Patents and SPCs are not the only protection for, and incentive system that encourages, pharmaceutical innovation. Regulatory exclusivities play an increasingly important role, indeed so much so that they can often determine which patents are at potential risk of challenge. This webinar will address the two most important such exclusivities in Europe – that protecting the data filed in order to secure a marketing authorization for a new medicinal product (Data Exclusivity, or Regulatory Data Protection) and that providing market exclusivity as against similar medicinal products for the same indication where such indication is so rare that the medicinal product in issue has secured an orphan designation.
Trevor Cook is an English solicitor and a partner at WilmerHale. The primary focus of his practice is patent litigation, especially in the life sciences sector, and regulatory law in that sector. He has written, edited or contributed to numerous books on various aspects of intellectual property and regulatory law, including, as to the subject matter of this webinar, Pharmaceuticals, Biotechnology and the Law (LexisNexis Butterworths 2016).