Nanotechnology

Industry Team

As industry thought leaders, Harris Beach nanotechnology attorneys help clients navigate the complex legal, regulatory and public policy issues arising from this innovative applied science. Our interdisciplinary team leverages their technical backgrounds to provide insightful and effective intellectual property, risk management and financing strategies for nanotechnology applications in industries ranging from pharmaceuticals and medical devices to energy and manufacturing.

With the diverse potential applications of nanotechnology to many aspects of human endeavor comes a host of legal, societal and ethical issues. We help clients exploring the research and commercial opportunities of nanotechnology handle a wide spectrum of issues associated with this innovative applied science which is estimated to account for upward of $1 trillion in global commerce by the year 2015.

Harris Beach’s Nanotechnology Industry Team members are able to leverage their technical backgrounds and legal acumen to help nano-based businesses succeed. Our attorneys have formulated worldwide intellectual property strategies for universities and emerging nano-based businesses, and aggressively enforced their clients’ IP rights. Team members have also chaired and spoken at national nanotechnology conferences with regards to potential risks and perceived liabilities. They have published in the field, and serve on national committees that are writing informative white papers for thought leaders in Congress and regulatory agencies.

Our interdisciplinary nanotechnology industry team is comprised of attorneys and professionals experienced in such related practice areas as business and commercial litigation, corporate law, energy, environmental law, immigration, intellectual property, labor and employment, medical and life sciences, public finance and toxic tort. Complementing our legal services, our subsidiary HB Solutions LLC offers a broad range of non-legal consulting services to provide fully-integrated operational and strategic solutions to our nanotechnology clients.

Our services include:

Corporate Law

Harris Beach provides insightful and practical counsel on the range of strategic, operational and organizational challenges facing established technology companies
with nanotechnology related products and research programs, as well as early stage technology companies and entrepreneurs just entering the nanotechnology marketplace. Our services range from legal counsel on business entity decisions and preparing business plans to securing financing, to developing non-compete and confidentiality agreements, and interpreting regulatory compliance guidelines and securities law compliance, both in public offerings and private placements.

Harris Beach also assists clients with obtaining capital from individual and/or institutional investors, including venture capital. We have strong relationships with venture capitalists, mezzanine investors and financial institutions and we handle all aspects of both private placements and Initial Public Offerings (IPOs). Our attorneys help clients negotiate strategic alliances with selected companies and institutions that can provide strategic marketing services, development funding, licenses to needed technology and often equity capital.  We also advise clients on setting up strategic alliances for the purposes of marketing and/or global distribution strategies.

Economic Development/Incentives for Investors

We work with research complexes that include prominent nanotechnology tenants to facilitate identifying, securing and managing economic development incentive programs offered by the federal government and New York state. Specifically, in connection with such incentive programs, we offer eligibility evaluation, loan/grant application preparation, negotiation of project benefits, analysis of expected tax credits, deal structuring services and client representation through closing. Examples include our counsel to the developer of the Rochester Technology Park and representing a public benefit corporation with the development of the Saratoga Technology and Energy Park.

Harris Beach can help organizations understand federal regulations and procurement, import-export issues, and ethical oversight. New York state represents tremendous opportunity for organizations seeking to grow and expand business. Harris Beach has a strong reputation for its knowledge on how to conduct business in New York state. This knowledge assists clients, including nanotechnology companies, with advancing state and local government approvals as well as accessing grants and economic development incentive programs.

Energy/Cleantech Related Applications and Incentives

Our Energy Industry Team attorneys work with numerous renewable energy companies including wind, biodiesel/biomass and ethanol developers, and solar/PV companies who leverage nanotechnology to produce inexpensive, lightweight plastic solar panels. We help companies identify and benefit from public and private funding for renewable energy innovation and development through sources including Systems Benefit Charge funding of energy-related technology and market development programs administered by the New York State Energy Research and Development Authority (NYSERDA), and the state’s Energy Efficiency Portfolio Standard initiative designed to reduce consumption of electricity and natural gas while spurring creation of the infrastructure to support the creation of energy efficiency and cleantech jobs.

Environmental Law

We understand the environmental implications of nanotechnology and are well versed in the statutes that currently or may potentially apply to the manufacture, use and disposal of nanomaterials. Our attorneys can help guide businesses to research and develop nanotechnology in accordance with the Clean Air and Clean Water Acts and comply with the Toxic Substances Control Act.

Intellectual Property

The patent attorneys on our nano-technology team, with backgrounds in chemistry, biotechnology, physics and engineering, oversee the worldwide patent prosecution of numerous nanotechnology inventions for corporate and academic clients and their licensees. In addition to formulating prosecution strategies for clients’ nanotechnology inventions, we are routinely engaged to perform intellectual property analyses such as performing due diligence evaluations and patent landscape analyses, analyzing potentially competing products and patents, and performing related art surveys in connection with drafting claims for patent applications directed to platform technologies.

We routinely perform intellectual property audits and have extensive experience managing international client patent and trademark portfolios to protect identity and brand value. Our attorneys also analyze current and anticipated changes in the patent landscape for potential effects on nanotechnology-related intellectual property strategies. Additionally, in commercializing an invention, especially in an emerging field such as nanotechnology, it is critical to enforce patents, trade secrets and other intellectual property rights.

Litigation

If unresolved or problematic issues occur, we can also provide business and commercial litigation including e-discovery services should the need arise.

Regulatory Compliance

The nanotechnology field faces significant regulatory scrutiny from U.S. agencies including, but not limited to, the Food and Drug Administration, Consumer Product Safety Commission, Federal Trade Commission, Environmental Protection Agency, Department of Defense, Patent Office and National Institute for Occupational Safety and Health. Specifically, our nanotechnology team is familiar with current FDA regulations and its current case-by-case assessment methodology for products containing nanomaterials.

Harris Beach attorneys can help clients deal with the ambiguities of current nanotechnology regulation by providing a comprehensive analysis of existing legal authorities and alerting them to new laws as a regulatory blueprint is developed for nanotechnology. Our attorneys have authored a chapter on medical devices, and edited chapters on drugs, biologics and combination products for an ABA nanotechnology whitepaper specifically written for
industry thought leaders which is available on the Harris Beach web site or upon request.

Risk Assessment and Management

The nearly limitless application for nanomaterials and variability of nanoparticle characteristics add to the complexity of assessing nanoparticle toxicity and risk, especially since the health effects from human exposure to engineered nanoparticles are essentially unknown. Harris Beach has counseled start-up, mid-size, and large medical device and pharmaceutical companies in risk assessment and avoidance, with the goal of avoiding and limiting product liability litigation. Our pre-litigation risk management services include evaluation of the impact of new indications for use for established 510K products; off-label promotion by sales representatives, or implementation by health care providers of an off-label use; addition of a “black box” warning; effects of significant design changes; the products liability implications of filing a RiskMAP; impact of prior claims, lawsuits or mass tort litigation to competitor products; effect of direct-to-consumer marketing and advertising; and recall and crisis counseling.  We also counsel our clients on the impact of recent change in New York state law adopting federal Zubulake case law, holding that the costs of document production must be borne by producing parties (typically the defendant in product liability lawsuits) and assist clients to streamline their record retention policies, purge unnecessary documents, reduce their terabyte load and thereby reduce e-discovery costs before litigation ensues.

Non-Legal Consulting Services

Harris Beach recognizes that client solutions often involve more than just legal needs. Consequently, we offer a unique, comprehensive approach to meeting our clients’ pressing non-legal challenges through our affiliated consulting subsidiary HB Solutions LLC.

HB Solutions marketing and communications professionals assist clients in branding themselves and presenting their unique marketing propositions to potential technology partners and end users. HB Solutions can also aid clients with their strategic planning, project development, controversial and crisis communications management, public and media relations, as well as the tactical marketing vehicles to position and promote their products and services.

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