Maria Doukas

Maria Doukas

K&L Gates LLP

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Next Steps in the Dance: Amgen Files Citizen Petition at FDA Requesting Mandatory Compliance with BPCIA Patent Procedures

Amgen, Inc. (“Amgen”) has brought the discussion of the procedure for biosimilar applications from the courts to the FDA by filing a Citizen Petition (Docket No. FDA-2014-P-1771) on October 29, 2014 (“Petition”) requesting...more

11/12/2014 - Amgen Biologics Biosimilars BPCIA FDA Patent Litigation Patents Prescription Drugs

Left without a Partner: Amgen Sues Sandoz for Refusing to Dance in Accordance with BPCIA Patent Procedures

There has been a lot of curiosity within the biologics industry regarding how the “patent dance” procedures of the Biologics Price Competition and Innovation Act (“BPCIA”) would operate. This interest was piqued in July 2014...more

11/5/2014 - Amgen Biosimilars BPCIA Corporate Counsel FDA Patent Litigation Patents Public Health Service Act Sandoz

Purple is the New Orange: FDA Releases a Purple Book for Biosimilars

On September 9, 2014, the U.S. Food and Drug Administration (“FDA”) published the first edition of the Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or...more

9/16/2014 - Biosimilars BPCIA FDA Pharmaceutical PHSA Popular Purple Book

Shortcuts on the Patent Prosecution Highway

The Patent Prosecution Highway (PPH) is a program that allows applicants to leverage allowable claims in one participating office to obtain a patent faster and more efficiently for corresponding claims in another...more

2/27/2014 - Foreign Patent Applications Patent Cooperation Treaty Patent Prosecution Highway USPTO

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