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IP Alert: Rehearing Reverses Earlier Federal Circuit Decision Finding Silence Supported Negative Claim Limitation

July 6, 2022

On June 21, in Novartis Pharmaceuticals Corporation v. Accord Healthcare, Inc., a reshuffled Federal Circuit panel reversed course on rehearing to find that a negative claim limitation was not supported by silence in the patent’s specification. The panel (Moore, Linn, Hughes) vacated the decision of a prior panel (Moore, Linn, O’Malley), reported here, which issued before the retirement of Judge O’Malley.

Novartis is the owner of U.S. Patent No. 9,187,405 (the ’405 patent), which provides methods for treating relapsing remitting multiple sclerosis. The ’405 patent included method claims directed to administering fingolimod at a daily dose of 0.5 mg. The claims included a negative limitation requiring administering a daily dose of fingolimod “absent an immediately preceding loading dose regimen.” Novartis added the negative claim limitation during prosecution to overcome a prior art rejection. Nothing in the specification of the ’405 patent, however, mentioned the presence or absence of a loading dose.

Novartis sued HEC Pharm Co. (“HEC”) in response to HEC filing an Abbreviated New Drug Application (ANDA) seeking approval of a generic version of Gilenya, the drug covered by the ’405 patent. The district court determined that HEC infringed the ’405 patent. The district court also ruled that the negative claim limitation was sufficiently described, crediting Novartis’ expert testimony. The expert had opined that the phrase “Initially patients receive treatment for 2 to 6 months,” in the ’405 patent, disclosed treatment without an immediately preceding loading dose. On appeal of the written description issue, the Federal Circuit affirmed the district court and reasoned that “[a] specification that describes a reason to exclude the relevant negative limitation is but one way in which the written description requirement may be met.”

In its petition for rehearing, HEC argued that the court had erroneously relied on Novartis’ expert testimony. The reshuffled panel revisited the negative claim limitation, stating that the specification’s silence is not enough to satisfy the written description requirement. The panel concluded that the patent’s disclosure of “initially” providing treatment described the initial length of treatment, not the dosage with which the treatment begins. Because the negative claim limitation lacked written description support, the Federal Circuit held the claims invalid.

This decision reemphasizes the importance of ensuring claim limitations added during prosecution are sufficiently supported by the patent application as filed. In the absence of explicit support in the application as-filed, this case may require a disclosure establishing a negative claim limitation is “necessarily excluded” from the invention.

For more information on this holding, please contact Fitch Even partner Jonathan H. Urbanek, author of this alert.

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