We understand the complex issues faced by pioneering life science and technology businesses. Because many of our attorneys hold advanced degrees and have worked in the industry, our counsel is fueled by a broad knowledge base and real-world experience.
Our attorneys counsel frontline businesses engaged in innovation, development, and commercialization activities, and the institutions that support them, through contract research, data mining, analytical and product development, formulation, and production. One of the consistent features of these businesses is that their value is premised almost entirely on their intellectual property. As a result, they are capital intensive and have growth potential.
Our clients range from start-ups to established corporations in the fields of:
- Medical devices
- Computer hardware and software
- Information technology
- Communications technology
We work with our clients' investors and financial advisers to help secure financing through private and public offerings of equity and debt securities. Our attorneys help develop business strategies and plans for new commercial ventures, including assessing the legal and regulatory climate and any potential risk factors. We advise on all matters of research and development and assist in the acquisition and transfer of technology through licensing, strategic partnering, and joint venture transactions.
We are vigorous in protecting our clients' intellectual property and handle all litigation matters, including patent and copyright infringement, licensing, antitrust, class action, product liability, and all manner of complex commercial litigation. We have successfully litigated against the FDA, defending clients on alleged marketing and manufacturing violations and negotiated with the FDA’s Office of Chief Counsel and with the Regulatory, Compliance and Review departments within CDER, CBER, CDRH, and CFSAN.
FDA compliance is a critical factor in getting products to market for life sciences companies. We negotiate with the FDA and regulatory authorities worldwide on issues involving product approvals, marketing violations, CGMP resolutions, consent decrees, and the legal and regulatory matters that follow products throughout their life cycle. Our attorneys teach the "Introduction to Drug Law: Regulation of Drug Marketing, Manufacturing and Enforcement" to newly hired FDA attorneys, reviewers, and compliance officers at FDA headquarters.
Our attorneys are closely involved from premarket review and approval to compliance and governing issues and are able to swiftly identify challenges and opportunities that our clients might face. The institutional knowledge of the group facilitates collaboration between licensing and regulatory, intellectual property, financing, and acquisition.
We draw on our legal, business, and scientific experience to develop innovative yet pragmatic responses to the never-ending challenges that arise in the industry. Our life sciences team includes attorneys with doctorates and other advanced degrees in an array of scientific fields, from biochemistry and genetics to engineering and zoology.
We advise on:
- Entity selection and structuring, with an emphasis on tax issues
- Angel and venture capital investments
- Licensing and technology transfer
- Joint venture, strategic alliance, and collaboration agreements
- FDA and state enforcement
- Patent, copyright, and trademark protection
- Patent prosecution and litigation
- Distribution and marketing agreements
- IPOs and follow-on offerings
- Compensation arrangements, confidentiality agreements, invention assignments, and other employment issues
- Mergers and acquisitions
- Product marketing and labeling issues
- International transactions
- Federal supply issues
- Civil seizure claims
- Consent decrees
- Managed care, Medicare, and Medicaid issues
- Privacy and cybersecurity