Tag Archives: paid

USDOJ: Contributory Infringement Requires Conscious and Culpable Acts

The Supreme Court is being asked to resolve a high-stakes battle over when Internet Service Providers (ISPs) can be held liable for their users’ copyright infringement. Two petitions — Cox Communications, Inc. v. Sony Music Entertainment (No. 24-171) and Sony Music Entertainment v. Cox Communications, Inc. (No. 24-181) — stem from a Fourth Circuit decision involving a $1 billion jury verdict against Cox for music piracy on its network. In November 2024, the Court invited the Solicitor General (SG) to weigh in. In late May 2025, SG John Sauer filed the government's brief, recommending that the Supreme Court grant Cox’s petition to clarify—and  ultimately narrow—the standard for contributory infringement.

For this post, I take a step back and talk through some of the legal doctrines at issue — contributory & vicarious liability — in the context of ISP copyright infringement and then delve into how they might apply in Cox.

Background: The litigation began when a consortium of record companies and music publishers (including Sony Music) sued Cox Communications for copyright infringement based upon actions by Cox’s internet subscribers. The alleged infringements occurred in 2013–2014, when Cox users engaged in massive peer-to-peer file sharing of music over networks like BitTorrent. At the time, anti-piracy agent, MarkMonitor, sent Cox hundreds of thousands of infringement notices identifying Cox subscribers by IP address. But, Cox’s internal policy was to follow an admittedly lax “thirteen-strike” system: repeat infringers would receive warnings and temporary suspensions, but Cox often declined to permanently terminate paying customers’ accounts. Evidence presented in the case showed Cox implemented its policy haphazardly—terminating only 33 subscribers for copyright abuse while tolerating many more—because it “wanted to avoid losing revenue” from monthly subscriber fees.


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Federal Circuit Takes Center Stage in Trump’s Tariff Campaign

by Dennis Crouch

On May 28, 2025, the Court of International Trade issued a sweeping permanent injunction against President Trump's unilateral global tariffs, only to have the Federal Circuit grant an immediate administrative stay in a rare en banc order.  The stay is likely to remain in place only for about two weeks as the Court considers (likely en banc) whether to allow the tariffs to remain in place while it considers the merits of the U.S. government's appeal.  The dispute centers on fundamental questions about the scope of presidential emergency powers under the International Emergency Economic Powers Act (IEEPA) and represents one of the most significant judicial challenges to executive trade authority in decades.

The Court of International Trade's decision in V.O.S. Selections, Inc. v. United States, Slip Op. 25-66 (Ct. Int'l Trade May 28, 2025) [CIT Decision], struck down both President Trump's "Worldwide and Retaliatory Tariffs" and his "Trafficking Tariffs" as exceeding congressional delegation of authority.  The underlying legal framework is that the U.S. Constitution grants Congress, not the President, authority to set tariffs.  However, Congress has expressly delegated aspects of that authority to the President - most particularly under IEEPA, which authorizes the President to "regulate . . . importation" of foreign goods during declared national emergencies to address "unusual and extraordinary threat[s]" to national security, foreign policy, or the economy. 50 U.S.C. § 1702(a)(1)(B), § 1701(a). Congress enacted IEEPA in the 1970s after determining that President Nixon had abused a prior, more expansive delegation under the Trading with the Enemy Act (TWEA). See United States v. Yoshida Int'l, Inc., 526 F.2d 560 (C.C.P.A. 1975).


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On the Edge of Claim Construction: Federal Circuit Splits Over What Counts as a Tile’s ‘Edge’

by Dennis Crouch

Acufloor, LLC v. EvenTile, Inc., No. 2023-1887 (Fed. Cir. May 28, 2025)

Although new, this case offers a classic claim construction debate with three-way divide between the majority, dissent, and district court over what counts as the "edge" of a tile. The patents here cover a tile leveling device used during install to avoid "lippage"—where one tile's edge is higher than an adjoining tile's edge. The key dispute centered on what constitutes the "edge" of a tile when the claims require "edge-to-mortar-to-subfloor contact."  U.S. Patent Nos. 10,704,274 and 10,513,857.

The accused devices operate near the edge of the tile, but do not allow direct tile-to-mortar-to-subfloor contact at the very edge of the tile.  By arguing for a narrow construction of "edge"—limited specifically to the precise boundary line of the tile's surface—the defendants position themselves outside the patent claims.  The district court agreed and narrowly construed edge to "the line at which a surface of a tile terminates."  On appeal, both the the majority (Judge Bryson, joined by Judge Lourie) and the dissent (Judge Stark) agreed that the district court's construction was too narrow—concluding that "edge" of a tile in this patent is wider than the Euclidian edge definition.  However, the majority and dissent disagreed on whether the claimed "edge" contact necessarily include the very edge of the tile.

The majority construes "edge" to include the very boundary line of the tile, but also extends slightly inward to include some portion of the tile's surface adjacent to that line. In contrast, the dissent argues for a broader construction where the claimed "edge" is defined more expansively as a region or area around the tile’s boundary, and thus does not require mortar to reach precisely to the boundary line.


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Uninvited Guests: The Federal Circuit’s Problematic Revival of Waived Arguments

by Dennis Crouch

In a number of recent opinions, the Federal Circuit decided the case on grounds that were not raised on appeal by either party.  This unusual approach is something bound to happen with expert tribunals such as the Federal Circuit.  The problems with this approach: it undermines the adversarial process, creates a fairness problem, and depriving the parties of a meaningful opportunity to address—and potentially correct—issues pivotal to the court’s ultimate determination. A recently filed petition for certiorari asks the Supreme Court to step-in and provide the CAFC with guidance in the impropriety of the Federal Circuit's sua sponte revival of arguments that the government has impliedly waived in the appeal. In McLeay v. Stewart, petitioner Dr. Matthew McLeay particularly challenges the Federal Circuit's decision to affirm the rejection of his patent application based on enablement sub-grounds that the USPTO had effectively abandoned in its briefing. [Read the Petition].


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Inherent Disclosure and Implicit Construction

by Dennis Crouch

Sigray, Inc. v. Carl Zeiss X-Ray Microscopy, Inc., --- F.4th --- (Fed. Cir. 2025)

The Federal Circuit established an important precedent regarding inherent disclosure and implicit claim construction in this IPR appeal, holding that the Board's  purported interpretation of the prior art was rather an implicit claim construction that neither party requested.  The decision, went rely heavily on the Federal Circuit inherency decision in SmithKline Beecham Corp. v. Apotex Corp., 403 F.3d 1331 (Fed. Cir. 2005), allowing for inherency finding even for miniscule or undetectable features found in the prior art.  As I dug into the case though, I was surprised to find that the PTAB did not cite or reference SmithKline, nor did any of the briefs filed in the appeal.  As Judge Dyk wryly stated at oral arguments: "but of course, nobody showed them the SmithKline case." 

This case involved x-ray optics, with claims requiring "magnification of the projection x-ray stage is between 1 and 10 times." Although neither party ever asked for claim construction, the appellate panel went ahead to determine that this claim scope - based upon its "plain meaning" - "includes tiny, even undetectable, magnification" rejecting the PTAB's implicit construction that seemed to require a meaningful divergence from parallel.


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Perlmutter v. Trump: Does the President Control the Copyright Office?

By Dennis Crouch

In an extraordinary lawsuit filed today, Register of Copyrights Shira Perlmutter has sued President Trump and several administration officials, challenging her purported removal from office and the President's attempt to install Deputy Attorney General Todd Blanche as acting Librarian of Congress. Perlmutter v. Blanche, No. 25-cv-1659 (D.D.C. filed May 22, 2025). The case raises fundamental questions about the separation of powers and the unique status of the Library of Congress within our constitutional structure.

The controversy began on May 8, 2025, when President Trump fired Librarian of Congress Dr. Carla D. Hayden via email. Two days later, the administration terminated Ms. Perlmutter, who had served as Register of Copyrights since 2020.   The President then purported to appoint Deputy Attorney General Todd Blanche as acting Librarian of Congress under the Federal Vacancies Reform Act (FVRA) as well as Paul Perkins as acting Register of Copyrights. When Mr. Blanche's representatives arrived at the Library on May 12 to assume control, Library staff refused to recognize his authority and contacted the Capitol Police.  The standoff crystallized a fundamental question: Does the President have the power to unilaterally control Congress's library and the US Copyright office housed within?


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Rapunzel, Rapunzel, Let Down Your Generic Hair (and Let Us In)!

by Dennis Crouch

Rebecca Curtin – a law professor and parent who purchases princess dolls – filed a TTAB opposition against United Trademark Holdings’ application to register the mark “RAPUNZEL” for dolls and toy figures (Class 28). Curtin alleged the mark should not be registered because “RAPUNZEL” is a generic name, is merely descriptive, and fails to function as a trademark for doll products. UTH moved to dismiss the opposition, arguing that Curtin lacked standing (i.e., lacked “entitlement to a statutory cause of action”) under the Lanham Act’s opposition provision, 15 U.S.C. § 1063. Initially, the TTAB allowed Curtin’s case to proceed – relying on the Federal Circuit’s older, more permissive standing test from Ritchie v. Simpson, 170 F.3d 1092 (Fed. Cir. 1999), which had held that “any person who believes that she would be damaged” by a registration may oppose if she shows a real interest and a reasonable belief of harm. But by the final decision, the TTAB reversed course. Citing the Supreme Court’s intervening decision in Lexmark International, Inc. v. Static Control Components, Inc., 572 U.S. 118 (2014), and the Federal Circuit’s own decision in Corcamore, LLC v. SFM, LLC, 978 F.3d 1298 (Fed. Cir. 2020), the Board dismissed Curtin’s opposition for lack of a statutory cause of action. The TTAB concluded that “mere consumers” generally are not entitled to oppose a trademark registration under § 1063, because their interests fall outside the zone of interests protected by that statute.

The Federal Circuit has now affirmed that dismissal in Curtin v. United Trademark Holdings, Inc., No. 23-2140 (Fed. Cir. May 22, 2025).  Judge Hughes penned the opinion holding that: to oppose a trademark under § 1063, an individual’s interests and alleged injuries must fall within the Lanham Act’s protected zone of interests, and those injuries must be proximately caused by the mark’s registration.  See also, Rebecca Curtin, Zombie Cinderella and the Undead Public Domain, 85 Tennessee Law Review 961 (2018).

Although all modern theories indicate that consumer protection is a primary purpose of trademark law, Curtin’s consumer-focused concerns did not satisfy the statutory requirements (according to the court).  Still, I'm drawn by her arguments -- as Curtin's attorney Ryan Morris (Workman Nydegger) explained:

With regard to the purposes of the Lanham Act, it absolutely has everything to do with consumers. . . . The interests of the consumers are at the heart of the Lanham Act. And to exclude them arbitrarily doesn't make a lot of sense.

Oral args. 29:05.


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Federal Circuit Confronts “Divide and Conquer” Briefing Strategy in Patent Appeal

by Dennis Crouch

In a display of judicial frustration with attorney conduct, the Federal Circuit (i.e., Chief Judge Moore) recently confronted two appellants for apparently attempting to circumvent word count limitations through a "divide and conquer" briefing strategy.  The parties have responded to the court's show cause order in Focus Products Group International v. Kartri Sales Co., and we are now waiting for the court to act both on the merits of the case and potential sanctions.

The conduct dispute centers on how appellants Kartri Sales and Marquis Mills structured their briefs in appealing a district court decision that found the parties infringed both patents and trade dress related to shower curtain designs. The case was heard before a Federal Circuit panel consisting of Chief Judge Moore, along with Circuit Judges Clevenger and Chen. Patrice Jean of Hughes Hubbard & Reed represented Kartri Sales, Donald Cox his own firm represented Marquis Mills, and Morris Cohen of Goldberg Cohen represented the Sure Fit appellees.


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An IDS is Now the Best Defense Against IPRs: Ecto World v. RAI

by Dennis Crouch

In a significant development for PTAB practice, Acting USPTO Director Coke Morgan Stewart has issued a precedential decision that conclusively establishes IDS-cited art as grounds for discretionary denial while creating a narrow exception for "mega-IDSs." Ecto World, LLC v. RAI Strategic Holdings, Inc, IPR2024-01280_paper_13_20250519. The case places a burden on petitioners to demonstrate examiner error in situations where the ground for the IPR petition relies upon art that had been formally considered by the examiner during original prosecution.

This decision comes amid Stewart's broader transformation of PTAB practice since early 2025, characterized by the rescission of prior guidance limiting discretionary denials, the introduction of bifurcated review processes separating discretionary decisions from merits analysis, and the Director's personal involvement in discretionary determinations. The cumulative effect signals a decisive shift toward a more patent-owner friendly posture at the USPTO, with IPR institution rates reportedly dropping significantly over the past two months.


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Thin Ice That Held: Samsung’s IPR Strategy Survived Scrutiny at the Federal Circuit

by Dennis Crouch

Power2B, Inc. v. Samsung Elecs. Co., Ltd., Nos. 23-2184, 24-1399, 24-1400 (Fed. Cir. May 19, 2025)

Two key canons of claim construction are that of claim differentiation and claim term differentiation - each patent claim  is presumed to have its own scope and coverage, as is each element of each claim.  The use of different terms in different claims "connotes different meanings." CAE Screenplates Inc. v. Heinrich Fiedler GmbH & Co. KG, 224 F.3d 1308 (Fed. Cir. 2000).  But, these are not an incredibly strong presumptions, and the court has regularly construed different terms in separate claims to cover the same subject matter. See, Edwards Lifesciences LLC v. Cook Inc., 582 F.3d 1322 (Fed. Cir. 2009) and Nystrom v. TREX Co., 424 F.3d 1136 (Fed. Cir. 2005).

In its recent decision in Power2B v. Samsung, the Federal Circuit found another case where differing language did not differ the construction.  Power2B, Inc. v. Samsung Elecs. Co., Ltd., Nos. 23-2184, 24-1399, 24-1400 (Fed. Cir. May 19, 2025). The patents at issue describe a handheld device that uses a light-emitting stylus with various functionality.   The PTAB sided with petitioner Samsung on almost all claims of the two challenged patents: US7952570 and US8547364. But, a divided PTAB found that claim 20 of '364 patent had not been proven unpatentable, with the majority concluding that Samsung had not properly argued the "generating control signals by the input circuitry" limitation of claim 20.  On appeal, Samsung argued that the Board abused its discretion because that claim 20 limitation was not materially different from claim 13's "output indication" limitation, which Samsung had properly addressed, and that these different terms merely expressed the same concept.  Samsung that nothing in the specification or claims identifies any difference between an "output indication" and a "control signal."


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Federal Circuit on Negative Limitations and Secondary Considerations

by Dennis Crouch

In a pair of nonprecedential decisions, the Federal Circuit affirmed three PTAB inter partes review decisions--finding BillJCo's patents unpatentable as obvious under 35 U.S.C. § 103. BillJCo, LLC v. Apple Inc., Nos. 23-2189 (Fed. Cir. May 16, 2025); and No. 23-2188 (Fed. Cir. May 16, 2025). The cases were both decided by the same three-judge panel, with Judge Stoll authoring one opinion and Judge Chen the other. In reading the cases, one key take-away is that the cases represent another example of the Federal Circuit's rigid approach to secondary considerations of non-obviousness. I recently highlighted this same phenomenon in discussing Purdue Pharma's pending petition for certiorari. See Dennis Crouch, The Federal Circuit's Rigid Approach to Secondary Considerations, Patently-O (May 5, 2025). The opinions also illustrate the court's approach to claim construction, particularly regarding interpreting a claim term to include a negative limitation. One case also relies upon a key prior art from now Secretary of Commerce Howard Lutnick.


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Jurisdictional Boundaries in Patent Licensing Disputes: Misuse Counterclaim Creates CAFC Jurisdiction

by Dennis Crouch

I was researching my recent Brulotte / Kimble post and stumbled across a new decision from the Fourth Circuit ceding appellate jurisdiction to the Federal Circuit based upon a defendant's assertion of a patent misuse defense (in the form of a counterclaim) after being sued for breach of contract.

In Honeywell International Inc. v. OPTO Electronics Co., Ltd., --- F.4th ----, 2025 WL 1226294 (4th Cir. Apr. 29, 2025), the Fourth Circuit dismissed a cross-appeal in a patent licensing dispute, holding that the Federal Circuit has exclusive appellate jurisdiction when a party asserts a patent misuse counterclaim seeking patent unenforceability.  The opinion, authored by my law school classmate Judge Jay Richardson, has to go through several levels of analysis to reach the endpoint.  I dug into the briefs and found that Judge Richardson's decision is more his own creation than that of the parties - basing the decision on a theory not presented by either side. And, I think the court stretched the Supreme Court's Gunn v. Minton precedent perhaps a bit too tight.

The case is now pending in the Federal Circuit, and that court will certainly revisit its jurisdictional basis and will need to through some of the bumps and failings of the Fourth Circuit's decision. I think that there is some potential that the case will be ping-ponged back to the Fourth Circuit.


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Formalism, Fictions, and Federalism: Post Expiry Royalties Return to SCOTUS

by Dennis Crouch

I just read Atrium Medical's SCOTUS petition -- asking the court help resolve a circuit split involving the the Brulotte & Kimble doctrines that bars collecting royalties after a patent expires, even if agreed-to by contract.

In 1964, the Supreme Court established in Brulotte v. Thys Co. that "a patentee's use of a royalty agreement that projects beyond the expiration date of the patent is unlawful per se." 379 U.S. 29 (1964). The Court reaffirmed this rule in 2015 in Kimble v. Marvel Entertainment, LLC, where it held that "a patent holder cannot charge royalties for the use of his invention after its patent term has expired." 576 U.S. 446 (2015). The Kimble Court explained that this rule should be "simplicity itself to apply." A court "need only ask whether a licensing agreement provides royalties for post-expiration use of a patent. If not, no problem; if so, no dice." Importantly, license agreements can properly extend beyond a patent's expiration date if the post-expiration royalties are payments for something else—such as unexpired patents, trade secrets, or know-how—rather than for the continued use of the expired patent. Despite this straightforward directive, the circuits have split on how to determine what royalties are actually "for."


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The Standard for Conception: Don’t Ask “Will it Work”

by Dennis Crouch

In an interesting decision affecting one of the most high-profile patent disputes in biotechnology, the Federal Circuit has partially vacated and remanded a PTAB decision that awarded priority of invention for CRISPR-Cas9 technology in eukaryotic cells to scientists at the Broad Institute. Regents of the University of California v. Broad Institute, Inc., Nos. 2022-1594, 2022-1653 (Fed. Cir. May 12, 2025). The court determined that the PTAB applied an incorrect legal standard for "conception," a fundamental concept in patent law's priority determination under the pre-America Invents Act first-to-invent system.

Understanding Conception Under Patent Law: The court reiterated the classic definition of conception as "the formation in the mind of the inventor, of a definite and permanent idea of the complete and operative invention, as it is hereafter to be applied in practice." Burroughs Wellcome Co. v. Barr Lab'ys, Inc., 40 F.3d 1223, 1228 (Fed. Cir. 1994). The court emphasized that "conception is complete only when the idea is so clearly defined in the inventor's mind that only ordinary skill would be necessary to reduce the invention to practice, without extensive research or experimentation."

However, conception is not complete invention -- something that also requires construction to practice, either actual or constructive. Notably, it is the process of reduction to practice that truly shows that the invention works.  Backtracking, this means that for conception "an inventor need not know that his invention will work for conception to be complete."


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Transformative Changes: Copyright Leadership Dismissed as AI Report Questions Industry Practices

by Dennis Crouch

The copyright world experienced a major shift in May 2025 with the abrupt dismissal of Dr. Carla Hayden (Librarian of Congress), followed by the release of a landmark U.S. Copyright Office report on AI training that concluded many current industry practices likely do not qualify as fair use, and culminating in the firing of Shira Perlmutter (Register of Copyrights) just after the report's publication.  This drama  is not a resolution of the legal question, but rather seems to intensify and further politicize the debates over whether AI developers must seek permission and pay for the copyrighted works they use to train their systems.  As the report's opening paragraphs explain: "The stakes are high, and the consequences are often described in existential terms."

The report released last week in "pre-publication" form, titled "Copyright and Artificial Intelligence, Part 3: Generative AI Training," is the latest installment in the Copyright Office's attempt at comprehensive examination of AI's intersection with copyright law. AI training often requires uploading of entire copyrighted works into the systems, and so is easily categorized as prima facie copyright infringement -- absent a license or fair use excuse.  The 100+ page report offers a nuanced analysis, but ultimately suggests that in many situations the use will not be fair use.

The quick release of this report appears to have circumvented folks in leadership outside of the Office. Although it has not formal legal weight, courts are likely to consider its reasoning as persuasive authority as they decide the dozens of AI training copyright cases currently pending.

Update: Todd Blanche and Paul Perkins have been tapped by President Trump to be acting Librarian of Congress and Copyright Registrar, respectively.  Todd Blanche, recently appointed as Deputy Attorney General at DOJ has spent the past two decades litigating fraud and corruption issues, either as a prosecutor or for the defense.  Most recently, Blanche was defense attorney during a 2024 New York criminal trial, which resulted in Trump’s conviction on 34 felony counts.  Perkins has been with DOJ since 2016, and is an Associate Deputy Attorney General. Perkins spouse, Hilary Perkins was tapped earlier this year to be chief counsel for the Food and Drug Administration. However, Senator Josh Hawley forced her removal with arguments that she was pro-abortion. 


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Federal Circuit Affirms Trademark Refusal for “US SPACE FORCE” Mark

by Dennis Crouch

The Federal Circuit recently affirmed a decision from the Trademark Trial and Appeal Board (TTAB) that refused registration of the mark "US SPACE FORCE" based on false suggestion of a connection with the United States. In re Thomas D. Foster, APC, No. 2023-1527, slip op. at 1 (Fed. Cir. May 7, 2025).  The precedential outcome of the case is important -- I believe this is the first CAFC case affirming the four-part test for false connection that had been developed by the Board -- although the holding indicates that the test is more flexible than previously suggested.

During his first term, President Trump started the United States Space Force -- 20 December 2019.  Trump had actually proposed the agency that he simply called the "Space Force" in a March 13, 2018 speech.   Within the week, IP attorney Thomas D. Foster filed an intent-to-use registration application Section 1(b) of the Lanham Act to register "US SPACE FORCE" for various goods and services on behalf of his eponymous law firm.  It was not until later that the U.S. government formally announced the US Space Force.


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Throwing Out the Jury: How the Federal Circuit’s ‘Particularized Testimony’ Rule Further Threatens the Doctrine of Equivalents

by Dennis Crouch

The Supreme Court recently received a petition for certiorari from NexStep, Inc., challenging a Federal Circuit decision that epitomizes a four-decades-long trend of restricting the doctrine of equivalents (DOE). The petition in NexStep, Inc. v. Comcast Cable Communications, LLC (No. 24-1137), presents a fundamental question: Has the Federal Circuit improperly shackled the doctrine of equivalents with rigid, formulaic requirements contrary to Supreme Court precedent?  More particularly, the petition asks: "Whether a patentee must in every case present 'particularized testimony and linking argument' to establish infringement under the doctrine of equivalents."

The case also has a nice baseball analogy.  The patent requires a "single action" performed by a user, and the accused device needs three button pushes.  The patentee's expert, when presenting the DOE case to the jury, used a baseball pitcher analogy - recognizing that throwing a ball includes numerous small steps to accomplish the single action of throwing.  The argument here, which the jury agreed was meritorious, is that the three button pushes - while not literally the same as a single action - was the equivalent and thus infringing.  The Federal Circuit wanted more - holding that the jury did not have enough evidence to reach that conclusion.


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Estoppel Gutted: A Pelican’s Guide to Patent Litigation

by Dennis Crouch

In a significant decision narrowing the scope of Inter Partes Review (IPR) estoppel, the Federal Circuit has held that a patent challenger who previously pursued an IPR can still rely on system prior art in district court litigation, even when that system was fully documented in publications that could have been raised during the IPR.  A key implication from this case is that despite the estoppel provision, a printed publication from an IPR can be later used in the litigation as part of the same combination of references used in the IPR, so long as the publications are categorized by the patent challenger in the litigation as proving that the invention was known/used/on-sale. Ingenico Inc. v. IOENGINE, LLC, No. 23-1367 (Fed. Cir. May 7, 2025). Writing for a unanimous panel, Judge Hughes explained:

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 be raised during the IPR, such as that the claimed invention was known or used by others, on sale, or in public use.

The decision resolves a long-standing split among district courts regarding the proper interpretation of the term "ground" in 35 U.S.C. § 315(e)(2), which bars IPR petitioners from asserting in district court "any ground that the petitioner raised or reasonably could have raised during that inter partes review." The Federal Circuit held that "ground" refers to the specific statutory basis for invalidity (e.g., anticipation or obviousness based on patents or printed publications), not the prior art references themselves.  The Federal Circuit clarified that 'ground' refers specifically to the statutory bases available in an IPR (anticipation or obviousness via patents/printed publications). As such, petitioners remain free to use identical prior art evidence to support district court invalidity grounds not available in IPR—such as prior public use or sale.


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Clinical Trials Get a Legal Shield: Federal Circuit Reverses Pharma Patent Injunction

by Dennis Crouch

The Federal Circuit's May 6, 2025 decision in Jazz Pharmaceuticals v. Avadel focuses on the scope of injunctive relief for infringement under 271(e).  The appellate court held that a district court may not enjoin a pharmaceutical company from initiating new clinical trials or offering open-label extensions where such activities are protected by the Hatch-Waxman Act's safe harbor provision, even when the company's commercial product has been found to infringe a valid patent. The court reversed the portions of the injunction that would have prohibited these activities, and vacated and remanded the portion that barred seeking FDA approval for new indications.

Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC, No. 24-2274, slip op. (Fed. Cir. May 6, 2025).


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The Federal Circuit’s Rigid Approach to Secondary Considerations

by Dennis Crouch

Purdue Pharma has filed a petition for certiorari asking the Supreme Court to review what it characterizes as the Federal Circuit's overly rigid application of the "nexus" requirement for objective indicia of non-obviousness. I agree with the petition that the Federal Circuit's approach contradicts the Supreme Court's longstanding precedent requiring a flexible and expansive analysis of obviousness factors, exemplified both by the court's 2007 KSR decision as well as older cases, such as Minerals Separation v. Hyde, 242 U.S. 261 (1916).


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