FRKelly was represented by Roisin McNally Ph.D. at the recent BIO IP & Diagnostics Symposium. Roisin is a European Patent Attorney, a US Patent Agent and a member of the Life Sciences Patents Team at FRKelly.
The symposium took place just steps from the US Patent and Trade Mark Office (USPTO) in Alexandria, Virginia and attracted representatives from the Patent Offices, academia, BIO, LES, the biotech industry, research institutes and law firms.
This small and intense meeting critically reviewed recent case law relating to IP protection for diagnostic tests, methods of medical treatment and the reagents used to carry out the tests and methods.
Presentations were made by legal counsel and directors from Myriad, Sequenom, and Regeneron. The patent portfolios of these companies have all been negatively impacted by recent US patent office practice and court decisions. BIO (Biotechnology Innovation Organisation), the USPTO and EPO explained current practices and discussed concerns with practitioners.
Recent Federal Court decisions have found that simple diagnostics tests based on natural correlations fail to meet established tests to be statutory patent eligible subject matter regardless of providing a valuable contribution to life sciences. Tests using more complex methodologies may comprise the necessary “inventive step” of the test but the author of the patent application should not describe the methodologies as routine and conventional. Following the Vanda decision, the Federal Circuit appears to have endorsed the patent-eligibility of diagnostic tests that include treatment steps.
Participants discussed how to maximize patent protection for diagnostic claims under the current regime and in view of recent guidance from the USPTO and implementation of recent Federal Circuit case law. They also addressed the need for revised guidance for USPTO examiners. The inclusion of some form of treatment step in US claims for diagnostic methods is now highly recommended whereas this approach is generally not recommended in European claims.
The seminar occurred within days of an address by the Director of the USPTO, Andrei Iancu regarding a proposed guidance for assessment of patent eligibility of subject matter. The Director proposes that “eligibility rejections are to be applied only to claims that recite subject matter within defined categories of judicial exceptions and even then a rejection would only be applied if the claim does not integrate the recited exception into a practical application”.
The bio industry and IP practitioners are optimistic that the concerted efforts of Director Iancu together with proposals from BIO, AIPLA and IPO can soon make a difference in US examination of patent eligible subject matter. In the meantime however, applicants and practitioners must keep in mind current requirements and differences with other countries and draft specifications with basis for claims that will satisfy both US and European examiners.
The Life Science Patents Team at FRKelly can discuss the more technical aspects of the recent case law when drafting and prosecuting your applications in the diagnostics field. Feel free to contact us for further details.
Senior Associate | Patent Attorney