The Stem Cell Practice of Foley draws on the experience of attorneys from across the globe. Our approach enables our attorneys to integrate cross-disciplinary services to identify crucial issues and impart guidance for life science organizations.

Protecting IP Assets
There are many important questions concerning IP assets in the area of stem cells, including:

• How stem cells and their therapeutic and diagnostic use fit into the current IP landscape?
• What are the restrictions on patenting certain stem cell types by country, and what can be protected in Europe, Asia, and North America?
• How can individuals working in the industry protect IP prior to technology transfers and research collaborations, particularly during the acquisition and performance of grants, contracts, and other agreements?

Protecting IP portfolios in uncharted territory requires comprehensive due diligence. Foley is able to address IP-related questions at the onset of development so clients can better determine the value of their IP portfolio, take necessary precautions to protect value, and uncover potential roadblocks early on.

Developing a Business Plan — Legal Considerations
The advances in stem cell technologies and therapies offer the potential for tremendous medical benefits to individuals as well as substantial gain for companies and institutions. The expansion of opportunities for federal funding provides financial gain but raises many issues that stem cell companies should bear in mind, including:

• Budgets for the U.S. Department of Health & Human Services (HHS), National Institutes of Health (NIH), and other relevant appropriations for the upcoming fiscal year are likely to include significant funding for stem cell research activity.
• A potential increase of approximately $937 million over the prior fiscal year as well as $10.4 billion in funding for biomedical research included by the NIH could result in tremendous growth to the industry.

Understanding the state and federal regulations that affect research and development is critical in advancing a business plan reflecting the use of federal dollars, as is implementing an effective strategy to obtain this vital funding. Furthermore, understanding what the use of federal funding entails is critical as biotechnology companies and private equity firms seek out new business transactions. Foley's Life Sciences Industry Team and Government & Public Policy Practice professionals have the ability to work in tandem to provide counsel regarding business plans and business transactions as they relate to IP and federal dollars.

Private Equity Issues
Proper business planning is essential when exploring private equity ventures opportunities. With financial markets experiencing tumultuous times, financial questions related to stem cell companies continue to emerge.

• The life cycle for a technology company inception is approximately three years and $20 million dollars, while the life cycle for a stem cell company is approximately 10-12 years and $150 million. How will this play-out in the private equity market?
• Will alliances and licensing deals be enough to reach the necessary $150 million? How will venture capital funds get their return?
• Private equity firms are paying close attention to the banking industry. Have there been any recent deals that suggest private equity firms also are interested in life sciences and biotechnology businesses?

Foley Life Sciences Industry Team attorneys are strategically located throughout the world and possess experience and up-to-date knowledge on the current and local climates for private equity investment and stem cell related businesses.

Ethical, Regulatory, and Health Care Concerns
President Obama's Executive Order on March 9, 2009 opens many doors for institutions and companies developing stem cell technologies and therapies. Along with new avenues of federal funding come continued issues regarding how the funding can be applied, including:  

• The Dickey-Wicker Amendment still remains as a prohibition on the use of federal funds for the actual creation of stem cell lines. However, it does permit the use of funds for research on already created embryos. 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 have also 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 are evaluated and their potential impact on U.S. policy.

These issues will have a considerable impact on research and development, obtaining and utilizing federal dollars, and reporting activities. Biotechnology firms have the unique challenge of forging ahead despite many open-ended questions.

Litigation Concerning Stem Cells
With lingering questions related to the protection of IP portfolios, policies related to accepting federal funding and international contracting litigation become important as companies and research facilities draft necessary agreements. Foley attorneys 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
• Patents
• Royalties
• Licensing
• Research collaboration
• Basic research tools