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 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
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
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