Insights

In a bipartisan show of support for American inventors and technological leadership, Senators Chris Coons (D-DE), Thom Tillis (R-NC), and Mazie Hirono (D-HI) and Representatives Kevin Kiley (R-CA) and Scott Peters (D-CA) held a press conference on Wednesday, May 1, 2025, to highlight growing momentum behind the Promoting and Respecting Economically Vital American Innovation Leadership Act (known as the PREVAIL Act) and the Patent Eligibility Restoration Act (known as the PERA Act).  

The USPTO has made a series of recent announcements in April that should not go unnoticed as they serve as important reminders for best practices in patent prosecution. In particular, the USPTO’s announcements address continuation applications, a new working group to mitigate fraud, and the elimination of expedited examinations for design applications.

On March 13, 2025, the United States Court of Appeals for the Federal Circuit issued a decision about Patent Term Extensions (PTEs) under the Hatch-Waxman Act for reissue patents. In Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc. (No. 2023-2254), the Court confirmed that the PTE provision under 35 U.S.C. § 156 refers to the original patent’s issue date, not the reissue patent’s issue date. Thus, the issue date of the original patent should be used when calculating the extension period.

Senators John Cornyn(R-Texas), Chuck Grassley (R-Iowa), Richard Blumenthal (D-Conn.), and Dick Durbin (D.-Ill.) recently sponsored two bills, introduced on March 14th, that would affect patents in the pharmaceutical industry.

On Wednesday, March 5, 2025, the United States Patent Trial and Appeal Board (“PTAB”) handed down the latest decision in the COVID vaccine proceedings between Pfizer Inc. (“Pfizer”) and BioNTech SE (“BioNTech”) and ModernaTX, Inc. (“Moderna”). The PTAB found all challenged claims unpatentable in two patents held by Moderna related to Moderna’s COVID-19 vaccine technology: U.S. Patent Nos. 10,702,600 (the “’600 patent”) and 10,933,127 (the “’127 patent”), both entitled “Betacoronavirus mRNA Vaccine.”

In 2023 and 2024, several U.S. states enacted extensive “Right to Repair” laws, reflecting a growing legislative focus on ensuring consumers have access to the parts and resources needed to repair their own products without relying on the product’s original manufacturer. Most recently, California, Colorado, Minnesota, New York, Massachusetts, and Oregon implemented comprehensive regulations aimed at providing consumers direct access to tools, parts, and information for the repair of various electronic devices and equipment, including digital products and agricultural machinery. As the “Right to Repair” movement continues to gain significant traction across the United States, it is critical that manufacturers understand these laws and how these laws will impact their individual businesses.

On February 28, 2025, the USPTO announced that it was rescinding a 2022 memorandum issued by former USPTO Director Kathi Vidal, entitled “Interim Procedure for Discretionary Denials in AIA Post-Grant Proceedings with Parallel District Court Litigation,” which had curtailed discretionary denials of PTAB post-grant proceedings. The February 2025 announcement directs parties to refer to PTAB precedent for guidance, including the decisions in Apple Inc. v. Fintiv, Inc., IPR2020-00019, Paper 11 (PTAB Mar. 20, 2020) and Sotera Wireless, Inc. v. Masimo Corp., IPR2020-01019, Paper 12 (PTAB Dec. 1, 2020). The announcement further indicates that, to the extent any PTAB or Director Review decisions relied on the 2022 memorandum, the portions of those decisions shall not be binding or persuasive on the PTAB.

The Federal Circuit recently issued a decision in Kroy IP Holdings, LLC v. Groupon, Inc., No. 23-1359 (Fed. Cir. Feb. 10, 2025), holding that collateral estoppel does not preclude a patentee from asserting any unadjudicated claims of a patent where other claims of the same patent were held unpatentable in an inter partes review (“IPR”) by the Patent Trial and Appeals board (“PTAB”).

Design patents play a crucial role in protecting the aesthetic and functional aspects of electric vehicle (EV) charging stations and connectors, which are essential components in the growing EV market, and the burgeoning infrastructure supporting the same. Participants in this crowded market would be wise to protect their innovations and investments by filing for design patents directed to distinctive design elements of the products and services they offer, as part of a robust intellectual property strategy. Doing so can help such participants enhance their market position, obtain and then maintain market differentiation, and attract investors.

On November 22, 2024, World Intellectual Property Organization (WIPO) member states adopted the Riyadh Design Law Treaty (“Treaty”). This development is arguably the biggest advancement in international design law since 1999, when the Geneva Act of the Hague Agreement Concerning the International Registration of Industrial Designs (“the Hague Agreement”) was adopted.

The Federal Circuit recently held that a claim that a product is protected by patents when it is not may constitute false advertising. Defendants in this case, Dawgs Inc., accused the makers of Crocs of using the terms “patented,” ‘proprietary,” and “exclusive” in its advertising in a manner that misled consumers about the nature, characteristics, or qualities of its own products and the products of its competitors. Specifically, Dawgs alleged that Crocs made promotional statements that a patent covers its Croslite shoe material, that Croslite has numerous tangible benefits found in all of Crocs’ shoe products and that, because Croslite is “patented,” others’ products lack these same benefits. Crocs, Inc. v. Effervescent, Inc., No. 2022-2160, 2024 U.S. App. LEXIS 25001 (Fed. Cir. Oct. 3, 2024).

Traditionally, a response to a Final Office Action (“FOA”) issued by the United States Patent and Trademark Office (“USPTO”) often involves filing a Request for Continued Examination (“RCE”) in order for the Examiner to consider further claim amendments.  In 2013, the USPTO launched the After Final Consideration Pilot program 2.0 (“AFCP 2.0”) as an alternative.  The AFCP 2.0 program allows patent applicants to request consideration of an amendment after a FOA without additional fees and grants examiners extra time to review the after-final amendment.  This provides applicants the chance to file after-final amendments without incurring the significant fees associated with an RCE.  The AFCP 2.0 program also provides an opportunity for applicants to have an interview with the Examiner and this increased communication often led to efficient resolution of prosecution. 

The USPTO has proposed a rule rendering a patent unenforceable if it is disclaimed over another patent that is subsequently found invalid.  The FTC filed a comment letter in support of the USPTO’s proposed rule, noting that “the proposed rule would reduce the costs incurred by potential competitors challenging weak patents or defending against assertions of patent claims that are obvious variants of a single invention.”

In its first en banc decision in six years, the Federal Circuit in LKQ Corp. v. GM Global Technology Operations LLC, No. 2021-2348 (Fed. Cir. May 21, 2024) overruled the prevailing obviousness test for design patents; abandoning the decades-old standard known as the Rosen-Durling test, and embracing a less rigid approach to assessing obviousness for design patents.  As explained below, the decision creates uncertainty as to how the obviousness of design patents should be assessed in the future.  

The Federal Circuit’s decision in University of South Florida Board of Trustees v. United States, 22-2248 (Fed. Cir. Feb. 9, 2024) hints at the broad scope of the federal government’s license rights under the Bayh-Dole Act. 

On February 12, 2024, Judge David Alan Ezra of the Western District of Texas dismissed a lawsuit challenging the constitutionality of the Drug Price Negotiation Program of the Inflation Reduction Act of 2022, P.L. 177-169 (IRA).[1]

On Monday, February 5, 2024, the Federal Circuit held its first en banc oral argument on a patent case in five years.  This oral argument was for the case of LKQ Corp. v. GM Global, addressing a question of the patentability standard for design patents over prior art references under 35 U.S.C. §103.  The Federal Circuit took up this argument en banc as Appellant LKQ Corp. sought to overturn the 40-year old Rosen-Durling test of obviousness for design patents, first established In re Rosen (1982) and further clarified in Durling v. Spectrum (1996). 

The Federal Circuit recently denied a petition for rehearing en banc in the much watched In re Cellect matter.  The landmark panel decision determined how obviousness-type double patenting (“ODP”) is impacted when patent term adjustment (“PTA”) is added to the term of one or more patents in a family under 35 U.S.C. § 154(b), resulting in different terms for the family member patents that would otherwise expire on the same day.

On January 10, 2024, the United States Patent and Trademark Office (USPTO) published Guidelines for assessing enablement after the Supreme Court’s recent decision in Amgen Inc. et al. v. Sanofi et al.  The Guidelines inform Examiners and the public on the Office’s implementation of the Amgen opinion. In sum, the Guidelines maintain the status quo.   

The U.S. Patent and Trademark Office (USPTO) recently issued the one millionth U.S. Design Patent on September 26, 2023. U.S. Design Patent 1,000,000 is directed toward the ornamental design of a dispensing comb and was issued to Agustina Huckaby, an inventor and licensed cosmetologist from Fort Worth, Texas. This significant milestone, 181 years after the first design patent was issued in 1841, comes during a time of increased interest in design patents. The USPTO reports that in 2022, more than 50,000 design patent applications were filed, and that the USPTO has seen an 20% increase in design applications over the past five years.