Federal Circuit Redefines Prior Art Requirements Under § 102(e)/102(a)(2): In re Riggs

Patent

by Dennis Crouch

In a significant decision, the Federal Circuit has established a more rigorous test for determining when a published patent application claiming priority to a provisional application can be considered prior art as of its provisional filing date.  In re Riggs, Case No. 2022-1945 (Fed. Cir. Mar. 24, 2025).   The case is decided under pre-AIA 102(e), and so it is not entirely clear whether the same law applies post-AIA.

The basic idea behind 102(e)/102(a)(2) is intuitive — the earlier-filed application should be given priority over the later-filed application. But, the actual doctrine has always been controversial because it creates what I call “secret springing prior art.” When an application is filed but not yet published, it exists as a confidential document at the USPTO that no competitor can access. When that application eventually publishes (typically 18 months after filing), it suddenly becomes prior art — backdated to its original filing date. This creates a situation where inventors might develop what they believe is novel technology, only to have an earlier-filed but later-published application “spring forth” as invalidating prior art.

Riggs focuses on reaching back even further – to the provisional application filing date.  The key holding (more…)

The OxyContin Conundrum: Can a Creator of Crisis Patent Its Solution?

Patent

By Dennis Crouch

There is an almost ritualistic moment anytime I teach property and estates law.  The hand shoots up and a student asks what happens when those listed in a will - murder their benefactors to accelerate inheritance.  There tends to be some nervous laughter as well as genuine curiosity.  Virtually all jurisdictions have created some "slayer rule" stemming from the common law principle that "no one shall profit from their own wrong," preventing killers from inheriting from their victims.

I wonder if this same principle—that wrongdoers should not profit from their misconduct—resurfaces in the context of Purdue Pharma's recent Supreme Court filing. After playing a central role in fueling the devastating opioid OxyContin epidemic,  Purdue now seeks to extend and defend patents on abuse-deterrent formulations designed to mitigate the very crisis they helped create.  But, this ethical dilemma may be somewhat resolved with Purdue Pharma's March 2025 reorganization plan that proposes transforming into a "public benefit company" dedicated to addressing the opioid crisis.  The best analogy here may be to biblical Saul who through spiritual revelation was transformed from a persecutor of Christians to their most fervent apostle.  The plan for Purdue is a similar death and rebirth -- albeit part of a negotiated legal remedy rather than a moral or spiritual conversion. The company is being dissolved and reorganized with a new mission, but this is happening through court-supervised bankruptcy proceedings with specific financial and structural requirements.

Lets dig into this pending case: Purdue Pharma was recently granted a 30-day extension to submit its petition for certiorari, seeking review of a Federal Circuit decision that invalidated several OxyContin-related patents.  As is usual, the extension application includes strong foreshadowing that the eventual petition will focus on the core question of obviousness -- and particularly the role of objective indicia of non-obviousness.

Federal Circuit Affirms Invalidity of Purdue’s OxyContin Patents

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Sheet Music v. Sound Waves: When Old Copyright Law Meets Modern Music

Patent

The copyright dispute over Ed Sheeran's song "Thinking Out Loud" has made its way to the Supreme Court's doorstep.  The petition raises questions about judicial deference to administrative interpretations and the scope of copyright protection for musical compositions under the 1909 Copyright Act.  In the case, the Second Circuit had sided with Sheeran -- affirming dismissal of the infringement claim based largely on a technical limitation of pre-1976 copyright law.  Structured Asset Sales, LLC v. Sheeran.

The underlying dispute centers on allegations that Sheeran's Grammy-winning "Thinking Out Loud" (2014) infringes the copyright of Marvin Gaye and Ed Townsend's "Let's Get It On" (1973). Structured Asset Sales (SAS) owns a partial interest in Townsend's share and contends that Sheeran copied protected elements from the iconic soul classic.

The Second Circuit's decision hinged on the fact that the copyright was pre-1976.  Under the 1909 Copyright Act, the scope of copyright protection extends only to the elements contained in the "deposit copy" submitted to the Copyright Office at registration. In this case, that meant only the elements in the handwritten sheet music deposited in 1973, not the additional musical elements found in Gaye's sound recording.

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Prosecution Disclaimer Across Patent Family Members

Patent

by Dennis Crouch

Maquet Cardiovascular LLC v. Abiomed Inc., 2023-2045 (Fed. Cir. Mar. 21, 2025)

This new decision is a good read for patent prosecutors and litigators.  The decision  somewhat limits use of prosecution history for claim construction across patent families -- and ultimately vacates the district court judgment of non-infringement.  The case offers something of a roadmap for patent prosecutors to avoid prosecution disclaimer spreading across family members.

Maquet Cardiovascular owns U.S. Patent No. 10,238,783 claims an integrated guide mechanism for deploying blood pumps to specific locations in a patient's circulatory system. The integrated guide eliminates the need for supplemental guiding mechanisms. Maquet sued Abiomed for infringement of several claims of both the '783 patent and its parent, U.S. Patent No. 9,789,238.

The district court claim construction turned heavily on prosecution history from family member patents. Specifically, the district court added two key negative limitations to the disputed claim terms based on prosecution disclaimer: (1) the "guide wire lumen is not distal to the cannula," derived from prosecution of the parent ’238 patent, and (2) the "guide wire does not extend through the free space in between the rotor blades," based on prosecution history from the great-great-grandparent ’728 patent. 

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Tax Victory for Generic Drug Companies: Federal Circuit Affirms ANDA Litigation Expenses are Deductible

Patent

by Dennis Crouch

In a significant win for the generic pharmaceutical industry, the Federal Circuit recently affirmed that legal expenses incurred defending Hatch-Waxman patent litigation can be deducted immediately as ordinary business expenses rather than capitalized. The decision in Actavis Laboratories FL, Inc. v. United States, No. 2023-1320 (Fed. Cir. Mar. 21, 2025), affirms the earlier ruling by Court of Federal Claims Judge Ryan Holte in favor of Actavis.  The U.S. Government will now need to issue a tax refund of about $12 million just for 2008-2009.

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New PTAB Informative Decision Demands MPF Construction and Parallel Litigation Consistency

Patent

In a decision newly designated as "informative" by the USPTO, the Patent Trial and Appeal Board (PTAB) provided important guidance on the procedural requirements for inter partes review (IPR) petitions, particularly consistency between IPR proceedings and parallel litigation.

Cambridge Mobile Telematics, Inc. v. Sfara, Inc., IPR2024-00952, Paper 12 (P.T.A.B. Dec. 13, 2024).

In its decision, the Board exercised discretion to deny the petition because the petitioner failed to properly address claim construction, particularly whether the claim terms were means-plus-function under 35 U.S.C. §112(f). The petitioner had argued in related district court litigation that certain "component" terms (e.g., "mode-determining component," "first detecting component") were means-plus-function terms and thus indefinite due to lack of corresponding structure. However, in the IPR petition, the petitioner adopted a contradictory position—arguing that no explicit construction was needed and applying plain and ordinary meaning.

The PTAB found this contradictory position problematic because the petitioner had emphasized in district court proceedings that the classification as means-plus-function terms was "case-dispositive." The Board concluded the petitioner violated 37 C.F.R. §42.104(b)(3) by failing either to provide constructions explicitly, identify structure, or adequately justify its contradictory positions. Thus, the majority denied institution under 35 U.S.C. §314(a) due to procedural deficiencies in the petition.

The press bulletin release from the USPTO states:

In this decision denying institution, the Board addresses circumstances in which a petitioner argues in district court that a claim limitation should be construed as means-plus-function and argues in a petition for inter partes review that the PTAB should construe the same limitation using the plain and ordinary meaning. The majority opinion determines that the petition should, at a minimum, explain why the different positions are warranted or, alternatively, set forth a means-plus-function construction for the limitation.

Link.

Here, the denial was based on dual issues of (1) failure to discuss the MPF interpretation; and (2) clear contradiction with statements in the district court. Without the contradiction, I expect the panel would likely have been more lenient - especially in a situation like this where the claims do not use the word "means."  Likewise, had Cambridge Mobile acknowledged their district court position and provided some explanation for using plain meaning in the IPR context, the outcome might have been different, as the Board seems more concerned with the unexplained strategic inconsistency rather than the mere absence of MPF analysis.

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Narrowly Broad: The Federal Circuit’s Improper Expansion of Unreviewable Agency Discretion

Patent

by Dennis Crouch

The Federal Circuit's short precedential decision in Realtek v. ITC & DivX addresses ITC sanctions proceedings. The alleged bad act here involves patentee DivX who arguably altered its infringement theory against Realtek midstream and then ultimately dismissed its complaint against the Taiwanese semiconductor company after that pathway was also cut off. Realtek thought that the ITC should sanction the patentee, but the ITC refused.  The Federal Circuit recently dismissed the appeal -- holding that the court had no power to review this abuse of discretion claim.

Although the court's ultimate conclusion may be correct here, I explain below how the court's approach to the analysis is wrong.

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Guest Post by Profs. Masur & Ouellette: Patent Disclosure and After-Arising Technologies

Patent

Guest post by Professors Jonathan S. Masur (Chicago Law) and Lisa Larrimore Ouellette (Stanford Law).

This blog recently covered the Federal Circuit’s important decision in In re Entresto (Novartis Pharmaceuticals v. Torrent Pharma), 125 F.4th 1090 (Fed. Cir. 2025), which upheld patent claims even though they covered after-arising technology that was not described or enabled in the specification. As Dennis noted, the Federal Circuit appeared to depart from well-established prior law on the subject. But as we explain in our forthcoming article, Disclosure Puzzles in Patent Law, we believe the court should move the law further still from where it stands—and it should correct some of its reasoning along the way.

To review, In re Entresto involved a patent that claimed a pharmaceutical composition of two hypertension drugs, valsartan and sacubitril, “in combination.” When the patent was filed, the only known method of combining these chemicals was in a physical mixture. That is the only combination method disclosed in the specification. In the intervening years, however, scientists have discovered a means of combining the two chemicals in a “complex,” an arrangement in which they are connected by weak chemical bonds. This is the method used to make the accused infringing drug. The patent owner argued successfully that the claim language (“in combination”) was broad enough to cover this mode of combination. But the fact that the use of a complex was after-arising technology—and thus the specification said nothing about it—raised written description and enablement issues.

The Federal Circuit upheld the patent against both challenges for basically the same reason: that the specification demonstrated that the patentee possessed and enabled the full scope of the claims at the time the patent application was filed. In other words, the patent claimed the two chemicals “in combination,” and the specification had indeed described and enabled the two chemicals “in combination.” But the court’s reasoning was peculiar. The court asserted that the after-arising technology—the combination of the two chemicals into a complex—“is not what is claimed.” To argue otherwise, the Federal Circuit declared, would be to “erroneously conflate[] the distinct issues of patentability and infringement.” (more…)

Secretary of Commerce Clears House at USPTO Advisory Committees

Patent

by Dennis Crouch

In an unprecedented move, the Secretary of Commerce is terminating all current appointments to the Patent Public Advisory Committee (PPAC) and Trademark Public Advisory Committee (TPAC), effectively removing the entire membership of both committees.  New members will apparently be appointed shortly, with the USPTO planning to proceed with previously scheduled public committee meetings in May 2025.  The statute requires that "any vacancy on an Advisory Committee shall be filled within 90 days after it occurs."

Although my memory is sometimes faulty, I believe that this is the first time in the committees' 25 year history that an incoming presidential administration has dismissed all members.  The dismissed PPAC includes Loletta Darde, Earl Bright, Henry Hadad, Lateef Mtima, Marvin J. Slepian, Olivia Tsai, Maria Anderson, Idris McKelvey, and Jennifer Yokoyama.  The last three of these were appointed in January 2025 -- making them immediately suspect to the new administration seeking to make dramatic departures from approaches taken by President Biden's administration.  In general, this group was all put in place under President Biden and  would have likely been a contentious group to deal with -- potentially authoring negative reports and asking difficult questions.

The new committees will be more friendly to the new administration, but my hope is that they will still be able to provide independent guidance and counsel to the USPTO Director. The effectiveness of these advisory committees has always depended on their ability to bring diverse perspectives and constructive criticism to USPTO operations, rather than simply rubber-stamping agency decisions. While political alignment with the administration may facilitate communication, the value here is really derived from member expertise, connection to practice, and willingness to challenge assumptions when necessary.

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Patent Law Year in Review: Top-Nine Topics for 2025

Patent

by Dennis Crouch

I'm delivering a U.S. patent law year-in-review for the past year or so.  Here are Nine of the topics that deserve some focus.

1. The New USPTO under President Trump: The greatest ongoing issue is the about-face from President Trump to President Biden. The ultimate direction and outcome will become more clear as we move through 2025, but there have already been dramatic shifts, especially focused on workforce RTO and RIF and elimination of non-core USPTO activities. Meanwhile backlog is growing again.

2. The Only Federal Circuit En Banc Decision – LKQ v. GM: Shifts in design patent obviousness analysis moving away from the Rosen-Durling test toward the more flexible KSR standard.  We'll talk through how the USPTO is responding; global expansion of design rights; and the 20% rise in design patents in 2024 (while also having a growing backlog).

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IP as an Antitrust Exception: SCOTUS Denies Review in $1.6B BMC-IBM Dispute

Patent

The Supreme Court has denied BMC Software's petition for writ of certiorari -- formalizing the Fifth Circuit decision that nullified a $1.6 billion judgment against IBM.  The appellate court had overturned the district court's breach of contract finding and its subsequent large damages award.

This case involves two large companies, each with billions of dollars in annual revenues. But, the setup will be familiar to so many innovative companies across the nation that are forced by market realities to do business with the very competitors that are likely to be their undoing. Small businesses frequently find themselves in Faustian bargains -- one example being selling products on Amazon while knowing the tech giant is carefully analyzing customer interactions to identify profitable markets for directly competing products.

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Design-Around Victory: Amgen’s Self-Buffering Innovation Regeneron’s Claims

Patent

By Dennis Crouch

The Federal Circuit has affirmed the denial of a preliminary injunction against Amgen's biosimilar version of Regeneron's blockbuster drug EYLEA (aflibercept). Regeneron Pharms., Inc. v. Mylan Pharms. Inc., No. 2024-2351 (Fed. Cir. Mar. 14, 2025) (Lourie, J.). This latest ruling stands in contrast to the court's January 2025 decisions upholding preliminary injunctions against Samsung Bioepis and Formycon, effectively blocking their biosimilar launches. All three cases are part of consolidated multi-district litigation in the Northern District of West Virginia.

Each appeal involves the same U.S. Patent No. 11,084,865, which covers formulations of Regeneron's aflibercept, an ophthalmic drug used to treat angiogenic eye disorders by inhibiting vascular endothelial growth factor (VEGF). EYLEA generates approximately $6 billion in annual sales, making the stakes exceptionally high for Regeneron, the biosimilar manufacturers, and patients as well.

The critical distinction in Amgen's case is its distinctive formulation approach. While Samsung Bioepis and Formycon developed biosimilars that, like EYLEA, contain a separate buffer component, Amgen developed a "self-buffering" formulation where the aflibercept protein itself provides sufficient buffering capacity to stabilize the formulation without requiring a separate buffer.

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EcoFactor v. Google: Quick Review of Oral Arguments

Patent

The Federal Circuit recently heard oral arguments in the much-anticipated en banc review of EcoFactor, Inc. v. Google LLC, a case focusing on how courts evaluate expert testimony on patent damages.  And, in particular, when a court should step-in to bar expert testimony that does not have sufficient factual basis for its conclusions.  The arguments focused on whether EcoFactor's damages expert improperly derived royalty rates from license agreements that contained performative non-binding "whereas" clauses stating EcoFactor's belief about rates, while the operative provisions specified lump-sum payments.  It seems clear to me that these provisions were added as elements of the patentee's smaller license agreements in order to later be used in larger cases, such as the one against Google.

Judge Alan Albright (W.D.Tex.) admitted testimony from EcoFactor's damages expert, David Kennedy, who derived a per-unit royalty rate from three prior EcoFactor settlement agreements to calculate a $20 million damages award against Google for infringing EcoFactor's smart thermostat patent, U.S. Patent 8,738,327.

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EcoFactor v. Google: Listen Live This Morning

Patent

EcoFactor v. Google is the Federal Circuit’s first en banc utility patent case in years.  The court will beholding oral arguments this morning, starting at 10:00 am Eastern.

  • Listen here: https://www.youtube.com/watch?v=lwEZ2MlyOv8
  • Ginger Anders (Google) will face off against Brian Ledahl (EcoFactor) before 10 members of the Court of Appeal. (Judge Newman is being excluded, and Judge Cunningham is not on the roster.)

The case generally relates to a district court judge’s gatekeeper role to prevent the Jury from hearing less-than-stellar expert testimony. Early briefing in the en banc case was a bit scatter shot, and the court released an precedential statement reiterating that the rehearing en banc is “limited to addressing the district court’s adherence to Federal Rule of Evidence 702 and Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), in its allowance of testimony from EcoFactor’s damages expert assigning a per-unit royalty rate to the three licenses in evidence in this case.”

Federal Circuit Rejects “Once Generic, Always Generic” Rule in Trademark Dispute Between Whiskey Makers

Patent

by Dennis Crouch

Bullshine Distillery LLC v. Sazerac Brands, LLC, 2023-1682 (Fed. Cir. March 12, 2025)

In an interesting trademark decision, the Federal Circuit has clarified that terms once considered generic do not necessarily remain permanently unregistrable.  provides important guidance on genericness timing and addresses a question of first impression in trademark law.

The case involves two alcohol producers:

  • Bullshine Distillery sought to register “BULLSHINE FIREBULL” for alcoholic beverages;
  • Sazerac, owner of “FIREBALL” branded cinnamon whiskey, and opposed the registration claiming likelihood of confusion.

Bullshine counterclaimed seeking cancellation of Sazerac’s marks, arguing “fireball” was generic for spicy cinnamon-flavored alcoholic drinks. The Trademark Trial and Appeal Board (TTAB) denied both parties’ claims, finding FIREBALL was not generic either at registration or the opposition trial, and determining there was no likelihood of confusion between the marks.  Both parties appealed. The Federal Circuit, in an opinion by Chief Judge Moore, affirmed the TTAB decisions in both cases. 

(more…)

Convergence: Island IP Points to Wave of Rule 36 Petitions

Patent

by Dennis Crouch

Island Intellectual Property has filed a rare supplemental brief in its pending Supreme Court case, drawing the Court's attention to the growing body of certiorari petitions challenging Federal Circuit practices.  The brief, submitted under Supreme Court Rule 15.8, highlights several new petitions that address the same questions Island IP raised about summary judgment standards and the Federal Circuit's use of Rule 36 affirmances. The Court is set to decide whether to grant or deny certiorari at its next conference, scheduled for March 21, 2025.  The petition challenges two Federal Circuit practices: (1) the improperly loose application of summary judgment standards in patent eligibility cases and (2) the Federal Circuit's use of one-word Rule 36 summary affirmances.

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What Does it Mean to Prove Prior Art Date by a Preponderance of the Evidence?

Patent

by Dennis Crouch

In CQV Co., Ltd. v. Merck Patent GmbH, No. 2023-1027 (Fed. Cir. Mar. 10, 2025), the Federal Circuit vacated and remanded a PTAB post-grant review (PGR) decision that had upheld the validity of Merck's patent against sales of a commercially available product. This case highlights a significant divergence between the evidentiary standards for proving prior art status in district court litigation versus AIA trials. It also sets up another increasingly common scenario where neither the patentee nor the patent challenger are US entities. Here, Merck is German and CQV is Korean.

Merck's US10647861 covers transparent α-alumina flakes with specific characteristics that are used in pearlescent pigments for various applications including automobile paint. CQV, a competitor in the pigment market, filed a post-grant review petition challenging claims 1-22--arguing that Merck's commercially available Xirallic product (specifically "Sample C") disclosed the invention and rendered the claims obvious.

Unlike in IPR proceedings, where petitioners are limited to patents and printed publications as prior art, PGR allows challenges based on any ground of invalidity, including prior art products that were "on sale" or "otherwise available to the public" as here. This case particularly focuses on how much certainty is required to establish that a product qualified as prior art under the "preponderance of the evidence" standard used in PGR proceedings.

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President Trump Formally Nominates John Squires as USPTO Director

Patent

by Dennis Crouch

President Trump has formally nominated John A. Squires to serve as Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office. The White House announced the nomination on Tuesday, and the Senate received it on Monday, March 10, referring it to the Committee on the Judiciary. The nomination confirms reporting by Dani Kass at Law360 from mid-February that identified Squires as the likely pick.

Squires currently serves as a partner at Dilworth Paxson LLP and brings substantial intellectual property experience to the role, including a nine-year tenure as Chief IP Counsel at Goldman Sachs (2000-2009). He has particularly focused on emerging technologies including artificial intelligence, blockchain, fintech, and cybersecurity.  In addition though, Squires holds chemistry degree from Bucknell. According to reports, Squires beat out several other candidates for the role, including acting USPTO Director Coke Morgan Stewart; Intel's intellectual property policy leader Vishal Amin (who served as IP czar during Trump's first administration); former chief counsel for the Senate subcommittee on IP under Sen. Thom Tillis (R-N.C.) Brad Watts; and Pillsbury Winthrop Shaw Pittman LLP partner Bill Atkins.

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Method Claims can Cover an Entire Process Flow – Including All Conditional Branches

Patent

by Dennis Crouch

Sierra Wireless, ULC v. Sisvel S.p.A., Nos. 2023-1059, 2023-1085, 2023-1089, 2023-1125 (Fed. Cir. Mar. 10, 2025). 

In this case, the Federal Circuit has vacated and remanded, holding that the PTAB (1) improperly construed the claims and (2) abused its discretion by relying on testimony from an expert witness who did not meet the Board's defined standard for ordinary skill in the art. Both of these holdings will be housed within patent law's extensive closet full of "tricks-and-traps" for the unwary. 

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