Life Science Update | October 2025
USPTO, JPO, and EPO Meet to Discuss Global IP Challenges Joseph Mallon, Ph.D. & Ashley C. Morales Beginning on October 20, 2025, recently confirmed United States Patent and Trademark Office (USPTO) Director...
USPTO, JPO, and EPO Meet to Discuss Global IP Challenges
Beginning on October 20, 2025, recently confirmed United States Patent and Trademark Office (USPTO) Director John A. Squires met with European Patent Office (EPO) Vice-President Steve Rowan and Japanese Patent...
A Request for Sanctions Before the ITC Is Not Appealable to the Federal Circuit
REALTEK SEMICONDUCTOR CORPORATION v. ITC Before Reyna, Bryson, and Stoll. Appeal from the United States International Trade Commission. Summary: The Federal Circuit lacks jurisdiction to hear appeals of non-final determinations from...
Johnson & Johnson Study Shows Promise for the Treatment and Potential Cure of Multiple Myeloma
On June 3, 2025, the Journal of Clinical Oncology published a study funded by Johnson & Johnson, which showed that one-third of patients with relapsed/refractory multiple myeloma who were treated...
An Award of Attorneys’ Fees and Costs Under 35 U.S.C. §285 Does Not Preclude Sanctions Pursuant to the Court’s Inherent Authority
PS PRODUCTS INC. V. PANTHER TRADING CO. INC. Before Moore, Stoll, and Cunningham. Appeal from the Eastern District of Arkansas. Summary: Section 285 does not prohibit an award of deterrence...
Nobel Prize in Medicine Awarded to American Scientists for Discovery of microRNA
On October 7, 2024, the 2024 Nobel Prize in Physiology or Medicine was jointly awarded to two American scientists, Victor Ambros (of UMass Medical School) and Gary Ruvkun (of Harvard Medical School), for their discovery of microRNA, a new class of small noncoding RNA molecules, and the role microRNAs play in turning genes on and off, known as gene regulation.
Knobbe Martens, Over a Dozen Attorneys Recognized in Managing IP 2024 IP STARS Guide
IRVINE, Calif., October 10, 2024 – Knobbe Martens is proud to share that the firm and its partners have once again been recognized for outstanding intellectual property work by Managing...
Branded Manufacturers Decline to Remove Patents From the Orange Book After Receiving Letters From the FTC
On Friday, June 21, 2024, the FDA updated its Patent Listing Dispute List to indicate that the ten pharmaceutical companies who had received warning letters from the FTC in April did not make changes to their patent listings in the FDA’s catalog in view of the warning letters.
USPTO Issues Training Materials to Examiners for Searching FDA and NIH Resources
On March 20, 2024, The USPTO issued an alert, notifying practitioners that the USPTO had developed training materials for patent examiners regarding searching for prior art in FDA and NIH databases. The new training materials were presented to the public at the Biotechnology, Chemical, and Pharmaceutical Partnership Meeting, held in person at the USPTO headquarters in Alexandria, Virginia, and at the USPTO Silicon Valley Regional Office in San Jose, California, on March 19, 2020.
Federal Circuit Avoids Deciding Whether Statements to Foreign Patent Office Can Disavow U.S. Claim Scope
K-FEE SYSTEM GMBH v. NESPRESSO USA, INC.
Before Taranto, Clevenger, and Stoll. Appeal from the U.S. District Court for the Central District of California.
Summary: The Federal Circuit did not need to decide whether statements to the European Patent Office (EPO) can disavow claim scope in a U.S. patent because the statements in this case were too ambiguous to constitute disavowal.
The FDA Approves Two New Gene Therapies for the Treatment of Sickle Cell Disease
On December 8, 2023, the U.S. Food and Drug Administration (FDA) approved two new gene therapies for the treatment of sickle cell disease. The first, Casgevy™ (exagamglogene autotemcel (exa-cel)), is the first-ever approved cell-based gene editing therapy to be used in humans, and was developed in joint partnership between Vertex Pharmaceuticals and CRISPR Therapeutics. Casgevy™ is indicated for the treatment of sickle cell disease in patients 12 years and older with recurrent vaso occlusive crises (VOCs). The second, Lyfgenia™ (lovotibeglogene autotemcel (lovo-cel)), is developed by bluebird bio, and is indicated for the treatment of patients 12 years or older with sickle cell disease and a history of vaso-occlusive events (VOEs).
Knobbe Martens and 17 Attorneys Receive Top Rankings From Managing IP
Knobbe Martens is pleased to announce that Managing Intellectual Property (MIP) has once again recognized the firm for its top-tier intellectual property practices in the publication’s 2023 IP STARS guide....
Federal Circuit Revisits Standard for Enablement of Antibody Claims
In Baxalta Incorporated v. Genentech, Inc., 2022-1461, the Federal Circuit affirmed the district court’s decision granting Genentech’s motion for summary judgment that claims 1-4, 9, and 20 of U.S. Patent No. 7,033,590 (“the ’590 patent”) are invalid for lack of enablement.
The ’590 patent is directed to resolving a known issue in treating Hemophilia A, a blood clotting disorder. Previously, to treat Hemophilia A, a patient was often intravenously administered Factor VIII. However, some patients cannot be effectively treated with Factor VIII because their bodies develop Factor VIII inhibitors.
Potential Claim Construction Error Is Harmless When Not Relied Upon by the Board
BOT M8 LLC v. SONY INTERACTIVE ENTERTAINMENT LLC
Before Prost, Reyna, and Cunningham. Appeal from the Patent Trial and Appeal Board.
Summary: A party challenging the Board’s decision by alleging claim construction errors must demonstrate the harmfulness of the alleged errors for the Board’s decision to be reversed.
Federal Circuit Finds Patent for Dietary Supplements Invalid Under § 101 for Reciting Naturally Occurring Milk Components
Occurring Milk ComponentsIn ChromaDex, Inc. v Elysium Health, Inc., Appeal No. 2022-1116, the Federal Circuit upheld the invalidity of a claim reciting a supplement comprising nicotinamide riboside (“NR”), a component found in cow’s milk, under 35 U.S.C. § 101, finding that the claim read on a product of nature.
Patent Term Adjustment Under 35 U.S.C. 154(b)(1)(C)(iii) Requires Reversal of Adverse Determination of Patentability
SAWSTOP HOLDING LLC V. VIDAL
Before Newman, Linn, and Chen. Appeal from the United States District Court for the Eastern District of Virginia
Summary: When a patent claim is subject to adverse determinations of patentability first before the PTO and again after appeal, the claim is not entitled to patent term adjustment for the period of the appeal even if the claim eventually issues after post-appeal prosecution and amendment.
Required Testing as Part of an Offer for Sale Does Not Preclude a Finding of a Commercial Sale for On-Sale Bar Defense
SUNOCO PARTNERS MARKETING v. U.S. VENTURE, INC.
Before Prost, Reyna, and Stoll. Appeal from the United States District Court for the Northern District of Illinois.
Summary: References to testing in an offer for sale do not necessarily trigger application of the experimental use exception to the on-sale bar defense.
Prosecution History Disclaimer and Estoppel Lead To Noninfringement
TRAXCELL TECHNOLOGIES, LLC V. NOKIA SOLUTIONS AND NETWORKS
Before Prost, O’Malley, and Stoll. Appeal from the Eastern District of Texas.
Summary: An applicant’s arguments distinguishing prior art during patent prosecution constituted a disclaimer of claim scope and estopped the patentee from relying on the doctrine of equivalents to show infringement.
