The Federal Circuit affirmed a District of Delaware finding of non-infringement in an ANDA litigation due to the patentee’s clear and unmistakable disavowal of claim scope during prosecution. Specifically, the court held that...more
The Federal Circuit recently reversed a district court decision that found a patent that did not describe after-arising technology failed to satisfy the written description requirement. In so doing, the Federal Circuit...more
2/14/2025
/ Abbreviated New Drug Application (ANDA) ,
Claim Construction ,
Enablement Inquiries ,
Generic Drugs ,
Intellectual Property Litigation ,
Intellectual Property Protection ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
Section 112 ,
Written Descriptions
The District of Delaware recently denied a motion to dismiss a patent infringement complaint involving gene editing technology that sought relief under the Safe Harbor Provision of the Hatch-Waxman Act. Specifically, the...more
1/20/2025
/ Biotechnology ,
Food and Drug Administration (FDA) ,
Hatch-Waxman ,
Intellectual Property Litigation ,
Life Sciences ,
Motion to Dismiss ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
Regulatory Requirements ,
Safe Harbors
In a Hatch-Waxman case, the District Court for the District of New Jersey recently found that a generic label that included an allegedly infringing permissive use did not induce infringement where the label cautioned against...more
The District Court for the District of Delaware recently held on summary judgment that a patent with 2,295 days of combined patent term adjustment (PTA) and patent term extension (PTE) was not invalid for obviousness-type...more
12/20/2023
/ Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Obviousness ,
Obviousness-Type Double Patenting (ODP) ,
Patent Infringement ,
Patent Litigation ,
Patent Term Adjustment ,
Patents ,
Pharmaceutical Patents ,
Safe Harbors
The District Court of Delaware dismissed a generic drug company’s declaratory judgment counterclaims of non-infringement and invalidity, finding that the court no longer had subject matter jurisdiction after the generic...more
The District Court for the Northern District of West Virginia recently found method of treatment claims directed to treating a specific disease at a specific dose invalid for lack of written description based on the context...more
7/6/2020
/ Evidence ,
Hatch-Waxman ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Patent Prosecution History ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Treatment Method Patents ,
Written Descriptions
Hear from the FDA and the leaders of the biosimilars and innovator biologics industries about the impact of the pandemic on the global IP market and gain practical guidance for what is coming down the pipeline.
The novel...more
6/5/2020
/ Best Practices ,
Biologics ,
Biosimilars ,
Continuing Legal Education ,
Coronavirus/COVID-19 ,
Diagnostic Tests ,
Food and Drug Administration (FDA) ,
Infectious Diseases ,
Intellectual Property Litigation ,
Intellectual Property Protection ,
IP License ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Webinars
The Federal Circuit affirmed the grant of a defendant’s Rule 12(c) motion for judgment on the pleadings based on non-infringement, holding that under the plain text of patent term extension (PTE) statute an accused drug...more
The Federal Circuit recently held a generic drug developer lacked Article III standing to appeal an adverse patentability determination by the Patent Trial and Appeal Board (PTAB) because it failed to prove that it suffered...more
Despite evidence that defendants monitored plaintiffs’ product development and attempted to match its dosing intervals, the District Court of Delaware found no willful infringement because that activity took place before the...more
The Federal Circuit reversed a decision from the District Court for the District of Delaware invalidating three patents on anticipation grounds, finding the district court improperly relied on disclosures from multiple...more
3/2/2020
/ Anticipation ,
Disclosure ,
Hatch-Waxman ,
Obviousness ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
Prior Art ,
Remand ,
Reversal ,
Treatment Method Patents
Chief Judge Stark granted a defendant’s Rule 12(c) motion for judgment on the pleadings based on non-infringement, holding that plaintiff’s patent term extension (PTE) did not extend to the accused product because the PTE was...more
On January 15, 2020, the United States and China signed a Phase 1 trade agreement (the “Agreement”). The Agreement addresses a broad range of economic issues including intellectual property, agriculture, financial markets,...more
The Federal Circuit ruled that statutory disclaimer terminates the case or controversy between the parties in an infringement suit as to those claims, and immediately deprives the district court of the authority to take...more
9/9/2019
/ Appeals ,
Claim Preclusion ,
Disclaimers ,
Judicial Authority ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Patents ,
Vacated
The Federal Circuit recently upheld a district court’s decision to tax a patent infringement plaintiff with its opponent’s attorneys’ fees based on an inadequate presuit investigation into infringement, even though the patent...more
In Amerigen Pharmaceuticals Limited v. UCB Pharma GmbH, generic drug manufacturer Amerigen appealed a decision of the Patent Trial & Appeal Board finding UCB’s patent to certain chemical derivatives of diphenylpropylamines...more
1/28/2019
/ Abbreviated New Drug Application (ANDA) ,
Appeals ,
Article III ,
Generic Drugs ,
Intellectual Property Protection ,
Inter Partes Review (IPR) Proceeding ,
Obviousness ,
Patent Infringement ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Standing
On September 8, 2016, the Federal Circuit affirmed a decision from the Eastern District of Virginia in which the district court held that UCB, Inc.’s Cimzia® antibody does not infringe Yeda’s U.S. Patent No. 6,090,923 (“the...more