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…)
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. (more…)
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).
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. (more…)
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. (more…)
The Federal Circuit’s recent decision in In re Xencor, Inc. (Fed. Cir. March 13, 2025) confirms what patent practitioners have long suspected – Jepson claim formats carry significant drawbacks that outweigh their potential benefits. In a decision issued March 13, 2025, the court held that the limiting preamble of a Jepson claim must be supported by sufficient written description, adding yet another reason to avoid this increasingly rare claim format.
Background on Jepson Claims
Jepson claims, named after Ex parte Jepson (1917), follow a specific format that begins with a preamble describing known prior art elements, followed by a transition phrase like “wherein the improvement comprises,” and concluding with the new elements that constitute the claimed improvement.
Although 37 CFR § 1.75(e) states that improvement inventions “should” use this format, practitioners have almost universally abandoned it. As the chart shows, the percentage of U.S. patents using Jepson claims has plummeted from around 8% in the early 1980s to nearly 0% today.
As I’d discuss below, Xencor offers another significant risk reason to avoid using Jepson claims. However, practitioners had already largely abandoned them for multiple compelling reasons. The central problem is that Jepson claims create at least an implied admissions about what constitutes prior art, potentially making inventions appear as minor improvements rather than significant advances. Irving Kayton and Gene Quinn – folks who have both trained thousands of patent attorneys – have long warned that Jepson claims should be avoided. Gene wrote: “No patent attorney in their right mind would follow this suggestion” when referring to the §1.75(e) recommendation to use Jepson format.
The Xencor decision now adds an additional major drawback: the need to provide written description support for both the improvement and the preamble, creating a “worst of both worlds” scenario where applicants must describe the prior art with the same level of detail as their improvement, even though they’ve implicitly admitted the preamble content isn’t novel.
The Xencor Decision
USPTO’s Appeals Review Panel (ARP) (part of the PTAB) had rejected Xencor’s patent application for anti-C5 antibodies. The application included claim 8, written in Jepson format:
In a method of treating a patient by administering an anti-C5 antibody with an Fc domain, the improvement comprising:
said Fc domain comprising amino acid substitutions M428L/N434S as compared to a human Fc polypeptide,
wherein numbering is according to the EU index of Kabat,
wherein said anti-C5 antibody with said amino acid substitutions has increased in vivo half-life as compared to said antibody without said substitutions.
Xencor argued that only the improvement portion of its Jepson claim (after the “improvement comprising” transition) required written description support. The company contended that because the preamble was admittedly prior art, it shouldn’t need to demonstrate possession of what was already known.
The Federal Circuit firmly rejected this argument, holding that “the limiting preamble of a Jepson claim must be supported with sufficient written description.” Judge Schroeder, sitting by designation on the court wrote the opinion and explained:
[T]he Jepson claim invention is the totality of what is set out in the claim. . . . The invention is not only the claimed improvement, but the claimed improvement as applied to the prior art, so the inventor must provide written description sufficient to show possession of the claimed improvement to what was known in the prior art.
The court reasoned that allowing patentees to avoid written description requirements for Jepson preambles would enable abuse:
A patentee cannot be permitted to use a Jepson claim to avoid the requirement that she be in possession of the claimed invention simply by asserting something is well-known in the art.
As an example, the court noted that “a patentee cannot obtain a Jepson claim with a preamble that says that a time machine is well-known in the art without describing a time machine.”
On the facts, the court affirmed that Xencor failed to provide adequate written description for both the genus of anti-C5 antibodies and the method of “treating a patient” mentioned in the preamble. Despite Xencor’s arguments to the contrary, the Appeals Review Panel had correctly determined that the company hadn’t established that anti-C5 antibodies were well-known in the art.
Claim 9 in the Xencor case, though not drafted in Jepson format, faced similar scrutiny regarding its preamble. The claim began with “[a] method of treating a patient by administering an anti-C5 antibody comprising,” and Xencor argued that only the “administering” portion was limiting, while “treating a patient” was merely contextual. The Federal Circuit disagreed, finding that “treating a patient” was indeed limiting because it gave “life, meaning, and vitality” to the claim, particularly to the “increased in vivo half-life” limitation. This determination proved fatal to the claim, as the court found the application lacked adequate written description for this limitation – the specification failed to describe treating any patients with any diseases using anti-C5 antibodies, and merely mentioned three general classes of diseases as possible treatment targets. The court’s ruling established that when preamble language is deemed limiting, it requires proper written description support, just as any other claim limitation would.
In prior posts, I have written about Xencor’s Claim 9 and its means-plus-function language, including “means for binding human C5 protein.” Although the claim as a whole was found invalid, the panel held that the specification doesn’t need to describe equivalents of the corresponding structure to satisfy written description and definiteness requirements. The Panel explained that § 112, ¶ 6 distinguishes between what must be “described in the specification” and what constitutes “equivalents thereof.” The Panel noted: “If Congress had intended the statute to require a description of equivalents, it could have placed ‘and equivalents thereof’ before ‘described in the specification,’ which it did not do.” Despite this favorable ruling on the means-plus-function aspect, claim 9 still failed the written description requirement for the same reason as claim 8 – the broad “treating a patient” limitation wasn’t adequately described.
= = =
In addition to Judge Schroeder sitting by designation, the panel also included Circuit Judges Hughes and Stark. The appellant, Xencor, Inc., was represented by attorneys Julie Goldemberg who argued the case along with, Michael Abernathy, Christopher Betti, Maria Doukas, Amanda Williamson, and William Peterson, all from Morgan, Lewis & Bockius LLP. Peter Sawert argued for the USPTO and was joined on the briefs by Mary Kelly, Amy Nelson, and Farheena Rasheed from the Office of the Solicitor.
Note that recently Rasheed has shifted her this week and is now acting Vice Chief Administrative Patent Judge at the Patent Trial and Appeal Board. Amy Nelson is now “Acting Deputy General Counsel for Intellectual Property Law and Solicitor.” Nelson has been with the USPTO for 30 years. Her first 15 were as an an examiner and SPE. She then took 5-years “off” to clerk at the Federal Circuit and litigate for WilmerHale. In 2010 she rejoined and has been with the Solicitor’s office since then arguing CAFC cases.
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.
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.
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.”
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.
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. (more…)
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. (more…)
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. (more…)
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. (more…)
The Federal Circuit is currently reviewing a trademark opposition dispute, Heritage Alliance & AFA Action, Inc. v. The American Policy Roundtable (Appeal No. 24-1155), centered around two competing marks: IVOTERGUIDE.COM and IVOTERS.COM. The following are, more than anything, a set of my notes on the case as I’m thinking through its importance. (more…)
The fine line between construing claims in light of the specification and improperly importing limitations from the specification represents one of patent law’s most persistent interpretive challenges. The Federal Circuit in Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc) established that while claims “must be read in view of the specification,” courts must avoid “reading a limitation from the specification into the claim” absent express definition (lexicography) or disavowal.
In IQRIS Technologies LLC v. Point Blank Enterprises, Inc., 2023-2062 (Fed. Cir. Mar. 7, 2025), the Federal Circuit has vacated and remanded a S.D. Fla. grant of summary judgment of noninfringement on this issue, finding that the district court’s claim construction improperly limited the term “pull cord.”
The case centers on two IQRIS patents, US7814567 and US8256020, which share a common specification and relate to quick release systems for tactical vests worn by soldiers, law enforcement officers, and first responders. The patent propose a “pull cord” that actuates a release hook to detach portions of the vest.
Point Blank and National Molding were accused of infringement based on their “Quad Release” and “Evil Twin” quick-release systems. Both systems have use triggers that the user pulls or flips, that then actuate “Bowden” cables (similar to bicycle brake cables) to release the vest. One example of this trigger is shown above. (more…)
The United States International Trade Commission (USITC or ITC) operates as an independent, quasi-judicial federal agency the mission of safeguarding US domestic industries from injury caused by foreign imports. This is a protectionist agency. In the patent context, the ITC exercises its authority under Section 337 of the Tariff Act of 1930, which prohibits the importation of articles that infringe valid U.S. patents. Unlike district courts, the ITC cannot award monetary damages but instead provides exclusion orders that block infringing imports at the border and cease-and-desist orders that prevent domestic sales of previously imported infringing products. These orders are then enforced by US Customs and Border Protection (CBP), a branch of Homeland Security. The ITC is attractive to patent holders because of its relatively expeditious “target date” of 16-18 months from institution to final determination (compared to multi-year district court proceedings), its experienced Administrative Law Judges who frequently handle patent matters, the difficulty respondents face in staying ITC investigations during parallel PTAB trial proceedings, and, as mentioned above, the availability of injunctive relief (via exclusion order) despite eBay.
One measure Congress took to ensure the ensures stays on-mission is through the “domestic industry” requirement. Before the ITC can block infringing imports, the patent holder must to show the existence of a domestic industry “relating to the articles protected by the patent.” 19 U.S.C. § 1337(a)(2). This requirement has two components: the “economic prong” and the “technical prong” that we’ll dig into later.
When is Transnational Activity Sufficiently Domestic: The Federal Circuit’s recent decision in Lashify highlights an ongoing situation with regard to domestic industry. Lashify, Inc. v. ITC, No. 23-1245 (Fed. Cir. Mar. 5, 2025). Lashify designs its fake eyelash products in the U.S., but manufactures them abroad, and the question is when domestic non-manufacturing activity is enough to satisfy the domestic industry requirement.
In February 2021, Gesture Technology sued several companies, including Apple, LG Electronics, and Google, for infringing its U.S. Patent No. 7,933,431. The patent, which expired in July 2020, covers technology for using cameras to detect user gestures as input for controlling handheld computing devices. Four IPR petitions followed:
Unified Patents filed on May 14, 2021. IPR2021-
00917;
Apple filed on May 21, 2021. IPR2021-00920;
LG Electronics and Google later filed “nearly identical” petitions that were joined with Apple’s IPR. IPR2022-00091 and IPR2022-00359.
The PTAB instituted the IPRs and ultimately came out with a mixed result – cancelling most of the claims, but leaving a couple standing (claims 11 and 13). On appeal, the Federal Circuit has now affirmed. Apple Inc. v. Gesture Technology Partners, LLC, No. 23-1475 (Fed. Cir. Mar. 4, 2025) (precedential); Gesture Technology Partners, LLC v. Unified Patents, LLC, No. 23-1444 (Fed. Cir. Mar. 4, 2025) (non-precedential). In the pair of opinions, both authored by Judge Prost, the court focused both on procedural IPR issues as well as substantive patent law issues. In this post, I focus mainly on the court’s explanation of the obviousness standards, claim construction under §112 ¶6, IPR jurisdiction over expired patents, and IPR estoppel. The Federal Circuit explanation here makes sense except for its analysis of estoppel, which comes at the bottom of the post. (more…)
The USPTO has withdrawn its artificial intelligence strategy document published in January 2025, just days before the presidential transition. Acting Director Coke Morgan Stewart recently indicated the strategy has been removed because it was “driven in part by Biden executive orders” that have since been rescinded by the Trump administration.
This move is part of a broader reassessment of federal AI policy following President Trump’s executive order on January 23, 2025, titled “Removing Barriers to American Leadership in Artificial Intelligence.” This new EO outlines a fundamental shift in approach, emphasizing “America’s global AI dominance” rather than the previous focus on “safe, secure, and trustworthy development.”
The PTAB Bar Association has issued an urgent plea to Congressional leaders and Commerce Secretary Howard Lutnick advocating for stability at the Patent Trial and Appeal Board amid significant disruptions at the USPTO. [Letter to Congress][Letter to Lutnick]. Meanwhile, Acting Director Coke Morgan Stewart recently addressed the patent community at Gene & Renée Quinn’s IPWatchdog LIVE 2025 event, offering reassurances about the Office’s operations despite ongoing challenges.
The Supreme Court is poised to decide whether to grant review in the pair of R.36 cases that have been pending now since last fall, ParkerVision and Island IP. These cases challenging the Federal Circuit’s practice of issuing one-word “AFFIRMED” judgments under Rule 36 without providing any explanation. ParkerVision’s reply brief was filed on February 28, 2025 rests on a straightforward statutory interpretation: 35 U.S.C. § 144 requires the Federal Circuit to “issue to the Director its mandate and opinion” when deciding appeals from the Patent Trial and Appeal Board (PTAB). I agree with ParkerVision on this point — the term “opinion” is a legal term of art that unambiguously requires a court to explain its reasoning—something a one-word affirmance plainly fails to do. What was fairly amazing about the opposition brief, filed last month by the Chinese electronics giant TCL, is the absence of any direct push-back against central statutory interpretation question. As ParkerVision notes, “Respondents concede the question presented. They do not dispute that § 144 of the Patent Act requires the Federal Circuit to decide an appeal from the Patent Trial and Appeal Board (PTAB) by issuing an ‘opinion.'” (more…)
