Maria Doukas

Maria Doukas

K&L Gates LLP

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Zarxio®, First BPCIA Approved Biosimilar, Added to Purple Book

In September 2014, the FDA published the first edition of the Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations (“Purple Book”), the...more

4/25/2015 - Amgen Biosimilars BPCIA FDA Orange Book Pharmaceutical Patents Purple Book Sandoz

Denied Again: FDA Denies Amgen’s Citizen Petition Requesting Certification of Compliance with BPCIA Patent Dance

As discussed previously in Next Steps in the Dance: Amgen Files Citizen Petition at FDA Requesting Mandatory Compliance with BPCIA Patent Procedures, Amgen Inc. (“Amgen”) filed a Citizen Petition with the FDA requesting that...more

3/31/2015 - Amgen Biosimilars BPCIA Citizen Petitions FDA Patents Pharmaceutical Patents Popular

Dancing Not Required: District Court Denies Amgen’s Bid for Preliminary Injunction, Finds BPCIA “Patent Dance” Optional

The biologics industry has been closely monitoring Amgen Inc.’s (“Amgen’s”) lawsuit against Sandoz Inc. (“Sandoz”) for refusing to engage in the BPCIA’s “patent dance” with respect to Sandoz’s application for Zarxio®, a...more

3/23/2015 - Biosimilars BPCIA FDA Patent Litigation Patents Pharmaceutical Pharmaceutical Manufacturers Sandoz v Amgen

FDA Approves First Biosimilar: Sandoz’s Zarxio®

On Friday, March 6, the FDA announced its approval of Sandoz, Inc.’s (“Sandoz’s”) Zarxio®, a biosimilar of Amgen Inc.’s (“Amgen’s”) Neupogen® (filgrastim), for the same five indications approved for Neupogen®. This follows...more

3/10/2015 - Biosimilars FDA Pharmaceutical Pharmaceutical Manufacturers Sandoz

ODAC Committee Votes to License Sandoz’s Zarxio®

As noted in our previous client alert, FDA Accepts First Biosimilar Application Filed under Section 351(k) of the Public Health Service Act, Sandoz Inc. (“Sandoz”) filed the first biosimilar application under the Biologics...more

1/9/2015 - Amgen Biosimilars BPCIA FDA Pharmaceutical Prescription Drugs Public Health Service Act Sandoz

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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