Tag:Americas

1
After Nine Year Battle, Appeals Court Upholds US$540,000 Award to Sculptor for Use of Memorial Images on U.S. Postage Stamp
2
Social Media: 10 Fundamental Questions All Businesses Should Consider About Their Online Presence
3
Teva and Its Potential Impact on Patent Litigation
4
IP Rights in Big Data
5
ODAC Committee Votes to License Sandoz’s Zarxio®
6
Big Data Speaks Loudly and Carries a Big Stick
7
Patent Office Issues New Examination Guidelines for Subject Matter Eligibility
8
Federal Circuit Affirms Dismissal of Sandoz’s BPCIA-Related Declaratory Judgment Action Regarding Enbrel® Patents, but Declines to Address BPCIA Interpretation
9
Declaratory Judgment Action Premature: Decision Suggests “Patent Dance” Mandatory for Biosimilar Applicants
10
Flying Doughnuts – Future Reality?

After Nine Year Battle, Appeals Court Upholds US$540,000 Award to Sculptor for Use of Memorial Images on U.S. Postage Stamp

A long litigation battle by sculptor Frank Gaylord against the U.S. government has resulted in the confirmation of an award of more than US$540,000. In 1990, Mr. Gaylord won a competition to work on a federal memorial to veterans of the Korean War (Memorial), which had been authorized by the U.S. Congress. Ultimately, the Memorial comprised 19 stainless steel statues, designed to represent a platoon of soldiers in formation on the ground. The Memorial was completed, installed, and opened to the public in Washington, DC, in 1995. Mr. Gaylord filed a number of copyright registrations, covering the various statues. Read More

Social Media: 10 Fundamental Questions All Businesses Should Consider About Their Online Presence

Twenty years ago, the social media world we now live in was the stuff of science fiction. Today, social media is a critical business tool creating unprecedented opportunities for direct consumer interaction, brand awareness, checking the pulse of key constituents and so much more. This incredible opportunity is not risk-free, however, and is the subject of new laws, application of old laws to new situations, and a significant amount of murkiness. Fortunately, the risks can be managed by considering the issues created by social media and that begins with asking the right questions. Please click here to view a discussion of ten important questions every business can start with to better benefit from its social media presence.

Teva and Its Potential Impact on Patent Litigation

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.

IP Rights in Big Data

In our last Big Data blog posting, we cautioned that the protection of the intellectual property rights (IP) in Big Data may warrant its own focus.  While there are legitimate concerns about finding IP  in data, because data may be an inert lump of code, bits, or pieces of information, it is worthwhile to think about the different kinds of IP that arise in conjunction with and in the context of Big Data.  This blog entry focuses on the IP opportunities ‘in relation to’ Big Data.

Read More

ODAC Committee Votes to License Sandoz’s Zarxio®

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

“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

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

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

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?

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.

Read More

Copyright © 2024, K&L Gates LLP. All Rights Reserved.