The fast-paced world of nanotechnology is raising a broad range of significant cross-sectoral and transnational legal challenges, including determining and protecting ownership and commercial rights, creating new companies and joint ventures, raising capital to conduct R&D and apply new technologies, and identifying, evaluating and managing health, safety and environmental risks.
Sidley’s highly-regarded practice teams work together to provide clients involved in nanotechnologies with a full range of legal services. From initial investment through production, distribution, use, and end-of-life, Sidley can help clients understand and protect their intellectual property in nano materials and processes. Sidley also helps clients to navigate and negotiate complex regulatory schemes overseen by the FDA, EPA, OSHA, and European Commission, and advises on investments and international and commercial trade issues. In addition, Sidley represents companies facing litigation, and can help companies prepare for and assess risks of litigation involving nanotechnology.
The nascent field of nanotechnology presents a number of unique challenges. Sidley lawyers can assist companies in developing and protecting their nanotechnology investments. Successful strategies include using creative licensing agreements, forming cross-licensing groups and alliances, identifying companies in distress and acquiring their IP assets, and strategic development of patent portfolios, possibly in collaboration with foreign researchers. Because a large number of nano inventions are published in open technical journals, it is a powerful strategy to analyze critically the validity of competitor’s patents based on such public information. Further, as many researchers and inventors are employed by universities, creative arrangements between companies and universities concerning IP rights are often needed. We advise companies on the critical analysis of competitor’s patents and on developing and nurturing a mutually beneficial relationship between universities and companies.
Sidley lawyers advise clients participating in international efforts to establish nanotechnology standards on a wide range of topics. Chris Bell from our Houston office is a member of the U.S. international negotiating team working on the ISO effort to create international nanotechnology standards on terminology, nomenclature, measurement, characterization, health and safety, and environmental issues. Mr. Bell was one of the lead authors of the recently published ISO Technical Report 12885:2008 on Safe Practices in Occupational Settings Relevant To Nanotechnologies. He is currently the international project leader for the creation of an ISO Technical Report on a product stewardship oriented risk management for nanotechnologies, based on work conducted jointly by the Environmental Defense Fund and DuPont.
The ISO standards will likely have significant commercial and legal impacts on nanotechnologies, since many countries adopt ISO standards as legal requirements, and conformance to ISO standards is commonly required in commercial transactions. The ISO standards on terminology, measurement, and characterization may also have significant intellectual property consequences. The importance of this standards-setting effort is reflected in the heavy participation by several U.S. government agencies (including EPA, OSHA, NIOSH, NIST and the Department of Defense). Sidley lawyers are also involved in other standards setting initiatives in the nanotechnologies area, such as the standards writing process spearheaded by ASTM International (which the FDA has indicated it will take into account in developing regulatory standards for nanotechnologies in the pharmaceutical sector).
Our Brussels office works with government agencies regulating nanotechnology in the European Union, including the European Commission. In addition, lawyers from our Brussels office advise manufacturing clients on anticipated revised EU regulation of nanotechnology. Maurits Lugard, who leads the firm’s EU Regulatory Practice, has nine years of regulatory and legal experience at the European Commission. The EU Regulatory Group regularly advises clients on EU regulations applicable to various fields, including food and drug, pharmaceutical and biotechnology, intellectual property, environmental, energy, information technology and e-commerce, data protection, and consumer protection and safety.
Sidley also advises clients on international trade issues. We advise on international law-related issues associated with the rapid development and application of nanotechnologies, including identifying and resolving potential trade barriers, complex international intellectual property issues, and international arbitrations. A number of our International Trade lawyers served at the World Trade Organization, the United States Trade Representative, and the European Commission. We maintain offices in the international trade nerve centers of Washington, D.C., Brussels, and Geneva.
Health, Safety & Environment
Successfully managing health, safety and environmental (HSE) issues will be critical to the commercial success and public perceptions of nanotechnologies. The unique properties of nanomaterials likely will pose challenges on a variety of fronts, including human exposure (e.g., inhalation, dermal), environmental fate and transport, toxicity, ecotoxicity, risk assessment, personal protective equipment, and engineering controls. There will also likely be concerns about potential consumer exposure associated with products containing nanomaterials.
With more than 35 lawyers providing regulatory counseling, civil litigation and criminal enforcement and defense representation, we regularly provide clients with cost-conscious, innovative, and practical solutions to the most pressing HSE issues. Sidley has extensive experience with the HSE regulatory issues related to the R&D, manufacturing, distribution, use, and end-of-life phases of products directly relevant to nanotechnology regulation. The international ISO standards work that Sidley is involved in has a major HSE focus. On the R&D and product development front, Sidley lawyers counsel clients on compliance with the full range of TSCA requirements pursuant to which EPA will regulate nanomaterials, including R&D exemptions, placing new chemicals on EPA’s TSCA Chemical Inventory, and responding to testing and reporting requirements. Chris Bell served as the team leader in the drafting of an American Bar Association “white paper” on the regulation on nanotechnology under TSCA, and is participating on a similar ABA team writing a white paper on the regulation of nanotechnology under the FFDCA. Our extensive experience helping clients obtain necessary air and water permits and manage wastes, including dealing with complex scientific issues related to risk (i.e., toxicity and exposure), is directly relevant to how federal and state governments will regulate nanotechnology manufacturing practices. We are also experienced in assisting clients on public disclosure requirements such as California’s Proposition 65.
Products Liability & Toxic Torts
Sidley lawyers are already representing clients in toxic tort litigation involving nanomaterials, where neighboring property owners are alleging that nanoparticles released into the air have caused property damage. Sidley has a team of litigators dedicated to the study of nano-tort issues. This team draws upon the firm’s broad-ranging experience in asbestos, other toxic tort cases, medical device and pharmaceutical products liability litigation. Our products liability cases often focus on presenting and evaluating our clients’ actions in light of developing science, making us uniquely qualified to advise clients in emerging fields like nanotechnology. We also are working closely with a number of the prominent defense experts in the nanotechnology field.
Sidley lawyers have more than three decades of experience in representing companies in personal injury, toxic tort, medical monitoring and consumer fraud litigation ranging from state, nation, and worldwide class actions and multidistrict litigations (MDL) to individual cases. Given the breadth of our experience, we appreciate that no two litigations are exactly the same. As our record demonstrates, we also understand that there are many ways to prevail in litigation, independent of trial. Accordingly, we are highly adept at tailoring and implementing creative and cost-effective strategies for resolving both individual cases and multiple cases. Finally, we are well-versed in the development of early case assessments and pre-litigation audits aimed at identifying potential products liability risks, as well as in the development of litigation plans for mass tort and multi-state consumer protection litigation.
Our lawyers frequently use new case management strategies, client-friendly extranet facilities, as well as the latest document management and trial presentation tools. We have developed a wealth of resources invaluable to the successful defense of complex nanotechnology claims such as Daubert motions, expert databases, scientific publications, computerized litigation support and trial presentation technology.