Maria Doukas

Maria Doukas

K&L Gates LLP

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What Constitutes Interchangeability? AbbVie Submits Citizen Petition to Suggest Requirements

On December 16, 2015, AbbVie submitted a citizen petition regarding the requirements necessary to show interchangeability of a biosimilar product. This petition follow’s AbbVie previous citizen petition and supplement...more

1/7/2016 - AbbVie Biosimilars BPCIA FDA Pharmaceutical Industry Public Health Service Act Safety Standards

The Name Game: Institutional Investors Submit Citizen Petition Regarding Biosimilar Labeling

On November 23, 2015, a group of fifteen institutional investors submitted a citizen petition to the FDA regarding biosimilar labeling (“Investors’ Citizen Petition”). The group includes investors from the public sector and...more

12/18/2015 - AbbVie Biosimilars FDA Generic Drugs Investors Labeling Sandoz

BPCIA: Amgen Begins the Patent Dance With AbbVie

On November 25, 2015, Amgen Inc. (“Amgen”) announced it submitted its first biologics license application (“BLA”) to the FDA under the Section 351(k) biosimilar approval pathway provided in the Biologics Price Competition and...more

12/7/2015 - Amgen Biologics BPCIA Inter Partes Review Proceedings Patent Applications Popular

BPCIA Statute: Has the Music Stopped or Will the Patent Dance Continue?

In July, a divided Federal Circuit issued a ruling in the Amgen Inc. et al. v. Sandoz Inc., Case No. 2015-1499 appeal and held: (1) the Biologics Price Competition and Innovation Act’s (“BPCIA’s”) “patent dance” provisions...more

10/28/2015 - Amgen Biologics Biosimilars BPCIA En Banc Review FDA Patent Dance Patent Infringement Patent Litigation Patents Pharmaceutical Industry Pharmaceutical Patents Popular Prescription Drugs Sandoz Sandoz v Amgen

The Name Game Continues: AbbVie Files Supplemental Citizen Petition Raising Additional Concerns Regarding Biosimilar Labeling

AbbVie previously filed a citizen petition to the FDA arguing against its interim labeling requirements for biosimilars under the Biologics Price Competition and Innovation Act (“BPCIA”). In its supplemental petition, AbbVie...more

9/2/2015 - Amarin Biologics Biologics Price Competition and Innovation Act of 2009 Biosimilars BPCIA DOJ FDA HELP Labeling Patent Litigation Patents Pharmaceutical Industry Pharmaceutical Patents Prescription Drugs Purple Book

BPCIA Statute: Patent Dance Is Optional, But Opting Out Has Consequences

The Federal Circuit issued a ruling on July 21, 2015 in the Amgen Inc. et al. v. Sandoz Inc., Case No. 2015-1499, appeal after hearing oral arguments on June 3, 2015. See BPCIA: A “Choose Your Own Adventure” Statute?...more

7/27/2015 - Amgen Appeals Biologics Biologics Price Competition and Innovation Act of 2009 BPCIA FDA Patent Applications Patent Infringement Patents Popular Sandoz Sandoz v Amgen

The Name Game: AbbVie’s Citizen Petition Regarding Biosimilar Labeling

On June 2, 2015, AbbVie submitted a citizen petition to the FDA arguing against its interim labeling requirements for biosimilar products under the Biologics Price Competition and Innovation Act (“BPCIA”). As of now, the FDA...more

6/18/2015 - AbbVie ANDA Biosimilars BPCIA Citizen Petitions FDA Generic Drugs Labeling Pharmaceutical Industry

BPCIA: A “Choose Your Own Adventure” Statute?

On June 3, 2015, the Federal Circuit heard oral argument on Amgen Inc.’s (“Amgen”) appeal of the Northern District of California’s decision holding that the Biologics Price Competition and Innovation Act’s (“BPCIA’s”) “patent...more

6/16/2015 - Amgen Biosimilars BPCIA FDA IP License Notice Provisions Patent Dance Patent Litigation Patents Pharmaceutical Industry Pharmaceutical Patents Sandoz v Amgen

Amgen Prevails on Temporarily Excluding Zarxio® From Market

After an unsuccessful attempt to obtain a preliminary injunction against Sandoz Inc.’s (“Sandoz”) Zarxio® in the District Court for the Northern District of California, Amgen Inc. (“Amgen”) has prevailed before the Federal...more

5/11/2015 - Appeals Biosimilars Generic Drugs Pharmaceutical Industry Pharmaceutical Patents Sandoz v Amgen

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 Industry 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 Industry 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 Industry 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 Industry 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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