New guidance rescinds Biden-era guidance from February 2024 and signals a pro-patent, pro-AI landscape.
On November 28, 2025, the United States Patent and Trademark Office ("USPTO") published revised guidance on...more
12/8/2025
/ Artificial Intelligence ,
Biden Administration ,
Executive Orders ,
Intellectual Property Protection ,
Inventors ,
New Guidance ,
Patent Applications ,
Patent Examinations ,
Patents ,
Regulatory Reform ,
Trump Administration ,
USPTO
The Food and Drug Administration ("FDA") issued two draft guidance documents that would largely eliminate clinical efficacy and switching studies and instead rely on the precision of modern analytical methods to accelerate...more
12/4/2025
/ Biosimilars ,
Drug Pricing ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Interchangeability ,
Life Sciences ,
New Guidance ,
Patent Litigation ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Reform ,
Regulatory Requirements
With the aim of accelerating approval of biosimilars, the U.S. Food and Drug Administration ("FDA"), in its draft guidance "Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated...more
11/4/2025
/ Biosimilars ,
Clinical Trials ,
Draft Guidance ,
Efficacy Claims ,
FDA Approval ,
Healthcare ,
Life Sciences ,
Pharmaceutical Industry ,
Regulatory Agenda ,
Regulatory Reform ,
Regulatory Requirements
Life sciences and biopharma companies often rely on clinical trial results and "clinically proven effective" language in patent claims, but this approach carries significant risks if key details are publicly disclosed before...more
10/2/2025
/ Bayer ,
CAFC ,
Clinical Trials ,
Life Sciences ,
Mylan Pharmaceuticals ,
Obviousness ,
Patent Applications ,
Patent Invalidity ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prior Art
Senate Bill S. 4878 seeks to force innovator pharmaceutical companies to select a single Orange Book listed patent for the 30-month stay. ...more
8/27/2025
/ Abbreviated New Drug Application (ANDA) ,
FDA Approval ,
Generic Drugs ,
Hatch-Waxman ,
Healthcare ,
Life Sciences ,
Orange Book ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Patient Access ,
Pharmaceutical Patents ,
Prescription Drugs ,
Proposed Legislation ,
Stays
The One Big Beautiful Bill Act ("OBBB") expands exemptions for orphan drugs from mandatory Medicare price negotiations and modifies their eligibility timeline....more
7/29/2025
/ Drug Pricing ,
Health Insurance ,
Healthcare ,
Medicare ,
New Legislation ,
One Big Beautiful Bill Act ,
Orphan Drugs ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Reform ,
Trump Administration
A new interim process for the acting director to exercise discretion as to whether to institute an inter partes review ("IPR") or a post-grant review ("PGR") was announced on March 26, 2025, in which discretionary...more
4/4/2025
/ Administrative Procedure ,
Director of the USPTO ,
Filing Deadlines ,
Intellectual Property Litigation ,
Intellectual Property Protection ,
Inter Partes Review (IPR) Proceeding ,
Patent Trial and Appeal Board ,
Patents ,
Post-Grant Review ,
Proposed Rules ,
USPTO
A new interim process for the Director to exercise discretion as to whether to institute an inter partes review(IPR) or a post grant review (PGR) was announced on March 26, 2025, in which discretionary considerations and...more
3/31/2025
/ Administrative Procedure Act ,
Appeals ,
Director of the USPTO ,
Intellectual Property Protection ,
Inter Partes Review (IPR) Proceeding ,
New Guidance ,
Patent Infringement ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Post-Grant Review ,
USPTO
The U.S. Patent and Trademark Office ("USPTO") raised patent fees and introduced new surcharges....more
The U.S. Patent and Trademark Office ("USPTO") has withdrawn its proposed rule regarding terminal disclaimer requirements....more
The Supreme Court denies Cellect LLC's petition for certiorari to consider whether patent term adjustment ("PTA") should be included in patent term for obviousness-type double patenting ("ODP") purposes....more
10/15/2024
/ Denial of Certiorari ,
Double Patent ,
Obviousness ,
Obviousness-Type Double Patenting (ODP) ,
Patent Applications ,
Patent Infringement ,
Patent Litigation ,
Patent Term Adjustment ,
Patents ,
Petition for Writ of Certiorari ,
SCOTUS ,
USPTO
The USPTO has extended the public comment deadline in order to afford all stakeholders an opportunity to weigh in on the subject matter eligibility of AI inventions....more
9/23/2024
/ Artificial Intelligence ,
Comment Period ,
Deadlines ,
Innovative Technology ,
Intellectual Property Protection ,
Inventions ,
Inventors ,
Machine Learning ,
Patent Applications ,
Patent Litigation ,
Patent-Eligible Subject Matter ,
Patents ,
Public Comment ,
USPTO
The Situation: Senate Bill 150 ("S.B. 150")—the Affordable Prescriptions for Patients Act of 2023—unanimously passed the Senate and would amend 35 U.S.C. § 272(e) to limit, under certain circumstances, the number of patents...more
7/30/2024
/ Biosimilars ,
Intellectual Property Protection ,
Life Sciences ,
Patent Applications ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Proposed Legislation ,
Regulatory Agenda ,
Regulatory Reform
The Situation: Concerns that uncertain and unpredictable patent subject matter eligibility jurisprudence thwarts U.S. economic and technological advancements are especially acute in the fast advancing AI space. Stakeholders...more
The United States Patent and Trademark Office ("USPTO") is seeking public input about the need for a statutory experimental use exception in light of the common law jurisprudence. ...more
The Situation: The National Institutes of Health ("NIH") proposed a new policy requiring entities that receive licenses from the NIH to certain taxpayer-funded inventions to submit Access Plans for ensuring broader patient...more
The Situation: Earlier this year, Florida became the first state to receive authorization for its Section 804 Importation Program ("SIP") from the U.S. Food and Drug Administration ("FDA"). This initial step toward the legal...more
5/29/2024
/ Abbreviated New Drug Application (ANDA) ,
Canada ,
Department of Health and Human Services (HHS) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Healthcare ,
Imports ,
Intellectual Property Protection ,
Manufacturers ,
Pharmaceutical Industry ,
Pharmacist ,
Prescription Drugs ,
Supply Chain
In denying Petitioner Medivis, Inc.’s (“Medivis”) Request for Rehearing of the Patent Trial and Appeal Board’s (“PTAB”) Final Written Decision (“FWD”) in Medivis, Inc. v. Novarad Corp. inter partes review, the PTAB found that...more
The USPTO is seeking public input on whether prior art must be authored by humans and how, if at all, AI-generated disclosures should be treated differently from non-AI generated disclosures....more
The Federal Circuit denied Cellect, LLC's petition for rehearing en banc of the In re Cellect case, which held that the expiration of a patent for obviousness-type double patenting ("ODP") purposes is the expiration date...more
1/26/2024
/ En Banc Review ,
Intellectual Property Protection ,
Obviousness ,
Obviousness-Type Double Patenting (ODP) ,
Patent Infringement ,
Patent Litigation ,
Patent Term Adjustment ,
Patent Term Extensions ,
Patent Trial and Appeal Board ,
Patents ,
Petition For Rehearing
The Situation: On December 8, 2023, the National Institute of Standards and Technology ("NIST") released a proposed framework for federal agencies regarding the exercise of the government's march-in rights for federally...more
12/20/2023
/ Bayh-Dole Act ,
Biotechnology ,
Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Health and Safety ,
Healthcare ,
Inflation Reduction Act (IRA) ,
Intellectual Property Protection ,
Inventions ,
Life Sciences ,
March-in Rights ,
NIST ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Prescription Drugs
The Senate Judiciary Committee is showing renewed Congressional interest in oversight of the pharmaceutical industry, with five bipartisan drug bills on the agenda for review and discussion on February 9, 2023....more
In Mobility Workx, LLC v. Unified Patents, LLC, the Federal Circuit in a split decision concluded that Mobility Workx, LLC’s constitutional challenges to structure and funding of the Patent Trial and Appeal Board (“PTAB”) are...more
10/26/2021
/ Administrative Proceedings ,
America Invents Act ,
Constitutional Challenges ,
Due Process ,
Fees ,
Inter Partes Review (IPR) Proceeding ,
Patent Infringement ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
United States v Arthrex Inc ,
USPTO
On September 29, 2021, the Federal Circuit in In re: Vivint, Inc. (Fed. Cir. 2021) held that 35 U.S.C. § 325(d) applies to both inter partes review (IPR) petitions and requests for ex parte reexamination. Accordingly, the...more
The Supreme Court unanimously finds that the AIA's "on sale" statutory language did not alter the pre-AIA "on-sale" bar.
On January 22, 2019, the U.S. Supreme Court held that the America Invents Act ("AIA") did not change...more
1/28/2019
/ America Invents Act ,
Appeals ,
Assignment of Inventions ,
Confidentiality Agreements ,
Helsinn Healthcare SA v Teva Pharmaceuticals USA Inc ,
Inventions ,
On-Sale Bar ,
Patent Applications ,
Patent Infringement ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Public Use ,
Reaffirmation ,
Reversal ,
SCOTUS ,
Section 102 ,
Third-Party Relationships