Patents – Page 15 – IP Law Watch

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®.

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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.

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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.

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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.

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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.

Business Method Patents in Australia: Mere Computer Implementation Not Enough

Nov 20 2014

Research Affiliates LLC v Commissioner of Patents [2014] FCAFC 150

On 10 November 2014, the Australian Full Federal Court (Court) held that a method of creating an index of securities using a standard computer was a ‘scheme’, and, hence, not a patentable invention.

The Court applied the Australian High Court test from National Research Development Corporation v Commissioner of Patents (1959) 102 CLR 252 that a patentable invention must produce an “artificially created state of affairs”. The Court said that this test is not satisfied by mechanistic application of artificiality or physical effect, but by understanding the claimed invention as a matter of substance not form. Read More

Next Steps in the Dance: Amgen Files Citizen Petition at FDA Requesting Mandatory Compliance with BPCIA Patent Procedures

Nov 13 2014

Amgen, Inc. has brought the discussion of the procedure for biosimilar applications from the courts to the FDA by filing a Citizen Petition (Docket No. FDA 2014 P 1771) on October 29, 2014, requesting that the FDA mandate compliance with the framework for biosimilar applications laid out by the Biologics Price Competition and Innovation Act.

To read the full alert, click here.

High Court Confirms That Extension of Time Provisions Apply to Requests for Pharmaceutical Extensions of Term

Nov 11 2014

In a recent decision, the High Court of Australia has ruled that the extension of time provisions of the Australian Patents Act 1990 (Act) can be used to extend the time for requesting an extension of term of a patent relating to a pharmaceutical substance.

The dispute was based on a request by Lundbeck to extend the term of Australian patent 623144. The extension of term request was filed after the applicable deadline and was, therefore, accompanied by an application for an extension of time. Read More

Left without a Partner: Amgen Sues Sandoz for Refusing to Dance in Accordance with BPCIA Patent Procedures

Nov 05 2014

There has been a lot of curiosity within the biologics industry regarding how the “patent dance” procedures of the Biologics Price Competition and Innovation Act (“BPCIA”) would operate. This interest was piqued in July 2014 when Sandoz Inc.’s (“Sandoz”) biosimilar application for a biosimilar of Amgen Inc.’s (“Amgen”) Neupogen® was the first accepted by FDA under section 351(k) of the Public Health Service Act. Apparently, Sandoz has refused to engage in the “patent dance” in accordance with the BPCIA, leaving Amgen without a dance partner. Amgen did not take kindly to being stranded on the dance floor and has opted to sue Sandoz for its allegedly unlawful refusal to follow the BPCIA’s patent resolution procedures.

To read the full alert, please click here.

Category:Patents