Patent, Protect, or Pause: Triaging AI-Drafted Invention Disclosures in Biopharma
Key Takeaway: As AI-drafted invention disclosures become more common, counsel are reading past the polished prose, and thinking harder about privilege, and confidentiality. If invention disclosures sound different lately, look...
Shared Function, Not Shared Structure: Ex parte Chowdhury and the Improper Markush Grouping Rejection
Key Takeaway: A Markush group of structurally dissimilar biomolecules is proper if the specification describes its members as performing the same function within the claimed invention. On August 25, 2026,...
FDA Approves First mRNA-Based Flu Vaccine, Highlighting Growing Patent Value in mRNA Platforms
Key Takeaway: The FDA’s approval of mFLUSIVA may indicate increased commercial and strategic value of mRNA vaccine patents. On August 5, 2026, Moderna announced that the U.S. Food and Drug...
No “Duty to Innovate” – California’s Highest Court Finds Gilead Sciences Not Negligent for Delaying Release of Allegedly Safer HIV Drug
Key Takeaway: California court holds that drug manufacturers do not have a duty to commercialize a safer drug to replace a nondefective one. In the Gilead Tenofovir Cases, a group...
Federal Circuit Affirms Invalidation of Patent for Lack of Enablement of Claims Directed to a Method of Treating a Patient With “A Unit Dosage” in Wyeth LLC v. Astrazeneca Pharmaceuticals LP.
Key Takeaway: Federal Circuit invalidates patent claims directed to a method for treating non-small cell lung cancer through administration of “a unit dosage” of an irreversible epidermal growth factor receptor...
When “About” Becomes Indefinite: Federal Circuit Provides Guidance for Life Science Patent Applications Regarding Limits of Approximation in Enviro Tech v. Safe Foods
Key Takeaway: The term “about” remains useful in biotech and pharmaceutical claims, but only if the patent provides objective guidance about what the term means. Absent that guidance, “about” may...
Changes to Mexican Patent Law May Impact Life Science Patent Prosecution
Key Takeaway: While recent amendments to Mexico’s patent laws promote faster prosecution and earlier decisions on patents, concerns abound as to the feasibility and integrity of the prosecution process. On...
Amendments to Mexico’s Federal Law for Protection of Industrial Property Inform More Flexible International IP Strategy for Biotech Companies
Key Takeaway: Amendments to Mexico’s Federal Law for Protection of Industrial Property align more with U.S. Patent and Trademark Office standards for restoring priority and application revival, increasing international patent...
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....
AI Risks With the Patent Office: What Life Science Companies Should Be Asking Now
Key Takeaway(s): AI tools are reshaping patent preparation and prosecution, but statements made to the USPTO are permanent, and AI-generated inaccuracies don’t come with warning labels. Efficiency gains are real, but...
Well-Known Genus, Novel Method: A Post-Amgen Framework for Written Description & Enablement
Key Takeaways: Recent Federal Circuit decision draws a meaningful distinction between patents that claim a broad genus as the invention itself and those that claim a novel therapeutic method using...
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...
One Battle After Another: Broad Institute Wins at PTAB in CRISPR Dispute
Key Takeaways: Interference proceedings, though increasingly rare, are heavily evidence-based and determine which party is the first inventor when two or more applicants claim the same patentable invention. Sometimes, an...
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...
AI and Genomics: A New Era of Personalized Medicine
Key Takeaway: Advances in AI and genomic analysis will allow medical providers to tailor treatment for individual patients at the genome level, but challenges exist for protecting AI-assisted inventions. Genomic...
Practical Application and Particular Treatment: What the USPTO’s December 4 Memorandum Means for Life Sciences §101 Eligibility
The USPTO’s December 4, 2025 memorandum on Subject Matter Eligibility Declarations (SMEDs) seeks to raise awareness of the “underutilized path” of submitting Rule 132 declarations, referred to as “SMEDs”, for...
Proposed Legislation to Codify “Skinny Label” Safe Harbor
On December 5, 2025, the Skinny Labels, Big Savings Act (H.R. 6485) was introduced in the House of Representatives. The bill, if enacted, would shield certain drug manufacturers who have...
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...
Patent Exclusivity and Price Controls: Teva v. Kennedy
On November 20, 2025, the D.C. District Court issued its opinion [1] in a lawsuit where Teva Pharmaceuticals USA, Inc. challenged the validity of the Medicare Drug Price Negotiation Program...
