CAFC Delivers Guidance on Presumption of Obviousness, Negative Claim Limitations in Win for Generic Drugmaker

“It was reasonable for the Board to find that…a skilled artisan would recognize that the reference discloses a complete formulation—excluding the possibility of an additional active ingredient.” – CAFC

CAFCThe U.S. Court of Appeals for the Federal Circuit (CAFC) ruled on Monday that the U.S. Patent and Trademark Office Patent Trial and Appeal Board (PTAB) correctly held certain claims of Almirall, LLC’s U.S. Patent 9,517,219 for an acne treatment invalid as obvious. Almirall appealed the PTAB’s final decision in IPR2018-00608, in which the Board had found that the ‘219 patent, which covers methods of treating acne or rosacea, would have been obvious over the prior art at the time of invention.

Amneal petitioned the PTAB for inter partes review (IPR) of the patent in 2018, arguing that claims 1-8 would have been obvious over two international patents (“Garrett” and “Nadau-Fourcade”) and the combination of Garrett and a publication referred to as “Bonacucina.”

The PTAB’s ruling turned on whether a person of ordinary skill in the art (POSITA) would have found it obvious to substitute an acrylamide/sodium acryloyldimethyl taurate copolymer (A/SA) thickening agent taught by Nadau-Fourcade or Bonacucina for the “carbomer” (cross-linked acrylic acid polymers) gelling agent in Garrett’s formulations to arrive at the claimed invention. Garrett does not teach using an A/SA agent.

The claims also disclose specific optimal ranges for the claimed composition. Of relevance, the Board held that “Garrett discloses a range for each of the various components of the composition that either fully encompasses or overlaps/abuts the ranges and amounts for those components recited in the challenged claims, and this is sufficient to create a presumption of obviousness as to the claimed amounts.”

Almirall challenged this holding on appeal, arguing that the PTAB was “presuming obviousness based on overlapping ranges because no single reference discloses all of the claimed ranges.” Almirall said that Garrett “only discloses ranges for carbomer thickeners, not A/SA thickeners as claimed” and that “Nadau-Fourcade and Bonacucina cannot be used in combination with Garrett to establish a presumption of obviousness because the presumption applies only when a single reference discloses all claimed ranges.”

However, the CAFC agreed with Amneal that the Board did not err in applying a presumption of obviousness to overlapping ranges. The facts of the case, as well as Amneal’s expert testimony, was enough to support the Board’s finding that “Garrett’s gelling agents and A/SA agents are ‘used in very similar concentrations for similar formulations.’” The court further agreed with the Board’s holding that Almirall’s evidence of unexpected results and failure of others was unpersuasive.

Importantly, the CAFC said that, even if the presumption of obviousness didn’t apply, the outcome would have been the same because “Ultimately, despite Almirall’s attempts to argue otherwise, this case does not depend on overlapping ranges,” said the court. “It is simply a case of substituting one known gelling agent for another.”

As to Almirall’s argument that the Board erred in determining the claims obvious, the CAFC first addressed the drugmaker’s contention that the Board erred in concluding that Garrett discloses the negative adapalene claim limitation in independent claims 1 and 6. The relevant language of those claims discloses:

“A method for treating a dermatological condition selected from the group consisting of acne vulgaris and rosacea….

wherein the topical pharmaceutical composition does not comprise adapalene.” (emphasis added in opinion)

Almirall argued that even though Garrett does not mention adapalene, “more is needed for a disclosure of a negative claim limitation.” But the court agreed with Amneal that the Board’s finding that Garrett effectively teaches the claim limitation is supported by substantial evidence and said that Almirall’s argument otherwise “is contrary to our precedent.” The court continued:

“[A] reference need not state a feature’s absence in order to disclose negative limitation.” AC Techs., S.A. v. Amazon.com, Inc., 912 F.3d 1358, 1367 (Fed. Cir. 2019). Instead, it was reasonable for the Board to find that, in the context of Garrett, a skilled artisan would recognize that the reference discloses a complete formulation—excluding the possibility of an additional active ingredient.

Finally, the court agreed that the Board’s findings of a motivation to combine Garrett with Nadau-Fourcade and Garrett with Bonacucina were supported by the record; and that Almirall’s arguments that a POSITA would not have had a reasonable expectation of success in incorporating Nadau-Fourcade’s A/SA copolymer into Garrett’s formulations or Bonacucina’s A/SA copolymers into Garrett’s formulations failed.

“A finding of a reasonable expectation of success does not require absolute predictability of success,” wrote the court.

Ultimately, the court held that “the Board’s decision was supported by substantial evidence and not erroneous as a matter of law.”

 

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4 comments so far.

  • [Avatar for Anon]
    Anon
    March 17, 2022 10:04 am

    Mr. Malone,

    I “get” your negativity from your own past experience.

    But here — again — your “advice” only FEEDS those who would choose to harm your endeavors.

    You are playing directly into the hands of the Efficient Infringers.

    Advice ONLY of “Don’t” or “Stop,” is BAD advice.

    Do we need to change?

    Absolutely.

    But the change that you have been vocal about is NOT the change that does the cause of the small inventor, the cause of the disruptive innovation ANY good.

    Please stop your advice of only stop.

  • [Avatar for Pro Say]
    Pro Say
    March 16, 2022 03:14 pm

    Precedential? No; nothing precedential here. Move along folks.

    Furthermore . . . beware the Ides of March . . . and negative claim limitations.

  • [Avatar for Josh Malone]
    Josh Malone
    March 16, 2022 11:07 am

    Rampant patent invalidation does not promote progress in useful arts by securing to inventors the exclusive right to their discoveries. It’s time to close the patent division of the USPTO, it isn’t working.

  • [Avatar for B]
    B
    March 15, 2022 01:18 pm

    Personally, I didn’t get much out of the discussion about 112 support for negative limitations from the opinion. Same with the likelihood of success discussion. Nothing particularly new.

    Great writing, Eileen – I just don’t see why the CAFC considers the opinion precedential.