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Plausibly Alleging Access Requires More Than Social Media Visibility

by Amit Kumar Saha, PhD | May 29, 2025 | Copyrights

The US Court of Appeals for the Ninth Circuit affirmed a district court’s dismissal of a copyright action, finding that the plaintiff failed to plausibly allege either that the defendant had “access” to the work in question merely because it was posted on social media, or that the accused photos were substantially similar to any protectable elements of plaintiff’s photographs. Rodney Woodland v. Montero Lamar Hill, aka Lil Nas X, et al., Case No. 23-55418 (9th Cir. May 16, 2025) (Lee, Gould, Bennett, JJ.)

The dispute arose between Rodney Woodland, a freelance model and artist, and Montero Lamar Hill, also known as Lil Nas X, a well-known musical artist. Woodland alleged that Hill infringed on his copyright by posting photographs to his Instagram account that bore a striking resemblance to images Woodland had previously posted. Woodland claimed that the arrangement, styling, and overall visual composition of Hill’s photos closely mirrored his own, asserting that these similarities constituted unlawful copying of his original work.

Woodland’s original images had been publicly shared on his Instagram account, where he maintained a modest following. He did not allege any direct contact or interaction with Hill or his representatives, nor did he claim that Hill had acknowledged or referenced his work. Instead, Woodland’s claim rested on the contention that the similarities between the two sets of photographs were so substantial that copying could be inferred. In his complaint, Woodland asserted that Hill had access to his publicly posted images and that the degree of similarity supported a finding of unlawful copying. The district court dismissed the complaint, holding that Woodland failed to plausibly allege either access or substantial similarity. Woodland appealed.

The Ninth Circuit affirmed, agreeing with the district court that Woodland failed to satisfy the pleading standard necessary to survive a motion to dismiss. The Ninth Circuit explained that to state a viable claim for copyright infringement, a plaintiff must alleged both the fact of copying and the unlawful appropriation of protected expression. The Court found that Woodland failed to establish either element.

The Ninth Circuit considered two principal legal issues:

Whether Woodland sufficiently alleged that Hill had access to Woodland’s copyrighted works
Whether the photographs posted by Hill were substantially similar to Woodland’s photographs in their protectable elements under copyright law

On the issue of access, the Ninth Circuit found that the merely alleging availability of Woodland’s photos on Instagram did not, by itself, plausibly demonstrate that Hill had seen them. The Court noted that in the era of online platforms, “the concept of ‘access’ is increasingly diluted.” And while that might make it easier for plaintiffs to show “access,” there must be a showing that the defendants had a reasonable chance of seeing that work under the platform’s policies. The mere fact that Hill used Instagram and Woodland’s photos were available on the same platform raised only a “bare possibility” that Hill viewed the photos. Woodland had not plausibly alleged that Hill “followed, liked, or otherwise interacted” with Woodland’s posts [...]

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Take That Conception Out of the Oven – It’s CRISPR Even If the Cook Doesn’t Know

by Connor M. Larson | May 22, 2025 | America Invents Act, Patents

Addressing the distinction between conception and reduction to practice and the requirement for written description in the unpredictable arts, the US Court of Appeals for the Federal Circuit explained that proof of conception of an invention does not require that the inventor appreciated the invention at the time of conception. Knowledge that an invention is successful is only part of the case for reduction to practice. Regents of the Univ. of Cal. et al. v. Broad Inst. et al., Case No. 22-1594 (Fed. Cir. May 12, 2025) (Reyna, Hughes, Cunningham, JJ.)

The Regents of the University of California, the University of Vienna, and Emmanuelle Charpentier (collectively, Regents) and the Broad Institute, Massachusetts Institute of Technology, and the President and Fellows of Harvard College (collectively, Broad) were each separately involved in research concerning CRISPR systems that “are immune defense systems in prokaryotic cells that naturally edit DNA.” At issue was the invention of the use of CRISPR systems to modify the DNA in eukaryotic cells. Regents and Broad filed competing patent applications resulting in an interference proceeding under pre-AIA law at the US Patent & Trademark Office Board of Patent Appeals & Interferences to determine which applicant had priority to the invention.

The main issue before the Board was a priority dispute over who first conceived of the invention and sufficiently reduced it to practice under pre-AIA patent law. Regents submitted three provisional patent applications dated May 2012, October 2012, and January 2013 and moved to be accorded the benefit of the earliest filing date, May 2012, for the purpose of determining priority. Alternatively, Reagents sought to be accorded either October 2012 or January 2013 as its priority date. The Board found that Regents’ first and second provisional applications (filed in May and October 2012, respectively) were not a constructive reduction to practice because neither satisfied the written description requirement of 35 U.S.C. § 112. The third provisional application, filed in January 2013, was the first to amount to a constructive reduction to practice of the counts in interference. The Board then ruled that Broad was the senior party for the purposes of priority in the interference proceeding because Broad reduced the invention to practice by October 5, 2012, when a scientist submitted a manuscript to a journal publisher. The Board ruled that Regents failed to prove conception of the invention prior to Broad’s actual reduction to practice. Regents appealed.

Regents argued that in assessing conception, the Board “legally erred by requiring Regents’ scientist to know that their invention would work.” The Federal Circuit agreed and vacated the Board’s decision. As the Court explained, there are three stages to the inventive process: conception, reasonable diligence, and reduction to practice. At the conception stage, “an inventor need not know that his invention will work for conception to be complete.” Rather, knowledge that the invention will work, “necessarily, can rest only on an actual reduction to practice.” The Board therefore legally erred by requiring Regents to know its invention would work to prove [...]

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Up in Smoke: Statutory Trademark Damages Can Exceed Actual Damages

by Taylor MacDonald | May 15, 2025 | Trademarks

Addressing a jury’s statutory damages award that surpassed the plaintiffs’ actual damages, the US Court of Appeals for the Eleventh Circuit affirmed the district court’s denial of the defendant’s motion for judgment as a matter of law (JMOL), finding that the award was consistent with trademark damages law given the jury’s finding of no willfulness and was not violative of constitutional due process. Top Tobacco, L.P. v. Star Importers & Wholesalers, Inc., Case No. 24-10765 (11th Cir. Apr. 30, 2025) (Pryor, Grant, Kid, JJ.)

Top Tobacco, Republic Technologies, and Republic Tobacco (collectively, Republic) sued Star Importers & Wholesalers for trademark violations and the sale of counterfeit cigarette rolling papers. Prior to trial, the district court granted summary judgment in favor of Republic. Thus, the only issues tried to the jury were damages related, including whether Star’s conduct had been willful, whether the company’s president should be personally liable, and the appropriate damages award.

Republic sought damages under 15 U.S.C. § 1117(c) of the Lanham Act, permitting the jury to look beyond actual damages and award up to $200,000 per non-willfully infringed mark or $2 million per willfully infringed mark. The jury instructions explained to the jury that it could consider multiple factors, including lost revenue, the conduct’s willfulness, and whether the counterfeit goods were a public safety risk. The instructions also clarified that the statute permitted both compensatory and punitive rationales for the award, as long as it was not a windfall for Republic. Ultimately, the jury found that Star’s conduct had not been willful and granted the plaintiffs $123,000 per infringed mark. Star moved for JMOL, arguing the total $1.107 million award was inconsistent with the finding of no willfulness. The district court denied the motion. Star appealed.

The Eleventh Circuit affirmed the district court’s denial of the JMOL motion, concluding that:

The jury was permitted to provide an award greater than actual damages.
The jury was permitted to consider punitive and deterrence rationales despite finding the actions were not willful.
The award did not violate constitutional due process.

Applying the principles of statutory construction, the Eleventh Circuit explained that because § 1117(a) permits an award for actual damages, § 1117(c)’s purpose was explicitly to allow awards greater than the actual loss suffered. Further, the jury’s role of factfinder under the Seventh Amendment precluded the district court from overriding a verdict that fell within the statute. Finally, the Court noted that the jury instructions were a safeguard against punishing defendants without any regard for actual damages because the instructions protected against a windfall for the plaintiff. In this case, the jury had facts regarding the marks’ strength, potential dangers of the counterfeit papers’ chemicals, and the prevalence of counterfeiting in the industry. Thus, the Court found that the jury had substantial evidence for the award – which was below the statutory maximum – and that it was not a windfall for Republic.

Similarly, the Eleventh Circuit reasoned that since the jury awarded damages below the statutory maximum [...]

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Clickbait: Actual Scope (Not Intended Scope) Determines Broadening Reissue Analysis

by Tim Dunker | May 15, 2025 | Patents

The US Court of Appeals for the Federal Circuit affirmed the Patent Trial & Appeal Board’s rejection of a proposed reissue claim for being broader than the original claim, denying the inventors’ argument that the analysis should focus on the intended scope of the original claim rather than the actual scope. In re Kostić, Case No. 23-1437 (Fed. Cir. May 6, 2025) (Stoll, Clevenger, Cunningham, JJ.)

Miodrag Kostić and Guy Vandevelde are the owners and listed inventors of a patent directed to “method[s] implemented on an online network connecting websites to computers of respective users for buying and selling of click-through traffic.” Click-through links are typically seen on an internet search engine or other website inviting the user to visit another page, often to direct sales. Typical prior art transactions would require an advertiser to pay the search engine (or other seller) an upfront fee in addition to a fee per click, not knowing in advance what volume or responsiveness the link will generate. The patent at issue discloses a method where the advertiser and seller first conduct a trial of click-through traffic to get more information before the bidding and sale process. The specification also discloses a “direct sale process” permitting a seller to bypass the trial and instead post its website parameters and price/click requirement so advertisers can start the sale process immediately.

The independent claim recites a “method of implementing on an online network connecting websites to computers of respective users for buying and selling of click-through traffic from a first exchange partner’s web site.” The claim requires “conducting a pre-bidding trial of click-through traffic” and “conducting a bidding process after the trial period is concluded.” A dependent claim further requires “wherein the intermediary web site enables interested exchange partners to conduct a direct exchange of click-through traffic without a trial process.”

The patent was issued in 2013, and the inventors filed for reissue in 2019. The reissue application cited an error, stating that the “[d]ependent claim [] fails to include limitations of [the independent] claim,” where the dependent claim “expressly excludes the trial bidding process referred to in the method of [the independent] claim,” which would render it invalid under 35 U.S.C. § 112. To fix the error, the inventors attempted to rewrite the dependent claim as an independent claim that omitted a trial process.

The examiner issued a nonfinal Reissue Office Action rejecting the reissue application as a broadening reissue outside of the statutory two-year period. The examiner found that the original dependent claim is interpreted to require all steps of the independent claim, including the trial period, and further to require a direct sale without its own trial, beyond the trial claimed in the independent claim. The inventors attempted to rewrite the dependent claim as the method of independent claim with “and/or” language regarding the trial process versus direct to sale process. The amendment was rejected for the same reasons. The Board affirmed on appeal.

Whether amendments made during reissue enlarge the scope of [...]

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No Article III Appellate Standing Under the Sun

by Anisa Noorassa | May 15, 2025 | Patents

The US Court of Appeals for the Federal Circuit dismissed Incyte’s appeal of a Patent Trial & Appeal Board decision, holding that a disappointed validity challenger lacked appellate standing to challenge the Board’s final written decision. Incyte Corp. v. Sun Pharmaceuticals Industries, Inc., Case No. 23-1300 (Fed. Cir. May 7, 2025) (Moore, C.J.; Hughes, Cunningham, JJ.) (Hughes, J., concurring).

After the Board upheld the validity of challenged claims of a patent owned by Sun Pharmaceuticals in a post-grant review proceeding (PGR), Incyte appealed and sought a determination that the claims were unpatentable. Sun Pharmaceuticals challenged whether Incyte had Article III standing to support an appeal to the Federal Circuit based on a lack of injury-in-fact.

The Federal Circuit focused on its jurisdiction to hear the appeal as a threshold issue and whether Incyte, as the party seeking review, met its burden of establishing Article III standing at the time it filed its appeal.

As context, the Federal Circuit noted that standing requires a concrete, actual, or imminent injury that is traceable to the challenged conduct and likely to be redressed by the court’s decision. Incyte asserted it had standing to appeal based on potential infringement liability and under the competitor standing doctrine.

Addressing potential infringement liability, the Federal Circuit noted Incyte’s reliance on a supplemental declaration from an in-house business development leader submitted during briefing. Noting that Incyte’s Article III standing was “not self-evident,” the Court ruled that Incyte should have presented evidence prior to its reply brief and declined to consider the supplemental evidence. Incyte was on notice that its appellate standing was challenged, and that evidence of its standing should have been submitted at the earliest possible opportunity. Finding no good cause for the delay, the Court declined to exercise its discretion to consider Incyte’s supplemental evidence and, based only on earlier submitted evidence, found that Incyte failed to establish that it had “concrete plans for future activity” that would create a “substantial risk of future infringement.”

In its discussion of the competitor standing doctrine, which allows competitors to challenge patents that could harm their competitive position, the Federal Circuit found the doctrine inapplicable because Incyte failed to show it would suffer economic harm from the Board’s ruling on patent validity. Rather, the Board’s ruling upholding specific patent claims “does not, by the operation of ordinary economic forces, naturally harm a [challenger] just because it is a competitor in the same market as the beneficiary of the government action (the patentee).” As the Court explained, “it is not enough to show a benefit to a competitor to establish injury in fact; the party seeking to establish standing must show a concrete injury to itself.”

The Federal Circuit held that because Incyte had not shown it was currently engaged in or had non-speculative plans to engage in conduct covered by the challenged patent, it was unable to establish injury-in-fact.

In his concurrence, Judge Hughes stated that while Incyte lacked Article III standing, he believed that Federal Circuit precedent was [...]

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False Connection: Post-Application Date Evidence Can Be Considered

by Ashley K. Justice | May 15, 2025 | Trademarks

The US Court of Appeals for the Federal Circuit affirmed the Trademark Trial & Appeal Board’s refusal to register a mark on the grounds of false connection, explaining that the false connection inquiry can include evidence that arises during the examination after filing. In re Thomas D. Foster, APC, Case No. 23-1527 (Fed. Cir. May 7, 2025) (Moore, Prost, Stoll, JJ.)

Under § 2(a) of the Lanham Act (15 U.S.C. § 1052(a)), a trademark can be refused registration if it “falsely suggests a connection with persons, living or dead, institutions, beliefs, or national symbols.” To determine if a mark falsely suggests a connection, the Board can use a non-exhaustive four-part test that inquires whether:

The mark is the same, or a close approximation of, the name previously used by another person or institution.
The mark points uniquely or unmistakably to that person or institution.
That person or institution is not connected with the activities performed by the applicant under the mark.
The fame or reputation of the person or institution is such that, when the mark is used with the applicant’s goods or services, a connection with the person or institution would be presumed.

Here, Thomas D. Foster filed a trademark application for the mark US SPACE FORCE on March 19, 2018, six days after President Trump proposed forming a “Space Force.” Registration was refused on the grounds of a false suggestion of a connection with the US government. The Board affirmed and denied reconsideration. Foster appealed.

Foster argued that the Board improperly considered evidence that post-dated the application’s filing date and that substantial evidence did not support the Board’s findings under the first two elements of the four-part false connections test.

Regarding Foster’s first argument, the Federal Circuit found it permissible to use facts that arise after an application’s filing date and during the examination process to assess a false connection. The Court reasoned that this was consistent with other § 2 inquiries that consider evidence that arises through the date the Board issues its decision, such as likelihood of confusion (§ 2(d)) and distinctiveness (§ 2(f)). Therefore, the Court found that the Board did not err in its consideration of evidence that arose during the examination process.

The Federal Circuit disagreed with Foster’s second argument, finding that substantial evidence supported the Board’s findings under the false connection test. Under the first part of the test, the Board found that US SPACE FORCE was the same as, or a close approximation of, a name or identity of the United States. The Court concluded that this was supported by substantial evidence, specifically pre-application evidence (President Trump’s announcement and national news articles discussing the formation of the US Space Force) and post-application evidence (the official establishment of the US Space Force and national news articles). Under the second part of the test, the Board had found that US SPACE FORCE pointed uniquely and unmistakably to the United States. The Board again relied on news coverage and the fact that [...]

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Breaking New Grounds to Limits of IPR Estoppel

by Amol Parikh | May 15, 2025 | Patents

In a matter of first impression, the US Court of Appeals for the Federal Circuit found that inter partes review (IPR) estoppel does not preclude a petitioner from relying on the same patents and printed publications as evidence in asserting a ground that could not have been raised during the IPR proceeding, such as that the claimed invention was known or used by others, on sale, or in public use. Ingenico Inc. v. IOENGINE, LLC, Case No. 23-1367 (Fed. Cir. May 7, 2025) (Dyk, Prost, Hughes, JJ.)

IOENGINE owns patents directed to a portable device, such as a USB thumb drive, that includes a processor that causes communications to be sent to a network server in response to user interaction with an interface on a terminal. Ingenico filed a declaratory judgment action against IOENGINE after one of Ingenico’s customers was sued for infringement based on Ingenico’s products. Ingenico filed IPR petitions challenging the asserted patents, which resulted in final written decisions that held most of the challenged claims unpatentable.

Back at the district court, IOENGINE proceeded with the remaining claims. At summary judgment, IOENGINE moved, under 35 U.S.C. § 315(e)(2), to preclude Ingenico from relying on “documentation related to DiskOnKey Upgrade software,” arguing that Ingenico reasonably could have been expected to raise that prior art during the IPR proceedings. The district court ruled that “Ingenico will be estopped from relying on those documents [to prove invalidity] except to the extent . . . that they form part of a substantively different combination of references that could not reasonably have been raised in the IPRs.”

At trial, Ingenico introduced evidence of a prior art USB device known as the DiskOnKey. The DiskOnKey device was offered with various software applications, including an application called Firmware Upgrader, and was equipped with capabilities described in a Software Development Kit (together, the DiskOnKey system). Ingenico argued that the DiskOnKey system invalidated the asserted claims as anticipated or obvious because it was either “on sale” or “in public use” under 35 U.S.C. § 102(b), or “known or used by others . . . before the date of the invention” under 35 U.S.C. § 102(a). The jury returned a verdict finding the patents were infringed but invalid as anticipated and obvious. Both parties appealed.

IOENGINE did not dispute the jury’s finding that the DiskOnKey system invalidated the claims-at-issue as anticipated or obvious if the DiskOnKey system was prior art, but instead argued that the jury’s finding that the Firmware Upgrader portion of the DiskOnKey system was either “on sale” or “in public use,” or “known or used by others . . . before the invention.”

The Federal Circuit found that the jury’s finding that the Firmware Upgrader was accessible to the public was supported by substantial evidence. Specifically, Ingenico had introduced a press release promoting the launch of the Firmware Upgrader and a website from which the Firmware Upgrader was available for download. IOENGINE argued that this evidence did not show actual use, but the Court rejected [...]

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Hatch-Waxman or Not, Clinical Trials Aren’t Subject to Injunction

by Christopher M. Bruno | May 15, 2025 | Patents

Analyzing the permissible scope of an injunction under the Hatch-Waxman Act, the US Court of Appeals for the Federal Circuit reversed the district court’s prohibitions on an open-label extension (OLE) of a then-running clinical trial and new clinical trials and remanded for further consideration of whether prohibiting a request for an additional indication was appropriate. Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals LLC, Case No. 24-2274 (Fed. Cir. May 6, 2025) (Lourie, Reyna, Taranto, JJ.)

This appeal is one of several disputes between Jazz and Avadel regarding their competing sodium oxybate products. Jazz markets two such products: Xyrem, approved for treating excessive daytime sleepiness and certain cataplexy, and Xywav, which, in addition to Xyrem’s indications, also may be used for treating idiopathic hypersomnia. Avadel filed a § 505(b)(2) new drug application (NDA) to market its own product, Lumryz. During the pendency of the Lumryz application, Jazz obtained a patent and asserted that Avadel infringed it under 35 U.S.C. § 271(e)(2), part of the Hatch-Waxman Act, based on its filing of the Lumryz NDA. The patent was never Orange Book listed, so Avadel did not need to submit any patent certification.

The US Food & Drug Administration (FDA) approved Lumryz. Avadel launched the product, and Jazz amended its complaint to assert traditional § 271(a) – (c) infringement. Ultimately, Avadel and Jazz stipulated infringement, the patent was determined not invalid, and the jury awarded damages based on the post-launch infringement. After further proceedings, the district court permanently enjoined Avadel from seeking an idiopathic hypersomnia indication for Lumryz, offering an OLE phase of its then-running Lumryz idiopathic hypersomnia clinical trial, and against initiating new clinical trials. Avadel appealed, arguing that each of these restrictions was improper.

The Federal Circuit largely agreed with Avadel, reversing the first two prohibitions, and remanded the case back to the district court for further consideration of the prohibition against any new clinical trials. Turning first to the prohibition on new clinical trials, the Court held that initiating new trials for the purposes of submission to the FDA fell squarely within the Hatch-Waxman Safe Harbor for experimentation (under § 271(e)(1)) and thus could not be enjoined (per §271(e)(3)). Jazz unsuccessfully argued that Avadel had waived its Safe Harbor position, which required factual development.

Next, the Federal Circuit rejected the district court’s injunction against an OLE, concluding that the district court had not applied the Supreme Court’s four-factor eBay (2006) test for injunctions when deciding the appropriateness of such extraordinary relief. Refusing to determine whether an OLE extension qualified as safe-harbored activity in the first instance, the Court explained that only if such activity were deemed to be infringing on an appropriate record could it be enjoined.

Finally, with respect to prohibiting Avadel from seeking an idiopathic hypersomnia indication for Lumryz, the Federal Circuit concluded that the propriety of that restriction may turn on whether the infringement qualified under the Hatch-Waxman Act, reasoning that an injunction might run afoul of the § 271(e)(4) limitation on the scope of injunctive relief. [...]

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No Protectable Code: No Literal or Nonliteral Copying

by Keval Amin | May 15, 2025 | Copyrights

The US Court of Appeals for the Eighth Circuit affirmed a district court’s ruling that a plaintiff failed to establish copyright protection for its software platforms, drawing a distinction between “literal” copying (direct duplication of source code) and “nonliteral” copying (reproduction of structure, sequence, or user interface). InfoDeli, LLC v. Western Robidoux, Inc., et al., Case No. 20-2146 (8th Cir. May 5, 2025) (Gruender, Kelly, Grasz, JJ.)

InfoDeli partnered with Western Robidoux, Inc. (WRI), a commercial printing and fulfillment firm co-owned by family members, in 2009 to form a joint venture. The agreement leveraged InfoDeli’s expertise in developing custom webstore platforms and WRI’s capacity for printing and fulfillment. Their collaboration served major clients such as Boehringer Ingelheim Vetmedica Inc. (BIVI) and CEVA Animal Health, LLC, both providers of animal health products. InfoDeli built webstores enabling the companies’ sales teams to order promotional materials, which WRI then fulfilled. InfoDeli developed the Vectra Rebate platform for CEVA, allowing marketing staff to issue customer coupons that were also fulfilled by WRI.

By early 2014, tensions emerged. Without informing InfoDeli, WRI hired a competitor, Engage Mobile Solutions, to replace InfoDeli’s platforms for CEVA and BIVI. Engage used open-source software, in contrast to InfoDeli’s proprietary systems. WRI also shared InfoDeli-developed content with Engage to aid the transition. Shortly thereafter, WRI abruptly terminated its joint venture with InfoDeli.

InfoDeli sued WRI, CEVA, BIVI, and Engage for copyright infringement, tortious interference, and violations of the Missouri Computer Tampering Act related to certain webstores. The defendants counterclaimed conversion and tortious interference. The district court ruled in favor of the defendants on the copyright claims and denied InfoDeli’s motion on the counterclaims. After a jury sided with the defendants, InfoDeli filed motions for judgment and a new trial, both of which were denied. InfoDeli appealed.

The Eighth Circuit found that InfoDeli failed to prove its platforms were protected by copyright. The Court distinguished between “literal” and “nonliteral” copying, explaining that literal copying referred to direct duplication of original source code while nonliteral copying involved reproducing the overall structure or user interface. The district court had already determined that the nonliteral elements of InfoDeli’s platforms were not copyrightable. On appeal, InfoDeli did not challenge this determination regarding the individual elements. Instead, InfoDeli argued that the platforms should be protected “as a whole,” claiming that the interrelationship of elements made them protectable. However, the Eighth Circuit found that InfoDeli did not explain how the elements’ arrangement exhibited the required creativity for copyright protection.

InfoDeli further argued that the district court erred in not considering the verbatim copying of its source code. However, since InfoDeli’s complaint only alleged infringement of nonliteral elements, the Eighth Circuit found that the district court properly focused on those claims.

InfoDeli also argued that the district court erred by relying on InfoDeli’s expert’s list of protectable elements for the BIVI platform. However, the Court rejected this claim, pointing to precedent holding that when a plaintiff identifies specific elements as protectable, it effectively concedes that the remaining elements [...]

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No Supremacy Clause Preemption Where State Statute Doesn’t Conflict With Federal

by Lois D. Mermelstein | May 8, 2025 | Life Sciences

The US Court of Appeals for the Fifth Circuit explained that ordinarily, when state law contradicts with federal law, the state law may be preempted by the federal law under the US Constitution’s Supremacy Clause. However, under Supreme Court precedent, state unfair-competition laws that accurately mirror the relevant provisions of federal law are not subject to preemption. Zyla Life Sciences, LLC v. Wells Pharma of Houston, LLC, Case No. 23-20533 (5th Cir. April 10, 2025) (Oldham, Ho, Duncan, JJ.)

Under the federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 301 et seq., no one may sell any new drug without prior approval from the US Food and Drug Administration (FDA). Because compounded drugs are not new but are merely remixed versions of existing drugs, registered compounding facilities are allowed to sell compounded drugs as long as they satisfy additional criteria specified in the FDCA. Six states mirror federal law by making it illegal to sell any new drug without FDA approval and provide for suit under traditional state unfair-competition law if a party sells drugs in violation of these state laws.

Zyla and Wells Pharma are competitors. Zyla sells FDA-approved suppositories containing indomethacin, a drug used to treat various ailments such as rheumatoid arthritis. Wells Pharma sells compounded indomethacin suppositories that are not FDA approved, but Wells Pharma is a registered compounding facility and thus satisfies at least one provision of the exemption. Zyla, seeking to enjoin Wells Pharma from manufacturing and selling its compounded suppositories in the six states mirroring the FDCA, filed suit under those states’ unfair-competition laws. Wells Pharma moved to dismiss under Fed. R. Civ. Pro. 12(b)(6), arguing that the state laws were preempted. After the district granted the motion, Zyla appealed.

The issue before the Fifth Circuit was whether the state laws conflict with the FDCA by incorporating it. As the Court explained, a state triggers implied “[o]bstacles-and-purposes preemption . . . when state law stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress.” Here, (quoting the California statute) the six state statutes at issue bar selling a “new drug” that has not been approved “under Section 505 of the [FDCA].” The Fifth Circuit, citing the 1949 Supreme Court decision in California v. Zook as controlling, concluded that where there is no conflict in statutory terms between the state and federal statutes, there is no preemption. Both a state and the federal government may regulate the same conduct – whether a state has provided an additional remedy in state law is irrelevant – and the FDCA itself permits states to regulate conduct related to drug safety and effectiveness concurrently with the federal government.

The Fifth Circuit reversed the district court’s order granting Wells Pharma’s motion to dismiss and remanded the case.