United States: No Nexus For Novartis Gilenya Patent

In Novartis AG v. Torrent Pharmaceuticals Ltd., the Federal Circuit affirmed the decision of the USPTO Patent Trial and Appeal Board (PTAB) invalidating all claims of U.S. Patent 8,324,283, which is one of four Orange Book-listed patents for GILENYA. Among other issues, the court affirmed the PTAB's finding that the asserted objective indicia of non-obviousness lacked sufficient nexus to the claimed invention to warrant a different outcome.

The Patent At Issue

The patent at issue was U.S. Patent 8,324,283, issued to Novartis AG and Mitsubishi Pharma Corp. The patent claims a formulation for fingolimod, which is marketed as Gilenya® for the treatment of multiple sclerosis. Claim 19 recites fingolimod compositions in particular:

19. A solid pharmaceutical composition suitable for oral administration, comprising mannitol and 2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol or a pharmaceutically acceptable salt thereof.

According to the patent, formulating fingolimod (and other S1P receptor agonists) with a sugar alcohol (such as mannitol) overcomes previously encountered problems with solid formulations, and provides a stable product.

The PTAB Proceedings

The PTAB instituted IPR on the grounds of asserted obviousness over the combination of U.S. Patent 6,004,565 (Chiba) and a general reference by Aulton (Pharmaceutics: The Science of Dosage Form Design), but denied institution on grounds that cited U.S. Patent 6,277,888 (Sakai) as a primary reference, because it was focused on liquid compositions of fingolimod.

According to the Federal Circuit decision, Chiba disclosed "a solid oral composition of fingolimod combined with a generic excipient," while Aulton "recommends mannitol as a common diluent used in '[t]ableting by the wet granulation process,'" and describes mannitol as 'expensive,' but 'commonly used' as an excipient in solid oral compositions.

In its Final Written Decision, the PTAB found all claims obvious in view of Chiba and Aulton, and cited Sakai as providing "additional evidence of the reason to combine fingolimod and mannitol," even though it was focused on liquid compositions, because it "'directly instructs that the two ingredients should be combined.'"

The Federal Circuit Decision

The Federal Circuit Decision was authored by Judge Chen and joined by Judges Taranto and Stoll. The court addressed Novartis's "series of challenges to the Board's analysis of the evidence and ultimate determination of unpatentability."

On the evidence, the court found no due process violation in the PTAB's citation of Sakai after denying institution on grounds relying on Sakai, for two primary reasons. First, the court found the PTAB's discussion of Sakai was not inconsistent with its institution decision because it cited Sakai as "merely reinforc[ing] its finding that Chiba and Aulton strongly suggest the combination of fingolimod and mannitol in a solid oral composition." Second, the IPR petition had cited Sakai as supporting "motivation to combine the teachings of Chiba and Aulton," and Sakai was "debated ... at length throughout the proceeding."

On the merits, the court determined that the PTAB had given due consideration to Novartis's arguments, and that its decision finding motivation to combine Chiba and Aulton was supported by substantial evidence.

No Nexus For Objective Indicia Of Non-Obviousness

The court gave separate consideration to Novartis's arguments regarding objective indicia of non-obviousness. In particular, Novartis argued that Gilenya "enjoyed commercial success, industry praise, and met a long-felt but previously unsolved need" since it was "the first commercially available solid oral treatment for multiple sclerosis," i.e., the first solid dosage form approved by FDA. The court summarized Novartis's argument on this issue as follows:

Distilled down, Novartis argues that, as a matter of law, a feature that is known in the art but not actually available to the market—i.e., in commerce—cannot be used to disprove Novartis' attempts to establish a nexus based on that claimed feature.

Phrased that way, it is not surprising that the court disagreed.

Citing the Supreme Court decision in KSR and its earlier decision in Asyst Technologies, Inc. v. Emtrak, Inc., the court explained:

In evaluating whether the requisite nexus exists, the identified objective indicia must be directed to what was not known in the prior art—including patents and publications—which may well be the novel combination or arrangement of known individual elements.

*****

Here, Novartis' nexus argument for its objective indicia evidence is based solely on a single premise—Gilenya being the first commercially-available solid oral multiple sclerosis treatment. The treatment of multiple sclerosis with a solid oral composition, however, was indisputably known in the prior art.

The fact that Gilenya was the first to receive FDA approval for commercial marketing does not overcome the fact that solid multiple sclerosis compositions were already known. Thus, we agree with the Board that Novartis' proffered evidence is not probative of the nonobviousness inquiry

Thus, the Board affirmed the PTAB decision invalidating all claims of the '283 patent.

Nexus For An FDA-Approved Product

Since portions of the IPR record are redacted, I cannot review all of Novartis's arguments on commercial success. I would like to think that if Novartis had argued that the claimed formulation was required to satisfy FDA stability requirements, the FDA approval–and consequent commercial success, industry praise, and satisfaction of long-felt need–would have had sufficient nexus to the claimed invention. What do you think?

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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