecules and polymer chemistry.

Sige also has extensive experience in inter-partes patent office actions, including oppositions, and providing strategic patent counseling, including addressing product life cycle management and patent portfolio development issues, as well as preparing third-party patent landscape analyses.

Prior to joining Proskauer, Sige was a partner at another Am Law 100 firm.

While in graduate school, Sige worked on elucidating the 3-D structure of an auto-catalytic RNA using molecular biological, biochemical and biophysical techniques. He also previously worked for a major manufacturer of photocopiers and printers, where he helped develop novel color toner particles using electrochemical, photochemical and polymer chemical techniques.