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 research, product development, formulation, production, and distribution. One of the consistent features of these businesses is that their value is premised almost entirely on their intellectual property. As a result, they often are capital intensive and have growth potential.

With perspectives from both inside and outside the industry, we provide guidance to companies negotiating regulatory, technological, organizational, and financial challenges. Our clients range from start-ups to established corporations in the fields of:

  • Pharmaceuticals
  • Biotechnology
  • Medical devices
  • Bioinformatics
  • Computer hardware and software
  • Information technology
  • Communications technology
  • Chemicals
  • Food
  • Animal health

We work with our clients' investors and financial advisers to help secure financing through venture sources as well as 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 aspects of research and development and assist in the acquisition and transfer of technology through licensing, strategic partnering, joint venture transactions, and mergers and acquisitions.

We are vigorous in protecting our clients' intellectual property through the pursuit of patent, copyright, and trade secret protection. We also have broad experience in all facets of litigation, including patent and copyright infringement, licensing, antitrust, class action, product liability, and complex commercial litigation. We have successfully litigated against the Food and Drug Administration (FDA), defending clients on alleged marketing and manufacturing violations, and have 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 counsel clients on compliance and 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 cycles. 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.

We draw on our legal, business, and scientific experience to develop innovative yet pragmatic responses to the complex and evolving challenges that arise in the industry. Our Life Sciences and Technology Group 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, including tax issues
  • Angel and venture capital investments
  • Licensing and technology transfer
  • Joint venture, strategic alliance, and collaboration agreements
  • Privacy and cybersecurity
  • FDA and state enforcement
  • Patent, copyright, and trademark protection
  • Patent prosecution and litigation
  • Manufacturing, 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

Contact

Brian D. Doerner
Practice Leader
Tel 215.864.8615
doerner@ballardspahr.com

Douglas M. Fox
Practice Leader
Tel 410.528.5505
foxd@ballardspahr.com