United States – Page 11

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

Trademark Clearinghouse – First Annual Renewal Deadline Approaching

Oct 23 2014

The Trademark Clearinghouse (TMCH) is the central repository for validated trademarks for the purpose of protecting brands under the Internet Corporation for Assigned Names and Numbers’ (ICANN) New Generic Top-Level Domains program (new gTLD program), permitting participation in both the Sunrise and Claims processes that ICANN established to give preference to brand owners. If your company was an early registrant in the TMCH, it is likely that your registrations had an effective date of November 5, 2013, which is the date that the TMCH went ‘live’. While the TMCH procedures provide for multi-year registrations, many registrants initially paid their US$150 fee for only a single year of registration. If so, your deadline to renew is November 5, 2014.

U.S. Trademark Trial and Appeal Board Sustains First Fraud Claim Since In re Bose in 2009

Oct 21 2014

On September 30, 2014, in Nationstar Mortgage LLC v. Mujahid Ahmad, the U.S. Trademark Trial and Appeal Board (Board) sustained a claim of fraud on the U.S. Patent and Trademark Office (USPTO) for the first time since the Federal Circuit issued its 2009 decision in In re Bose, upholding an opposition to the mark NATIONSTAR for various real estate brokerage, mortgage and management services.

In response to fraud allegations, Ahmad needed to show that he was using the NATIONSTAR mark with each of the services prior to the filing date of his in-use application. Read More

The Debate Continues: What is a ‘Transformative Use’ for ‘Fair Use’ Purposes

Oct 01 2014

In a recent decision by the U.S. Circuit Court of Appeals for the Seventh Circuit (Seventh Circuit), Judge Frank Easterbrook expressly joined the ongoing debate over the scope of ‘transformative use’ analysis in the ‘fair use’ defense to copyright infringement. In Kienitz v. Sconnie Nation LLC, the court reviewed the trial court’s determination that the using of a photograph of the mayor of Madison, Wisconsin, on a critical T-shirt was ‘fair use’ and did not create liability under the Copyright Act. In finding ‘fair use’, the trial court found support in the recent opinion in Cariou v. Prince, in which the U.S. Circuit Court of Appeals for the Second Circuit held that the use of a photographic image in a work of ‘appropriation art’ was ‘transformative’ and thus a ‘fair use’.

Patents for Humanity: It’s Not Just an Invention

Sep 25 2014

The deadline for submission of applications for the U.S. Patent & Trademark Office (USPTO) competition, PATENTS FOR HUMANITY, has been extended to October 31, 2014. The purpose of the program is to incentivize patent owners, applicants and licensees to use their technologies to address humanitarian issues in any of the following categories:

medicine
nutrition
sanitation
household energy
living standards. Read More

Purple is the New Orange: FDA Releases a Purple Book for Biosimilars

Sep 15 2014

On September 9, 2014, the U.S. Food and Drug Administration (“FDA”) published the first edition of the Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations (“Purple Book”). The Purple Book is the biological equivalent of the pharmaceutical Orange Book, and seeks to aid regulatory agents, generic manufacturers, and physicians by arming them with information related to biological products such as biosimilars including, for example, providing information regarding the interchangeability of products. Read More

Tag:United States