by Dennis crouch

In October 2024, the USPTO terminated proceedings in approximately 3,100 patent applications due to the fraudulent use of a U.S. practitioner’s signature. The bulk of the applications are Chinese origin filed through Dr. Yu "Mark" Wang, who operated a patent services firm called Wayne and King LLC (W&K). According to USPTO findings, Wang, who was not a registered patent practitioner, used the electronic signature of registered patent agent without her knowledge or consent. Most recently, one of the impacted patentees - Diamond Art Club LLC - filed a lawsuit challenging the the termination based upon "arbitrary and capricious" action by the agency.  In particular, the patent applicant argues that it is being unfairly punished as the victim: "If the misconduct described by the Defendants did in fact occur, Plaintiff was the victim of the misconduct." [DAC Complaint]

by Dennis Crouch

In a significant development affecting the legal profession and potentially patent practice, Judge Richard J. Leon of the U.S. District Court for the District of Columbia has partially granted WilmerHale's motion for a temporary restraining order against President Trump's recent executive order targeting the firm. Wilmer Cutler Pickering Hale and Dorr LLP v. Executive Office of the President, No. 25-cv-917 (D.D.C. Mar. 28, 2025).

The firm's complaint, filed on March 28, 2025, names dozens of federal agencies and officials as defendants, including Coke Morgan Stewart in her official capacity as Acting Under Secretary of Commerce for Intellectual Property and Acting Director of the United States Patent and Trademark Office. This inclusion is particularly relevant to patent practitioners, as the order threatened to severely impair WilmerHale's ability to represent clients before the USPTO.

WilmerHale's complaint noted that its Intellectual Property department regularly represents "patent applicants, patent holders, and patent challengers before U.S. Patent and Trademark Office in patent prosecution and post-grant proceedings." The executive order, if fully implemented, would have restricted WilmerHale attorneys' access to federal buildings and limited federal employees from engaging with them, potentially preventing effective advocacy before the USPTO.

Judge Leon granted temporary relief as to Sections 3 and 5 of the executive order, which would have required government contractors to disclose business relationships with WilmerHale, threatened government contracts involving the firm, restricted WilmerHale employees' access to federal buildings, and limited government employees from engaging with firm personnel. The court found these provisions likely violate the First Amendment, with Judge Leon noting that "the retaliatory nature of the Executive Order at issue here is clear from its face."  The parties must file a joint status report by March 31, 2025, proposing an expedited schedule for further proceedings.

by Dennis Crouch

In a significant procedural shift, Acting USPTO Director Coke Morgan Stewart has announced a new "Interim Process for PTAB Workload Management" that fundamentally changes aspects of how America Invents Act (AIA) patent challenges are handled. The March 26, 2025 memorandum bifurcates the institution decision process by centralizing discretionary denial authority with the Director herself.  This follows the Feburary 28, 2025 action rescinding former Director Vidal's June 2022 memorandum that had significantly curtailed discretionary denials based on the Fintiv factors when parallel district court litigation is pending. I expect this change will substantially increase the percent of IPR/PRG petitions denied at the institution stage.

USPTO leadership appears to have a goal of increasing discretionary denials to protect patentees from harassment and delay in enforcing their property right.  In addition, though, it appears that the Office has a genuine concern about workload management as stated in the memo. The PTAB is being stretched thin by staff shortages caused by the return-to-office (RTO) requirement coupled with reduction-in-force (RIF) efforts from President Trump and Elon Musk's White House.  A substantial number of PTAB judges have quit and further reductions are expected in the coming month.  The memorandum indicates that the new procedures are "temporary in nature due, in part, to the current workload needs of the PTAB."

One difficulty with discretionary denials in the past is that patentees had little room in their briefs to address the issue in any detail.  As discussed below, the new rule provides substantial space for patentees to brief the issue. This will also alter district court proceedings, with patentees again seeking to move faster at the outset to obtain an early trial date and accused infringers seeking delay as well as preemptive stays.

by Dennis Crouch

The pending cert petition in Celanese v. ITC asks whether the sale of products made using a secret process triggers the on-sale bar post-AIA.  In my view, the case sets up a fundamental tension between a straight reading of the statutory text and longstanding precedent.  My bet is on the precedent.

Although Congress has repeatedly tinkered with U.S. patent law over the past several decades, the America Invents Act of 2011 was clearly the most dramatic rewriting of  the law since 1952. The fundamental change to Section 102 was the transition from first-to-invent to first-to-file.   In addition, the law was amended throughout to focus on the "claimed invention" rather than simply the "invention."  This second change is important for the Celanese case.  35 U.S.C. § 102(a)(1)  now reads:

A person shall be entitled to a patent unless ... (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.

The AIA also added a definition of the new term, defining "claimed invention" as "the subject matter defined by a claim in a patent or an application for a patent." 35 U.S.C. § 100(j).  This heightened specificity was largely downplayed as a clarification that courts were already following. In particular, for anticipation situations courts were already asking whether the asserted prior art disclosed the invention as claimed.

But, one key divergence from this practice involves ...

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

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.

• Rick Beato has a great analysis of the two songs: https://www.youtube.com/watch?v=0kt1DXu7dlo

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.

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. 

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.

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.

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.

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.