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Patent Invalidity Patent Infringement Disclosure Requirements

Amundsen Davis LLC

Preserving Patent Rights: Impact of Public Use on Patenting

Amundsen Davis LLC on

For a business planning to market a product that incorporates an invention, having an enforceable patent to protect the invention is often desirable. Two recent federal circuit cases reiterate what many patent holders and...more

Smart & Biggar

Dexlansoprazole formulation patent invalid and not infringed by Apotex

Smart & Biggar on

On February 7, 2024, the Federal Court dismissed Takeda’s action under subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations in relation to dexlansoprazole (Takeda’s DEXILANT). Justice Furlanetto...more

Goodwin

Genentech Files Complaint Against Pfizer Regarding Herceptin

Goodwin on

Genentech filed a complaint last Friday in the District of Delaware against Pfizer for infringement of 40 patents under the BPCIA regarding PF-05280014, Pfizer’s biosimilar of Herceptin® (trastuzumab). According to the...more

McDermott Will & Emery

ANDA Update - October 2015

McDermott Will & Emery on

Federal Circuit Interprets Statutory Requirements for Biosimilar Regulatory Pathway - Amgen Inc., v. Sandoz Inc., (Fed. Cir. July 21, 2015): In a case of first impression, the U.S. Court of Appeals for the Federal...more

Patterson Belknap Webb & Tyler LLP

Disclosure Requirements Under the BPCIA

The Biologics Price Competition and Innovation Act (BPCIA) provides for a series of disclosures between a biosimilar applicant and the innovator company, commonly referred to as the “patent dance.” 42 U.S.C. §262(l). While...more

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