Analyzing the permissible scope of an injunction under the Hatch-Waxman Act, the US Court of Appeals for the Federal Circuit reversed the district court’s prohibitions on an open-label extension (OLE) of a then-running...more
5/15/2025
/ Appeals ,
Clinical Trials ,
Food and Drug Administration (FDA) ,
Hatch-Waxman ,
Injunctive Relief ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Safe Harbors
The US Senate Judiciary Committee advanced to the full Senate six bills intended to reduce pharmaceutical prices and enhance market competitiveness. The package collectively targets several aspects of the pharmaceutical...more
4/17/2025
/ Antitrust Provisions ,
Biosimilars ,
Drug Pricing ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
New Legislation ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents
This post has been updated since its original publication date.
On November 15, 2024, the US Senate Judiciary Subcommittee on Intellectual Property advanced the Inventor Diversity for Economic Advancement (IDEA) Act, one...more
On November 15, 2024, the US Senate Judiciary Subcommittee on Intellectual Property advanced the Inventor Diversity for Economic Advancement (IDEA) Act, one of three significant bills it considered this year to reform the...more
The US Court of Appeals for the Federal Circuit held that a branded pharmaceutical manufacturer properly pled a theory of inducement by alleging that the generic competitor promoted its product as “generic” to the branded...more
The US Court of Appeals for the Federal Circuit affirmed that the 35 U.S.C. § 271(e)(1) safe harbor protecting certain infringing acts undertaken for regulatory approval applied to an alleged infringer’s importation of...more
Seeking to undo the current jurisprudence “mess” on the issue of patent eligibility, the Senate Judiciary Committee’s Subcommittee on Intellectual Property heard testimony on January 23, 2024, on the Patent Eligibility...more
In light of the 2023 Supreme Court of the United States decision in Amgen Inc. v. Sanofi, the US Patent & Trademark Office (PTO) published guidelines for PTO employees to use, regardless of technology, to ascertain compliance...more
On November 8, 2023, the US Senate Judiciary Subcommittee on Intellectual Property heard testimony from four witnesses on the proposed Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act....more
In late June 2023, Senators Chris Coons (D-DE) and Thom Tillis (R-NC) introduced two bills in Congress that, if enacted, would change the patent adjudication landscape:
- The Promoting and Respecting Economically Vital...more
Considering whether the US Patent & Trademark Office (PTO) Director must complete review of the Patent Trial & Appeal Board’s (Board) inter partes review (IPR) decision within the statutory deadline for a final written...more
Addressing a case where a patent owner filed hundreds of applications as part of a strategy to maintain extraordinarily lengthy patent coverage, the US Court of Appeals for the Federal Circuit affirmed a district court’s...more
The US Court of Appeals for the Federal Circuit denied mandamus relief, finding that a party is not entitled to petition the director for review of a Patent Trial & Appeal Board (Board) decision denying institution of an...more
The US Court of Appeals for the Fourth Circuit held that a corporation that is not physically present in a district is not “found” in the district for purposes of the federal statute that authorizes courts to order discovery...more
Considering numerous claim construction, infringement and damages issues related to patents allegedly covering Apple’s iPhones 5 and 6 series technology, a panel of the US Court of Appeals for the Federal Circuit determined...more
2/17/2022
/ Appeals ,
Apple ,
Claim Construction ,
Damages ,
iPhone ,
Liability ,
License Agreements ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Technology
A split panel of the US Court of Appeals for the Federal Circuit concluded that the structure and functions of the Patent Trial & Appeal Board (PTAB) survived yet another constitutional challenge, this time based on the...more
Examining whether portfolio patent licenses can be sufficiently comparable to a single-patent license for the purposes of supporting a patent damages verdict, a split panel of the US Court of Appeals for the Federal Circuit...more
10/1/2021
/ Appeals ,
Apportionment ,
Corporate Counsel ,
Damages ,
Daubert Standards ,
Direct Infringement ,
Licenses ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Vacatur
Through a splintered set of opinions, the Supreme Court of the United States held that appointment of administrative patent judges (APJs) serving on the Patent Trial and Appeal Board (PTAB) violated the Appointments Clause of...more
6/25/2021
/ Administrative Patent Judges ,
Appointments Clause ,
Arthrex Inc v Smith & Nephew Inc ,
Executive Branch ,
Executive Powers ,
Inter Partes Review (IPR) Proceeding ,
Patent Trial and Appeal Board ,
Patents ,
SCOTUS ,
United States v Arthrex Inc ,
USPTO
Addressing for the first time whether the US Patent & Trademark Office (PTO) can assert prosecution laches as a defense in a civil action brought under 35 U.S.C. §145, the US Court of Appeals for the Federal Circuit held that...more
Reaffirming that a person of ordinary skill in the art must have been able to actually create a disclosure at the time of invention in order for it to serve as an obviousness reference, the US Court of Appeals for the Federal...more
Addressing whether the phrase “a plurality of” should apply to each element in a series, the US Court of Appeals for the Federal Circuit entered judgment of non-infringement, finding that the district court’s claim...more
Addressing whether purported trade secret information ought to remain under seal on appeal, the US Court of Appeals for the Sixth Circuit ruled in a one-judge order that the Defend Trade Secrets Act (DTSA) provided a...more
Addressing whether the Patent Trial and Appeal Board (PTAB or Board) too narrowly read its rules limiting reply briefs in an inter partes review (IPR) to preclude a petitioner’s argument as a “new theory of unpatentability,”...more