FDA Launches Expedited IND Pilot Program to Accelerate Human Trials, Raising IP Considerations for Sponsors
Key Takeaways: The Expedited Investigational New Drug (IND) Pilot Program is intended to evaluate whether leveraging qualified research institutions (QRIs) and a rolling review process can improve the efficiency of...
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...
Knobbe Martens’ Standout Life Sciences Work Recognized in Annual LMG Rankings
Firm receives top-tier rankings for patent strategy, prosecution and litigation across life sciences industry IRVINE, Calif., October 1, 2025 – Knobbe Martens is proud to share that Legal Media Group...
National Institutes of Health (NIH) Announces Plan to Centralize Peer Review Process
On March 6, 2025, the National Institutes of Health (NIH) announced plans to centralize peer review of all applications for grants, cooperative agreements and research and development contracts within its...
Edwards v. Meril at the Supreme Court: Testing the Scope of Hatch-Waxman’s Safe Harbor
On October 11, 2024, Edwards[1] filed a petition for a writ of certiorari with the U.S. Supreme Court.[2] The question presented, as framed by Edwards, is: “Whether, under Hatch-Waxman’s safe...
FDA Provides Perspective on Goals and Challenges for Regulation of Artificial Intelligence in Medical Devices, Drug Design, and Clinical Research
A recent article[1] authored by Haider J. Warraich, MD[2]; Troy Tazbaz[3]; and Robert M. Califf[4], MD in the Journal of the American Medical Association, reviews the history of artificial intelligence...
Knobbe Martens Again Honored as a Top Life Sciences Firm by LMG
IRVINE, Calif., October 16, 2024 – Knobbe Martens’ across-the-board strength in the life sciences space was again recognized by Legal Media Group (LMG), as the firm and its partners received...
Novartis Loses Bid for Preliminary Injunction Against MSN Pharmaceuticals
Judge Andrews of the District of Delaware recently denied Novartis’s request for a preliminary injunction against MSN Pharmaceuticals. Novartis Pharm. Corp. v. MSN Pharm. Inc., Civil Action No. 20-md-2930-RGA, Dkt. No. 1456 (D. Del. Aug. 12, 2024). Novartis had requested a preliminary injunction to block MSN Pharmaceuticals from launching a generic version of Novartis’s top-selling oral heart failure drug Entresto®.
Knobbe Martens Named a Top Performing Firm, Ten Individuals Ranked Highly for Patent Prosecution in Patexia Report
IRVINE, Calif., March 28, 2024 – Knobbe Martens is proud to announce that the firm and several of its professionals have achieved outstanding rankings in the 2024 Patexia Patent Prosecution...
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 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.
LMG Recognizes Knobbe Martens as Leading Life Sciences Firm
IRVINE, CALIF., September 21, 2023 – Knobbe Martens is pleased to announce that Legal Media Group (LMG) has again recognized the firm as having one of the top life sciences intellectual...
Implications of the Proposed EU Pharmaceutical Law Reform Overhaul
On April 26, 2023, the European Commission proposed a pharmaceutical law reform directed to replacing the existing pharmaceutical legislation. The reform aims to increase innovation and competition in the pharmaceutical industry, while reducing the cost of drugs for consumers.
Knobbe Martens Again Ranked Among Nation’s Top Life Sciences Firms by LMG
IRVINE, CALIF., September 26, 2022 – Knobbe Martens is pleased to announce that Legal Media Group (LMG) has again recognized the firm as having one of the top life sciences...
