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
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
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
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
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
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
Each year, Americans spend more than $1,500 per person on prescription drugs. Critics calling for measures to lower prescription drug costs often cast blame on alleged abuses of patent and competition laws. To address these...more
10/26/2021
/ Anti-Competitive ,
Biden Administration ,
Biosimilars ,
Biotechnology ,
Competition ,
Drug Pricing ,
Executive Orders ,
Federal Trade Commission (FTC) ,
Generic Drugs ,
Healthcare Reform ,
Intellectual Property Protection ,
Life Sciences ,
Patent Ownership ,
Patient Access ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Agenda ,
USPTO
We recently reported on bipartisan legislation introduced by Senators Patrick Leahy (D) and John Cornyn (R) to significantly revamp certain features of the America Invents Act (AIA), ten years after its debut. This proposed...more
10/22/2021
/ America Invents Act ,
Estoppel ,
Injury-in-Fact ,
Intellectual Property Protection ,
Inter Partes Review (IPR) Proceeding ,
Inventions ,
Patent Trial and Appeal Board ,
Patents ,
Proposed Legislation ,
Regulatory Agenda ,
Regulatory Reform ,
Regulatory Standards ,
Standing ,
USPTO
Partners Matt Johnson and Sarah Geers talk about former USPTO Director Andrei Iancu's impact on the PTAB, and what we might expect from a new director under the Biden Administration. They also comment on why patent litigation...more