Life Sciences
Foley’s Life Sciences Industry Team is composed of corporate, health care, regulatory, and IP attorneys, whose 360º approach helps address your immediate, specific legal issues, while our deep industry knowledge enables us to work with your long-term objectives in mind.
From fluctuating global financial markets and a rapidly changing IP environment to regulatory hurdles that can affect the products you bring to market, the life sciences industry poses challenges to start-ups and established enterprises alike. For more than 25 years, we have been partnering with life sciences companies like yours at all stages of development to help them make their mark on the industry. The cornerstone of our success is our ability to blend both technical and legal insight on the most complex life sciences innovation.
Foley’s corporate attorneys who focus in life sciences understand the unique requirements of the industry. Whether you are a start-up or a mature commercial business, we provide you with comprehensive strategic and transactional advice and capabilities that are specifically tailored to your unique needs. Our experience spans complex transactions involving life sciences companies, both domestic and foreign, including:
- Licensing and collaboration agreements
- Pre-clinical and clinical research counseling
- Manufacturing and distribution agreements
- Mergers, acquisitions, and public offerings
- Public and private debt and equity financings
- Joint ventures
- International commerce
Our goals and activities are aligned with yours: to deploy our resources and experience to enable you to continue to innovate, secure reliable funding, achieve financial objectives, and deliver valuable products to market. We seek to ensure that your transactions are not only financially and legally sound but also reflect prevailing commercial and financial terms to help you stay competitive in an evolving marketplace.
Recognizing that clients need more than legal insight to succeed, in June 2011, the firm launched Foley Ventures, a venture capital fund that invests exclusively in or with our clients. We are “putting our money where our mouth is” by taking an equity stake in our clients’ future prospects.
Developing and monetizing your patent portfolio is critical in today’s competitive global market for drug development. We understand that patent procurement and IP portfolio management occurs within the context of each client’s business objectives and goals. We approach your IP strategy with your unique objectives in mind, while providing counsel to help you remain competitive in the industry. Our team conducts careful drafting of patent applications and skillful procurement of worldwide patent rights. We provide enforcement strategies in a cost-effective manner using our client-centric, real-time Budget Management Tool, Foley Collaborate, and other client initiatives, such as alternative fee arrangements that include risk-sharing. Our attorneys conduct due diligence analyses, freedom to operate opinions, and negotiate licensing and distribution agreements.
We have significant experience representing global life sciences companies in litigation proceedings. When your IP interests are threatened, we aggressively represent you in litigation, interferences, International Trade Commission actions, and other adversarial proceedings to help ensure optimal protection and exploitation of our your valuable technologies.
In the era of health care reform, it is critical that you prepare for scrutiny by payers as you develop plans for drug coverage and reimbursement, craft promotional materials, and consider pricing parameters. Our attorneys work with life sciences companies like yours to create successful strategies for drug and medical device products. We also provide counsel on government compliance and defense in enforcement actions, such as class action suits and whistleblower cases related to allegations of improper payments (kickbacks) to health care practitioners (HCPs), product pricing, and off-label promotion. Our team includes former attorneys from FDA, CMS, OIG, and DOJ.
In addition, we regularly counsel our life sciences clients on health-care-related issues, including: clinical trial design and reimbursement; IRBs; clinical lab certifications; privacy and consent issues, “Sunshine Act” and state reporting of payments to HCPs; 340B participation; government-required drug price reporting; labor and employment issues unique to this highly regulated sector; compliant business structures and customer contracts; sponsored CME; beneficiary inducements; patient assistance programs; negotiation of corporate integrity agreements with the OIG; and general regulatory and governmental compliance.
The surging interest in stem cell technologies has highlighted an array of legal issues, touching on IP, regulatory concerns, public policy, financing, and real estate development. To address these issues effectively, you need a unified perspective on the critical legal and business questions.
Foley provides you with a comprehensive offering of stem cell legal services, including IP, regulatory affairs (FDA, USDA), public policy, taxation, real estate law, payor issues, general business law, licensing, securities, antitrust counseling, labor and employment law, international trade, and health law.
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On March 23, 2010, President Barack Obama signed the Patient Protection and Affordable Care Act, which included the Biologics Price Competition and Innovation Act of 2009. For the first time, the Act created a regulatory approval pathway for “biosimilars,” biological products shown to be biosimilar to a licensed reference product. Notably, the Act also established a 12-year market exclusivity period for the licensed reference product, as well as procedures for resolving patent disputes based on a biosimilar application. With the release of FDA draft guidance on February 9, 2012, active discussion on many issues related to execution and operations have surfaced as new regulations and procedures are put into action.
Our Life Sciences team comprises experienced biotechnology attorneys in the areas of IP and IP litigation, FDA regulatory, and corporate law, all with an understanding of the complex legal and business issues surrounding biosimilars and the impact on enterprises operating in biotechnology industry.
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