Federal Circuit: District Court Did Not Err In Declining to Find Infringement By Moderna’s Activities Involving COVID-19 Vaccine

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July 2025

Federal Circuit: District Court Did Not Err In Declining to Find Infringement By Moderna’s Activities Involving COVID-19 Vaccine

The Intellectual Property Strategist

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On June 4, 2025, a Federal Circuit panel consisting of Judges Taranto, Chen, and Hughes issued a unanimous opinion, authored by Judge Taranto, in Alnylam Pharmaceuticals, Inc. v. Moderna, Inc., Case No. 2023-2357. The panel affirmed the U.S. District Court for the District of Delaware’s decision that appellee’s activities involving its mRNA-based COVID-19 vaccine SPIKEVAX® did not infringe appellant’s U.S. Patent Nos. 11,246,933 (’933 patent) or 11,382,979 (’979 patent). Slip Op. at 2–3.

To continue reading Jeffrey Ginsberg and Sarah Brand's article in The Intellectual Property Strategist, please click here.

Firm Highlights

Geoffrey Potter to Speak at National Association of Boards of Pharmacy 122nd Annual Meeting

On Wednesday, May 13, Partner Geoffrey Potter will present a program at the National Association of Boards of Pharmacy's 122nd Annual Meeting on the illegal importation of pharmaceuticals by alternative funding programs for employer-sponsored health plans. He will open a panel presentation titled "The Increasing Complexity of the Supply Chain: Shining a Light on Alternative Funding Programs and Prescription Drug Facilitators/Non-Dispensing 'Pharmacies.'" He will speak about how millions of insured workers and their families are forced to use dangerous and illegal misbranded medications paid for by their healthcare plans and what pharmacy boards can do to stop it. To learn more, please click here.

Department of Labor Proposes New Safe Harbor for Fiduciary Investment Selection in Participant-Directed Retirement Plans

Introduction On March 24, 2026, the Department of Labor (the “Department”) published proposed regulations (the “Proposed Regulations”) implementing Section 3(c) of President Trump's Executive Order 14330, titled "Democratizing Access to Alternative Assets for 401(k) Investors" (the “Order”). The Proposed Regulations address the fiduciary duty of prudence under the Employee Retirement Income Security Act of 1974 ("ERISA") related to the selection of investment options for participant-directed individual account plans, including alternative investments as defined under the Order (“Alternative Investments”)[1]. The stated goal of the Proposed Regulations is to alleviate regulatory burdens and litigation risks that, in the Department's view, have interfered with the ability of American workers to achieve sufficiently competitive returns and meaningful asset diversification through their retirement accounts. The Department...

It’s All Relative: Judge Komitee Holds That an Infringing Sale Can Take Place at Multiple Times Both Before and After a Patent Issues

Judge Eric Komitee recently denied a motion to dismiss patent infringement claims accusing flood prevention products sold pursuant to a contract that was entered into before the patent issued but delivered and installed after issuance. In 2013, plaintiff FloodBreak, LLC filed its patent application for a device that prevents flooding in subway systems. In 2016, while that application was pending, defendants T. Moriarty & Son, Inc. and James P. Moriarty, Jr. (collectively, “TMS”) contracted with the Metropolitan Transportation Authority (“MTA”) to supply flood-mitigation devices for the New York City subway. After the patent issued in 2017, FloodBreak sued TMS’s supplier and obtained a stipulated judgment that its devices infringe. FloodBreak then filed suit against TMS alleging infringement by TMS’s offer...

“Not an Arm of New Jersey”: Judge Gardephe Denies Motion for Summary Judgment Based on Eleventh Amendment Immunity

On March 30, 2026, United States District Judge Paul G. Gardephe (S.D.N.Y) denied Defendant New Jersey Transit Corporation’s (“NJ Transit”) motion for summary judgment on all of Plaintiff Bytemark, Inc.’s (“Bytemark”) claims. Bytemark, Inc. v. Xerox Corp., et al, No. 17-cv-1803 (S.D.N.Y. March 30, 2026). Bytemark provides a secure mobile ticketing platform for transit, tourism, and events. Bytemark has sued several defendants, including NJ Transit, for patent infringement, breach of contract, trade secret misappropriation, unfair competition, and unjust enrichment. Bytemark alleges that two defendants, after entering into confidentiality agreements with Bytemark, used Bytemark’s intellectual property and trade secrets to secure a contract with NJ Transit for mobile ticketing and cut Bytemark out of the bidding process. Id. at *2–4. In October 2022, NJ...

Ninth Circuit Finds First Amendment Right to Donate to Patient Assistance Charities, With Possible Impact on Enforcement of Federal Anti-Kickback Statute

Last week, the Ninth Circuit issued a published decision striking down California’s Assembly Bill 290 (“AB 290”) on First Amendment grounds. See Fresenius Med. Care Orange Cnty., LLC v. Bonta, No. 24-3654 (9th Cir. Apr. 7, 2026). Its central holding was that providers of medical services have a protected First Amendment right to make donations to patient assistance charities that engage in expressive activity, even if those donations are driven by commercial self-interest. Although the case did not directly involve the federal Anti-Kickback Statute (“AKS”)—or any federal statute—it arguably calls into question the constitutionality of AKS proceedings often brought against pharmaceutical manufacturers that make analogous donations to patient assistance charities out of alleged self-interest. AB 290, the California statute at issue...

Firm Achieves Significant Lanham Act Win for Johnson & Johnson

On April 17, 2026, Patterson Belknap secured a significant victory for our clients, Johnson & Johnson and Janssen Biotech, Inc. (“J&J”), when the U.S. District Court for the Southern District of New York denied a preliminary injunction in a Lanham Act suit filed by Bayer HealthCare LLC (“Bayer”). The dispute concerned a retrospective scientific study sponsored by J&J that compared the real-world efficacy of both companies’ prostate cancer medications, concluding that J&J’s ERLEADA was associated with a reduction in overall risk of death approximately 50% greater than Bayer’s NUBEQA. Bayer alleged that the study was methodologically flawed, and that J&J’s publication of the study results therefore constituted “false advertising.” The statements at issue included a presentation given by the study authors at a medical...

All Activity Rings [Patents] Closed—Judge Rochon Grants Motion for Summary Judgment of Non-infringement on Seven Design Patents

Judge Jennifer L. Rochon (S.D.N.Y.) recently granted Defendant Apple, Inc.’s (“Apple”) motions for summary judgment of non-infringement of seven design patents. Plaintiff Michael Shunock (“Shunock”) asserted U.S. Patent Nos.: D956,802; D956,803; D956,804; D956,805; D956,806; D956,807; and D956,808 (together, the “Asserted Patents”) against “Apple’s Activity Rings” used in the Apple Watch and iPhone. Slip Op. at 1-2. The Asserted Patents claim “‘[t]he ornamental design for a display screen with graphical user interface, as shown and described” in various figures. Id. at 12. Shunock moved for partial summary judgment on invalidity and Apple moved for summary judgment on invalidity and non-infringement. Id. at 1-2. Both parties also moved to preclude expert testimony from opposing experts. Id. at 1-2. The court granted Apple’s...

Justin Zaremby to Speak at American Law Institute’s 2026 Legal Issues in Museum Administration Conference

On Wednesday, April 29, Partner Justin Zaremby will speak on a panel at the American Law Institute's 2026 Legal Issues in Museum Administration conference titled "Structuring Collaborations Between Museums and Third Parties." Mr. Zaremby will join Barbara Andrews (Legal Manager and IACUC Administrator, California Academy of Sciences) and Cristina del Valle (Senior Associate General Counsel, The Metropolitan Museum of Art) to explore important governance, tax, and IP considerations for museums' transactional activities, including corporate sponsorships, licensing, and joint programming with for-profit and nonprofit entities. To learn more, please click here.

Fresenius Ruling May Shift Anti-Kickback Enforcement

When is it illegal to donate to a charity? According to the federal government, when you're a pharmaceutical manufacturer, and the charity helps Medicare patients afford your medicines. The government has argued that such donations may be illegal kickbacks. Courts have largely agreed with this view, but a recent decision by the U.S. Court of Appeals for the Ninth Circuit in Fresenius Medical Care Orange County LLC v. Bonta raises new doubts, suggesting that businesses have a First Amendment right to donate to certain charities — even when those donations are motivated by economic self-interest and have distortive economic effects. To continue reading Jonah Knobler's article in Law360, click here.

Firm Secures Appellate Victory on Behalf of Brita Products Company

On April 16, 2026, the firm secured an appellate victory on behalf of Brita Products Company ("Brita"), a unit of The Clorox Company, in a putative class action challenging the labeling of Brita's water filtration products. The U.S. Court of Appeals for the Ninth Circuit upheld a lower court ruling dismissing the complaint, agreeing that the product labeling contained no misstatements and would not mislead a reasonable consumer. Plaintiff originally sued Brita in the U.S. District Court for the Central District of California, alleging that certain representations on the products’ labels, such as “Cleaner, Great-Tasting Water,” implied that the filters fully remove all contaminants from tap water or reduce them to levels below lab detection limits. The district court granted Brita’s motion to dismiss...

Geoffrey Potter to Speak at National Association of Boards of Pharmacy 122nd Annual Meeting

On Wednesday, May 13, Partner Geoffrey Potter will present a program at the National Association of Boards of Pharmacy's 122nd Annual Meeting on the illegal importation of pharmaceuticals by alternative funding programs for employer-sponsored health plans. He will open a panel presentation titled "The Increasing Complexity of the Supply Chain: Shining a Light on Alternative Funding Programs and Prescription Drug Facilitators/Non-Dispensing 'Pharmacies.'" He will speak about how millions of insured workers and their families are forced to use dangerous and illegal misbranded medications paid for by their healthcare plans and what pharmacy boards can do to stop it. To learn more, please click here.

Department of Labor Proposes New Safe Harbor for Fiduciary Investment Selection in Participant-Directed Retirement Plans

Introduction On March 24, 2026, the Department of Labor (the “Department”) published proposed regulations (the “Proposed Regulations”) implementing Section 3(c) of President Trump's Executive Order 14330, titled "Democratizing Access to Alternative Assets for 401(k) Investors" (the “Order”). The Proposed Regulations address the fiduciary duty of prudence under the Employee Retirement Income Security Act of 1974 ("ERISA") related to the selection of investment options for participant-directed individual account plans, including alternative investments as defined under the Order (“Alternative Investments”)[1]. The stated goal of the Proposed Regulations is to alleviate regulatory burdens and litigation risks that, in the Department's view, have interfered with the ability of American workers to achieve sufficiently competitive returns and meaningful asset diversification through their retirement accounts. The Department...

It’s All Relative: Judge Komitee Holds That an Infringing Sale Can Take Place at Multiple Times Both Before and After a Patent Issues

Judge Eric Komitee recently denied a motion to dismiss patent infringement claims accusing flood prevention products sold pursuant to a contract that was entered into before the patent issued but delivered and installed after issuance. In 2013, plaintiff FloodBreak, LLC filed its patent application for a device that prevents flooding in subway systems. In 2016, while that application was pending, defendants T. Moriarty & Son, Inc. and James P. Moriarty, Jr. (collectively, “TMS”) contracted with the Metropolitan Transportation Authority (“MTA”) to supply flood-mitigation devices for the New York City subway. After the patent issued in 2017, FloodBreak sued TMS’s supplier and obtained a stipulated judgment that its devices infringe. FloodBreak then filed suit against TMS alleging infringement by TMS’s offer...

“Not an Arm of New Jersey”: Judge Gardephe Denies Motion for Summary Judgment Based on Eleventh Amendment Immunity

On March 30, 2026, United States District Judge Paul G. Gardephe (S.D.N.Y) denied Defendant New Jersey Transit Corporation’s (“NJ Transit”) motion for summary judgment on all of Plaintiff Bytemark, Inc.’s (“Bytemark”) claims. Bytemark, Inc. v. Xerox Corp., et al, No. 17-cv-1803 (S.D.N.Y. March 30, 2026). Bytemark provides a secure mobile ticketing platform for transit, tourism, and events. Bytemark has sued several defendants, including NJ Transit, for patent infringement, breach of contract, trade secret misappropriation, unfair competition, and unjust enrichment. Bytemark alleges that two defendants, after entering into confidentiality agreements with Bytemark, used Bytemark’s intellectual property and trade secrets to secure a contract with NJ Transit for mobile ticketing and cut Bytemark out of the bidding process. Id. at *2–4. In October 2022, NJ...

Ninth Circuit Finds First Amendment Right to Donate to Patient Assistance Charities, With Possible Impact on Enforcement of Federal Anti-Kickback Statute

Last week, the Ninth Circuit issued a published decision striking down California’s Assembly Bill 290 (“AB 290”) on First Amendment grounds. See Fresenius Med. Care Orange Cnty., LLC v. Bonta, No. 24-3654 (9th Cir. Apr. 7, 2026). Its central holding was that providers of medical services have a protected First Amendment right to make donations to patient assistance charities that engage in expressive activity, even if those donations are driven by commercial self-interest. Although the case did not directly involve the federal Anti-Kickback Statute (“AKS”)—or any federal statute—it arguably calls into question the constitutionality of AKS proceedings often brought against pharmaceutical manufacturers that make analogous donations to patient assistance charities out of alleged self-interest. AB 290, the California statute at issue...

Firm Achieves Significant Lanham Act Win for Johnson & Johnson

On April 17, 2026, Patterson Belknap secured a significant victory for our clients, Johnson & Johnson and Janssen Biotech, Inc. (“J&J”), when the U.S. District Court for the Southern District of New York denied a preliminary injunction in a Lanham Act suit filed by Bayer HealthCare LLC (“Bayer”). The dispute concerned a retrospective scientific study sponsored by J&J that compared the real-world efficacy of both companies’ prostate cancer medications, concluding that J&J’s ERLEADA was associated with a reduction in overall risk of death approximately 50% greater than Bayer’s NUBEQA. Bayer alleged that the study was methodologically flawed, and that J&J’s publication of the study results therefore constituted “false advertising.” The statements at issue included a presentation given by the study authors at a medical...