IP UPDATE
Exploring the latest in intellectual property law
IP UPDATE
Exploring the latest in intellectual property law
Results for "Patent infringement"
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Knowledge of Patent, Evidence of Infringement Are Necessary, but Not Sufficient, to Establish Willfulness

by | Mar 11, 2021 |

Addressing claim construction, enablement, damages and willfulness, the US Court of Appeals for the Federal Circuit found that evidence of a defendant’s knowledge of the asserted patent and proof of infringement were, by themselves, legally insufficient to support a finding of willfulness. Bayer Healthcare LLC v. Baxalta Inc., Case No. 19-2418 (Fed. Cir. Mar. 1, 2021) (Stoll, J.)

Bayer owns a patent on certain recombinant forms of human factor VII (FVIII), a protein that is critical for blood coagulation. Recombinant FVIII is useful as a treatment for coagulation disorders, primarily Hemophilia A. Natural FVIII has a short half-life, making therapeutic administration expensive and inconvenient. Adding polyethylene glycol (a process known as PEGylating) to FVIII at random sites was found to increase the protein’s half-life but reduce its function. Bayer invented FVIII that is PEGylated in a specific region (the B-domain) so that it retains its function and maintains the longer half-life.

After Baxalta developed a PEGylated FVIII therapeutic, Adynovate®, Bayer sued Baxalta for infringement of its patent. During claim construction, the district court construed the claim preamble “an isolated polypeptide conjugate” to mean “a polypeptide conjugate where conjugation was not random,” finding that Bayer had disclaimed conjugates with random PEGylation. The district court also construed “at the B-domain” to mean “attachment at the B-domain such that the resulting conjugate retains functional FVIII activity,” rejecting Baxalta’s proposal of “at a site that is not any amine or carboxy site in FVIII and is in the B-domain” because Bayer had not disclaimed PEGylation at amine or carboxy sites. Before trial, Baxalta moved for clarification of the term “random” in the construction of the preamble, but the district court “again” rejected Baxalta’s argument that Bayer defined “random” conjugation as “any conjugation at amines or carboxy sites.”

Before trial, Baxalta moved to exclude the testimony of Bayer’s damages expert regarding his proposed reasonable-royalty rate. The expert had defined a bargaining range and proposed to testify that the royalty rate should be the midpoint of the range based on the Nash Bargaining Solution. The district court permitted the expert to testify as to the bargaining range but excluded the opinions regarding the midpoint as insufficiently tied to the facts of the case.

After trial, the district court granted Baxalta’s pre-verdict motion for judgment as a matter of law (JMOL) of no willful infringement. Subsequently, the jury returned a verdict that the claims were infringed and not invalid for non-enablement, and awarded damages based on an approximately 18% royalty rate for the period for which the parties had presented sales information. Baxalta moved for JMOL or a new trial on infringement, enablement and damages. Bayer moved for pre-verdict supplemental damages for the period between the presented sales data and the date of judgment, and for a new trial on the issue of willfulness. The district court denied all of Baxalta’s motions and Bayer’s motion for new trial, but granted Bayer’s motion for supplemental damages, applying the jury’s ~18% rate to sales data for the later period. [...]

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Patent Owner’s Disavowal of Appeal from District Court’s Noninfringement Judgment Moots IPR Appeal

by | Jan 14, 2021 |

Addressing the standard for mootness in inter partes review (IPR) proceedings following a district court noninfringement judgment, the US Court of Appeals for the Federal Circuit held that a petitioner’s IPR appeal was moot after the patent owner decided not to appeal the final judgment of noninfringement. ABS Global, Inc. v. Cytonome/ST, LLC, Case No. 19-2051 (Fed. Cir., Jan. 6, 2021) (Stoll, J.) (Prost, C.J., dissenting in part).

In June 2017, Cytonome/ST filed a complaint against ABS asserting infringement of six patents, including the patent of interest in this case. ABS filed a petition for IPR of all claims of the patent. In April 2019, the Patent Trial and Appeal Board (PTAB, the Board) issued its final written decision invalidating certain claims of the patent. Two weeks later, the district court granted ABS partial summary judgment, holding that the accused products did not infringe any of the asserted patent’s claims. In June 2019, ABS appealed the PTAB’s final written decision. In a briefing before the Federal Circuit, Cytonome/ST’s counsel filed an affidavit stating that Cytonome/ST “has elected not to pursue an appeal of the district court’s finding of non-infringement as to the patent and hereby disclaims such an appeal.” In June 2020, the district court entered final judgment, including as to non-infringement of the patent.

The Federal Circuit dismissed ABS’ appeal of the PTAB’s final written decision on the ground that the appeal was moot in view of the district court’s non-infringement judgment. The Court characterized the question as one under the voluntary-cessation doctrine. In the context of intellectual property infringement cases, the voluntary-cessation doctrine requires the property owner claiming mootness to prove that the “allegedly wrongful behavior could not reasonably be expected to recur,” i.e., that it will not assert the intellectual property right against the same accused products again. If it does, the burden shifts to the accused infringer to show that it “engages in or has sufficiently concrete plans to engage in activities” that would not be covered by the property owner’s non-assertion decision.

Applying the doctrine, the Federal Circuit concluded that Cytonome/ST could not reasonably be expected to assert infringement of the patent against ABS because ABS had already secured a district court judgment that the accused products do not infringe and Cytonome/ST disclaimed any appeal of the non-infringement judgment. In effect, ABS was insulated from liability for infringement, including for future infringement for products that are “essentially the same” as ABS’ currently accused products pursuant to the Kessler doctrine. Further, the Court found that ABS had not demonstrated it could reasonably expect Cytonome/ST to sue it for infringement of the patent in the future as ABS had not shown it had current or concrete future plans to engage in activities not covered by Cytonome/ST’s disavowal: “Cytonome’s disavowal of its right to appeal the summary judgment of noninfringement ‘estops Cytonome from asserting liability against ABS for infringement of the…patent claims in connection with the accused products, thereby allowing ABS to make, use, and sell those products [...]

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No curtain call yet: Mixed verdict in patent, trademark, standing case

by | Oct 9, 2025 | ,

The US Court of Appeals for the Federal Circuit addressed a wide array of issues in a long-running dispute over shower curtain technology. The Court provided important guidance on patent claim scope using intrinsic evidence, trademark standing and ownership of the mark in issue, trade dress functionality under TrafFix, and the need for district courts to provide a reviewable explanation when issuing patent infringement summary judgment based on the facts of this case. Focus Products Grp. Int’l, LLC v. Kartri Sales Co., Inc., Case No. 23-1446 (Fed Cir. Sept. 30, 2025) (Moore, Clevenger, Chen, JJ.)

The decade-long dispute started when Focus Products sent a cease-and-desist letter to Kartri Sales and its supplier, Marquis Mills International. The letter asserted patent infringement but was largely ignored. Focus Products then filed suit asserting three utility patents, two trademarks (HOOKLESS® and EZ ON), and unregistered trade dress rights in the appearance of its shower curtains.

Four months after the Supreme Court’s 2017 decision in TC Heartland v. Kraft Foods Group Brands, Kartri raised a venue objection and filed a motion to dismiss or transfer venue. The district court denied the motion, finding it to be unreasonably late, especially considering that Kartri actively conducted litigation after TC Heartland.

The district court construed several disputed claim terms. Based on its constructions, it found no triable issue of fact and granted summary judgment of patent infringement to Focus Products. However, the district court found genuine disputes of material fact regarding trademark and trade dress infringement and ordered a bench trial on those issues.

On the eve of trial, Kartri asserted unclean hands and equitable estoppel defenses. The district court denied these defenses because they were improperly raised for the first time immediately preceding trial.

After a bench trial, the district court held that:

  • Focus Products had standing to enforce the unregistered EZ ON mark.
  • Kartri infringed the mark and Focus Products’ trade dress, which was determined to be nonfunctional.
  • Kartri infringed Focus Products’ HOOKLESS® mark.

Accordingly, the district court awarded lost profits, reasonable royalties, attorneys’ fees, and enhanced damages for willful infringement. Kartri appealed.

The Federal Circuit affirmed the district court’s denial of Kartri’s motion to transfer venue under TC Heartland, finding Kartri’s objection untimely. Kartri waited four months after TC Heartland to raise the issue, during which time discovery had progressed significantly. The Court emphasized that venue objections must be raised seasonably and that continued litigation in the chosen forum may constitute forfeiture.

The Federal Circuit largely reversed the district court’s infringement findings, explaining that the district court erred in its claim construction because Focus Products had disclaimed shower rings with a flat upper edge during prosecution. While an affirmative disclaimer usually originates from the patent applicant, the Court found clear and unmistakable disavowal through the applicant’s acquiescence to the examiner’s species election, claim cancellation, and narrowed claim scope. This disclaimer was reinforced by the prosecution of a related asserted patent, which explicitly claimed the disclaimed feature. A patentee cannot try [...]

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What we have here is a failure to communicate: Expert must map all claim limitations to the accused infringement

by | Oct 2, 2025 |

The US Court of Appeals for the Federal Circuit reversed jury verdicts of infringement, finding that they were not supported by substantial evidence because of deficiencies in the patent owner’s expert testimony. Finesse Wireless LLC v. AT&T Mobility LLC, Case No. 2025 WL 2713518 (Fed. Cir. Sept. 24, 2025) (Moore, C.J.; Linn, Cunningham, JJ.)

AT&T Mobility was accused of infringing two patents owned by Finesse Wireless, both directed to methods for mitigating intermodulation product interference in radios. The accused technology involved Nokia radios implementing passive intermodulation (PIM) cancellation. Nokia intervened in the case. A jury found all asserted claims valid and infringed, awarding Finesse more than $166 million in lump sum damages. AT&T and Nokia moved for judgment as a matter of law (JMOL) on both noninfringement and the damages award, and alternatively sought a new trial. The district court denied the motions. AT&T and Nokia appealed.

The Federal Circuit reversed the district court’s denial of JMOL on noninfringement and vacated the damages award, concluding that the jury verdicts were not supported by substantial evidence. The Court’s decision turned largely on shortcomings in the testimony of Finesse’s infringement expert, whose analysis was the sole basis for Finesse’s infringement case.

For the first patent, the Federal Circuit found that Finesse’s expert failed to demonstrate that Nokia’s PIM cancellation feature received all input signals required by the asserted claims. The expert relied on a Nokia diagram but misinterpreted it by mistakenly identifying a signal generated by the radio as one of the required input signals. Although the expert was made aware of the error, he did not clearly correct his position or identify alternative signals that satisfied the claim limitation. Finesse argued that the expert had corrected a “misimpression,” but the Court disagreed, finding that the expert failed to provide a clear and consistent explanation reconciling his contradictory positions.

The asserted claims of the second patent required seven multiplications involving three signals. Finesse’s expert relied solely on a Nokia document that listed only three multiplications yet equated them to the seven required by the claims. The Federal Circuit found this testimony inadequate, noting that the expert failed to explain how the three multiplications mapped to the seven required. On appeal, Finesse argued that the document actually evidenced 10 multiplications, but the Court was unpersuaded. Neither Finesse nor its expert explained how the 10 multiplications corresponded to the seven required multiplications, nor did they reconcile this new position with the expert’s prior reliance on only three multiplications.

Because Finesse failed to present expert testimony that adequately mapped each claim limitation to the accused method, the Federal Circuit reversed the jury’s infringement findings for both patents and vacated the damages award.

Practice note: The decision underscores the importance of detailed and consistent expert analysis in patent infringement cases, particularly when expert testimony is the sole basis for proving infringement.



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Don’t get too comfy: Prosecution disclaimer also applies to design patents

by | Jul 24, 2025 |

Concluding that the principles of prosecution history disclaimer apply to design patents, the US Court of Appeals for the Federal Circuit reversed a district court’s denial of judgment as a matter of law and entry of a jury verdict that found liability for design patent infringement. Top Brand, LLC v. Cozy Comfort Company, LLC, Case No. 24-2191 (Fed. Cir. July 17, 2025) (Dyk, Reyna, Stark, JJ.)

Top Brand and Cozy Comfort compete in the market for oversized hooded sweatshirts. Cozy Comfort owns a design patent directed to “the ornamental design for an enlarged over-garment with an elevated marsupial pocket.” It accused Top Brand of infringing the patent through its sale of certain hooded sweatshirts and wearable blankets. In response, Top Brand filed a declaratory judgment action seeking findings of noninfringement and invalidity. Cozy Comfort counterclaimed for design patent and trademark infringement.

During prosecution, Cozy Comfort overcame an anticipation rejection by distinguishing the prior art under the ordinary observer test, pointing to specific features such as the shape and placement of the marsupial pocket and the bottom hem line. Top Brand argued that these statements constituted a clear disclaimer of claim scope, and that the accused products fell within the surrendered subject matter.

The district court disagreed, instructing the jury to compare the accused products to the design as claimed (without considering any prosecution disclaimer). The jury found infringement, and the court entered judgment accordingly, denying Top Brand’s motion for judgment as a matter of law. Top Brand appealed.

Top Brand argued that the district court erred by failing to apply prosecution history disclaimer, asserting that the accused design was within the scope of the subject matter Cozy Comfort had disclaimed. Cozy Comfort responded that the disclaimer doctrine does not apply to design patents and, even if it did, Cozy Comfort’s prosecution statements were not sufficiently clear to constitute a disclaimer.

The Federal Circuit disagreed, concluding that prosecution history disclaimer applies to design patents. The Court reasoned that allowing patentees to recapture disclaimed subject matter in litigation would undermine the integrity of the patent system. The Court emphasized that Cozy Comfort’s statements during prosecution clearly surrendered the identified features as supporting a finding of overall similarity. Because the accused design incorporated those surrendered features, the Court concluded that no reasonable jury could find infringement.

Accordingly, the Federal Circuit reversed the district court’s denial of judgment as a matter of law and vacated the jury’s verdict.



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New Administration, Same Patent Reform Bill

by | May 8, 2025 |

A bipartisan group of senators and congressional representatives reintroduced the Patent Eligibility Restoration Act (PERA), which aims to reform the law of patent eligibility under 35 U.S.C. § 101. PERA seeks to address the challenges posed by recent Supreme Court decisions and restore clarity and predictability in the US patent system.

PERA preserves the existing categories of subject matter currently enumerated in § 101 but adds several categories of excluded subject matter. PERA proposes to eliminate all judicial exceptions to patent eligibility, specifying that certain categories, such as mathematical formulas that are not part of an invention, processes that a human could perform, mental processes, unmodified human genes, and unmodified natural material, are not eligible for patents.

A separate bipartisan group of senators and congressional representatives reintroduced the Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act, which aims to protect and increase the value of US intellectual property rights by making significant reforms to the Patent Trial & Appeal Board.

PREVAIL seeks to limit Board challenges to entities that have been sued or threatened with a patent infringement lawsuit, close the statutory bar joinder loophole to prevent time-barred entities from joining instituted inter partes review (IPR) proceedings, and prevent serial petitions by applying estoppel at the time the challenge is filed instead of when the Board issues its final written decision.



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Broadcast Alert! Applying Conventional Machine Learning to New Data Isn’t Patent Eligible

by | Apr 24, 2025 |

The US Court of Appeals for the Federal Circuit affirmed a district court’s ruling that patents applying established machine learning methods to new data are not patent eligible under 35 U.S.C. §101. Recentive Analytics, Inc. v. Fox Corp. et al., Case No. 23-2437 (Fed. Cir. Apr. 18, 2025) (Dyk, Prost, Goldberg, JJ.)

Recentive sued Fox, alleging infringement of four patents designed to tackle long-standing challenges in the entertainment industry – namely, optimizing the scheduling of live events and refining “network maps,” which determine the content aired on specific channels across various geographic markets at set times. These patents aim to streamline broadcast operations and enhance programming efficiency.

The patents at issue can be divided into two categories: network maps and machine learning training. The machine learning training patents focus on generating optimized event schedules by training machine learning models with parameters such as venue availability, ticket prices, performer fees, and other relevant factors. The network map patents describe methods for dynamically generating network maps that assign live events to television stations across different geographic regions. These methods utilize machine learning to optimize television ratings by mapping events to stations and updating the network map in real time based on changes to the schedule or underlying criteria. The patents’ specifications explain that the methods employ “any suitable machine learning technique” using generic computing machines.

Fox moved to dismiss on the grounds that the patents were subject matter ineligible under § 101. Recentive acknowledged that the concept of preparing network maps had existed for a long time. Recentive also recognized that the patents did not claim the machine learning technique. Nonetheless, Recentive argued that its patents claimed eligible subject matter because they involve using machine learning to generate custom algorithms based on training the machine learning model. Recentive characterized its patents as introducing “the application of machine learning models to the unsophisticated, and equally niche, prior art field of generating network maps for broadcasting live events and live event schedules.”

The district court disagreed and granted Fox’s motion. Applying the Alice framework, at step one, the court determined that the asserted claims were “directed to the abstract ideas of producing network maps and event schedules, respectively, using known generic mathematical techniques.” At step two, the court determined that the machine learning limitations were no more than “broad, functionally described, well-known techniques” that claimed “only generic and conventional computing devices.” The court denied Recentive’s request for leave to amend because it determined that any amendment would be futile. Recentive appealed.

For the Federal Circuit, this case presented a question of first impression: whether claims that do no more than apply established methods of machine learning to a new data environment are patent eligible.

Step One

While Recentive claimed that its machine learning approach was uniquely dynamic and capable of uncovering hidden patterns in real time, the Federal Circuit found these features to be merely standard aspects of how machine learning operates. The Court explained that iterative training and model updates are not [...]

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A Patent Without a Pulse: Provisional Rights Don’t Outlive the Patent

by | Apr 10, 2025 |

The US Court of Appeals for the Federal Circuit dismissed an appeal from a patent applicant seeking provisional rights on a patent that would issue only after it had already expired, finding that the applicant lacked the necessary exclusionary rights to support a claim for provisional rights. In re: Donald K. Forest, Case No. 23-1178 (Fed. Cir. Apr. 3, 2025) (Taranto, Schall, Chen, JJ.)

Donald K. Forest applied for a patent on December 27, 2016. Forest’s patent application claimed priority through a chain of earlier-filed patent applications dating back to March 27, 1995. If Forest’s patent application matured into a patent, it would have expired 20 years after the 1995 priority date (i.e., prior to the 2016 filing date). The patent examiner nevertheless examined and rejected the proposed claims. The Patent Trial & Appeal Board partially affirmed the examiner’s rejection of certain claims on grounds of obviousness and double patenting. Forest appealed.

The Patent & Trademark Office raised a threshold issue that since Forest’s application could only result in an expired patent, he lacked a personal stake in the appeal sufficient to establish jurisdiction. Forest countered that he could still acquire “provisional rights” under 35 U.S.C. § 154(d) – a limited right to royalties for certain pre-issuance activities – despite the expiration of any issued patent as it issued.

The Federal Circuit dismissed the appeal, explaining that since Forest could not be granted a patent until after the patent’s expiration date, he would never receive any exclusionary rights. The Court clarified that provisional rights only arise once a patent issues and crucially do not extend beyond the statutory patent term. Because Forest sought the issuance of a patent that would confer no enforceable rights – either exclusionary or provisional – the Court dismissed the appeal for lack of jurisdiction.

The Federal Circuit’s primary conclusion was predicated on the principle that provisional rights are only available when a patent issues with enforceable exclusionary rights, meaning the patent must issue before its expiration date. The Court emphasized that provisional rights under § 154(d) are expressly provided “in addition to other rights provided by” the patent statute. Because this statutory language indicates that provisional rights are not standalone, the Court determined that provisional rights depend on the existence of a valid, enforceable patent.

According to the Federal Circuit, the entire purpose of provisional rights is to provide temporary relief to the patentee during the gap between publication of a patent application and issuance of a patent. However, such rights only arise if the issued patent provides enforceable rights. The Court reasoned that provisional rights are meant to encourage early publication and protect patentees from pre-issuance infringement, but only as a precursor to full patent protection.

The Court rejected Forest’s interpretation of § 154(d), explaining it would create an anomalous situation where provisional rights could survive without any corresponding enforceable rights, allowing a patentee to collect royalties on a patent that could never be asserted in infringement litigation.

Practice Note: Patent rights, whether provisional [...]

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What’s the (Re)issue? Patent Term Extensions for Reissue Patents

by | Mar 27, 2025 |

Addressing the calculation of patent term extensions (PTEs) under the Hatch-Waxman Act, the US Court of Appeals for the Federal Circuit affirmed a district court decision that under the act the issue date of the original patent should be used to calculate the extension, not the reissue date. Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc., Case No. 23-2254 (Fed. Cir. Mar. 13, 2025) (Dyk, Mayer, Reyna, JJ.)

Merck owns a patent that is directed to a class of 6-mercapto-cyclodextrin derivatives. Four months after the patent issued, Merck applied to the US Food & Drug Administration (FDA) for approval of sugammadex, which it intended to market as Bridion®. During FDA’s review of Merck’s new drug application (NDA), Merck filed a reissue application that included narrower claims. The reissue application issued and included all the original claims and 12 additional claims. FDA regulatory review continued throughout the examination of the reissue application and extended almost two years beyond the date the patent reissued. In all, the FDA regulatory review lasted nearly 12 years.

The Hatch-Waxman Act provides owners of patents related to pharmaceutical products a process to extend the term of their patent rights to compensate for time lost during regulatory review of their NDAs. The act contains a clause providing that “the term of a patent . . . shall be extended by the time equal to the regulatory review period . . . occur[ring] after the date the patent is issued.” Having been unable to market the invention covered by the patent for almost 12 years because of FDA’s regulatory review, Merck filed a PTE application for its reissue patent seeking a five-year extension (the maximum allowed under the act) based on the patent’s original issue date. The US Patent & Trademark Office (PTO) agreed and granted the five-year extension.

Between the reissue date and the PTO’s grant of the five-year extension, Aurobindo and other generic manufacturers had filed abbreviated new drug applications (ANDAs) seeking to market generic versions of Bridion®. Merck sued for infringement. At trial, Aurobindo argued that the PTO improperly calculated the PTE by using the original issue date instead of the reissue date because only 686 days of FDA’s regulatory review occurred after the reissue date, as opposed to the almost 12 years which had passed since the initial issue date. The district court disagreed, finding that Aurobindo’s proposed construction “would undermine the purpose of the Hatch-Waxman Act.” Aurobindo appealed.

Aurobindo argued that the act’s reference to “the patent” referred to the reissue patent because that is the patent for which the patentee was seeking term extension. Merck argued that the act’s text, read in light of other patent statutes and the history of patent reissue, required the opposite conclusion (i.e., a PTE based on the original issue date).

The Federal Circuit agreed with Merck, explaining that while the language of the PTE text may be ambiguous, that ambiguity may be resolved by considering the PTE text in light of the history of [...]

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The Devil Is in the Details: Bioequivalence, In Vitro Testing Not Enough to Establish Infringement

by | Dec 19, 2024 |

Addressing for the first time the issue of whether bioequivalence data and in vitro testing can show that an abbreviated new drug application (ANDA) product with different immediate and delayed release portions infringed on a patent, the US Court of Appeals for the Federal Circuit upheld the district court’s finding of noninfringement. Galderma Laboratories, L.P. v. Lupin Inc., Case No. 24-1664 (Fed. Cir. Dec. 6, 2024) (Moore, C.J.; Linn, Prost, JJ.)

Galderma owns and markets Oracea® (doxycycline USP) 40 mg capsules, which are used to treat papules and pustules associated with rosacea. Galderma’s patents cover a unique once-daily oral formulation of doxycycline, combining 30 mg of immediate release (IR) and 10 mg of delayed release (DR) pellets. Lupin filed an ANDA to market a bioequivalent 40 mg doxycycline product, featuring 22 mg IR and 18 mg DR pellets, and using the same enteric polymer for the DR portion as Oracea®. Galderma sued Lupin under the Hatch-Waxman Act, alleging patent infringement.

Despite Lupin’s different pellet composition, Galderma contended that Lupin’s product effectively contained 30 mg IR and 10 mg DR because of a “weak enteric coat” on the DR pellets, causing early release of some doxycycline. Lupin presented two key pieces of evidence:

  • A two-stage in vitro dissolution test at pH 1.1 and 4.5, showing some DR pellet release at pH 4.5.
  • Bioequivalence data comparing Oracea® and Lupin’s product.

The district court ultimately ruled in favor of Lupin. Galderma appealed. The issue on appeal was whether Galderma’s evidence of bioequivalence and in vitro testing was indeed insufficient to establish literal infringement or infringement under the doctrine of equivalents (DoE).

The Federal Circuit agreed with the district court: in vitro testing and bioequivalence were not enough to establish literal infringement. Crucially, Galderma’s two-stage in vitro dissolution test didn’t accurately mimic in vivo conditions. The Court highlighted that the pH 4.5 environment used in the test wasn’t physiologically relevant for a fasted stomach, which typically has a pH between 1 and 2. Moreover, the bioequivalence data failed to address the differing proportions of IR and DR pellets. Consequently, the Court found no clear error in the district court’s factual findings.

Nor did the DoE save Galderma. The Federal Circuit applied two different tests: the function-way-result test and the insubstantial differences test. Under the function-way-result test the court is charged with determining whether the accused product performs the same function, in the same way, to achieve the same result as the claimed invention. Under the insubstantial differences test – as its name suggests – the court is charged with determining whether the differences between the claimed invention and the accused product are insubstantial.

Again, Galderma relied on bioequivalence data and its in vitro testing to argue that either DoE test was satisfied. The Federal Circuit was not persuaded, finding no clear error in the district court’s reasoning. As for the function-way-result test, the in vitro testing did not show that Lupin’s ANDA product used the same function or method as the asserted [...]

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