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
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 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
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
The Federal Circuit recently affirmed the Patent Trial and Appeal Board’s (“PTAB”) final written decisions finding the claims of Yeda Research and Development Co., Ltd.’s (“Yeda”) U.S. Patent Nos. 8,232,250, 8,399,413, and...more
10/26/2018
/ Appeals ,
Evidence ,
Multi-Party Litigation ,
Mylan Pharmaceuticals ,
Obviousness ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Patents ,
POSITA ,
Prior Art ,
Reaffirmation ,
Sandoz ,
Teva Pharmaceuticals
The Federal Circuit recently denied Power Integrations, Inc.’s (“PI”) attempt to obtain a writ of mandamus to circumvent the bar in 35 U.S.C. § 314(d) to appeal the Patent Trial and Appeal Board’s (“PTAB”) decisions denying...more
Following the logic set forth in SAS Institute, Inc. v. Iancu, 138 S. Ct. 1348 (2018), the Federal Circuit granted Petitioner Adidas AG’s (“Adidas”) motion to remand IPR2016-00921 and IPR2016-00922 to the Patent Trial and...more
The Situation: The Biologics Price Competition and Innovation Act was considered in a November 2017 decision by the United States Court of Appeals for the Federal Circuit.
The Result: The court found that the commercial...more
11/29/2017
/ aBLA ,
Amgen ,
Amgen v Apotex ,
Appeals ,
Biologics ,
Biologics Price Competition and Innovation Act of 2009 ,
Biosimilars ,
Claim Construction ,
Hatch-Waxman ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
SCOTUS ,
Witness Statements
On April 26, 2017, the U.S. Supreme Court heard oral argument in Sandoz Inc. v. Amgen Inc. (Nos. 15-1039, 15-1195), on appeal from the Federal Circuit's July 21, 2015, opinion interpreting various provisions of the Biologics...more
5/15/2017
/ Amgen ,
Appeals ,
Biologics ,
Biosimilars ,
BPCIA ,
Certiorari ,
Commercial Marketing ,
Declaratory Judgments ,
Food and Drug Administration (FDA) ,
Notice and Comment ,
Notice Requirements ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Sandoz ,
Sandoz v Amgen ,
SCOTUS
For more than 60 years, Section 102(b) of the Patent Act precluded patentability when the invention was "in public use or on sale in this country [for] more than one year" before the filing of a patent application. That...more