Pharmaceutical & Regulatory Law

Our experience and understanding of the pharmaceutical sector is well-established and widely recognised, not least because of our trail blazing track record in the field, and the unmatched scientific acumen of our lawyers in areas such as medicine, molecular biology, biochemistry and pharmacology.

The pharmaceutical industry is one of the world’s most heavily regulated sectors, and we have particular expertise on all facets of European medicine and regulatory law. Whether as part of patent life cycle management or to challenge the market entry of competitors, we understand the importance of developing an integrated strategy which takes the regulatory landscape into account. We are able to advise on an array of issues such as regulatory data and data exclusivity; market authorisation; alternative routes to product approval and Supplementary Protection Certificates, an area where our experience is a standout in the industry.

"They are of course a top-notch place to go to on the life sciences side and related conflicts"
Chambers and Partners

Advisory Examples

  • Advising numerous pharmaceutical / biotech clients on competitor market access issues, including conducting and co-ordinating analysis and monitoring of regulatory applications, supply chains and product launches
  • Advising clients on obtaining SPC protection, including representing clients at UK IPO hearings and before the courts and co-ordinating SPC applications across Europe
  • Assisting clients in opposing SPCs, including SPC squatting issues
  • Advising on the orphan drug exclusivity provisions
  • Advising numerous pharmaceutical clients on branding and advertising issues