Federal Circuit Backtracks On Negative Claim Limitations In Fingolimod Patent

• Published date: 19 August 2022
• Subject Matter: Intellectual Property, Patent
• Law Firm: Gallet Dreyer & Berkey
• Author: Mr Andrew Berks

Novartis Pharms. Corp. v. Accord Healthcare Inc., No. 2021-1070 (Fed. Cir. June 21, 2022).

In a reversal of fortunes, the Federal Circuit entertained a petition for rehearing from the losing side of a decision on Jan. 3, 2022 in this case, and has now decided that the claims are invalid for failure to meet the written description requirement. This case hinges on whether a negative claim limitation, 'absent an immediately preceding loading dose regimen' is supported by the specification even though the disclosure is silent as to 'loading doses.' The District Court and the earlier Jan. 3, 2022 decision held that this claim limitation was supported in the disclosure, but on June 21 a new panel reversed.

The patent at issue is US 9,187,405 which claims the use of the drug fingolimod in the treatment of multiple sclerosis. Each claim of the '405 patent requires administering fingolimod 'at a daily dosage of 0.5 mg, absent an immediately preceding loading dose regimen' (emphasis added). This loading dose claim limitation was added in prosecution to overcome prior art.

Novartis sued several generic drug companies for infringement of the '405 patent in an ANDA litigation. The generic drug companies denied infringement and counterclaimed that the '405 was invalid. The parties zeroed in on written description as the invalidity question to be decided.

The District Court concluded that the negative claim limitation was sufficiently supported by the patent specification, and the original Federal Circuit panel agreed in a split decision (Linn, O'Malley, dissent by Moore). The original majority asserted that there is no new and heightened standard for negative claim limitations, citing to Inphi Corp. v. Netlist, Inc., 805 F.3d 1350, 1356 (Fed. Cir. 2015). The majority held that the patent applicant possessed the invention (claim-recited dosages) as of the patent filing date and rejected defendant HEC's arguments that the patent applicant used 'mathematical sleights of hand' and that the specification lacked 'blaze marks' to support the negative claim limitation.

But Judge Moore, in her dissent, was troubled that there was no explicit or implicit suggestion of the negative claim limitation in the specification. She states that 'silence is not disclosure,' and that loading doses are not discussed in the specification. Moreover, Judge Moore noted that the MPEP ' 2173.05(i) states the mere absence of a positive recitation is not enough, and silence alone is insufficient to...