Actelion Pharmaceuticals LTD v. Mylan Pharmaceuticals Inc., No. 2022-1889 (Fed. Cir. (N.D. W. Va.) Nov. 6, 2023). Opinion by Stoll, joined by Reyna and Stark.
Actelion owns two patents directed to improved formulations of epoprostenol, a naturally occurring substance useful for treating cardiovascular diseases. After Mylan sought FDA approval to manufacture and sell a generic version, Actelion sued Mylan for infringement.
During the litigation, the parties disputed the meaning of the claim term “a pH of 13 or higher.” Mylan argued that the proper construction cannot cover any pH values less than 13, while Actelion argued that the claimed pH “is given as an order of magnitude that is subject to rounding,” meaning the term encompasses pH values that round to 13, such as 12.5. In support, Actelion cited three textbooks explaining how to calculate pH and identify significant figures for pH values. Mylan argued that the textbooks at most support interpreting “13” as a narrower range of 12.995 to 13.004.
The district court adopted Actelion’s proposed construction based on the intrinsic evidence alone without addressing the extrinsic evidence. Following claim construction, the parties stipulated to infringement. Mylan appealed.
On appeal, the Federal Circuit noted that “the sole and narrow question before us involves the meaning of ‘a pH of 13 or higher.’” The court explained that “there is no blanket rule that ranges, or specifically open-ended ranges, must foreclose rounding.” The court also observed that the disputed claim term “lacks approximation language like ‘about,’” although the court “d[id] not find the absence of approximation language dispositive here” and “reject[ed] any invitation to create a bright-line rule.”
After analyzing Actelion’s and Mylan’s proposals, the Federal Circuit deemed “both views equally plausible here; that the absence of approximation language might suggest no approximation, but that the nature of measuring a pH value might nonetheless reasonably require a margin of error.” The district court therefore needed to consider “whether a pH of 13 carries any meaning to a person of ordinary skill in the art as regards precision of measurement, significant digits, or rounding.” The Federal Circuit ruled that “this case is one where the proper claim construction cannot be reached without the aid of extrinsic evidence,” and “the district court should have considered, at minimum, the textbook excerpts offered and addressed by the parties.”
Thus, the Federal Circuit vacated the claim construction and the judgment of infringement and remanded for the district court to consider the extrinsic evidence.
Allgenesis Biotherapeutics Inc. v. Cloudbreak Therapeutics, LLC, No. 2022-1706 (Fed. Cir. (PTAB) Nov. 7, 2023). Opinion by Moore, joined by Stoll and Cunningham.
Allgenesis filed an IPR petition challenging the patentability of a Cloudbreak patent directed to new treatment options for an eye condition called pterygium. The Patent Trial and Appeal Board issued a final written decision finding that Allgenesis failed to show that the challenged claims were unpatentable. Allgenesis appealed.
The Federal Circuit dismissed the appeal for lack of standing. The court explained that “although a party does not need Article III standing to file an IPR petition or to obtain a Board decision, … the party must establish Article III standing once it seeks review of the Board’s decision in this Court.” As pertinent here, Allgenesis needed to demonstrate an “injury in fact” by showing it has “suffered an invasion of a legally protected interest that is concrete and particularized and actual or imminent, not conjectural or hypothetical.”
Allgenesis asserted standing based on two grounds—its potential infringement liability and an unfavorable priority determination by the Board.
In support of the first ground, Allgenesis submitted a declaration in support of standing from the company’s Vice President of Finance. The Federal Circuit ruled, however, that the testimony was conclusory and “insufficient to establish that Allgenesis has any concrete plans to develop and bring to market” a treatment for pterygium that poses a substantial risk that Cloudbreak will sue for infringement. Allgenesis “made no assertion that Cloudbreak has sued or threatened to sue Allgenesis if it brings [its] product to market.” Thus, Allgenesis failed to show an injury in fact based on potential infringement liability.
As for the second ground, the Federal Circuit rejected Allgenesis’s argument that it suffered an injury in fact based on the Board’s priority determination, which Allgenesis argued affected the scope of its own patent rights. The Federal Circuit ruled that the allegations of harm were “not sufficiently specific to establish any injury in fact.” Also, “collateral estoppel will not attach to the Board’s non-appealable priority determination” in the IPR. If an examiner were to reach the same priority determination during prosecution of Allgenesis’s pending patent application, “Allgenesis can challenge that determination in a separate appeal.”