Archive for May, 2011

What’s New in Nanogovernance? A Brief View from All Sectors

Posted May.29, 2011 under Chemicals, Cosmetics, Environment, EPA, European Union, Government Agencies, Governmental Interaction, Health, Nanosilver, Pesticides, Regulation, Safety
usalawyerstoday.com

usalawyerstoday.com

On May 19, 2011, the American Bar Association’s Section of Environment, Energy, and Resources (Pesticides, Chemical Regulation and Right-to-Know Committee) and Section of Science and Technology Law (Nanotechnology Committee) presented a webinar on the subject of “Nano Governance:  The Current State of Federal, State, and International Regulation.”  Speakers came from all sectors, including private law firms and industry.

Listening to these excellent and expert speakers for a full afternoon, certain clear points and patterns emerged that I will share briefly here.

1.  Size.  It really is all about size.  Every speaker acknowledged the role of the size of nanoparticles in developing testing protocols and approaches to regulation.  Nanomaterials may behave differently from macroscale materials of the same substance, and may differ from one another in significant ways.

2.  Progress.  Regulatory agencies are turning their attention to the health and safety aspects of nanotechnology.  There is a pervasive concern about the prevalence of these technologies and the paucity of studies.

3.  Fragmentation.  Attention to the potential issues raised by nanotechnology continues to be highly fragmented.  There has been intensely focused attention to some issues, but others remain to be addressed.

For example, EPA, through its authority under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), has focused attention on regulating nanosilver and other nanomaterials in FIFRA-registered products.  Under FIFRA, all pesticides need to be registered (i.e. licensed) before they may be sold, and as part of that process, a pesticide applicant must show that its product will not “cause unreasonable adverse effects on the environment.”  Currently, some pesticides that contain nanomaterials are already on the market, having been licensed prior to EPA’s scrutiny of nanomaterials.  Other applications are pending for registration of pesticides containing nanomaterials.  EPA’s draft policy proposal would treat a pesticide as “new” if it contains a nanoscale material, regardless of whether a non-nanoscale form of that same ingredient is already in a registered product.  Thus, for example, nanosilver would be treated as “new” even though silver is a registered pesticide.  But risks assessment lags behind.  According to webinar speaker William Jordan, Senior Policy Advisor, Office of Pesticide Programs for EPA, “more data are needed in all disciplines to have adequate information to assess the risks of nanosilver.”

Nanomaterials elsewhere in products and the environment are subject to potential regulation under other federal statutes, and some state programs (California being represented at the webinar).  But progress in one area does not necessarily mean progress elsewhere.  The EU and Australia are progressing, but the need remains for some vehicle to standardize definitions and approaches.  And standardization remains a debatable issue in itself.

4.  Industry Uncertainty.  Webinar speaker Rosalind Volpe, Executive Director of an industry association, Silver Technology Working Group (a program of Silver Research Consortium LLC, Durham, NC), expressed the concerns of the industry that EPA’s steps to regulate nanosilver give the impression that nanomaterials are harmful.  The industry is concerned that there is a “cloud of uncertainty” over it, which discourages investors and deters innovation, even where the nanomaterials used may not pose any health or safety problems.

5.  Bottom Line.  The bottom line, as usual, seems to be the need for an appropriate balance between technological progress and safety of humans and the environment.

Other speakers at the webinar included representatives of:

Nanotechnologies Industries Association, Brussels, Belgium

Chemical Control Division, Office of Pollution Prevention and Toxics, EPA

U.S. Consumer Product Safety Commission

California Nanotechnology Initiative

California Department of Toxic Substances Control

Environmental Defense Fund, Inc.

. . . and several attorneys in private practice

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Thoughts on War Dust and Nanoparticles

Posted May.20, 2011 under Environment, Government Agencies, Health, Regulation, Research, Safety

nano 6Last week, the news media reported the results of a study conducted by Navy Capt. Mark Lyles, the chair of medical sciences and biotechnology at the Center for Naval Warfare Studies at the Naval War College, which purported to explain the cause of a wide range of symptoms and illnesses experienced by current and former U.S. troops in Iraq, Afghanistan, and Kuwait.  Minute dust particles containing toxic metals, bacteria, and other substances may be responsible for such health problems as cancers, respiratory ailments, heart disease, and neurological conditions in vets.  The key to the particular toxicity of the substances, as contained in the dust, is thought to be the tiny size of the particles.  For various reasons, the dust in that region of the world is much finer than ordinary dust, and the tiny particles are easily inhaled deep into the lungs, where disease processes can begin.

Although these dust particles are not the same as nanoparticles, this study raises a red flag about the need for caution about exposures to nanoparticles, whether in the workplace or the environment.  As repeatedly noted in this blog, the size of nanoparticles is key to their behavior, and some early studies have indicated that toxicity may increase as the size of particles decreases.  As the President’s Cancer Panel stated in its 2008-2009 Annual Report, the small size of nanoparticles means that “they can be inhaled, ingested, and absorbed through the skin, entering the blood stream, penetrating cells throughout the body (including the brain), and perhaps interfering with DNA processes.” (p. 40)  In the environment, the particles could potentially wreak ecological havoc.  Several studies have shown that some kinds of nanoparticles have leached into the environment, thus red-flagging the need for determining exactly how they affect the environment.

It is a fact of contemporary life that devastating results could come from exposure to engineered particles just as much as from biological organisms or a toxic soup of substances in the soil-dust of the planet.  With engineered nanomaterials, it is currently anyone’s guess as to when, how, or if such devastating results could occur.

At best, this new study of war dust is a reminder of the present, urgent need to conduct health and safety studies on nanomaterials.  At worst, it is a portent of things to come.

 

For a news report on the Navy researcher’s results, see

http://www.usatoday.com/news/military/2011-05-11-Iraq-Afghanistan-dust-soldiers-illnesses_n.htm

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Justices Consider Many Options in Microsoft v. i4i Patent Case Oral Arguments

Posted May.10, 2011 under Litigation, Patents, Statutes, Supreme Court

supctOn April 18, 2011, the U.S. Supreme Court heard oral arguments in Microsoft v. i4i Limited Partnership, a patent case I previously addressed in this blog.  The central issue before the Court involved the standard of proof used to determine the validity of a patent in patent infringement litigation.  The court below had held that a party sued for patent infringement who raises invalidity of the patent as a defense must prove invalidity by clear and convincing evidence.  Microsoft, the petitioner, argued that because Section 282 of the Patent Act, 35 U.S.C. § 282 – which provides a presumption of validity for a patent – does not specify a heightened standard, the standard should be a preponderance of the evidence, thereby making it easier to challenge the validity of a patent.  i4i argued that the clear and convincing evidence standard, which has been followed for decades, should continue to apply.  Chief Justice Roberts has recused himself from the case because of investments he holds in Microsoft.

Early in the argument, Justice Kagan noted that the early cases addressing the subject contained broad language suggesting a heavy burden of persuasion.  Justice Ginsberg further noted the absence of any attempt by Congress to clarify the standard in the Act.  Absent statutory language to the contrary, Justice Kagan suggested simply following precedent and applying the clear and convincing evidence standard.

Justice Breyer acknowledged that the Supreme Court could make a change to the procedural way this issue is resolved.  He framed the problem as an economic one, a need to achieve balance between providing legal protection for inventions that warrant it and preventing undeserving inventions from taking advantage of the protections of patent law.  One approach to the central issue in the case, he suggested, would be to ask the Patent Office for reconsideration.  Another would be to let the jury apply the clear and convincing standard to the “brute facts,” then allow the judge to make the ultimate decision about validity.

Much of the questioning involved Microsoft’s argument that a clear and convincing standard is not appropriate in a case in which the PTO did not previously consider the  prior art evidence introduced by the defendant in the infringement litigation.  The justices considered whether accepting that argument would mean that two different standards should apply, depending on whether the evidence had been considered by the PTO.  i4i countered with several justifications for applying the clear and convincing standard across the board.  One point was the unfairness of a lower standard, which would make it easier for a single non-expert jury to invalidate a patent when so many parties (inventor, investors, licensees) relied upon the patent at the time it was issued.  Along this vein, another approach considered by the Court during the argument was to instruct the jury to apply the clear and convincing evidence standard, but include a further instruction that the jury could consider, in appropriate circumstances, that the PTO had not considered the prior art.

The variety of suggestions discussed in the oral arguments make prediction of the ultimate result difficult.  It is still possible that the Court will find a clear answer in the language of Section 282.  Firms with patents on nanotechnology applications could be disappointed to find that the Court rejects an across-the-board use of the clear and convincing evidence standard.  If that happens, infringers will have an advantage over original inventors, and more patents will be held invalid in court.  The effect could be significant, perhaps having a chilling effect on advances in science and on investment in original inventions.

The transcript of the oral argument may be found at

http://www.supremecourt.gov/oral_arguments/argument_transcripts/10-290.pdf

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