Cytiva BioProcess R&D AB v. JSR Corp., et al., Nos. 2023-2074, -2075, -2191, -2192, -2193, -2194, -2239, -2252, -2253, -2255 (Fed. Cir. (PTAB) Dec. 4, 2024). Opinion by Prost, joined by Taranto and Hughes.
JSR filed six IPRs challenging certain claims of three patents owned by Cytiva. The three patents relate to chromatography matrices and processes for isolating target compounds using those matrices. The Board found all challenged claims unpatentable except for four process claims, which it found to be not unpatentable. Cytiva appealed and JSR cross-appealed.
The Federal Circuit affirmed the determinations of unpatentability but reversed the determination that the four process claims were not unpatentable.
To start, the Federal Circuit rejected Cytiva’s argument that the Board erred by failing to perform a lead-compound analysis in its obviousness determination. A lead-compound analysis typically involves evaluating “whether a new chemical compound would have been prima facie obvious over particular prior art compounds.” But the Federal Circuit held that “a lead-compound analysis is not required where the prior-art references expressly suggest the proposed modification,” which was the case for Cytiva’s patents.
Next, the Federal Circuit addressed both (1) Cytiva’s challenge to the Board’s finding certain composition claims unpatentable, and (2) JSR’s cross-appeal challenge to the Board’s finding the four process claims not unpatentable. The Federal Circuit saw no material difference in these claims and thus “conclude[d] that these claims must rise or fall together.”
As part of the analysis, the Federal Circuit ruled that “the term ‘Fab part of an antibody’ may refer to either a Fab part of a full antibody or a Fab fragment.” Applying that construction, the Federal Circuit addressed whether skilled artisans would have had a reasonable expectation of success in arriving at the claimed invention. The court concluded that, “if a limitation of a claim is inherent, there is no question of a reasonable expectation of success in achieving it.” In other words, “no reasonable expectation of success argument or analysis is required where the sole disputed limitation was an inherent property of the claimed composition already determined to be obvious.” Applying that rule, the Federal Circuit affirmed the Board’s findings that the composition claims were unpatentable and reversed the Board’s findings that the four process claims were not unpatentable.
Mirror Worlds Technologies, LLC v. Meta Platforms, Inc., Nos. 2022-1600, -1709 (Fed. Cir. (S.D.N.Y.) Dec. 4, 2024). Opinion by Taranto, joined by Prost and Stark.
Mirror Worlds sued Meta Platforms (Facebook) for infringing three patents directed to storing, organizing, and presenting data in time-ordered streams on a computer system. At the close of discovery, Facebook moved for summary judgment of noninfringement and invalidity under 35 U.S.C. § 101. The court granted summary judgment of noninfringement but denied summary judgment of ineligibility under § 101. Mirror Worlds appealed the noninfringement determination, and Facebook cross-appealed the § 101 determination.
On appeal, Mirror Worlds first argued that testimony from its expert created a genuine dispute of material fact whether Facebook met the “glance view” limitations of two of the asserted patents. The limitations require a pop-up window where document-specific information appears when passing a cursor over a document. Agreeing with the district court, the Federal Circuit held that the evidence relied on by Mirror World’s expert—unauthenticated screenshots from third-party websites—was inadmissible under the Federal Rules of Evidence. Further, Facebook’s expert offered uncontroverted testimony that the elements Mirror World relied on for infringement contained information only about the source or author, rather than summary information contained within the document as the claims required.
Next, addressing the third patent, Mirror Worlds argued the district court erred by finding that the term “data unit” included a search query and information not of direct user interest. The district court construed “data unit” to mean “an item of information,” and the Federal Circuit agreed with that construction. Thus, the broad term “data unit” did not suggest any limitation to exclude a search query or information not of direct user interest, and there was no support in the intrinsic record for such a limitation.
Finally, Mirror Worlds argued that even under the court’s construction of “data unit,” there was sufficient evidence to avoid summary judgment of noninfringement. According to Mirror Worlds, the evidence created a genuine issue of material fact as to whether the accused feature contained “all” the data received or generated by the underlying system, as required by the claims. The Federal Circuit rejected the argument, ruling that the evidence could not be reasonably understood to support Mirror World’s assertions. Thus, the Federal Circuit affirmed the judgment of noninfringement of all three patents.
Because the Federal Circuit agreed with the district court’s noninfringement ruling, and because the patents expired more than six years ago, the Federal Circuit did not reach the cross-appeal regarding invalidity.
Galderma Laboratories, L.P., et al. v. Lupin Inc., et al., No. 2024-1664 (Fed. Cir. (D. Del.) Dec. 6, 2024). Opinion by Moore, joined by Linn and Prost.
Galderma owns and markets Oracea® 40 mg capsules as a treatment for papules and pustules associated with rosacea. Following FDA approval, Oracea was added to the Orange Book, which identified two Galderma patents as encompassing Oracea. The patented formulations have about 30 mg immediate release (IR), and about 10 mg delayed release (DR), doxycycline. The claims require steady state blood levels, which Oracea achieves through some doxycycline released right away (IR) and some released later (DR).
Lupin filed an abbreviated new drug application (ANDA) to market a 40 mg doxycycline product, claiming bioequivalence to Oracea. Lupin submitted certifications that the Galderma patents are invalid or will not be infringed by Lupin’s ANDA product. In response, Galderma sued Lupin for infringement.
The district court held a bench trial and found that Lupin did not infringe the patents. Galderma then appealed, arguing that the court erred by disregarding certain test data in Lupin’s ANDA, allowing certain test results into evidence, imposing limitations not present in the claims, and not finding infringement under the doctrine of equivalents. The Federal Circuit disagreed with all four arguments and thus affirmed.
Addressing Lupin’s first two arguments, the Federal Circuit saw no clear error in the district court’s findings. Lupin’s ANDA included results from a two-stage in vitro dissolution test, and Galderma sought to rely on those test results. But Galderma did not prove that the test results represented in vivo behavior of Lupin’s ANDA product.
Turning to Galderma’s argument that the district court imposed limitations during its infringement analysis not required by the claims, the Federal Circuit disagreed. The court instead agreed with Lupin that Galderma’s argument merely challenged the district court’s factual findings.
Finally, the Federal Circuit rejected Galderma’s arguments under the doctrine of equivalents, again seeing no clear error in the district court’s findings. Galderma relied on the two-stage in vitro test, which the court already rejected, and also provided evidence of bioequivalence. The Federal Circuit ruled that the evidence of bioequivalence “at most showed substantially the same result,” which “is insufficient to meet either the ‘function, way, result test’ or the ‘insubstantial differences’ test” for equivalents.
PS Products Inc., et al. v. Panther Trading Co. Inc., No. 2023-1665 (Fed. Cir. (E.D. Ark.) Dec. 6, 2024). Opinion by Moore, joined by Stoll and Cunningham.
PSP sued Panther for infringement of a design patent directed to a long-spiked electrode for a stun device. In response, Panther sent PSP a Rule 11 letter and draft motion for Rule 11 sanctions alleging the infringement allegations were frivolous and venue was statutorily improper. Panther also moved to dismiss for failure to state a claim and for improper venue. PSP did not respond to Panther’s letter or motion to dismiss.
Panther then discovered a prior art marketing brochure from PSP, and so sent PSP another letter. PSP did not respond but did move to voluntarily dismiss the case with prejudice, which the court granted. Panther then filed a motion for attorneys’ fees and costs under 35 U.S.C § 285 and $100,000 in deterrence sanctions under the court’s inherent power. The court deemed the case exceptional and awarded fees and costs under § 285, and the court subsequently ordered PSP and its attorney to jointly and severally pay $25,000 in deterrence sanctions to the court.
PSP appealed the $25,000 in deterrence sanctions, arguing that the court legally erred by imposing deterrence sanctions under its inherent power when it had already awarded fees and costs under § 285. The Federal Circuit disagreed, holding that “the district court can impose sanctions under its inherent power in addition to awarding attorney fees and costs under § 285.” After summarizing the circumstances that led to the sanctions, the Federal Circuit ruled that “the facts of this case support the district court’s award of sanctions.”
As part of the appeal, Panther requested attorneys’ fees and costs for defending the appeal, arguing it was frivolous as argued. The Federal Circuit ruled that, “although it is a close call, this appeal is not frivolous.” While the appeal and PSP’s arguments were “entirely without merit, they are not quite frivolous” because, for example, whether the district court could award deterrence sanctions in addition to attorneys’ fees under § 285 “ha[d] not previously been decided by this court.”