The Situation: The Hatch-Waxman Act allows generic drug manufacturers to "carve out" a brand's patented indications from their proposed labeling. Generic manufacturers often rely on these so-called "skinny labels" to try to...more
7/9/2024
/ Abbreviated New Drug Application (ANDA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Life Sciences ,
Patent Infringement ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Federal courts will no longer give controlling weight to agency interpretations of ambiguous laws....more
The USPTO is seeking public input on whether prior art must be authored by humans and how, if at all, AI-generated disclosures should be treated differently from non-AI generated disclosures....more
The USPTO's April 11, 2024, guidance clarifies how existing USPTO rules apply to the use of AI by practitioners when interacting with the USPTO....more
The Situation: The U.S. Supreme Court recently denied certiorari in Thaler v. Vidal, leaving intact the Federal Circuit's ruling that only human beings, and not artificial intelligence ("AI") systems, can be inventors under...more
6/23/2023
/ Algorithms ,
Artificial Intelligence ,
Denial of Certiorari ,
Intellectual Property Owner’s Association (IPO) ,
Intellectual Property Protection ,
Inventors ,
Machine Learning ,
Patent-Eligible Subject Matter ,
Patents ,
SCOTUS ,
USPTO
In Short -
The Background: In recent months, artificial intelligence ("AI") platforms have taken the world by storm, introducing new, powerful tools for generating original and useful content based on training data and user...more
6/12/2023
/ Algorithms ,
Artificial Intelligence ,
Data Collection ,
Data Privacy ,
Data Protection ,
Data Security ,
Defend Trade Secrets Act (DTSA) ,
EULA ,
Machine Learning ,
Popular ,
Third-Party ,
Trade Secrets
In Short -
The Situation: Workforces are increasingly using generative artificial intelligence ("AI") platforms to generate diverse content ranging from marketing materials, translations, source code, and more....more
The Senate Judiciary Committee is showing renewed Congressional interest in oversight of the pharmaceutical industry, with five bipartisan drug bills on the agenda for review and discussion on February 9, 2023....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
The case relates to so-called "skinny labels," in which the filer of an Abbreviated New Drug Application ("ANDA") seeks FDA approval to market a generic version of a branded drug, but "carves out" from its label certain...more
1/21/2022
/ Abbreviated New Drug Application (ANDA) ,
Generic Drugs ,
Inducement ,
Intellectual Property Protection ,
Life Sciences ,
Motion to Dismiss ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
President Biden has selected Leonard P. Stark—Chief Judge of the U.S. District Court for the District of Delaware—to be the next member of the Federal Circuit, filling the vacancy that will be left behind when Judge Kathleen...more
On October 17, 2020, the Standing Committee of the National People’s Congress in China promulgated the fourth amended Patent Law of the People’s Republic of China, which came into force in its original form in 1985, with...more
11/19/2020
/ China ,
CNIPA ,
Design Patent ,
Generic Drugs ,
Intellectual Property Protection ,
Patent Infringement ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Punitive Damages ,
Statutory Damages
Similar to the laws in the United States and Europe, Chinese law allows those accused of patent infringement to commence actions for declaring non-infringement of patents to clear away the uncertainties. A key precondition...more
Citing its priority to facilitate the timely development and approval of generic drugs, the U.S. Food and Drug Administration ("FDA") solicits stakeholder input on the types of patents that should be listed in the Orange...more
On June 25, 2018, the United States Supreme Court agreed to review the Federal Circuit's decision in Helsinn Healthcare v. Teva Pharmaceuticals, No. 17-1229.
In Helsinn, the Federal Circuit considered whether the America...more
On May 26, 2017, the United States District Court for the District of Delaware announced new procedures for assigning cases and handling case-dispositive issues....more
Section 271(f)(1) of the Patent Act provides that a party infringes a patent claim when it "supplies or causes to be supplied in or from the United States all or a substantial portion of the components of a patented invention...more
2/27/2017
/ Appeals ,
Component Parts Doctrine ,
Cross-Border Transactions ,
Exports ,
Extraterritoriality Rules ,
Life Technologies Corp v Promega Corp ,
Manufacturer Liability ,
Motion to Set Aside the Verdict ,
Patent Act ,
Patent Infringement ,
Patents ,
Reversal ,
SCOTUS