Tag: Patent dance

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Australian Patent Office considers plausibility in a test for sufficiency
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Sandoz v. Amgen – Biosimilars at the U.S. Supreme Court
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Sandoz v. Amgen—Biosimilars at the Supreme Court—Oral Argument
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BPCIA: A “Choose Your Own Adventure” Statute?
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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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Declaratory Judgment Action Premature: Decision Suggests “Patent Dance” Mandatory for Biosimilar Applicants
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Next Steps in the Dance: Amgen Files Citizen Petition at FDA Requesting Mandatory Compliance with BPCIA Patent Procedures
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Left without a Partner: Amgen Sues Sandoz for Refusing to Dance in Accordance with BPCIA Patent Procedures

Australian Patent Office considers plausibility in a test for sufficiency

The emergence of “plausibility” as a test for inventive step, sufficiency and industrial applicability represents a significant legal development in Europe in recent years.  Now the concept of plausibility has reached Australian shores, with the Australian Patent Office applying it in a test for sufficiency.

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Sandoz v. Amgen – Biosimilars at the U.S. Supreme Court

The U.S. Supreme Court unanimously decided Sandoz Inc., v. Amgen Inc., on Monday June 12, 2017, construing the Biologics Price Competition and Innovation Act (BPCIA).  The Court held:  (1) that the patent dance is not enforceable by injunction under Federal law, and  (2) that a biosimilar applicant’s 180-day “notice of commercial marketing” can be provided before FDA approval.  (See Sandoz Inc. v. Amgen Inc., Nos. 15-1039 and 15-1195, slip op. and our IP Alert Sandoz v. Amgen—Biosimilars at the Supreme Court—Oral Argument.)

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Sandoz v. Amgen—Biosimilars at the Supreme Court—Oral Argument

All nine U.S. Supreme Court justices heard argument on Wednesday April 26th, in Sandoz Inc., v. Amgen Inc.  The Supreme Court is reviewing interpretations of the Biologics Price Competition and Innovation Act (BPCIA) made by the U.S. Court of Appeals for the Federal Circuit. Wednesday’s arguments focused on four main issues:

  1. whether the FDA could preliminarily grant licensure prior to the expiration of the 12 year statutory period;
  2. whether the notice of commercial marketing requires official licensure to be made;
  3. whether the “patent dance” was required by the BPCIA; and
  4. whether state law could be used to enforce compliance with the “patent dance” elements of the BPCIA.

Industry watchers hope that the Supreme Court will streamline the process for getting biosimilars to market by providing increased certainty.

To read the full alert, click here.

By: Theodore J. Angelis, Peter Giunta, Kenneth C. Liao, Margaux L. Nair and Jenna Bruce

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).

To read the full alert, click here.

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.

To read the full alert, click here.

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.

To read the full alert, click here.

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.

To read the full alert, click here.

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

Amgen, Inc. 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, requesting that the FDA mandate compliance with the framework for biosimilar applications laid out by the Biologics Price Competition and Innovation Act.

To read the full alert, click here.

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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