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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.'"
After 18 years of litigation, the Federal Circuit has once again ruled in the patent infringement case Halo v. Pulse. The February 28, 2025 opinion, authored by Judge Bryson, deals with enhanced damages, attorney fees, prejudgment interest, and the denial of a new damages trial. On the biggest issue, punitive damages, I explain why the Federal Circuit was wrong in affirming the district court’s refusal to enhance damages. In my view, the Federal Circuit sidestepped the practical implications of the jury's willfulness, treating the verdict as a checkbox rather than a meaningful factual finding for enhanced damages.
The pendulum of the mind alternates between sense and nonsense, not between right and wrong.
- Carl Jung (Memories, Dreams, Reflections)
By Dennis Crouch
In a significant policy shift, Acting USPTO Director Coke Stewart has rescinded the June 21, 2022, Vidal memorandum that had significantly curtailed discretionary denials of PTAB post-grant proceedings. This rescission signals a potentially dramatic return to broader PTAB discretion in denying institution of inter partes reviews (IPRs) in cases with parallel district court litigation. I believe we can expect a significant uptick in discretionary denials of IPR institution petitions. And, patent holders in district court will be looking for ways to quickly move cases forward in order to provide evidence that IPR denial is appropriate.
Since its creation under the AIA, the PTAB has rapidly established itself as America's most active patent litigation forum -- and the only one that is effectively risk-free for patent challengers. Before the AIA created the IPR system, district courts rarely invalidated patents on obviousness grounds because of the doctrine's technical complexity that often went beyond the span of generalist federal judges and juries. PTAB judges are hired for their willingness and ability to dig deeply into complex obviousness arguments involving the combination of multiple references. Over the past decade, the PTAB has invalidated tens of thousands of patent claims as obvious. To put this in perspective, I am fairly confident the PTAB has invalidated more patent claims on obviousness grounds in its short life than all federal courts combined since the founding of our patent system in 1790. AIA Trials have been a huge shock to the patent system -- a shock that has almost entirely favored patent challengers. Thus, Director Stewart's new policy change is important as it is likely to redirect access to this powerful alternative forum.
The vast majority of patent appeals are heard by the U.S. Court of Appeals for the Federal Circuit. Such cases typically include at least one claim or compulsory counterclaim "arising under" U.S. patent laws. However, patent-related issues occasionally arise in contexts outside the Federal Circuit’s jurisdiction, notably in breach-of-license disputes involving patent misuse. One such case is the recent Ninth Circuit decision, C.R. Bard, Inc. v. Atrium Medical Corp., 112 F.4th 1182 (9th Cir. 2024).
The Bard dispute highlights ongoing issues surrounding patent misuse and specifically invokes the Supreme Court’s influential decisions in Brulotte v. Thys Co., 379 U.S. 29 (1964), and Kimble v. Marvel Entertainment, LLC, 576 U.S. 446 (2015).
I sometimes have difficulty following doublethink. The recent implementation of the Republican Administration's executive orders on diversity initiatives has created a nuanced and seemingly contradictory landscape in federal agencies, including the USPTO.
I am teaching professional responsibility this semester and it is fascinating to read about all the different ways legal professionals can stumble on their own feet. In a recent nonprecedential decision, the Federal Circuit upheld the USPTO's denial of a former patent examiner's application to register as a patent practitioner. Behnamian v. Stewart, No. 24-1139 (Fed. Cir. Feb. 26, 2025). [24-1139.OPINION.2-26-2025_2473270]
The case highlights the importance of candor and truthfulness in registration applications and the high ethical standards expected of those seeking to practice before the USPTO.
