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IP Bulletin, May 2015

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05.21.2015 | Legal Update

The Nutter IP Bulletin provides periodic IP news updates and practical tips

FDA Announces Availability of the Final Guidance for Expedited Access to Devices Intended for Unmet Medical Needs

On April 13, 2015, the U.S. Food and Drug Administration (FDA) announced the availability of the Center for Diseases and Radiological Health’s (CDRH) final guidance document entitled “Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions.” This final guidance document outlines the FDA’s new Expedited Access Pathway (EAP) program for select medical devices that address unmet medical needs. Among other things, this document details a new Program Evaluation that the FDA will use to publish statistics related to the program in order to assess whether or not changes should be made to the EAP program.

To read about CDRH’s final guidance document and our recommendations in view of the same, please click here. 

What Constitutes Trademark “Use?”

The United States requires a showing of use for extension of trademark protection, so questions regarding what is sufficient to demonstrate use of a trademark are common among both domestic and international clients. With the increased use of technology to market and advertise products, the use of marks has been changing over time. Recent U.S. court decisions have attempted to clarify exactly what is required for a sufficient showing of use in the United States.

To read more about what constitutes trademark “use,” please click here. 

PTAB Issues Representative Decision on Scope of Estoppel in IPR Proceedings

Those considering petitioning for inter partes review (IPR) of a patent should take note of a recent decision issued by the Patent Trial and Appeal Board (the Board) with respect to the estoppel provisions of 35 U.S.C. §315(e)(1). The decision is one of only a handful of institution decisions that have been designated as “representative” by the Board. The Board took a strict, but by-the-book approach in deciding that a petitioner was estopped from raising a new combination of references in a second IPR when the references were relied upon individually or in combination with other references in a previous IPR.

To read more about the Board’s interpretation of the “could have been raised” standard, and its impact on your IPR strategies, please click here. 

Nutter’s IP Bulletin How-To Series on Branding

What to Do Once Your Trademark Registers—The Brand & New Media
Eleventh in The Series

Nutter’s series on building a brand began with the selection of a mark and the process of formally protecting it via trademark registration. At this point in the series, the mark is registered and ready for use and investment to elevate it into a brand. One area that can impact your brand is the use of your mark in “new media,” such as the Web and social media services. New media works differently than anything that has come before and there is a great deal to consider, from reserving domains and usernames to monitoring use—both your own and others’—across these mediums.

To read more about building a brand through new media, please click here.

Nutter's IP Bulletin is a bi-monthly publication of the Intellectual Property practice group at Nutter McClennen & Fish LLP in Boston. Assistance in the preparation of this issue was provided by Rory P. Pheiffer, Heather B. Repicky, Derek Roller, and Michael P. Visconti, III. For further information, please contact your Nutter attorney at 617-439-2000.

Recognized as a "Go-To" patent firm by IP Law & Business and Corporate Counsel, Nutter is dedicated to making its clients' strategic goals a reality and to maximizing the protection and value of their intellectual property. The firm has a long track record as the trusted IP advisor to innovative public and private companies, medical institutions and research universities, investors, entrepreneurs and inventors.

This update is for information purposes only and should not be construed as legal advice on any specific facts or circumstances. Under the rules of the Supreme Judicial Court of Massachusetts, this material may be considered as advertising.

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