Federal Circuit Orders District Court to Consider Extrinsic Evidence in Claim Construction

In Actelion Pharmaceuticals Ltd. v. Mylan Pharmaceuticals Inc., Appeal No. 22-1889, the Federal Circuit held that where a disputed claim term remained ambiguous after analysis of the intrinsic evidence, the district court was ordered to address the extrinsic evidence.

Actelion sued Mylan for patent infringement. The claims at issue recited a bulk solution with “a pH of 13 or higher.” Actelion argued that “a pH of 13” should be interpreted to include pH values that round to 13, for example 12.5. Actelion cited three textbooks to support its argument. Mylan argued that “a pH of 13” did not include any pH values less than 13 or, alternatively, that the cited textbooks supported a narrower range of 12.995-13.004. The district court did not consider the textbooks. Based on the intrinsic record alone, the district court construed “a pH of 13” as encompassing values from 12.5 to 13.4.  The parties stipulated that Mylan infringed the patent under that claim construction, and Mylan appealed.

The Federal Circuit found both Actelion’s and Mylan’s interpretations were plausible based on the claim language, specification, and prosecution history alone. Accordingly, the Federal Circuit concluded that the district court should have considered extrinsic evidence such as the cited textbooks.  The Federal Circuit vacated the district court’s judgment and remanded for consideration of the extrinsic evidence.

For more information, see Federal Circuit Says Extrinsic Evidence Should Have Been Considered in Claim Construction, Kingery, Brianne M. & Hilton, Robert J., Ph.D. (Nov. 10, 2023).

No Standing to Appeal IPR Without Plans or Injury

In Allgenesis Biotherapeutics, LLC v. Cloudbreak Therapeutics, LLC, Appeal No. 22-1706,  the Federal Circuit dismissed an IPR appeal for lack of Article III standing, finding that appellant’s planned future products did not create a substantial risk of future infringement and that an adverse priority ruling by the Board did not constitute injury in fact.

Allgenesis petitioned for inter partes review (“IPR”) on all claims of a patent owned by Cloudbreak. The challenged claims were directed to compositions and methods for treating pterygium (surfer’s eye) with an inhibitor called nintedanib. Allgenesis asserted as prior art its pending application on nintedanib treatments.  The Patent Trial and Appeal Board (the “Board”) issued a final written decision upholding challenged claims and determining Allgenesis’s pending application on nintedanib treatments was not prior art to the challenged patent.  Allgenesis appealed to the Federal Circuit.

The Federal Circuit dismissed Allgenesis’s appeal for lack of Article III standing.  First, the court found Allgenesis did not show specific, concrete plans that would create a substantial risk of future infringement.  Allgenesis had argued that it planned to develop nintedanib treatments for pterygium, and thus it reasonably expected Cloudbreak to enforce the challenged patent against Allgenesis’s future product.  The Federal Circuit rejected that argument because it found Allgenesis’s supporting evidence “generic” and “conclusory.”  Second, the court did not find injury in fact based on the Board’s determination that the challenged patent had priority over Allgenesis’s pending application on nintedanib treatments.  The Federal Circuit reasoned that the Board’s decision would not have a preclusive effect on the pending application, reiterating its holding in Best Medical Intl., Inc. v. Elekta Inc., 46 F.4th 1346 (Fed. Cir. 2022), that collateral estoppel does not apply to non-appealable judgments.  The court clarified that Allgenesis could have standing if a patent examiner reaches an adverse priority determination in the prosecution of its pending application.

The Remedy Is Writ: Statutory Deadline Doesn’t Divest the PTAB’s Jurisdiction

In Purdue Pharma L.P. v. Collegium Pharmaceutical, Inc., Appeal No. 22-1482, the Federal Circuit held that in a Post-Grant Review proceeding (PGR), the PTAB retains the authority to issue a Final Written Decision after the statutory deadline.

Purdue obtained a stay of Collegium’s PGR against one of its patents pending a bankruptcy proceeding.  The bankruptcy court eventually lifted the stay, but only after the statutory deadline for issuance of the PTAB’s Final Written Decision had passed.  Purdue moved to terminate the PGR, arguing that the PTAB had lost its determinative authority.  The PTAB denied the motion and issued its decision, finding Purdue’s patent claims anticipated and lacking written description.  Purdue appealed.

The Federal Circuit affirmed the PTAB’s denial of the motion to terminate, citing Supreme Court precedent that if a statute does not specify a consequence for missing a statutory deadline, courts should not impose one.  The court rejected Purdue’s arguments that statutory language did specify a consequence for the PTAB’s missed Final Written Decision deadline, holding that each of Purdue’s arguments was contradicted by Supreme Court precedent.  The Federal Circuit further explained that the legislative history of the America Invents Act, which sought to expedite PTAB review, supported its decision because if the PTAB could not issue a Final Written Decision, the parties would be forced to inefficiently re-brief the issues to a district court.  The Federal Circuit also disagreed with Purdue’s contention that this decision would render the statutory deadline meaningless—the court noted that parties could petition for a writ of mandamus to compel a decision after the deadline passed.

The Federal Circuit concluded by affirming the PTAB’s finding of lack of written description.