Protecting the IP of med devices is undergoing rapid change, requiring manufacturers to revisit their IP programs: changes in US and European regulation, convergence of technologies, attacks by patent trolls.

 Some of these changes were outlined at last Friday’s MassMedic conference in Waltham, MA, with presentations by counsel from here and the EU.  Highlights:

            *Last year’s America Invents Act created a more robust method of challenging a patent by a proceeding within the Patent and Trademark Office; the hope was to limit expensive and drawn-out suits in US District Courts.  Unfortunately now many challenges are mounted in BOTH venues, and it is not clear that defendants will be able to “stay” or delay the Court proceedings while the PTO determines patent validity.

            *Convergence of medical technology with other technologies (notably in mobile medicine) has complicated the identification of an alleged infringer.

            *Riding the trend of introducing med devices in Europe before the US to take advantage of what is perceived to be a more manageable regulatory path, the EU is considering a “unitary” patent which, once granted, would cover most EU countries (alas, not all).  (Presently, a grant of European patent must then be “registered” in each country individually.)

            *So-called patent “trolls,” non-operating entities which sue manufacturers seeking royalties for infringement, are turning more to med device companies. Not all such entities are predatory; plaintiffs may include universities, research facilities, emerging companies with innovative technology whose rights are ignored by large manufacturers.  (The methods used to assert claims, the popular courts in which to bring suit, and some strategies to resist were discussed by my partner Tony Fitzpatrick; let me know if you would like to see his power-points on this volatile topic.)