Americas – Page 3 – IP Law Watch

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

Jun 22 2015

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 has adopted the same labeling approach as used for generic pharmaceutical drugs. However, AbbVie argues in its petition that “[b]iosimilars are not generic drugs and should not be labeled like generic drugs.”

To read the full alert, click here.

BPCIA: A “Choose Your Own Adventure” Statute?

Jun 17 2015

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.

Amgen Prevails on Temporarily Excluding Zarxio® From Market

May 12 2015

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).

To read the full alert, click here.

U.S. Copyright Office Chief Testifies: Eight Issues Ready for Legislation

May 08 2015

On April 29, 2015, U.S. Register of Copyrights, Maria Pallante, testified to the House Judiciary Committee providing the Copyright Office’s perspective on updates to U.S. copyright law. In addition to recommending a more autonomous Copyright Office and flagging policy issues that warrant further analysis and attention, Ms. Pallante identified eight issues deserving current legislative action:

1. Music Licensing. After undertaking a comprehensive study last year to assess the impact of copyright law on the music marketplace, the Copyright Office recommends

greater negotiating room for public performance rights while preserving the benefits of collective licensing for smaller actors
U.S. recognition of a full public performance right for sound recordings
federal copyright protection for pre-1972 sound recordings.

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

Apr 27 2015

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®.

To read the full alert, click here.

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

Apr 01 2015

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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International Design Update

Mar 31 2015

New Members to the Hague System

The Hague Agreement concerning the International Deposit of Industrial Designs (Hague System) is administered by World Intellectual Property Organization (WIPO) and has been around for almost 100 years. It is a mechanism, similar to the Madrid Protocol System for trade marks, of registering an industrial design in several countries by means of a single application, filed in one language and with one set of fees. The Hague System produces the same effect of a grant of protection in each of the designated contracting countries as if the design had been registered directly with each national office, unless protection is refused by the national office.

An Ounce of Prevention: Act Now with “.sucks” Registration Opening

Mar 30 2015

As many brand owners may know, the Internet Corporation for Assigned Names and Numbers (“ICANN”) recently approved the .sucks gTLD. The Sunrise period for trademark owners to register .sucks domain names containing their trademarks begins on March 30, 2015; the general availability period begins on June 1, 2015. We recommend that brand owners consider registering their main brand or trademark as a .sucks domain to block third parties from doing the same.

To read the full alert, click here.

United States Supreme Court Holds That Trademark Trial and Appeal Board Determination of Likelihood of Confusion May Bind Subsequent Court Infringement Case

Mar 26 2015

On March 24, 2015, in a case covered here in a previous posting (On Tap at the U.S. Supreme Court: An Important Trademark Case, September 3, 2014), the United States Supreme Court (Supreme Court) held that a determination of likelihood of confusion by the Trademark Trial and Appeal Board (TTAB), in an administrative tribunal which determines registerability, may preclude further litigation of the issue in a subsequent infringement case. In B&B Hardware, Inc. v. Hargis Industries, Inc., the Supreme Court reversed a decision by the Eighth Circuit Court of Appeals, which had determined that a TTAB finding would not bind an infringement court because, among other reasons, the factors considered by the TTAB were not identical to those considered by the trial court. The Supreme Court, though, by a 7-2 vote, held that when the ordinary elements of issue preclusion are met and where the issues in the two cases are identical, the ruling by the agency tribunal controls. The Supreme Court also found that even though the specific factors considered in a likelihood of confusion analysis may vary somewhat, they are not ‘fundamentally different’ and that the ‘likelihood of confusion’ standard is the same for registration and infringement purposes.

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

Mar 23 2015

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.

Tag:Americas