On September 2, 2015, the USPTO Patent Trial and Appeal Board (PTAB) denied institution of another Inter Partes Review brought by Kyle Bass, the Coalition for Affordable Drugs, and other related entities. In denying the Tecfidera IPR petition, The PTAB sidestepped Biogen’s argument that the institution should be denied because its “primary purpose” was to “depress stock prices and benefit through short sales of that stock,” and instead made a decision on the merits, finding that the cited references did not establish obviousness.

The Biogen Tecfidera® Patent at Issue

The patent at issue in this case is Biogen’s U.S. 8,399,514, listed in the Orange Book for Tecfidera®.

Claim 1 of the ‘514 patent recites:

1. A method of treating a subject in need of treatment for multiple sclerosis comprising orally administering to the subject in need thereof a pharmaceutical composition consisting essentially of (a) a therapeutically effective amount of dimethyl fumarate, monomethyl fumarate, or a combination thereof, and (b) one or more pharmaceutically acceptable excipients, wherein the therapeutically effective amount of dimethyl fumarate, monomethyl fumarate, or a combination thereof is about 480 mg per day.

As noted in this article, Kyle Bass’s groups have challenged another Orange Book-listed Tecfidera® patent, U.S. 8,759,393. That petition is still pending.

The Obviousness Challenges

The PTAB identified three grounds of unpatentability asserted in the IPR petition: (i) obviousness over Kappos and the ICH Guideline; (ii) obviousness over a ClinicalTrials.gov entry and the ICH Guideline, and (iii) obviousness over prior art “admissions” in the patent and the ICH Guideline.

The ICH Guideline is a general guidance document discussing the importance of “dose-response information” to “the safe and effective use of drugs.” It is relied on as a secondary reference to support the premise that the determination of a specific, effective dose would have been obvious.

Kappos is an abstract that prospectively describes “A randomised, placebo-controlled phase II trial of a novel oral single agent fumarate therapy, BG00012, in patients with relapsing-remitting multiple sclerosis.” The PTAB noted the following deficiencies in this reference:

  • Kappos does not indicate that “BG00012″ is the dimethyl fumarate (“DMF”) recited in the challenged claims
  • Kappos does not indicate that a “therapeutically effective amount” of the compound was administered
  • Kappos does not indicate that DMF is useful for treating multiple sclerosis (“MS”)

Because Petitioner has failed to establish that Kappos teaches that DMF would be useful for treating MS, we need not evaluate whether the claimed dosage would or would not have been obvious based on ICH Guideline.

The ClinicalTrials.gov entry discussed the possible use of DMF to treat MS. The PTAB found it to be “deficient as a prior art teaching of DMF being useful to treat MS for many of the same reasons that Kappos is deficient.” According to the PTAB, the item “at best, describes a ‘possible therapeutic efficacy in MS,'” and did not provide “a reasonable likelihood of success.”

The “admission” was the following statement in the patent:

Fumaric acid esters, such as DMF, have been proposed for treatment of MS (see, e.g., [1] Schimrigk et al., Eur. J. Neurol., 2006, 13(6):604-10; [2] Drugs R&D, 2005, 6(4):229-30).

The PTAB declined to decide whether that statement in and of itself “can be relevant prior art in an IPR,” and considered instead the disclosure of the Drugs R&D reference, which was made of record in the IPR.

Did the the PTAB improperly reformulate the asserted ground of obviousness?

According to the PTAB, Drugs R&D discussed the development of a different fumarate compound for oral treatment of psoriasis, stated that “Biogen is currently evaluating ‘the product’ in trials as an oral treatment for MS,” and referenced Biogen’s Phase II trials. As with the other references, the PTAB found that “nothing in the admission or Drugs R&D supports a finding that DMF is useful for treating MS,” but at most reflected “a ‘hope’ that DMF will be useful in treating MS.”

The PTAB therefore denied institution of the IPR challenging the ‘514 patent.

Is Tecfidera® Out of the Woods?

As noted above, another IPR petition challenging another Tecfidera® patent is still pending. However, because the ‘514 patent is the last-to-expire of the Orange Book listed patents, even successful challenges of the other patents might not clear the patent landscape for generic competition.

Will outcomes like this teach the stock market not to react to Kyle Bass’s IPR filings?

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