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ODAC Committee Votes to License Sandoz’s Zarxio®

Jan 09 2015

Sandoz Inc. filed the first biosimilar application under the Biologics Price Competition and Innovation Act on July 24, 2014 for a biosimilar version of Amgen Inc.’s Neupogen® (filgrastim). The FDA issued a Briefing Document for the Oncologic Drugs Advisory Committee Meeting held January 7, 2015 concluding that Sandoz’s biosimilar, referred to as EP2006 in the FDA’s Briefing Document, is highly similar to and has no clinically meaningful differences from Neupogen®.

To read the full alert, click here.

Big Data Speaks Loudly and Carries a Big Stick

Jan 06 2015

“Speak softly and carry a big stick” connotes a policy of beginning gently but holding a decisive weapon in reserve. Big Data doesn’t do that. When Big Data ‘speaks,’ it tends to blurt out its conclusion and can have an immediate impact, deserved or undeserved, because Big Data is not based on careful statistical sampling and is not aimed at determining causation. Big Data correlates masses of good, bad and indifferent data, ie, it can be ‘messy’ and its correlations are not necessarily accurate relative to a desired question. So what will happen when ‘the data’ indicates an outcome that people believe or act on because the ‘data says so?’ That is the topic of this blog. Read More

Patent Office Issues New Examination Guidelines for Subject Matter Eligibility

Dec 19 2014

On December 16, 2014, the United States Patent and Trademark Office published new guidelines for determining patent eligibility under 35 U.S.C. § 101. These guidelines do not have the force of law, but nevertheless establish the specific procedures that the Examiners apply during examination of patent applications. These guidelines are effective immediately, supersede previous guidelines regarding nature-based products, and supplement previous guidelines regarding abstract ideas. Based on Supreme Court decisions, the new guidelines set forth an analytical framework that is designed to “promote[] examination efficiency and consistency across all technologies” and is particularly relevant for patents directed to natural products, software, and business methods.

To read the full alert, click here.

IP Australia Rejects MH370 Trade Mark Application

Dec 18 2014

On 8 March 2014, Malaysian Airlines flight 370 disappeared. Five days later, Aoan International Pty Ltd (Aoan) filed an application to register MH370 as a trade mark in class 41 of the NICE classification of goods and services for various services.

IP Australia initially rejected the application under section 41 of the Trade Marks Act 1995 (Cth) (Act) on the basis that other traders should be entitled to refer to MH370 with respect to the services proposed to be offered by Aoan. IP Australia then reconsidered its decision and decided to reject the application under section 42(a) of the Act saying that the trade mark was scandalous on the basis that the trade mark would offend a section of the community. Read More

Australian Government Reveals Plan to Crackdown on Online Piracy – but not too Hard!

Dec 16 2014

The Australian Government announced last week that it will implement measures proposed by Attorney General, George Brandis, and the Australian Minister for Communications, Malcolm Turnbull, to reduce “high levels of online copyright infringement”.

The announcement is timely – given the owners of the film Dallas Buyers Club issue of proceedings in the Federal Court of Australia in November, against five internet service providers (ISPs) including iiNet, seeking orders to have the ISPs disclose the identities of alleged pirates. Read More

Federal Circuit Affirms Dismissal of Sandoz’s BPCIA-Related Declaratory Judgment Action Regarding Enbrel® Patents, but Declines to Address BPCIA Interpretation

Dec 12 2014

The biologics industry has been eagerly awaiting the Federal Circuit’s ruling on Sandoz Inc.’s (“Sandoz”) appeal from the United States District Court for the Northern District of California’s dismissal of its declaratory judgment action due to lack of Article III jurisdiction. In particular, the industry has been waiting to see whether the Federal Circuit would uphold the district court’s ruling that Sandoz’s lawsuit was barred by the Biologics Price Competition and Innovation Act (“BPCIA”). Unfortunately, the Federal Circuit declined to address the district court’s interpretation of the BPCIA, providing no further guidance on the topic. Instead, the Federal Circuit simply affirmed the district court’s ruling that there was no subject matter jurisdiction, relying on Hatch-Waxman generic drug cases as precedent.

To read the full alert, click here.

Declaratory Judgment Action Premature: Decision Suggests “Patent Dance” Mandatory for Biosimilar Applicants

Dec 09 2014

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.

Flying Doughnuts – Future Reality?

Dec 09 2014

Airbus filed a suite of patent applications recently, one of which includes a futuristic looking new concept for a passenger aircraft.

Dubbed the ‘flying doughnut’, and looking like a craft one would expect to see only in a science fiction movie, the aircraft features a circular cabin accessed via a cavity in the middle, contained in the middle of a giant triangular wing.

The aircraft design allows for a wider passenger cabin than traditional passenger aircrafts, with the circular cabin making the most of the greater width. An important advantage of this new aircraft is that the circular cabin is better able to withstand pressurisation loads without compromising cabin space.

Recording Trade Mark Licence Agreements in the Middle East

Dec 09 2014

Many businesses operate in the Middle East through entities licensed to use their trade marks. These businesses should be aware that many Middle Eastern countries require that trade mark licence agreements are recorded with the respective Trade Mark Registers or other named authorities in these countries. Not recording a licence agreement could lead to monetary penalties being imposed on the licensee or an inability to enforce trade marks against third party infringers.

For example, Bahrain, Qatar, Saudi Arabia and the United Arab Emirates each have more or less equivalent provisions in which a trade mark licence agreement must be in writing, it cannot include unregistered trade marks and it has no legal effect against third parties unless it is recorded on the respective Trade Mark Registers (or other named authorities in these countries). Each of these countries has slightly different processes and requirements for seeking registration of a trade mark licence agreement. Read More

The Color Red Sparks a Dispute Between Banks

Dec 09 2014

The Secondary Distinctiveness of a Trademark: Ruling of the Court of Justice of the European Union

If a ‘significant part’ (at least 70%) of the consumer group is able to recognize given goods as deriving from a specific company using the trademark, then the mark has certainly acquired distinctiveness, including in the case of ‘secondary distinctiveness as a result of use’.

The European Court of Justice held on 19 June 2014 in a ruling (C-217/13 and C-218/13) in the case of Oberbank AG, Banco Santander SA and Santander Consumer Bank AG vs. Deutsche Sparkassen und Giroverband e.V. (DSGV), the result of three pre-trial questions submitted to the Court of Justice by the German Federal Patent Office (Bundespatentgericht). The findings were as follows: Read More

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