IP Law Watch – Page 47 – Legal issues, law and regulations concerning the world of IP

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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EU Data Protection Regulation

Jun 18 2015

On 15 June 2015 the European Council published its final proposed text for the new General Data Protection Regulation. The Regulation is being adopted to provide legal certainty and transparency for businesses and to provide individuals with the same level of rights and obligations in all EU Member States.

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).

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Legal Works as Creative Works: The Original Decision of the Court of Venice

Jun 15 2015

In March, the IP Court of Venice (Court) provided a unique ruling on copyright law.

The Court ruled on an issue concerning the application of Italian copyright laws to protect a legal work created by a lawyer works.

A lawyer (Plaintiff) sued an entity (Entity), which was organizing an exposition for the infringement of Plaintiff’s moral rights due to the non-authorized use of a document containing IP policy guidelines (Document) to be distributed among the exhibitors, which entirely reproduced a document drafted years ago by the Plaintiff for another entity.

European Union Trade Mark Law Reform – Revised Drafts Released

Jun 12 2015

On 8 June 2015, the Council of the European Union published the final texts of its proposal to amend the Community Trade Mark Regulation (Regulation) and Trade Mark Directive (Directive).

The revised drafts reflect the key issues which have been the subject of significant debate in the last year, including:

harmonisation of trade mark law and practice between EU member states
measures to protect brand owners’ rights with respect to counterfeit goods in transit
cooperation between Office for Harmonization in the Internal Market (OHIM) and national trade mark offices
governance and finances of OHIM.

ASA and CAP Publish Annual Report 2014

Jun 05 2015

‘Make Every UK Ad a Responsible Ad’

On 27 May, the Advertising Standards Agency (ASA) and the Committee for Advertising Practice (CAP) published their Annual Report for 2014. The Annual Report emphasises the ASA and CAP’s continuing work to implement the strategy unveiled during 2014. This strategy aims to ‘make every UK ad a responsible ad’ through the following five strands:

Understanding
Support
Impact
Proactive
Awareness

Tamawood v Habitare: a Recent Australian Decision on Copyright Infringement in Building Designs

May 22 2015

Earlier this week the Full Court of the Federal Court of Australia (Full Court) delivered its judgment in the case of Tamawood v Habitare Developments, a copyright infringement case in respect of project home designs.

Habitare Developments had engaged designer/builder Tamawood to create designs for project homes for a new development. However, due to a falling out between the parties, Habitare Developments ultimately engaged architects Mondo to create the final plans for the development and engaged another builder to construct the houses. Tamawood commenced proceedings against all parties for copyright infringement. The respondents denied that Tamawood’s designs had been used as a starting point and that copyright had been infringed.

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.