Patents – Page 13 – IP Law Watch

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.

High Court to Consider Whether Isolated Genetic Material is Patentable in Australia

Feb 19 2015

On 13 February 2015, the High Court of Australia (High Court) heard and granted Yvonne D’Arcy’s application for special leave to appeal the Full Federal Court of Australia’s (Full Federal Court) decision in D’Arcy v Myriad Genetics Inc [2014] FCAFC 115.

The unanimous decision of the five-judge bench of the Full Federal Court was that Myriad Genetics Inc’s patent claims directed to particular isolated BRCA1 genes were patentable subject matter in Australia.

Single Patent Filing and Examination in Australia and New Zealand Almost a Reality

Feb 17 2015

As we reported late last year, the Intellectual Property Laws Amendment Bill 2014 was read by the Australian House of Representatives. On 9 February 2015, the bill passed the Australia Senate and will soon become law in Australia as the Intellectual Property Laws Amendment Act 2015.

One significant aspect of the new law is the introduction of a Single Application Process (SAP) and a Single Examination Process (SEP) for Australia and New Zealand patent applications. Read More

Australia’s Very Exclusive Patent Licensee Club

Feb 11 2015

Bristol-Myers Squibb Company v Apotex Pty Ltd [2015] FCAFC 2

The Full Federal Court of Australia (Court) has held that an ‘exclusive licensee’ within the definition of the Patents Act 1990 (Cth) (Patents Act), must be granted the exclusive right to undertake ALL of the activities falling within the meaning of “exploit”. Accordingly, a grant of a licence to advertise, market, promote, sell and distribute, but not manufacture, does not create an “exclusive licensee”, as defined in the Patents Act. There can only be one exclusive licensee and the patentee cannot reserve any of the exclusive rights to exploit to itself. Read More

Teva and Its Potential Impact on Patent Litigation

Jan 30 2015

The Supreme Court recently handed down its 7-2 opinion in Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc. The case involved a Federal Circuit review of a district court’s determination that Teva’s patent claims were not indefinite with respect to the phrase “molecular weight.” During trial, the District Court construed the phrase “molecular weight” by considering expert declarations from both parties relating to different ways to calculate a molecular weight, and how the specification supported or conflicted with each of the ways to calculate molecular weight. The District Court credited Teva’s expert declaration at the expense of Sandoz’s expert declaration.

To read the full alert, click here.

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.

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.

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.

Category:Patents