June 2025

Federal Circuit Clarifies Enablement Standards: Amgen Doesn’t Apply to Anticipatory Prior Art

The Federal Circuit delivered an important clarification on the enablement standard for prior art Agilent Technologies, Inc. v. Synthego Corp., No. 2023-2186 (Fed. Cir. June 11, 2025), affirming PTAB decisions that invalidated all claims of two CRISPR gene-editing patents. The case featured arguments by IP luminaries Mark Lemley and Edward Reines, with the patent challenger, Reines, coming up on top this time.  The case distinguishes Amgen Inc. v. Sanofi, 598 U.S. 594 (2023): establishing clear boundaries between the enablement requirements for patent validity under 35 U.S.C. § 112 and the enablement standards for anticipatory prior art under § 102.

The unanimous Judge Prost decision also establishes that abandoned patent applications and research projects retain their full potency as prior art, rejecting arguments that abandonment should diminish their anticipatory effect.  The patentee's appellant brief had pointedly asked:

Did the Board err in finding that the claims were anticipated by and obvious over a prior art reference that never worked, was ultimately withdrawn, and which offered quadrillions of possible art combinations with no guidance to choose one that might work?

In rejecting the appeal, the court reinforced that prophetic examples in prior art can serve as anticipating references even in unpredictable fields, provided they contain sufficient enabling disclosure, and also concluded that the PTAB's decision was based upon substantial evidence.


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SCOTUS: Pairing RADesign’s Discovery Rule with Jem’s Laches Defense

by Dennis Crouch

The Supreme Court has rescheduled its consideration of the copyright statute of limitations petition in RADesign v. Michael Grecco (No. 24-768), moving the conference from May 29, 2025, to June 5, 2025. This delay appears strategic, as the Court has simultaneously distributed for the same June 5 conference another intellectual property limitations case: Jem Accessories, Inc. v. Harman International Industries, Inc. (No. 24-1011), which presents questions about laches in trademark law.  Both of these cases are sparked by prior statute of limitations cases - particularly the two laches cases of Petrella v. Metro-Goldwyn-Mayer, Inc., 572 U.S. 663 (2014) (copyright) and SCA Hygiene Products Aktiebolag v. First Quality Baby Products, LLC, 580 U.S. 328 (2017) (patent) alongside the 2024 SOL case of Warner Chappell Music, Inc. v. Nealy, 601 U.S. ___ (2024).

The pairing of these cases suggests the Court may be considering extending its trans-doctrinal approach to limitations and laches doctrines across intellectual property law. Both petitions raise basic questions about when rights holders must act to preserve their claims, though they approach the issue from different statutory frameworks.


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Discovering the Crown Jewels: Irreversible Harm in the Digital Age

by Dennis Crouch

Micron Technology has petitioned the Supreme Court for a writ of mandamus to reverse a discovery order requiring the company to produce 73 pages of its most sensitive source code in paper form to Chinese state-owned semiconductor manufacturer Yangtze Memory Technologies Company (YMTC). The case, In re Micron Technology Inc., presents significant questions about the enforcement of protective order terms and the consideration of national security concerns in patent litigation discovery.  The dispute centers on YMTC's request for printed copies of source code from Micron's "150 Series Traveler Presentation," which apparently describes the company's most technologically advanced 3D NAND semiconductor products and contains code that fewer than a dozen of Micron's 50,000+ employees have access to.  Micron is seeking to turn this into a national security and competitiveness issue based upon the fact that YMTC was only founded in 2016 but has already become the global leader in 3D NAND flash based upon strong support from the Chinese government.  The company is also listed in the "Entity List."


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Maintaining a Speedy and Robust IPR Process Should Be a Major Focus of John Squires’ Patent Quality Efforts

Guest Post by Shawn Miller, Professor of Practice, University of San Diego School of Law; CodeX Fellow, Stanford Law School; Creator, Stanford NPE Litigation Database

Just a week ago, I began dusting off the half-written paper drafts of two empirical research projects that have mostly sat on my shelf the past year while teaching an overload to aid my colleagues on sabbatical. Brushing up on current events at the USPTO, it is clear that neither patent policy stakeholders nor the second Trump administration waited around for this law professor’s summer break. We have seen several months of the very active Acting USPTO Director Coke Morgan Stewart’s reshaping of the Patent Trial and Appeal Board’s (“PTAB’s”) process of reviewing Inter Partes Review (“IPR”) petitions, particularly in ways that tend to favor patent owners. Additionally, within the past two weeks we have had the Judiciary Committee Hearing of John Squires, the President’s nominee to serve as his permanent USPTO Director.

It seems likely that Squires will be confirmed soon and begin to act on the priorities he outlined at his hearing, two of which just so happen to overlap the topics of the two projects I am scrambling to complete this summer: patent quality and IPR reform. With my slow writing pace and the clear indications that the “reform” the administration has in mind would actually tend to harm patent quality when and where it matters, I asked—and Professor Crouch graciously agreed—to publish this guest post.

To start, what is patent quality? Put simply, it is the likelihood that a granted patent meets all of the statutory requirements for protection. In other words, low quality patents are likely invalid. Different stakeholders naturally emphasize different aspects of patent quality; for instance patent owners might prioritize breadth sufficient to cover potential infringing products or claim sets robust enough to survive validity challenges. In my own research, I have focused on novelty and non-obviousness because granted patents lacking these traits are usually devoid of innovation, and promoting new technology is the primary objective for granting inventors exclusive rights in the first place. I qualify patent quality with “likelihood” because it makes sense to think of inventors’ rights as probabilistic and contingent on unknown or misunderstood information (e.g., prior art) that supports or casts doubt on the validity of the claimed matter down the road when a granted patent is tested during enforcement. (more…)

Federal Circuit Dismisses Patent Owner’s Appeal of Favorable IPR Decision for Lack of Standing

by Dennis Crouch

In Dolby v. Unified Patents, the Federal Circuit confronted an unusual procedural question: can a patent owner who prevails in an inter partes review (IPR) challenge the PTAB's reasoning underlying that favorable outcome? The court's answer was a resounding no - at least in this instance - dismissing Dolby's appeal for lack of standing.

Dolby successfully defended its patent claims before the PTAB, with the Board concluding that Unified Patents failed to prove any challenged claims unpatentable. Yet Dolby appealed, seeking not to overturn this favorable result but to challenge the Board's refusal to determine whether Unified had properly identified all real parties in interest under 35 U.S.C. § 312(a)(2). This statute requires that a petition "may be considered only if the petition identifies all real parties in interest."

Dolby argued that nine additional entities should have been named as additional real parties in interest, but the Board declined to adjudicate this dispute. Following its precedential decision in SharkNinja, the Board explained that it would not resolve real party in interest disputes unless they were material to time bar or estoppel issues in the current proceeding. Since no such issues were implicated, the Board saw no need to determine the identities of the actual parties behind Unified's challenge.


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Strict Standard for Overriding Patent Lexicography in COVID Vaccine Patent Battle

by Dennis Crouch

In a decision that reinforces the controlling force of explicit patent definitions, the Federal Circuit affirmed a district court's claim construction that effectively ended Alnylam Pharmaceuticals' patent infringement suit against Moderna over lipid nanoparticle technology used in COVID-19 vaccines. Alnylam Pharmaceuticals, Inc. v. Moderna, Inc., No. 2023-2357 (Fed. Cir. June 4, 2025). Writing for a unanimous panel, Judge Taranto explained that when a patent specification clearly defines a claim term, the patentee faces a demanding standard to establish exceptions to that definition, even where the definition might exclude disclosed embodiments or seemingly conflict with other parts of the specification.

The case centered on whether Alnylam's patents covering cationic lipids for nucleic acid delivery were infringed by Moderna's use of the SM-102 lipid in its SPIKEVAX COVID-19 vaccine. The dispute turned entirely on claim construction of the term "branched alkyl," which the specification explicitly defined as requiring "one carbon atom in the group (1) is bound to at least three other carbon atoms and (2) is not a ring atom of a cyclic group" "[u]nless otherwise specified."

Alnylam argued this definition did not apply to claims covering "branching" at the "alpha position" adjacent to biodegradable groups, where the chemical structure would permit only two carbon-carbon bonds rather than three. The Federal Circuit rejected this argument, finding no clear indication in the intrinsic record that the claims "otherwise specified" a departure from the explicit definition.


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The USPTO’s Statement on Required Practitioner Review of Information on an IDS

by David Hricik, Mercer Law School

Dennis pointed out that the Director has in Ecto World, LLC v. RAI Strategic Holdings, Inc, IPR2024-01280_paper_13_20250519 made it very difficult to obtain institution if a petition is based on art that was listed on an IDS even if it was not actually applied by an examiner, unless the art was listed on a “voluminous” IDS.  That is a step back from the more real-world approach that had included examining whether the reference had actually been applied.

Dennis points out that avoiding “voluminous” (whatever that means) IDSs should help insulate patents from institution.  Also reducing length is a statement by the Office that signing an IDS certifies that the practitioner has reviewed every reference listed.  Specifically, In its Guidance on Use of Artificial Intelligence-Based Tools, the Office the Office expressed a concern that, while AI can be used to populate IDSs, doing so posed “the danger of increasing the number and size of IDS submissions to the USPTO, which could burden the Office with large numbers of cumulative and irrelevant submissions.” 89 Fed. Reg. at 25615-16. As a result, it noted the duty of reasonable inquiry included “reviewing each piece of prior art listed on the form” to determine if it was compliant with 37 CFR 11.18(b). Id. at 25616. Thus, review is required and clearly irrelevant and marginally pertinent information should be removed to avoid filing a paper for an improper purpose. Id.

That approach, interestingly, is somewhat similar to what OED Director Moatz suggested maybe 20 years ago, which was heavily criticized by practitioners as unrealistic.  I am not sure the Office’s statement about reviewing each reference has achieved as much publicity now as it did back then, so stay tuned.

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 Decisions – 2024 Stats and Datapack

By Jason Rantanen

It’s time for the annual Federal Circuit statistics update! As I’ve done for the past few years, below I provide some statistics on what the Federal Circuit has been doing over the past year. These charts draw on the Federal Circuit Dataset Project, an open-access dataset that I maintain containing information on all Federal Circuit decisions and docketed appeals. The court’s decisions are collected automatically from its RSS feed, and my research team uses a combination of Python-based algorithmic processing and manual review to code information about each document.

One of my goals with this dataset is to make it publicly accessible so that anyone can use it in their own research. A complete copy of this year’s release is archived at https://dataverse.harvard.edu/dataverse/CAFC_Dataset_Project, and the codebook is also available there. If you’re a researcher interested in using the dataset, feel free to reach out—I’m happy to help you work with the data or answer questions about it.

On to the data!

Figure 1

Figure 1 shows the number of Federal Circuit opinions and Rule 36 summary affirmances by origin since 2010. These represent individual documents (i.e., a single opinion or Rule 36) rather than docket numbers (which is how the Federal Circuit reports its own metrics). Overall, about 20% of the Federal Circuit’s merits terminations were issued as Rule 36 summary affirmances.

Opinions vs. Summary Affirmances

For 2024, the overall number of merits decisions increased by about 70 compared to 2023. As in recent years, the highest number of merits decisions arose from the PTO. However, decisions arising from the district courts increased by about 20% in 2024. The court issued 115 merits decisions from the district courts in 2024, up from 95 in 2023 and close to 117 in 2022. In contrast, there was a decline in decisions arising from the PTO—from 190 in 2023 to 165 in 2024.

Figure 2a

Figure 2b

Figures 2a and 2b show the number of opinions versus Rule 36 summary affirmances arising from the district courts and PTO. In 2024, the Federal Circuit continued to issue Rule 36 affirmances fairly often in appeals from the PTO but only rarely in appeals from the district courts. Figure 3 displays the overall frequency of Rule 36 affirmances relative to opinions across all origins.

Figure 3

What about the opinions the court is issuing? As shown in Figures 4a and 4b, the court continues to issue nonprecedential opinions regularly in appeals from the district courts, and somewhat less frequently in appeals from the PTO. In other words, the court typically issues an opinion (rather than a Rule 36) in appeals from the district courts, but when it does, it’s just as likely to be nonprecedential as precedential. Conversely, while opinions in PTO appeals are less common, they are more likely to be precedential.

Figure 4a

Figure 4b

Dispositions

Figure 5 shows the general disposition of Federal Circuit appeals – in other words, whether the panel affirmed, affirmed-in-part, reversed-in-full, etc. Overall, affirmances in appeals from the district courts were a little less frequent last year (65% affirmance in full; 76% affirmance in full or part), while affirmances in appeals from the USPTO continued to be common (84% affirmance in full; 92% affirmance in full or part).

Figure 5a

Figure 5b

Figure 6 shows the distribution of terminating documents of any type for 2024 regular appeals. About 57% of terminating documents were Opinions or Rule 36 summary affirmances (i.e., merits decisions). Most of the remainder were dismissals (including voluntary dismissals), with a small number of transfers and remands (typically issued through orders). Note that these terminations are counted per document, and appeals dismissed for procedural reasons (such as failure to prosecute) are sometimes later reinstated—so the percentage of appeals ultimately terminated via dismissal is somewhat lower than shown in this figure.

As with the previous figures, the unit of record for Figure 6 is a document—i.e., an opinion or order. A single document, such as an opinion, may decide multiple appeals.

Miscellaneous Dockets

What about petitions for writs of mandamus? These, along with petitions for permission to appeal, are shown below. Figure 7 indicates a slight decrease in the number of decisions on petitions last year. Nearly all (42) of the 2024 decisions on miscellaneous docket matters involved petitions for writs of mandamus.

Figure 7

What were the outcomes of these petitions? Of the 20 decisions on writs of mandamus arising from the district courts in 2024, just one was granted—a substantial shift from recent years.

If you’d like to explore the data yourself, it’s archived on the Harvard Dataverse. I’ve also updated the docket dataset to include appeals filed in 2024. A printout of the Jupyter Notebook used to generate this report is available there, along with an Excel file containing the underlying data tables. If you use the datasets, please cite them as follows:

  • Replication materials for blog post:
    Rantanen, Jason, 2023, “Replication Data for ‘Federal Circuit Decisions Stats and Datapack'”, https://doi.org/10.7910/DVN/HPARYR, Harvard Dataverse, V6

  • Document dataset:
    Rantanen, Jason, 2021, “Federal Circuit Document Dataset”, https://doi.org/10.7910/DVN/UQ2SF7, Harvard Dataverse, V7, UNF:6:cbz6tO1MyVSewzIAncqf2A==

  • Docket dataset:
    Rantanen, Jason, 2021, “Federal Circuit Docket Dataset”, https://doi.org/10.7910/DVN/EKSYHL, Harvard Dataverse, V6, UNF:6:io8bOGQ323wHBLZMlUsm+w==

 

The Ethics of When Lawyers Make Mistakes

by David Hricik, Mercer Law School.

I recently wrote a paper on this topic and gave a CLE and thought it would be useful to pass it along.  It is here.

It goes through in a step-by-step way the way to approach fessing up to a mistake, as well as analyzing the different approaches that jurisdictions take to the issue. For example, some view the duty as arising from the need to keep a client reasonably informed, while others view it as part of a conflict-of-interest analysis. That matters because breach of the duty depends on which source applies: if it’s to keep the client reasonably informed, it’s basically triggered by knowing the client has a malpractice claim, but if it’s a fiduciary duty that is the source, then it’s triggered by the lawyer’s interest conflicting with the client’s.

Anyhow, it also addressed the critical issue of talking to your carrier and addresses a couple of related cases where lawyers’ duties were triggered by other sources.