Tag:Americas

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Big Data Round-Ups
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Next Steps in the Dance: Amgen Files Citizen Petition at FDA Requesting Mandatory Compliance with BPCIA Patent Procedures
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Left without a Partner: Amgen Sues Sandoz for Refusing to Dance in Accordance with BPCIA Patent Procedures
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DATA, DATABASE, METADATA, BIG DATA, PERSONAL DATA, DATA MINING…..
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Trademark Clearinghouse – First Annual Renewal Deadline Approaching
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U.S. Trademark Trial and Appeal Board Sustains First Fraud Claim Since In re Bose in 2009
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‘Like-Gating’? Facebook Says Dislike
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The Debate Continues: What is a ‘Transformative Use’ for ‘Fair Use’ Purposes
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Patents for Humanity: It’s Not Just an Invention
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Purple is the New Orange: FDA Releases a Purple Book for Biosimilars

Big Data Round-Ups

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

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

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.

Trademark Clearinghouse – First Annual Renewal Deadline Approaching

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

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

‘Like-Gating’? Facebook Says Dislike

Facebook Changes to its ‘Platform Policy’ can Affect Your Page

Facebook has announced a change to its Policy Platform that may affect the majority of users.

The policy change advises that Facebook will no longer allow advertisers to incentivise people to use social plugins or to like a Facebook Page (Page). This includes offering rewards, or gating apps or app content based on whether or not a person has liked a Page. It is still acceptable to incentivise people to login to your app, check-in at a place, or enter a promotion on your app’s Page.  Read More

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

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’.

Read More

Patents for Humanity: It’s Not Just an Invention

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

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

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