United States – Page 9

Fashion Designer Tory Burch Awarded US$41 million in U.S. Trade Mark Case

Jul 27 2015

In November 2013, fashion designer Tory Burch sued Youngran Kim, and three companies controlled by Kim, for counterfeiting and trade mark infringement relating to the sale of jewellery. The jewellery featured a registered logo trade mark design owned by Tory Burch. While this was not the basis of Tory Burch’s legal claim, it is worth noting that, as well as featuring Tory Burch’s logo device, the defendants’ jewellery also closely resembled jewellery designs that had been released by Tory Burch, as seen below.

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

Jul 24 2015

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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Connecticut Mandates Identity Theft Services for Social Security Number Data Breaches

Jul 07 2015

On June 30, 2015, Connecticut’s governor signed into law an amendment to the state’s data-security-breach-notice statute to mandate ‘appropriate’ identity theft prevention services for breaches involving social security numbers. Identity theft mitigation services are also required ‘if applicable’, e.g., if identify theft actually occurs. The services must be provided at no cost and for at least 12 months. The statute does not explain which identity theft ‘prevention’ or ‘mitigation’ services are mandated or which are ‘appropriate.’

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.”

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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).

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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).

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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®.

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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.

To read the full alert, click here.

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.

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