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Federal Circuit

Speculation of Harm Isn’t Standing: Not Every Adverse Board Decision Is Ticket to Appeal

by Keval Amin | Jun 12, 2025 | America Invents Act, Patents

After assessing whether a patent owner had standing to appeal the Patent Trial & Appeal Board’s final written decision, the US Court of Appeals for the Federal Circuit found no injury in fact to support Article III jurisdiction and dismissed the appeal. Dolby Labs. Licensing Corp. v. Unified Patents, LLC, Case No. 23-2110 (Fed. Cir. June 5, 2025) (Moore, Clevenger, Chen, JJ.)

Dolby owns a patent covering a prediction method involving an in-loop filter. Unified Patents, claiming to be the sole real party in interest (RPI), filed an inter partes review (IPR) challenging several patent claims as anticipated and obvious. Dolby contested the challenge, identifying nine additional entities it argued should have been named as RPIs (alleged RPIs). The Board declined to rule on Dolby’s inclusion, however, and proceeded with Unified as the sole RPI.

In its final written decision, the Board found that Unified failed to establish the unpatentability of any challenged claims. Consistent with the US Patent & Trademark Office’s practice, it also declined to address the RPI dispute, finding it immaterial – there was no evidence the alleged RPIs were estopped from filing their own IPRs later or that Unified had advantageously or strategically omitted them. Dolby appealed.

The Federal Circuit explained that when it reviews final Board decisions, its jurisdiction is constrained by Article III’s “Cases” and “Controversies” requirement. To establish standing, an appellant must demonstrate:

A concrete and particularized injury in fact that is actual or imminent, not speculative.
A causal link between the injury and the appellee’s challenged conduct.
A likelihood that the injury will be redressed by a favorable ruling.

Dolby asserted standing to appeal the Board’s refusal to address the RPI dispute based on three grounds:

Its statutory right to appeal as a “dissatisfied” party under 35 U.S.C. § 319.

The denial of its right to information under 35 U.S.C. § 312(a)(2).
An injury in fact arising from potential breaches of license agreements by the alleged RPIs and possible conflicts of interest involving the Board’s administrative patent judges.

The Federal Circuit rejected Dolby’s argument that it had a right to appeal based solely on dissatisfaction with the Board’s decision. The Court explained that the right to appeal a Board decision under the America Invents Act (AIA) requires Article III standing. The Court also dismissed Dolby’s argument for a statutory right to RPI information, finding that the AIA does not create an informational right. The Court explained that unlike statutes such as the Federal Advisory Committee Act or the Federal Election Campaign Act, which expressly grant public access to information, the AIA lacks a public access provision and explicitly limits judicial review of IPR-related determinations, including RPI disclosures.

As to Dolby’s right to appeal the Board decision, the Federal Circuit found Dolby’s argument too speculative to establish standing, citing four key deficiencies:

Dolby failed to assert that any alleged RPIs were party to license agreements, undermining its claim of potential breach.

Dolby provided no evidence of conflicts of [...]

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X-Ray Vision: Court Sees Through Implicit Claim Construction

by Connor M. Larson | Jun 5, 2025 | Patents

The US Court of Appeals for the Federal Circuit reversed the Patent Trial & Appeal Board’s final determination that challenged patent claims were not unpatentable, finding that the Board’s decision relied on an erroneous implicit claim construction. Sigray, Inc. v. Carl Zeiss X-Ray Microscopy, Inc., Case No. 23-2211 (Fed. Cir. May 23, 2025) (Dyk, Prost, JJ.; Goldberg, Chief Distr. J., sitting by designation).

Zeiss owns a patent related to X-ray imaging systems that incorporate projection magnification. Sigray filed a petition requesting inter partes review (IPR) of all claims in the patent. After institution, the Board issued its final written decision, which declined to hold any of the challenged claims unpatentable. Sigray appealed.

On appeal, Sigray argued that the claims were unpatentable based on a single prior art reference, Jorgensen. The Jorgensen reference “describes a system that uses an X-ray source to generate an X-ray beam, which then passes through a sample before being received by a detector.” Sigray argued that Jorgensen anticipated or rendered the challenged claims obvious. The parties agreed that Jorgensen explicitly disclosed all the limitations of the independent claim except for one reading “a magnification of the projection X ray stage . . . between 1 and 10 times.”

The parties’ arguments centered on whether the magnification limitation was inherently disclosed in Jorgensen. The Board concluded that “viewing the record as a whole, . . . [Sigray] has not shown persuasively that Jorgensen inherently discloses projection magnification within the claimed range. Sigray argued, and the Federal Circuit agreed, that the Board’s findings incorrectly relied on a flawed understanding of the claimed range. In Sigray’s view, “the Board implicitly and incorrectly construed the limitation ‘between 1 and 10’ to exclude unspecified, small divergence resulting in projection magnifications only slightly greater than 1.” This was illustrated by the Board’s determination that Sigray “failed to show that the . . . X-ray beam in Jorgensen diverges enough to result in projection magnification between 1 and 10 times.”

The Federal Circuit found that the Board’s use of the term “enough” indicated that the evidence it relied on supported a finding of some divergence in the X-ray beams. Because the beams were not completely parallel, the Court reasoned that some magnification necessarily resulted, and that even a miniscule amount (as disclosed in the prior art) fell within the claimed magnification range of 1 to 10. Since the Board made only one evidence-supported finding relevant to anticipation, the Court reversed on the independent claim and two dependent claims without remand. However, the Court remanded the case to the Board to determine whether the three remaining challenged claims, which recited further material limitations, would have been obvious.

No Fairytale Ending for Consumer Opposition: RAPUNZEL Reinforces Lexmark Standing Limits

by Hannah Hurley | May 29, 2025 | Trademarks

The US Court of Appeals for the Federal Circuit affirmed the Trademark Trial & Appeal Board’s dismissal of a trademark opposition brought by a consumer, holding that mere consumer interest is insufficient to establish standing under Section 13 of the Lanham Act (15 U.S.C. § 1063). The ruling reinforced the application of the Supreme Court’s Lexmark (2014) framework to administrative trademark proceedings and clarified that only parties with commercial interest fall within the “zone of interests” protected by the statute when challenging a mark. Curtin v. United Trademark Holdings, Inc., Case No. 23-2140 (Fed. Cir. May 22, 2025) (Taranto, Hughes, JJ.; Barnett, Distr. J., sitting by designation.)

United Trademark Holdings (UTH) applied to register the mark RAPUNZEL for dolls and toy figures. Rebecca Curtin, a law professor, doll collector, and mother, opposed the registration, arguing that “Rapunzel” is a generic or descriptive term and its registration would harm consumers by reducing competition and increasing prices for fairytale-themed dolls.

The Board dismissed Curtin’s opposition, concluding she lacked standing to oppose under § 1063. The Board applied the Lexmark framework, which requires a showing that the opposer’s interests fall within the zone of interests protected by the statute and that the alleged injury is proximately caused by the registration. The Board found that Curtin, as a consumer, failed both prongs. Curtin appealed.

Curtin argued she had statutory entitlement under the 1999 Federal Circuit decision in Ritchie v. Simpson, “a case that addressed a section of the Trademark Act barring registration of ‘immoral’ or ‘scandalous’ matter.”

The Federal Circuit affirmed the Board, holding that the Lexmark framework applied rather than Ritchie. The Court explained that while the Lanham Act may indirectly benefit consumers, the statutory cause of action is reserved for those with commercial interest. Since Curtin’s opposition was based on claims that the mark was generic, descriptive, or failed to function as a mark, her interest as a consumer did not fall within the zone of interests protected by the statute.

The Federal Circuit also found that Curtin’s alleged injuries, namely reduced marketplace competition, increased prices, and diminished access to diverse interpretations of the Rapunzel character, were too speculative and derivative of harm that might be suffered by commercial competitors. The Court reiterated that injuries must be direct and not merely downstream effects of harm to others. Curtin’s submission of a petition with more than 400 signatures from like-minded consumers did not alter the Court’s conclusion that her alleged harm was too remote to satisfy the proximate cause requirement.

Practice Note: The Federal Circuit’s decision reinforces that only parties with direct commercial stakes, such as competitors or potential market entrants, have standing to oppose trademark registrations on grounds such as genericness, descriptiveness, or fraudulence.

Stylish but Generic: ‘VETEMENTS’ Can’t Dress Up as Trademark

by Sarah Bro | May 29, 2025 | Trademarks

The US Court of Appeals for the Federal Circuit affirmed the Trademark Trial & Appeal Board’s refusal to register the mark VETEMENTS for clothing and related retail services, finding that the mark was generic under the doctrine of foreign equivalents. In re Vetements Group AG, Case Nos. 2023-2050; -2051 (Fed. Cir. May 21, 2025) (Prost, Wallach, Chen, JJ.)

Vetements Group AG applied to register the mark VETEMENTS for various clothing items and online retail store services for clothing items. The US Patent & Trademark Office refused registration, finding the mark generic or, in the alternative, merely descriptive without acquired distinctiveness under Section 2(e)(1) of the Lanham Act. The Board affirmed, applying the doctrine of foreign equivalents to translate “vetements” (French for “clothing”) and concluding that the term was generic for the applied-for goods and services pertaining to clothing. Vetements Group appealed.

The doctrine of foreign equivalents is used to evaluate whether a non-English trademark is generic or descriptive for the applied-for goods or services by translating the foreign-language mark into English, then applying the relevant legal tests. The Federal Circuit affirmed that the doctrine applies when the “ordinary American purchaser” would likely “stop and translate” the foreign word into English. The “ordinary American purchaser” includes all US consumers, including those familiar with the foreign language.

The Federal Circuit emphasized that words from modern languages are generally translated unless there is a compelling reason not to do so. It rejected Vetements’ argument that the doctrine should only apply if a majority of US consumers understand the foreign word. Instead, the Court held that it is sufficient if an “appreciable number” of US consumers would recognize and translate the term.

In this case, the Federal Circuit found that French is widely spoken and taught in the United States (the Board found that as of 2010, French was the fifth most spoken non-English language at home and the second most widely taught non-English language in US schools). The Court thus concluded that “vetements” is a common French word meaning “clothing,” and that given the mark’s use on apparel and in connection with clothing-related retail services, translation of the term into English was likely.

Under the doctrine of foreign equivalents, foreign terms used as trademarks are translated into English, then evaluated under the applicable standards, including genericness, descriptiveness, and likelihood of confusion. In assessing whether a term is generic, courts apply a two-part test: identifying the genus of goods or services at issue, and determining whether the relevant public understands the term primarily to refer to that genus.

Here, the genus was clothing and online retail services for clothing. The Federal Circuit agreed with the Board that “vetements,” once translated to “clothing,” directly named the genus of the goods and services. Therefore, the term was generic and ineligible for trademark protection.

Because the mark was found to be generic, the Federal Circuit explained that it did not have to reach the Board’s alternative holding that the VETEMENTS mark was merely descriptive without acquired distinctiveness [...]

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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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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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