Author - jennifer.dienes

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BPCIA Statute: Patent Dance Is Optional, But Opting Out Has Consequences
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BPCIA: A “Choose Your Own Adventure” Statute?
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Amgen Prevails on Temporarily Excluding Zarxio® From Market
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Zarxio®, First BPCIA Approved Biosimilar, Added to Purple Book
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Denied Again: FDA Denies Amgen’s Citizen Petition Requesting Certification of Compliance with BPCIA Patent Dance
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Dancing Not Required: District Court Denies Amgen’s Bid for Preliminary Injunction, Finds BPCIA “Patent Dance” Optional
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ODAC Committee Votes to License Sandoz’s Zarxio®
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Federal Circuit Affirms Dismissal of Sandoz’s BPCIA-Related Declaratory Judgment Action Regarding Enbrel® Patents, but Declines to Address BPCIA Interpretation
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Declaratory Judgment Action Premature: Decision Suggests “Patent Dance” Mandatory for Biosimilar Applicants
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Left without a Partner: Amgen Sues Sandoz for Refusing to Dance in Accordance with BPCIA Patent Procedures

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? (describing the parties’ oral arguments before the Federal Circuit). Amgen Inc. (“Amgen”) appealed the Northern District of California’s decision holding that the Biologics Price Competition and Innovation Act’s (“BPCIA’s”) “patent dance” provisions are optional and that the 180-day notice provision does not require licensure. See Dancing Not Required: District Court Denies Amgen’s Bid for Preliminary Injunction, Finds BPCIA “Patent Dance” Optional.

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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 dance” provisions are optional, and that the 180-day notice provision does not require licensure in Amgen, Inc., et al. v. Sandoz, Inc., et al., Case No. 14-cv-04741-RS (N.D. Cal. March 19, 2015).

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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 Circuit in excluding the biosimilar from the market, at least temporarily. On May 5, 2015, the Federal Circuit granted Amgen’s motion for an injunction “preventing Sandoz [ ] from marketing, selling, offering for sale, or importing into the United States its FDA-approved ZARXIO® biosimilar product until this Court resolves the appeal.” Amgen Inc. et al. v. Sandoz Inc. et al., Appeal No. 2015-1499, Dkt. 105 (Fed. Cir. March 27, 2015).

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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 biological equivalent of the pharmaceutical Orange Book. See FDA Releases a Purple Book for Biosimilars. The Purple Book has now been updated to include Sandoz, Inc.’s (“Sandoz”), Zarxio® (filgrastim), the United State’s first biosimilar approved under the Biologics Price Competition and Innovation Act (“BPCIA”). See FDA Approves First Biosimilar: Sandoz’s Zarxio®.

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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 the FDA mandate compliance with the Biologics Price Competition and Innovation Act’s (“BPCIA’s”) information exchange provisions, often referred to as the “Patent Dance.” In particular, Amgen requested that the FDA require a biosimilar applicant to certify that it will timely comply with Section 351(l)(2)(A) of the BPCIA by providing the brand holder with a copy of the biosimilar application and information describing the process(es) used to manufacture the biosimilar product covered by the application.

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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 biosimilar of Amgen’s Neupogen® (filgrastim), to see what, if any, guidance the district court would provide on the interpretation of the BPCIA. See Left without a Partner: Amgen Sues Sandoz for Refusing to Dance in Accordance with BPCIA Patent Procedures. This litigation has sparked additional interest in view of FDA’s recent approval of Zarxio®, which has led to industry-wide speculation regarding the litigation’s potential impact on Sandoz’s ability to market its now approved biosimilar. See FDA Approves First Biosimilar: Sandoz’s Zarxio®. The District Court of the Northern District of California has now provided an answer, siding with Sandoz’s interpretation that the BPCIA’s patent dance provisions are optional and the 180 day notice provision does not require licensure, and denying Amgen’s request for a preliminary injunction.

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ODAC Committee Votes to License Sandoz’s Zarxio®

Sandoz Inc. filed the first biosimilar application under the Biologics Price Competition and Innovation Act on July 24, 2014 for a biosimilar version of Amgen Inc.’s Neupogen® (filgrastim). The FDA issued a Briefing Document for the Oncologic Drugs Advisory Committee Meeting held January 7, 2015 concluding that Sandoz’s biosimilar, referred to as EP2006 in the FDA’s Briefing Document, is highly similar to and has no clinically meaningful differences from Neupogen®.

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Federal Circuit Affirms Dismissal of Sandoz’s BPCIA-Related Declaratory Judgment Action Regarding Enbrel® Patents, but Declines to Address BPCIA Interpretation

The biologics industry has been eagerly awaiting the Federal Circuit’s ruling on Sandoz Inc.’s (“Sandoz”) appeal from the United States District Court for the Northern District of California’s dismissal of its declaratory judgment action due to lack of Article III jurisdiction. In particular, the industry has been waiting to see whether the Federal Circuit would uphold the district court’s ruling that Sandoz’s lawsuit was barred by the Biologics Price Competition and Innovation Act (“BPCIA”). Unfortunately, the Federal Circuit declined to address the district court’s interpretation of the BPCIA, providing no further guidance on the topic. Instead, the Federal Circuit simply affirmed the district court’s ruling that there was no subject matter jurisdiction, relying on Hatch-Waxman generic drug cases as precedent.

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Declaratory Judgment Action Premature: Decision Suggests “Patent Dance” Mandatory for Biosimilar Applicants

Biosimilar applicants and branded biologics have been wondering how the procedures set forth in the Biologics Price Competition and Innovation Act (“BPCIA”) will be implemented since its enactment in 2010. The lack of guidance on this subject has already sparked litigation, including the recent litigation between Amgen Inc. (“Amgen”) and Sandoz Inc. (“Sandoz”) discussed in our previous client alert, Left without a Partner: Amgen Sues Sandoz for Refusing to Dance in Accordance with BPCIA Patent Procedures. However, Amgen and Sandoz are not the only parties that have brought disputes involving the BPCIA to the courts for resolution.

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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 when Sandoz Inc.’s (“Sandoz”) biosimilar application for a biosimilar of Amgen Inc.’s (“Amgen”) Neupogen® was the first accepted by FDA under section 351(k) of the Public Health Service Act. Apparently, Sandoz has refused to engage in the “patent dance” in accordance with the BPCIA, leaving Amgen without a dance partner. Amgen did not take kindly to being stranded on the dance floor and has opted to sue Sandoz for its allegedly unlawful refusal to follow the BPCIA’s patent resolution procedures.

To read the full alert, please click here.

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