United States – Page 10

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.

IP Rights in Big Data

Jan 16 2015

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.

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.

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.

Big Data Round-Ups

Dec 02 2014

Our October 30th blog introduced and explained the concept of Big Data. Here we look at some of the pitfalls of collecting the massive amounts of small data that combine to become Big Data. We imagine the ranges of bits and bytes of small data that combine to create Big Data as herds of grazing horses susceptible to round up and inclusion in a Big Data corral. 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.

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.

DATA, DATABASE, METADATA, BIG DATA, PERSONAL DATA, DATA MINING…..

Oct 30 2014

Because we are besieged by terms that include the word “data,” the phrase “big data” does not immediately capture attention. Big Data is comprised of little data, but it is more than a database. Data is shorthand for information stored digitally. The world is awash with information and we have not yet approached the high tide of information, of data, that is coming.

Each of us, as individuals, generates and is defined by data; and a subset of that is called personal data (with the subset being, roughly speaking, data identifying you or a device reasonably traceable to you). Our societal awareness of our personal data is rising as is legislation relating to how that is generated and managed. Read More

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