eVTOL Takes Flight: Navigating Certification, Regulation, and IP in Advanced Air Mobility
Key Takeaways: eVTOL aircraft are moving toward real-world deployment, but certification remains a critical hurdle alongside early operational programs like the FAA’s eIPP. As companies advance in parallel, careful coordination...
Kregg Koch Discusses How Medtech Innovators Can Build a Stronger IP Strategy Through Patent Filing, Portfolio Development, and AI
In an article published by nonprofit educational medtech incubator Fogarty Innovation, Knobbe Martens partner Kregg Koch shared practical strategies for medtech companies and entrepreneurs looking to protect and maximize the...
Federal Circuit Confirms Patent Eligibility of Gene Therapy Patent in Regenexbio Inc. v. Sarepta Therapeutics
Key Takeaway: Genetically engineered cultured host cells containing recombinant nucleic acids useful for gene therapy are patent-eligible for being markedly different from anything occurring in nature. In REGENXBIO Inc. v....
Tom Cowan Discusses IP Issues Relevant to “Dual-Use” Aerospace Technologies on The Space Hour Podcast
In a recent episode of The Space Hour podcast, Knobbe Martens partner Tom Cowan offered insights on the unique intellectual property (IP) challenges facing “dual-use” aerospace companies – those technology...
FDA Issues Recommendations for the Development of Individualized Therapies for Patients With Ultra-Rare Diseases
Key Takeaway: The FDA is developing a “plausible mechanism framework” to facilitate approval of individualized therapies for the treatment of rare genetic diseases that currently face approval challenges. As discussed previously...
Knobbe Martens Named Among Top Patent Prosecution Leaders in Patexia Report
IRVINE, Calif., April 1, 2026 – Knobbe Martens is pleased to share that the firm and several of its partners were highlighted in Patexia’s 2026 Patent Prosecution Leaders report for...
IP Considerations Following FDA Announcement on Flexibility for Cell and Gene Therapies
Key Takeaways: Manufacturing processes of cell and gene therapies (CGTs) may remain fluid well into development and even after FDA approval, and therefore sponsors of CGTs may benefit from patent...
New FDA Guidance Allows Biosimilar Applicants to Use Data From Outside the U.S. To Accelerate Their Approval in the U.S.
Key Takeaway: New FDA guidance released on February 23, 2026, and March 9, 2026, signals a continued shift toward regulatory flexibility aimed at accelerating approval of biosimilar treatments for rare...
Life Science Considerations on the USPTO’s New Guidelines for AI-Assisted Inventorship
On November 26, 2025, the United States Patent and Trademark Office (USPTO) issued revised guidelines for determining inventorship of AI-assisted inventions,[1] which is a significant development in life science innovations,...
USPTO’s Automated Search Pilot: Through a Biotech Lens
In October 2025, the U.S. Patent and Trademark Office (USPTO) launched the “Artificial Intelligence Search Automated Pilot Program,” or ASAP!, an initiative to identify potential prior art using artificial intelligence...
USPTO Proposes Rule and Director Implements Policy Likely to Limit Multiple Patent Validity Challenges
On Friday, October 17, the USPTO published a proposed rule that, if implemented, would likely reduce filings of inter partes review patent validity challenges. In addition, USPTO Director John Squires...
Protecting Inventions for In-Space Manufacturing – How the Space Act and Patent Claim Strategy Can Help
As the larger aerospace industry continues to grow, space technology companies are pursuing innovations for in-space manufacturing. This technology includes producing and/or assembling structures or other items in orbit, or...
U.S. Design “Rocket Docket” Grounded
The U.S. Patent Office’s program for expedited examination of design applications under 37 CFR 1.155 (often called the design “rocket docket”), which was suspended earlier this year, was formally canceled...
Space Technology Investments Clear the Launch Tower in 2025
Investments in space technology are off to a strong start in the first half of 2025. The rising trend over the last four years, as mentioned in a previous Knobbe...
Knobbe Martens Receives Top Rankings for Patent, Trademark, and Copyright Work from Managing IP
IRVINE, Calif., July 1, 2025 – Knobbe Martens is proud to share that the firm has once again been recognized as among the leading national intellectual property law firms in Managing...
Reissue Applications Are Bound by the Scope of the Claims as Written, Not as Intended
IN RE KOSTIC Before Stoll, Clevenger, and Cunningham. Appeal from the Patent Trial and Appeal Board. Summary: When considering whether a reissue claim broadens the scope of the original patent,...
Inventive Concepts Must Be Included in the Claim Language
United Services Automobile Association v. PNC BANK N.A., Before Dyk, Clevenger, and Hughes. Appeal from the United States District Court for the Eastern District of Texas. Summary: A claim that...
Results of The Deferred Subject Matter Eligibility Response Pilot Program
On June 18, 2025, the United States Patent and Trademark Office (USPTO) hosted an informational call to share the results of a study on the Deferred Subject Matter Eligibility (DSMER)...
Rare Disease Therapies Gain Momentum With Regulatory Support and Continued Market Growth
The landscape for rare disease treatments appears to be evolving rapidly, thanks to a confluence of regulatory momentum and a booming market forecast. Statements from key federal figures in recent...
Knobbe Martens, Dozens of Firm Partners Recognized in Legal 500 U.S.A. Guide
Firm again receives standout rankings in multiple practice areas, including prosecution, trademarks, licensing, and litigation IRVINE, Calif., June 17, 2025 – Knobbe Martens is proud to announce that the firm...
Patent Scorecard – Ranking Patent Portfolios in the Aerospace Industry
The Institute of Electrical and Electronics Engineers (IEEE) recently released its 2025 “Patent Scorecard” where it analyzes and ranks companies with large patent portfolios in various industries, including aerospace. The...
