Archive: July 2016

1
Federal Circuit Confirms Post-Licensure Notice of Commercial Marketing Is Mandatory in Biosimilar Litigation
2
ECJ Confirms that Brand Owners can Seek Remedies for IP Infringement Against Owners and Operators of Physical Marketplaces Selling Counterfeit Goods as “Intermediaries”
3
New Balance Unsuccessfully Challenges Trade Mark Infringement Claim in China but Walks Away with a Significantly Reduced Liability
4
The Communication to the Public is (Hyper) Linked to the Role of the User

Federal Circuit Confirms Post-Licensure Notice of Commercial Marketing Is Mandatory in Biosimilar Litigation

On July 5, 2016, a unanimous Federal Circuit panel held that Apotex failed to give Amgen proper notice of commercial marketing required by the Biologics Price Competition and Innovation Act (“BPCIA” or “Biologics Act”)[1] and must wait 180 days after giving Amgen post-licensure notice before commercially marketing its FDA-licensed biosimilar product.[2]  In affirming the district court’s preliminary injunction against Apotex until the end of the 180-day period, the Federal Circuit followed its previous holding in Amgen v. Sandoz,[3] a split-panel decision.  The court reiterated the bright-line rule that a biosimilar applicant must provide notice of commercial marketing to a reference product sponsor after the FDA grants licensure of the biosimilar product and cannot launch its product until 180 days following that post-licensure notice.

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By: Margaux L. Nair, Trevor M. Gates, Peter Giunta, Kenneth C. Liao

ECJ Confirms that Brand Owners can Seek Remedies for IP Infringement Against Owners and Operators of Physical Marketplaces Selling Counterfeit Goods as “Intermediaries”

On 7 July 2016, the Court of Justice of the European Union (ECJ) announced its judgment in case C-494/15, Tommy Hilfiger Licensing LLC and Others v Delta Center a.s.

The case concerned claims for trade mark infringement against Delta Center, the tenant of the “Prague market halls” marketplace, which rented sales spaces to sellers of counterfeit goods. Tommy Hilfiger and other trade mark owners brought an action before the Czech courts seeking an injunction under Article 11 of Directive 2004/48/EC, which states that: “Member States shall also ensure that rightholders are in a position to apply for an injunction against intermediaries whose services are used by a third party to infringe an intellectual property right, without prejudice to Article 8(3) of Directive 2001/29/EC”.

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New Balance Unsuccessfully Challenges Trade Mark Infringement Claim in China but Walks Away with a Significantly Reduced Liability

In a recent appeal decision in China, the international sportswear brand New Balance has unsuccessfully challenged a finding of trade mark infringement with respect to a Chinese language equivalent for NEW BALANCE. However, New Balance was able to reduce the amount payable as a result of its infringement by 95%.

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The Communication to the Public is (Hyper) Linked to the Role of the User

On 31 May 2016, the European Court of Justice (ECJ) issued its decision on the much-discussed issue of the requirements for a “communication to the public” in copyright infringement cases. It provided new guidelines on the interpretation of the article 3(1) of the InfoSoc Directive and article 8(2) of the Rental and Lending Rights Directive. The opportunity was given by the Regional Court of Cologne (Germany) that made a request for a preliminary ruling in the proceeding Reha Training v. GEMA, concerning the TV broadcast by means of TV sets on the premises of a rehabilitation centre. According to GEMA (the German copyright collection society), Reha Training failed to request permission and to pay the due royalties for communicating to the public TV programmes which belong to its repertoire.

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