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Tag Archives: U.S. patents

Prioritized Examination: Good News for Those That Need Quick U.S. Patents

One of our clients recently received a notice of allowance from the USPTO after only six months of filing and should receive an issued U.S. utility patent within eight months of filing. For those of you familiar with the U.S. patent system and accustomed to waits of 3, 4, 5 or more years to obtain a patent, this may sound impossible. However, it is now possible due to prioritized examination (sometimes referred to as Track One examination) that was implemented by the USPTO late last year. See our earlier blog entry.…

International Center for Technology Assessment et al v. Hamburg

On December 21, 2011, the International Center for Technology Assessment (ICTA), along with fellow plaintiffs Friends of the Earth (FOE), the Center for Environmental Health, Food and Water Watch, the Institute for Agriculture and Trade Policy, and the Action Group on Erosion, Technology and Concentration filed a complaint in the US District Court for the District of Norther California against Margaret A. Hamburg, Commissioner of the US Food and Drug Administration (FDA), requesting that "this Court enter an Order:


(1) Declaring that the Defendants have violated the Administrative Procedure Act by failing to respond to the 2006 Petition within a reasonable time;

(2) Declaring that the Defendants continue to be in violation of the Administrative Procedure Act by failing to respond to the 2006 Petition;

(3) Ordering Defendants to respond to the 2006 Petition as soon as reasonably practicable"

In May of 2006, ICTA filed a "Petition Requesting FDA Amend Its Regulations for Products Composed of Engineered Nanoparticles Generally and Sunscreen Drug Products Composed of Engineered Nanoparticles Specifically". The petition requested "that the Commissioner undertake the following actions with regards to all nanomaterial products:

1) Amend FDA regulations to include nanotechnology definitions necessary to properly regulate nanomaterial products . . . .

2) Issue a formal advisory opinion explaining FDA’s position regarding engineered nanoparticles in products regulated by FDA.

3) Enact new regulations directed at FDA oversight of nanomaterial products establishing and requiring . . .that: nanoparticles be treated as new substances; nanomaterials be subjected to nano-spefic paradigms of …

“Nano Risk Governance: Current Developments and Future Perspectives”

Nanotechnology Law & Business just published its new edition.  For those who might be interested, Volume 6.2 contains an article I co-authored with several nano-friends entitled: "Nano Risk Governance: Current Developments and Future Perspectives."  You can find the article here.  An abstract follows.

As with many new technologies, developing a framework for making risk management decisions for nanotechnology is a challenge. Risk assessment has been proposed as the foundation for many regulatory frameworks for nanomaterials. Although the traditional risk assessment paradigm successfully used by the scientific community since the early 1980s may be generally applicable, its application to nanotechnology requires a significant information base. The authors’ experience supporting federal agencies in the United States, Canada, and the European Union—as well as state agencies in Massachusetts and New York and cities such as Berkeley and Cambridge—suggests that nanomaterial regulatory frameworks could be built upon existing regulatory approaches with the addition of a more rigorous and transparent method for integrating technical information and expert judgment. The authors argue that the current focus on studying the amount of risk acceptable for a specific technology or material should be shifted toward comparative assessment of available alternatives, and the use of science and policy to identify alternative nanotechnologies and opportunities for risk reduction and innovation. This approach involves the use of both quantitative and qualitative decision analysis tools, offering roadmaps for assessing different information sources and making policy decisions. Two representative methods presented are the Alternatives Assessment method and the Multi-Criteria Decision Analysis method.…

Recap: US Chamber Nanotech Conference

By Helen Kim:

On November 13, 2007, the U.S. Chamber of Commerce hosted “Breaking the Barriers: The BIG Business of Nanotechnology” at 1615 H Street NW in Washington, D.C. The conference focused on issues of commercialization, regulatory concerns, and consumer education for the emerging field of nanotechnology. Events included speeches by Senator Ron Wyden; Dean Ronald McNeil of the business school at the University of Illinois-Springfield; John Marburger, science advisor to President Bush; and two roundtable discussions composed of educators, investors, researchers, and government officials.…