Patent Case Summaries December 8, 2021

Patent Case Summaries | Week Ending December 3, 2021

A weekly summary of the precedential patent-related opinions issued by the Court of Appeals for the Federal Circuit and the opinions designated precedential or informative by the Patent Trial and Appeal Board.

Biogen International GmbH, et al. v. Mylan Pharmaceuticals Inc., No. 2020-1933 (Fed. Cir. (N.D. W.Va.) Nov. 30, 2021). Opinion by Reyna, joined by Hughes. Dissenting opinion by O’Malley.

The Federal Circuit affirmed the district court’s determination that the claims of a Biogen patent are invalid for lack of written description.

Biogen’s patent is directed to a method of treating multiple sclerosis (MS) with a drug called dimethyl fumarate (DMF), and the pertinent claims require a therapeutically effective amount of about 480 mg/day (DMF480). Mylan filed an Abbreviated New Drug Application seeking to manufacture, use, and market a generic DMF product for the treatment of MS. Biogen then sued Mylan for infringement.

The patent specification makes only one reference to DMF480. The district court found that the specification did not reasonably convey that the inventors had “actually invented” a method of treating MS with a therapeutically effective dose of DMF480 as of the filing date of the patent’s provisional application. Thus, the court found the claims to be invalid. Biogen appealed.

The Federal Circuit affirmed, concluding that the district court did not clearly err in its determination. As the Federal Circuit explained, “the DMF480 dose is listed only once in the entire specification,” which “constitutes a significant fact that cuts against Biogen’s case, particularly because it appears at the end of one range among a series of ranges, including DMF concentrations of 100–1,000, 200–800, 240–720, and 480–720 mg/day.” The claims, by comparison, “are drawn exclusively to the specific DMF480 dose.” The Federal Circuit thus concluded that “the specification does not adequately support the asserted claims.” The court also noted that the fact “that Biogen later established the therapeutic efficacy of DMF480 is of no import to the written-description analysis.”

Judge O’Malley dissented, emphasizing Biogen’s explanations of “the distinction between clinical efficacy and therapeutic effects.” The district court had concluded (“in a two-sentence footnote”) that Biogen was judicially estopped from pointing out the distinction, and Judge O’Malley viewed that conclusion as erroneous, which “led the district court to legally err in its interpretation of Federal Circuit written description precedent.” And “the district court’s conflation of therapeutic and clinical efficacy caused it to erroneously require clinical data, rather than therapeutic effects.” Judge O’Malley, therefore, would have remanded for reconsideration “with the understanding that the patent is not about clinical efficacy—it is about therapeutic effect.”

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ModernaTx, Inc., et al. v. Arbutus Biopharma Corp., et al., Nos. 2020-1184, -1186 (Fed. Cir. (PTAB) Dec. 1, 2021). Opinion by Lourie, joined by O’Malley and Stoll.

Arbutus owns a patent directed to stable nucleic acid-lipid particles and methods of making, delivering, and/or administering them. Moderna petitioned for IPR, challenging the claims as anticipated or obvious. The Patent Trial and Appeal Board found some of the challenged claims unpatentable as anticipated, and other claims not unpatentable as obvious. Moderna appealed, and Arbutus cross-appealed.

The Federal Circuit first considered whether Moderna had standing to pursue its appeal. Moderna asserted that it had standing based on its status as a current licensee to the patent at issue “with actual monetary obligations … that are impacted by the Board’s validity determinations.”

The Federal Circuit held that Moderna lacked standing. The court explained that “Moderna’s evidence of financial burdens from the validity of th[e] patent is too speculative.” Thus, Moderna failed to demonstrate that it “had suffered or was suffering a ‘concrete’ injury from the existence of the [challenged] patent.” The patent was just “one of many licensed patents,” and Moderna provided “no evidence as to how, if at all, its obligations under the [license] would change” if the patent were declared invalid.

Next, the Federal Circuit turned to Arbutus’s cross-appeal directed to the Board’s anticipation findings. The court determined that substantial evidence supported the Board’s decision, including the disclosures in the prior art, the challenged patent itself, and testimony of expert witnesses.

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ModernaTx, Inc., et al. v. Arbutus Biopharma Corp., No. 2020-2329 (Fed. Cir. (PTAB) Dec. 1, 2021). Opinion by Lourie, joined by O’Malley and Stoll.

In addition to the patent discussed in the preceding opinion, Arbutus owns a second patent directed to stable nucleic acid-lipid particles and methods of making, delivering, and/or administering them. Moderna petitioned for IPR, challenging the claims as anticipated or obvious. Moderna’s arguments included that the ranges for the components in the claimed nucleic acid-lipid particle were disclosed or taught by the prior art, and that a presumption of obviousness should therefore apply. The Patent Trial and Appeal Board found that Moderna failed to meet its burden. Moderna appealed.

Arbutus first contended that Moderna lacked standing to pursue its appeal. Moderna responded that there is a substantial risk that Arbutus will assert the patent in an infringement suit. In support, Moderna provided a declaration detailing its “concrete plans” for its product as well as statements and actions by Arbutus that create a risk that Arbutus may bring an infringement suit. The Federal Circuit concluded that, “on the record before us, Moderna has demonstrated enough of a risk that it will be faced with an infringement suit” to support standing for the appeal.

On the merits, the Federal Circuit held that Moderna’s assertions regarding the disclosed ranges in the prior art were “an oversimplification based on unfounded assumptions.” A presumption of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art. Here, the prior art did not expressly disclose the claimed ranges, and Moderna failed to show that a person of ordinary skill would have nevertheless understood that the prior art references teach or suggest a range that overlaps the claimed range. Thus, the Federal Circuit concluded that the Board “correctly held that Moderna had not established that a presumption of obviousness applies based on overlapping ranges.”

Moderna also argued that the ranges reflected mere routine optimization of “result-effective variables.” The Federal Circuit held, however, that the Board correctly determined that Moderna failed to demonstrate that this was achievable through “routine optimization” as their burden required.

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