Foley & Lardner LLP

Stem Cell Technologies

Foley offers you a team of more than 20 attorneys experienced in stem cell technologies. This diverse team of both business attorneys and technical specialists counsels you on matters from IP strategy to real estate and taxation.
Advances in stem cell research have sparked new optimism over prospects for treating and curing a broad spectrum of maladies. Stem cell investigations already have illuminated the complexities of cell division and differentiation; on the horizon is the generation of cells and tissues for therapeutic use. Stem cells also are likely to advance drug development by allowing screening and testing in a wide range of cell types.

These advances offer the potential for tremendous medical benefits to individuals, as well as substantial economic gain for communities and institutions. It is not surprising, therefore, that the federal government, various state governments, and private investors are paying more and more attention to the stem cell field.

Foley provides a comprehensive offering of legal services to our stem cell clients. We integrate key disciplines within our firm to meet the diverse needs of life science organizations in areas of IP law, regulatory affairs (FDA, USDA), public policy, taxation, payor issues, business law, licensing, securities, antitrust counseling, labor and employment law, international trade, and health law. Drawing nationwide on the experience of Foley attorneys in these diverse legal areas, we anticipate and satisfy your particular needs in this fast-paced and ever-changing field of regenerative medicine.

Areas in which we provide services include:

Stem Cells From Prosecution to Litigation

Some of the more contentious and complex issues arising from stem cell research relate to IP assets and their protection, including: how the law treats IP assets created in the course of your stem cell research; patentability in the United States, China, Europe, and other jurisdictions; freedom to operate issues; what tools and therapies provide the greatest protection for your assets; and how you can leverage your portfolio to generate income; and the use of federal grants in research involving stem cells.

To address these and other associated issues, you may be required to collaborate with disparate entities. Therefore, it is vital to strike a balance between IP asset protection via well-drafted patent claims, and the ability to partner with other firms to exploit those patents via advantageous licensing agreements. We work closely with universities, research facilities, and private companies to develop comprehensive IP policies covering issues at the core of stem cell initiatives, including:

  • Technology transfer (Bayh-Dole Act)
  • Patents
  • Royalties
  • Licensing (domestically and internationally)
  • Research collaboration
  • Basic research tools (NIH Guidelines, licensing of genomic tools)

Regulatory Issues With Stem Cell Technologies

President Obama’s Executive Order on March 9, 2009 opened many doors for institutions and companies developing stem cell technologies and therapies. Along with new avenues of federal funding come continued questions relating to what and how that funding can be applied:

  • The Dickey-Wicker amendment still remains an issue on the use of federal funds for the unrestricted creation of embryonic stem cell lines. This regulatory challenge is an important aspect of compliance with the acceptance of federal funds.
  • Questions regarding the ethical requirements related to clinical trials and embryonic research also have been explored. Several entities have already published guidelines related to the treatment of human embryos and the method in which such embryos are obtained.
  • International questions will be raised as scientific advancements across the globe and their potential impact on U.S. policy are evaluated.
  • Europe’s restriction on the patenting of embryonic stem cell technology remains a challenge.

We work with you to develop standards and guidelines for protections and ethics. With a combination of significant regulatory and public policy experience, our attorneys understand not only current federal and state regulations, but how regulations being considered may impact your stem cell research, including:

  • Review of research
  • Changes in the way the FDA and other bodies issue drug approvals
  • Regulatory compliance with FDA and institutional review boards

We work with you and on your behalf to mitigate the impact of such regulations.

A Pro Bono Partnership With CIRM

California’s Proposition 71, a measure allocating $3 billion for stem cell research and the creation of the California Institute for Regenerative Medicine (CIRM), helped make California the bellwether state when it comes to stem cell research. True to our commitment to advising on public policy in the area of stem cell research, Foley developed a one-of-a-kind stem cell database for CIRM to assist researchers in obtaining valuable information on stem cell technologies that have been patented in the United States. In all, Foley attorneys retrieved, reviewed, and catalogued more than 3,000 patents. Patent claims were analyzed and collated into year categories and for specific research interests, such as the cell type, in vitro or in vivo use, and so forth.

The stem cell database is now located prominently on the CIRM Web site at http://tinyurl.com/cbd9t7v.

In addition to our work with CIRM, our Stem Cell attorneys have first-hand experience with and unique insight into the White House, Congress, executive branch departments, and regulatory agencies. Whether you are a coalition looking to educate the public on issues, or a private company or university looking for an effective strategy to obtain funding, we can help you find practical and politically viable answers to your questions. As your partner in public policy, our front-line position can help you reach your goals.

Tax Counseling for the Stem Cell Industry

With knowledge of the tax issues unique to our stem cell clients as well as a strong general business tax practice, our attorneys can help you realize your business objectives through tax-advantageous counseling, transactions, and planning. When controversies arise with federal and local tax authorities, we have the experience to provide you with a comprehensive response in tax audits, inquiries, and litigation.

We work with nonprofit and university research foundations to manage not only grant monies received for research, but also the tax issues related to IP assets developed under the grants. Tremendous tax planning opportunities are available from the moment IP of any kind is acquired or conceived. Our attorneys appreciate the subtle and complex distinctions that the tax laws create for various types of intellectual properties, and can provide you with comprehensive tax management strategies for such assets.

Real Estate Services for Stem Cell Enterprises

California’s Proposition 71 also spawned a number of real-estate-related side effects. One is the continuing migration of entrepreneurial scientists from other states to California in search of research monies and opportunity. Additionally, several California research universities have begun to draw up blueprints for new laboratories.

Depending on your needs and business objectives, we can work with you on local, regional, state, national, and international levels to address your real-estate-related needs. Our attorneys have participated in numerous projects involving a variety of creative financing structures, including tax-exempt revenue bonds, and have been active in the syndication of a variety of debt and equity interests in all types of real estate projects.

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