On May 24, 2024, member states of the World Intellectual Property Organization (WIPO) adopted a new treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge that was over 20 years in the making....more
The Federal Trade Commission (FTC) issued a policy statement on September 14, 2023, stating that “[b]rand drug manufacturers may be harming generic competition through the improper listing of patents in the Food and Drug...more
12/5/2023
/ Competition ,
Federal Trade Commission (FTC) ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
FTC Act ,
Generic Drugs ,
Hatch-Waxman ,
Healthcare ,
Life Sciences ,
Orange Book ,
Patents ,
Pharmaceutical Patents ,
Prescription Drugs ,
Section 5
On March 29, 2023, the Solicitor General of the United States asked the Supreme Court to review a Federal Circuit judgment in a Hatch-Waxman case between Teva and GSK. In its decision below, the Federal Circuit held that Teva...more
In Natural Alternatives International, Inc. v. Creative Compounds, LLC., Appeal No. 2018-1295, a divided panel of the Federal Circuit reversed and remanded a decision by the District Court for the Southern District of...more
4/1/2019
/ Appeals ,
Claim Construction ,
Judgment on the Pleadings ,
Method Claims ,
Patent Litigation ,
Patent-Eligible Subject Matter ,
Patents ,
Product of Nature Doctrine ,
Remand ,
Reversal ,
Section 101
Senator Orrin Hatch (R-UT) recently introduced a bill titled the “Hatch-Waxman Integrity Act of 2018” (HWIA). Sen. Hatch suggests that the HWIA will (i) “restore the careful balance the Hatch-Waxman Act struck to incentivize...more
7/24/2018
/ Abbreviated New Drug Application (ANDA) ,
Amended Regulation ,
Biosimilars ,
BPCIA ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Generic Drugs ,
Hatch-Waxman ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Proposed Legislation ,
USPTO
A pair of ongoing USPTO initiatives, Patents for Humanity and Patents 4 Patients, offer incentives that certain biotechnology patent applications may be eligible for. Patents for Humanity is open to patents and applications...more
The recent district court ruling in INO Therapeutics LLC et al v. Praxair Distribution, Inc. et al employed the two-step analytical framework of Mayo/Alice to evaluate subject matter eligibility under 35 U.S.C. § 101, and the...more
Janssen Biotech Inc. and Celltrion Healthcare have taken the next step over Janssen’s blockbuster arthritis biologic medicine Remicade (infliximab) and Celltrion’s biosimilar, as required by the Biologics Price Competition...more
7/1/2017
/ Biologics ,
Biosimilars ,
BPCIA ,
Celltrion ,
Good Faith ,
Janssen Pharmaceuticals ,
Lost Profits ,
Negotiations ,
Patent Dance ,
Patent Infringement ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents
On January 12, 2017, the U.S. Court of Appeals for the Federal Circuit issued an opinion affirming the judgement that Eli Lilly’s U.S. Patent No. 7,772,209 (“the ’209 Patent”) was valid and infringed under the doctrine of...more
Patent applications containing nucleic acid or protein sequences are required to include an electronic sequence listing using a required format and standard symbols. The United States Patent and Trademark Office (USPTO), in...more
Once a European patent application has been granted, all patentees must then choose to validate the granted application in one or more European countries. Such a decision may have long-term business and legal consequences. ...more
On September 20, 2016, the U.S. Court of Appeals for the Federal Circuit issued an opinion affirming the summary judgement that Abbott’s U.S. Patent No. 5,344,915 (“the ’915 Patent”) was sufficiently supported by the written...more
10/10/2016
/ Anticipation ,
Appeals ,
Board of Patent Appeals ,
Inherent Disclosure Doctrine ,
Patent Applications ,
Patent Litigation ,
Patents ,
Prior Art ,
Priority Date Cutoff ,
Priority Patent Claims ,
Remand ,
Summary Judgment ,
Written Descriptions
In This Presentation:
• Patent infringement suits
– Costly
– Risk of preliminary injunction
– Time consuming
– Risk of customers being sued
– Damages
• Lost profit or reasonable royalty
• Treble...more