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
More than a decade after the enactment of the America Invents Act (AIA), the Federal Circuit has issued its first opinion addressing an AIA derivation proceeding. In Global Health Solutions LLC v. Selner, the court clarified...more
9/26/2025
/ America Invents Act ,
Appeals ,
CAFC ,
Derivation Proceeding ,
Intellectual Property Protection ,
Interference Proceeding ,
Inventions ,
Inventors ,
Patent Applications ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Patents
For the first time under the bifurcated institution procedures, the Acting Director reversed her own prior discretionary denial, citing changed circumstances based on a settlement in the parallel district court litigation. ...more
9/3/2025
/ Denial of Institution ,
Intellectual Property Protection ,
Inter Partes Review (IPR) Proceeding ,
Parallel Proceedings ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Settlement ,
USPTO
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
Under a new U.S. Patent and Trademark Office (“USPTO”) policy issued in March 2025, pre-institution inter partes review (“IPR”) proceedings are now bifurcated, consisting of a first phase in which the director considers...more
7/8/2025
/ Hatch-Waxman ,
Intellectual Property Litigation ,
Inter Partes Review (IPR) Proceeding ,
National Security ,
Orange Book ,
Patent Applications ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Post-Grant Review ,
USPTO
On June 23, 2025, the Supreme Court invited the Solicitor General to submit a brief expressing the views of the United States—dramatically increasing the likelihood that the Court will eventually grant review—in Hikma...more
7/1/2025
/ Appeals ,
Food and Drug Administration (FDA) ,
Induced Infringement ,
Patent Infringement ,
Patent Litigation ,
Petition for Writ of Certiorari ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
SCOTUS ,
Solicitor General ,
Statutory Interpretation
Under a new U.S. Patent and Trademark Office ("USPTO") policy issued in March 2025, pre-institution inter partes review ("IPR") proceedings are now bifurcated, consisting of a first phase in which the director considers...more
6/25/2025
/ Hatch-Waxman ,
Intellectual Property Litigation ,
Intellectual Property Protection ,
Inter Partes Review (IPR) Proceeding ,
Orange Book ,
Patent Infringement ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
USPTO
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
In the closing weeks of 2024, USPTO Director Kathi Vidal announced her departure in a November LinkedIn post, stating that she would leave the Office during the second week of December to rejoin the partnership of...more
The Federal Circuit recently issued a decision in SoftView LLC v. Apple Inc. clarifying the scope of patent owner estoppel set forth in 37 C.F.R. § 42.73(d)(3)(i). 2024 WL 3543902 (Fed. Cir. July 26, 2024). The regulation...more
On July 9, 2024, Director Vidal reversed and remanded a denial of institution of inter partes review (IPR) relating to three Spin Master patents. See Prime Time Toys LLC v. Spin Master, Inc., IPR Nos. 2023-01339, 2023-01348,...more
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: The Hatch-Waxman Act allows generic drug manufacturers to "carve out" a brand's patented indications from their proposed labeling. Generic manufacturers often rely on these so-called "skinny labels" to try to...more
7/9/2024
/ Abbreviated New Drug Application (ANDA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Life Sciences ,
Patent Infringement ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Director Vidal recently vacated three discretionary denials of institution after finding that the three petitioners did not have a “significant relationship” with a prior petitioner. American Honda Motor Co., Inc. v. Neo...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
USPTO Director Kathi Vidal recently designated precedential section II.E.3 of Penumbra, Inc. v. RapidPulse, Inc. and clarified that the priority analysis for an AIA reference patent as prior art is different than for a...more
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
In its second-ever Final Written Decision in a derivation proceeding, the Patent Trial and Appeal Board (“PTAB”) determined that a patent application for a biocidal composition and method of producing said biocidal...more
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 Short -
The Situation: With the calendar officially turned to a new year several significant changes and regulatory initiatives are on the horizon at the Food and Drug Administration ("FDA")....more
The Federal Circuit recently held, in Cupp Computing AS v. Trend Micro Inc., that a disclaimer in an inter partes review (IPR) proceeding is not binding on the USPTO in the same proceeding in which the disclaimer is made....more
In Short: -
The Situation: President Biden and members of Congress have called for reform of certain patenting practices at the United States Patent and Trademark Office ("USPTO") under the premise that changes to the...more
The PTAB recently issued a rare decision instituting a derivation proceeding, in Global Health Solutions LLC v. Selner, DER2017-00031 (“GHC”). The GHC institution decision provides several lessons for future petitioners...more
A podcast from JAMS featuring Steven Bauer and Sarah Geers on how ADR can play a pivotal role in resolving IP-related disputes in the life sciences industry -
In this podcast, Steven Bauer, mediator and arbitrator at...more
4/1/2022
/ Arbitration ,
Arbitrators ,
Dispute Resolution ,
Intellectual Property Litigation ,
Inventors ,
Life Sciences ,
Mediation ,
Mediators ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Trade Secrets
On January 31, 2022, Sen. Thom Tillis (R-N.C.), the Ranking Member of the Senate Judiciary Committee Subcommittee on Intellectual Property, sent a letter to Janet Woodcock, Acting Commissioner of the FDA, and Drew...more
2/16/2022
/ Competition ,
Data Management ,
Deceptive Intent ,
Drug Pricing ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Life Sciences ,
Monopolization ,
Patient Access ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Regulatory Oversight ,
Regulatory Standards ,
USPTO