IP UPDATE
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Exploring the latest in intellectual property law
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Collateral estoppel remains inapplicable to unchallenged IPR claims

by | Aug 14, 2025 |

Returning to its decision in Kroy IP, the US Court of Appeals for the Federal Circuit denied a petition for panel rehearing and rehearing en banc, leaving undisturbed its prior opinion that collateral estoppel does not apply to the assertion of claims from a patent, even when other patentably indistinct claims from that patent have been found unpatentable in inter partes review (IPR) proceedings before the Patent Trial & Appeal Board. Kroy IP Holdings, LLC v. Groupon, Inc., Case No. 23-1359 (Fed. Cir. Aug. 1, 2025) (per curiam) (Moore, J., concurring) (Dyk, J., dissenting).

Kroy sued Groupon for patent infringement, and Groupon subsequently filed two IPR petitions. The Board ultimately found 21 of the asserted claims unpatentable. Kroy amended its complaint to remove those 21 claims and proceed only with claims that were not at issue in the IPR proceedings. Groupon moved to dismiss the complaint, arguing that Kroy was collaterally estopped from asserting the remaining claims because of the Board’s prior IPR rulings finding other patentably indistinct claims unpatentable. The district court agreed with Groupon, finding that the remaining asserted claims were not materially different from the unpatentable claims in terms of validity and granted the motion to dismiss with prejudice. Kroy appealed.

The Federal Circuit held that a Board determination finding certain patent claims unpatentable under the preponderance of the evidence standard did not collaterally estop Kroy from asserting other unreviewed claims of the same patent in district court litigation against Groupon. Groupon subsequently petitioned for panel rehearing and rehearing en banc, both of which the Federal Circuit denied per curiam.

Chief Judge Moore, joined by Judge Stoll, concurred in the decision. In her concurring opinion, Judge Moore explained that collateral estoppel does not apply where differing standards of proof exist (namely, the preponderance of evidence standard used by the Board versus the clear and convincing evidence standard applied in district courts) because this difference can materially affect a patent’s validity determination. She emphasized that collateral estoppel should apply consistently in patent cases and cautioned against deviating from the established collateral estoppel standards. Judge Moore also noted that policy concerns are mitigated by the ability to file a second IPR petition, because the Board is likely to grant review where a petition raises a substantially similar question of invalidity.

Judge Dyk, joined by Judge Hughes, dissented from the decision. The dissent advocated departing from the traditional burden-of-proof rule applicable in the collateral estoppel context to avoid duplicative litigation regarding patent validity. The dissent argued that the majority opinion conflicted with the Federal Circuit’s 2018 opinion in XY, LLC v. Trans Ova Genetics, which held that collateral estoppel extends between Board decisions and district court proceedings in pending or co-pending actions. According to the dissent, the majority’s approach permits repeated litigation of the validity of patent claims previously found unpatentable in IPR proceedings affirmed on appeal. The dissent expressed concern that applying collateral estoppel in this manner would enable patentees to evade the preclusive effect of adverse IPR [...]

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Dim damages methods can doom bright ideas

by | Aug 7, 2025 |

In a mixed ruling on evidentiary exclusions and damages methodology, the US Court of Appeals for the Federal Circuit affirmed in part, reversed in part, vacated in part, and remanded a district court’s decision that excluded patent validity evidence and granted judgment as a matter of law (JMOL). The Federal Circuit found that the district court erred in blocking the defendant’s invalidity case and directed it to reassess the reliability of the damages expert’s testimony under Rule 702. Jiaxing Super Lighting Co., Ltd. v. CH Lighting Technology Co., Ltd., Case No. 23-1715 (Fed. Cir. July 28, 2025) (Dyk, Chen, Hughes, JJ.)

Jiaxing Super Lighting and its affiliate Obert (collectively, Super Lighting) sued CH Lighting over three patents related to LED tube lamps – two covering structural designs and one addressing electrical safety. CH Lighting admitted infringement but argued that the structural patents were invalid under the America Invents Act’s (AIA) on-sale bar. The district court excluded key evidence, found the remaining expert testimony insufficient, and granted JMOL in Super Lighting’s favor. A jury later found CH Lighting liable and awarded damages, which the district court doubled. CH Lighting’s motions for a new trial and renewed JMOL were denied. CH appealed.

CH Lighting contended that certain 2014 LED tubes met all claim limitations and triggered the on-sale bar. The Federal Circuit disagreed, affirming the district court’s finding that CH Lighting’s expert lacked a proper foundation, having offered no concrete evidence or personal knowledge of the alleged sales. However, the Court found error in the exclusion of two key evidentiary items: testimony authenticating sales documents and an internal presentation showing competitor products predating the patents. The district court excluded the documents for lack of authentication and barred the presentation because of its connection to a dropped inequitable conduct claim, later reasoning that the products shown differed in wattage. The Federal Circuit rejected both rationales, explaining that the relevant inquiry focused on whether the products disclosed patented features, not their wattage. The Federal Circuit deemed these exclusions an abuse of discretion, warranting a retrial on validity.

The Federal Circuit separately upheld the jury’s findings on a different patent where the jury found the patent not invalid for anticipation and infringed. CH Lighting had argued that a prior art reference anticipated the asserted claims and that the accused chips could not infringe if the reference did not. The Court found, based on the conflicting testimony of the parties’ expert witnesses, that the jury was free to credit one expert over the other and therefore had substantial evidence supporting the jury’s no invalidity verdict. Similarly, the parties’ experts presented conflicting evidence on infringement and that Jiaxing’s expert’s theory was not necessarily inconsistent with the validity ruling. The Court thus affirmed the findings of validity and infringement.

Turning to damages, the Federal Circuit emphasized that expert testimony must be based on reliable methodology and sufficient factual grounding, reinforcing standards articulated in the recent EcoFactor, Inc. v. Google en banc decision. Because the jury [...]

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It’s not monkey business: NFTs can be trademarked

by | Jul 31, 2025 |

The US Court of Appeals for the Ninth Circuit concluded that a non-fungible token (NFT) is a “good” under the Lanham Act but reversed the district court’s grant of summary judgment for trademark infringement because the owner did not prove as a matter of law that the defendants’ use was likely to cause confusion. The Ninth Circuit also affirmed the district court’s dismissal of the defendants’ counterclaim for declaratory relief regarding copyright ownership. Yuga Labs, Inc. v. Ryder Ripps and Jeremy Cahen, Case No. 24-879 (9th Cir. July 23, 2025) (Bade, Forrest, Curiel, JJ.)

Yuga Labs is the creator of the Bored Ape Yacht Club (BAYC) NFT collection. Yuga created this collection through a smart contract recorded on the blockchain Ethereum. Each BAYC NFT has a cartoon of a bored ape and a sequential unique identifier called an ape ID. Per its terms and conditions, BAYC NFT consumers receive commercial and personal rights free of royalty fees.

Ryder Ripps and Jermey Cahen created the Ryder Ripps Bored Ape Yacht Club (RR/BAYC) using the same ape images and ape IDs. The collection was also hosted on an Ethereum blockchain smart contract. They criticized Yuga for “using neo-Nazi symbolism, alt-right dog whistles, and racist imagery” and alleged that they created RR/BAYC as satire and criticism. Ripps made the RR/BAYC smart contracts’ names “Bored Ape Yacht Club” and made the smart contract symbol “BAYC.” Ripps’ website includes an artist statement that the artwork is a “new mint of BAYC imagery.” NFT marketplace websites for RR/BAYC displayed a large header “Bored Ape Yacht Club” and in a smaller text “@ryder_ripps.”

Yuga sued Ripps and Cahen for several claims, including trademark infringement based on a false designation of origin theory, false advertising, and cybersquatting. In response, the defendants asserted that Yuga did not have enforceable trademark rights, and even if it did, the defendants’ use was protected by fair use and the First Amendment. The defendants asserted several counterclaims, including knowing misrepresentation of infringing activity under the Digital Millenium Copyright Act (DMCA), and sought declaratory judgment of no copyright ownership.

The district court granted Yuga’s motion for summary judgment on its false designation of origin and cybersquatting claims. Yuga withdrew its remaining claims, so the trial proceeded only for equitable remedies on the false designation of origin and cybersquatting. At trial, the district court found that Yuga’s BAYC marks were unregistered trademarks. The district court awarded Yuga disgorgement of the defendants’ profits, maximum statutory damages, and attorneys’ fees after finding that the case was exceptional due to the defendants’ willful infringement, bad faith intent to profit, and litigation conduct. The defendants were also permanently enjoined. The defendants appealed the grant of summary judgment and sought vacatur of the remedies.

The Ninth Circuit first addressed the defendants’ argument that NFTs are not goods protected by the Lanham Act. The Court concluded that NFTs are goods under the Lanham Act based on a US Patent & Trademark Office report that determined them as such. The Court also [...]

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Game over: Prior interference doesn’t preclude IPR proceeding

by | Jul 31, 2025 |

The US Court of Appeals for the Federal Circuit affirmed a Patent Trial & Appeal Board unpatentability determination during an inter partes review (IPR) proceeding, concluding that the Board’s decision to not apply interference estoppel fell within the general rule of unreviewability. IGT v. Zynga Inc., Case No. 23-2262 (Fed. Cir. July 22, 2025) (Prost, Reyna, Taranto, JJ.)

IGT owns an expired patent that addresses the need for gaming machines, such as slot machines and video poker machines, to securely communicate over a public network. The patent was issued in January 2007 from an application filed in April 2002 and published in August 2002. Zynga filed a patent application on August 21, 2003, that included claims copied from IGT’s published application.

In March 2010, the US Patent & Trademark Office (PTO) Board of Patent Appeals & Interferences (predecessor of the Patent Trial & Appeal Board, which Congress created in 2011) declared an interference proceeding between Zynga’s application and IGT’s patent. During the interference proceeding, Zynga argued IGT’s patent was obvious over three pieces of prior art. IGT argued that Zynga lacked standing because the claims in Zynga’s application were unpatentable for a lack of written description. The Board granted IGT’s motion for judgment on the “threshold issue” that Zynga’s application lacked adequate written description support, terminated the interference with a judgment against Zynga, and dismissed the motion that the claims were unpatentable as moot.

In April 2021, IGT sued Zynga alleging infringement of six patents, including the patent that was subject to the interference proceeding. Zynga filed an IPR petition for that patent, asserting obviousness based on new prior art. In its preliminary response, IGT argued that the Board should deny institution based on interference estoppel under 37 C.F.R. § 41.127(a)(1) because Zynga could have raised the newly asserted art in the interference proceeding. The Board rejected IGT’s interference estoppel arguments because:

  • The interference was terminated based on the “threshold issue” of lack of written description and therefore the Board did not analyze or decide any issues of unpatentability.
  • It would be unfair to estop Zynga, and to the extent that estoppel applied, the Board waived its application under 37 C.F.R. § 42.5(b).

IGT requested rehearing and precedential opinion panel review, arguing that interference estoppel barred institution. The PTO Director affirmed the Board’s decision, stating that interference estoppel under § 41.127 did not apply because IPR proceedings are governed by 37 C.F.R. pt. 42, which does not incorporate Part 41 or its estoppel provisions. The PTO Director also noted that the Board’s termination was based on a threshold issue. The Board proceeded with the review and ultimately concluded that all the challenged claims were unpatentable as obvious. IGT appealed.

IGT argued that the Board and PTO Director erred in ruling that interference estoppel did not bar the petition and challenged the Board’s holding that the claims would have been obvious over the newly asserted prior art.

The Federal Circuit concluded that the interference estoppel determination fell within the [...]

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Victory lap: Extraterritorial injunction permitted for breach of settlement agreement

by | Jul 24, 2025 |

The US Court of Appeals for the Fourth Circuit upheld a permanent injunction, concluding that the district court properly determined that a party’s violation of a settlement agreement would lead to irreparable harm. Wudi Industrial (Shanghai) Co., Ltd. v. Wong, Case No. 24-1186 (4th Cir. July 11, 2025) (King, Gregory, Rushing, JJ.)

The dispute originated in 2017 when Wudi registered the trademark GTRACING with the US Patent & Trademark Office. Wai L. Wong, asserting prior use of the similar mark GT OMEGA RACING, initiated cancellation proceedings before the Trademark Trial & Appeal Board. In 2020, the Board ruled in Wong’s favor. Wudi sought review in the Eastern District of Virginia under 15 U.S.C. § 1071(b), and Wong counterclaimed for trademark infringement.

In May 2021, the parties entered into a confidential global concurrent-use settlement agreement resolving their litigation. Under the agreement, Wudi was permitted to use GTRACING globally, except in designated regions including multiple European countries. Critically, paragraph 6(b) of the agreement prohibited Wudi from using the phrases “GTRACING” or “GT RACING” in online advertising or social media within the European carve-out. The district court subsequently granted a stay of the dispute pending compliance by the parties.

Following the compliance period, Wong alleged that Wudi violated the agreement by using prohibited terms in online marketing within the restricted regions. The district court granted Wong’s motion to enforce the agreement, ordering Wudi to remove specific content and cease future violations. The district court warned that continued noncompliance could result in contempt proceedings.

Wudi appealed, and the Fourth Circuit initially remanded the case, instructing the district court to apply the four-factor eBay test for injunctive relief. The district court found that Wudi had breached the agreement and that Wong had suffered irreparable harm to the goodwill of its marks. The court concluded that monetary damages were inadequate, the balance of hardships favored Wong, and enforcing the agreement served the public interest. The district court issued a permanent injunction. Wudi appealed again.

Wudi challenged the injunction on multiple grounds, including claims of extraterritorial overreach, improper application of the eBay factors, erroneous breach findings, exclusion of parol evidence, failure to apply the unclean hands doctrine, and improper award of attorneys’ fees.

The Fourth Circuit rejected Wudi’s arguments and affirmed the district court’s ruling. The Court held that the injunction merely enforced contractual obligations voluntarily undertaken by Wudi and that the district court properly applied the eBay test. The Court also found no abuse of discretion in the district court’s exclusion of parol evidence and its rejection of the unclean hands defense, finding that the district court properly concluded that reputational harm can demonstrate that irreparable injury will flow from the breach of a trademark-related settlement agreement.



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Valve turned: Prosecution history estoppel applies to closely related claims

by | Jul 24, 2025 |

The US Court of Appeals for the Federal Circuit reversed a jury’s infringement finding, concluding it was precluded by prosecution history estoppel. Colibri Heart Valve LLC v. Medtronic CoreValve LLC, Case No. 23-2153 (Fed. Cir. July 18, 2025) (Taranto, Hughes, Stoll, JJ.)

Colibri Heart Valve sued Medtronic CoreValve for infringing a patent covering a method of implanting an artificial heart valve. At trial, the district court denied Medtronic’s motion for judgment as a matter of law, allowing the jury to consider Colibri’s infringement theory under the doctrine of equivalents. The jury found in Colibri’s favor. Medtronic appealed.

The Federal Circuit reversed, finding that Colibri was estopped from asserting its equivalents theory. During prosecution, Colibri had canceled a claim that explicitly recited “retracting the movable sheath.” The asserted claim, while using different language, involved a similar concept: “pressing against the pusher member with a force that moves the pusher member outward from the moveable sheath.” The Court concluded that a skilled artisan would recognize these limitations as equivalent in light of basic physics.

Citing the Supreme Court’s 2002 Festo v. Shoketsu decision, the Federal Circuit emphasized that prosecution history estoppel can arise not only from formal amendments but also from the cancellation of closely related claims. Here, the cancellation of one claim effectively narrowed the scope of the remaining claims, triggering estoppel.

Accordingly, the Federal Circuit reversed the district court’s denial of judgment of noninfringement.



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Applicant-admitted prior art may inform but can’t be basis for IPR challenges

by | Jul 24, 2025 |

The US Court of Appeals for the Federal Circuit clarified that while applicant-admitted prior art (AAPA) may be cited as evidence of general background knowledge in inter partes review (IPR) proceedings, it cannot serve as the basis for an IPR ground. The Court also confirmed that the petitioner had Article III standing to cross-appeal based on concrete plans for future activity. Shockwave Medical, Inc. v. Cardiovascular Systems, Inc., Case No. 23-1864 (Fed. Cir. July 14, 2025) (Lourie, Dyk, Cunningham, JJ.)

Shockwave Medical owns a patent directed to treating atherosclerosis using a balloon catheter in combination with shockwaves generated by electrodes and a pulse generator. The patent specification acknowledged that “over-the-wire angioplasty balloon catheters” were well known in the art. Cardiovascular Systems, Inc. (CSI) filed an IPR petition asserting that it would have been obvious to modify a European patent application with the angioplasty balloon catheter disclosed in the AAPA.

The Patent Trial & Appeal Board found all but one claim unpatentable as obvious, relying on the AAPA solely as evidence of background knowledge. Both parties appealed.

Shockwave challenged the Board’s reliance on the AAPA, arguing that 35 U.S.C. § 311(b) prohibits using AAPA as a basis for an IPR petition. The Federal Circuit disagreed, reaffirming its prior decisions in Qualcomm I and Qualcomm II. In Qualcomm I, the Court explained that AAPA cannot be the basis of a ground in an IPR petition but can be evidence of background knowledge. In Qualcomm II, the Court found that the Board erred in determining that the use of AAPA was proper when the petitioner expressly included AAPA in one of its grounds. Relying on these decisions, the Court explained that while AAPA cannot form the basis of a ground in an IPR petition, it may be used to demonstrate the general knowledge of a person of ordinary skill in the art and to supply missing claim limitations.

Shockwave pointed to a table in the Board’s final written decision listing AAPA under “reference(s)/basis” as evidence that the Board improperly relied on AAPA as a ground. The Federal Circuit rejected this argument, distinguishing Qualcomm II and emphasizing that the petitioner, not the Board, defines the grounds for review. Because CSI did not rely on AAPA as a ground, its use was permissible.

CSI cross-appealed the Board’s finding that one claim was not obvious. Shockwave challenged CSI’s standing, but the Federal Circuit found that CSI had Article III standing because it had concrete plans to begin clinical trials and because of Shockwave’s public statements suggesting it would assert the patent. The Court concluded that these facts created a substantial risk of future infringement.

On the merits, the Federal Circuit agreed with CSI that the Board erred by failing to consider the prior art as a whole. The Court reiterated that the obviousness inquiry requires evaluating the combined teachings of the prior art, not individual references in isolation. Finding no evidence to support the Board’s conclusion, the Court reversed the Board’s decision as to the remaining [...]

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Appeal is too late to raise percolating claim construction dispute

by | Jul 17, 2025 |

The US Court of Appeals for the Federal Circuit affirmed a district court’s finding of noninfringement, concluding that the patent owner had improperly raised a claim construction issue for the first time on appeal – an argument not preserved at the district court level. Egenera, Inc. v. Cisco Systems, Inc., Case No. 23-1428 (Fed. Cir. July 7, 2025) (Prost, Taranto, Stark, JJ.)

Egenera owns a patent that enhances traditional server systems by enabling a one-time physical setup followed by flexible virtual reconfiguration. The company alleged that Cisco infringed specific claims of the patent.

During claim construction, the parties disputed the interpretation of two terms: “computer processor/processor” and “emulate Ethernet functionality over the internal communication network.” The district court adopted the ordinary meaning of “computer processor,” which excluded Cisco’s unified computing system from its scope. Regarding the term “emulate,” the district court considered whether it implied an absence from the internal communication network but made no further determinations as the parties did not explicitly raise a dispute regarding the remainder of the claim term. Based on its construction of “computer processor/processor,” the district court granted Cisco’s motion for summary judgment on certain claims. Later, at trial, a jury found no infringement of other asserted claims. Egenera moved for judgment as a matter of law (JMOL) or alternatively for a new trial, both of which the district court denied. Egenera appealed the post-trial rulings and the earlier summary judgment ruling.

The Federal Circuit affirmed the district court’s grant of summary judgment. It concluded that the record lacked sufficient evidence to show that Cisco’s system “emulated” Ethernet functionality as required by the asserted claims. The Court emphasized that Egenera’s argument focused narrowly on the construction of the term “emulate,” rather than on the evidentiary record. Moreover, neither party clearly indicated that the dispute centered on unresolved claim construction rather than factual issues. The Court noted that it will not address claim construction on appeal where the issue was not preserved in the district court and was inadequately presented on appeal. As a result, the Court confined its analysis to the sufficiency of the evidence and upheld the district court’s finding of noninfringement.

The Federal Circuit also affirmed the district court’s denial of JMOL. The Court emphasized that it needed to address only one of Cisco’s proposed noninfringement grounds to determine whether substantial evidence supported the jury’s verdict. It concluded that the jury had a sufficient evidentiary basis to find that Egenera failed to prove infringement.

Finally, the Federal Circuit upheld the district court’s denial of Egenera’s motion for a new trial. It rejected all of Egenera’s arguments, which alleged errors related to jury selection, jury instructions, expert testimony, closing arguments, and a verdict contrary to the weight of the evidence.



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State court action doesn’t create reasonable apprehension of related federal claims

by | Jul 17, 2025 |

Addressing whether a federal district court had jurisdiction over an action for declaratory relief that certain trade secrets and trademarks were invalid and not infringed, the US Court of Appeals for the Eighth Circuit concluded that state law claims for breach of contract, trade secret misappropriation, and trademark infringement did not create a reasonable apprehension of federal litigation sufficient to give rise to federal jurisdiction. Thunderhead of Ankeny, Inc. v. Chicken Bones of Kearney, Inc., Case No. 24-2741 (8th Cir. July 8, 2025) (Colloton, Arnold, Gruender, JJ.)

Nearly 20 years ago, David Anders sold his equity in Chicken Bones of Kearney, Inc., which ran a bar and grill called the Chicken Coop. Anders subsequently opened a new Chicken Coop restaurant. Chicken Bones sued Anders for misappropriating Chicken Bones’ trade secrets, trademarks, and trade dress. The parties settled, and Anders received a limited license to the Chicken Coop intellectual property. Anders then opened several other Chicken Coop locations under that license.

Believing that Anders had not complied with the license in opening the new restaurants, Chicken Bones sued Anders in state court for breach of the settlement agreement, misappropriation of trade secret recipes, and infringement of the Chicken Coop trademarks and trade dress. In response, Anders sued Chicken Bones in federal court, seeking declarations of noninfringement and invalidity. The district court dismissed the suit for lack of jurisdiction. Anders appealed.

The parties and the Eighth Circuit assumed that the district court would have jurisdiction only if the suit presented a federal question. The Eighth Circuit explained that to assess federal question jurisdiction in the case of a declaratory action, the Court must imagine a traditional action that presents the same controversy and determine whether a federal claim would appear on the face of the resulting complaint. “If, but for the availability of the declaratory judgment procedure, the federal claim would arise only as a defense to a state created action, jurisdiction is lacking.”

Applying this principle, the Eighth Circuit concluded that the district court did not have jurisdiction over Anders’ declaratory action because he primarily sought vindication of his defenses to Chicken Bones’ pending state law claims. While the Court recognized that Anders also sought declaratory relief in anticipation of potential federal trade secret, trademark, and trade dress claims, the Court reasoned that any federal law controversy between the parties was too speculative to support jurisdiction. While a threat of litigation can give rise to a justiciable controversy, there was no evidence that Chicken Bones would assert overlapping and duplicative federal law claims against Anders. The Eighth Circuit further found that Chicken Bones’ petition to cancel Anders’ federal trademark registration of a Chicken Coop logo did not change its analysis, because the petition merely confirmed the existence of a trademark infringement dispute between the parties, which Chicken Coop elected to adjudicate in state court.

The Eighth Circuit distinguished cases involving state law trade secret claims concerning a patented invention. Because there is no state patent system, such trade secret claims can [...]

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Motivation, expectation of success negate obviousness presumption in overlapping range case

by | Jul 17, 2025 |

The US Court of Appeals for the Federal Circuit affirmed (on its second review) a district court’s ruling upholding the validity of patent claims related to a long-acting injectable dosing regimen, finding that the presumption of obviousness does not apply automatically and must be grounded in specific factual findings, particularly regarding a skilled artisan’s motivation and expectations. Janssen Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc., Case No. 25-1228 (Fed. Cir. July 8, 2025) (Prost, Reyna, Taranto, JJ.)

Janssen sued Teva under the Hatch-Waxman Act in 2018 after Teva filed an abbreviated new drug application (ANDA) seeking approval for a generic version of Janssen’s drug. Teva stipulated infringement but challenged the patent’s validity, arguing that all claims were obvious in light of prior art. The patent at issue covered a dosing regimen involving two “loading doses” spaced about a week apart, followed by monthly maintenance injections, designed to improve patient compliance compared to traditional oral dosing.

In 2021, the district court rejected Teva’s obviousness arguments, citing key differences between the claims and prior art, including the specific dosage amounts, the sequence of administration, and the requirement for deltoid injections. In 2024, the Federal Circuit initially vacated that decision and remanded for further analysis. On remand, the district court again found the claims nonobvious, and Teva appealed again.

A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art. Teva argued that a presumption of obviousness should apply because the prior art disclosed equal loading doses (150 or 100 mg-eq) within the claimed range. The Federal Circuit disagreed, emphasizing that the presumption depends on factual premises (such as a skilled artisan’s motivation to optimize and expectations from routine experimentation), which were not met here. The Court noted that Janssen’s specific choice of a higher first dose followed by a lower second dose did not clearly fall within the presumption’s scope.

Turning to the obviousness analysis, the Federal Circuit found that the three primary prior art references did not disclose a loading-dose regimen. Teva’s additional references, which it claimed taught dose reduction strategies, were also deemed insufficient. The Court found that one expert cited a reference recommending a high first dose for acutely ill patients while another noted that long-acting injectables were not typically used for such patients. The Court found that the prior art taken as a whole undermined Teva’s position.

Teva further contended that the district court improperly considered safety and efficacy (factors not recited in the claims) and erred in finding that the multidose regimen added complexity that would discourage a skilled artisan. The Federal Circuit rejected these arguments, affirming that the district court appropriately considered the motivation to develop a safe and effective regimen and correctly found that the prior art lacked relevant safety or efficacy data for multidose approaches.



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