Friday, December 03, 2021

Mylan defeats patent validity of fumarate drug to treat multiple sclerosis [MS] based on 35 USC 112, lack of written description

Although Mylan "lost" its argument at PTAB, Mylan "won" its 112 argument in district court.

The district court held a four-day bench trial starting on February 4, 2020. J.A. 1001. On February 5, 2020, the Patent Trademark and Appeal Board (Board) issued a final written decision in a related inter partes review (IPR) proceeding, which Mylan initiated on July 13, 2018 and is the subject of a companion case to this appeal. See Mylan Pharms. Inc. v. Biogen MA Inc.¸ No. IPR2018-01403, 2020 WL 582736 (P.T.A.B. Feb. 5, 2020). In the IPR case, the Board rejected an obviousness challenge to the asserted ’514 Patent claims, which estopped Mylan from litigating obviousness issues in the trial court. See J.A. 3 n.2.

During trial, the parties agreed that, for purposes of this case, a person of ordinary skill in the art (POSA) is someone with “at least a medical degree, at least three years of training in neurology, and at least three years of clinical experience treating multiple sclerosis patients.” J.A. 20. The parties presented expert testimony from two neurologists who treat patients with MS—Dr. Greenberg for Mylan and Dr. Wynn for Biogen. J.A. 20. At the conclusion of the trial, the district court found that the specification did not reasonably convey to a POSA that the ’514 Patent inventors had “actually invented” a method of treating MS with a therapeutically effective dose of DMF480 as of February 8, 2007. J.A. 45. The court also found that Biogen’s arguments and Wynn’s testimony that a POSA would be drawn to the DMF480 dose upon reading the patent specification were “neither credible nor persuasive,” J.A. 30–31, and noted that Wynn conceded during cross examination that the sole DMF-dosage paragraph in the specification did not teach a POSA that DMF480 would be therapeutically effective for treating MS, J.A. 31.

The district court opined that Biogen’s attempt to “combin[e] a few selectively[ ]plucked disclosures from the specification . . . has been squarely rejected by the Federal Circuit.” J.A. 45. Based on the testimony offered at trial, the context of the ’514 Patent prosecution history, and “significant omissions from the specification,” the district court ultimately concluded that Mylan had satisfied its burden of showing by clear and convincing evidence that the asserted ’514 Patent claims were invalid for lack of written description under 35 U.S.C. § 112. Id. Biogen now appeals the district court’s decision.

As to standard of review

Whether a claim meets the written-description requirement is a question of fact, which this court reviews for clear error on appeal from a bench trial. Nuvo Pharm. (Ireland) Designated Activity Co. v. Dr. Reddy’s Laboratories Inc., 923 F.3d 1368, 1376 (Fed. Cir. 2019), cert. denied, 140 S. Ct. 902 (2020). The clear-error standard requires courts to exercise deference when reviewing findings of fact, unless there is a “definite and firm conviction that a mistake has been made.” Scanner Techs. Corp. v. ICOS Vision Sys. Corp. N.V., 528 F.3d 1365, 1374 (Fed. Cir. 2008) (internal quotation marks and citation omitted). Patent invalidity under the written-description doctrine must be established by clear and convincing evidence. Hynix Semiconductor Inc. v. Rambus Inc., 645 F.3d 1336, 1351 (Fed. Cir. 2011). Courts of appeals cannot reweigh a district court’s assessment of witness credibility, Advanced Magnetic Closures, Inc. v. Rome Fastener Corp., 607 F.3d 817, 832 (Fed. Cir. 2010), and must take into account the “unchallenged superiority” of a district court’s ability to make witness-credibility determinations and findings of fact, see Salve Regina Coll. v. Russell, 499 U.S. 225, 233 (1991).

As to law, one recalls that a patent challenger CANNOT argue lack of written description in an IPR:

Inter partes review is a trial proceeding conducted at the Board to review the patentability of one or more claims in a patent only on a ground that could be raised under §§ 102 or 103, and only on the basis of prior art consisting of patents or printed publications. <>/b>


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