20 EXPERT COMMENT


LSIPR Newsletter 04.14


STRATIFIED MEDICINE


BIOMARKERS AND PERSONALISED/


PROTECTING


With careful patent drafting and prosecution, it is possible to capture significant IP value in the clinically—and commercially—


important area of biomarkers, says Stephanie Pilkington of Potter Clarkson.


I


nterest in the promise of biomarkers and personalised/stratified medicine is building. In the UK, for example, the government announced a Diagnostics


for Stratified Medicine Catapult centre in August 2013, and partners including the Technology Strategy Board and the Medical Research Council have committed to spend more than £200 million ($336 million) over a five-year period to promote the development of stratified medicine, providing the tools, processes and systems for identifying the right therapy for the right patient, at the right time and at the right dose.


Te “revolutionary” National Lung Matrix trial announced by Cancer Research UK in April 2014 and jointly funded by Cancer Research UK, AstraZeneca and Pfizer with support from the UK National Health Service (NHS) illustrates this approach, where the aim is to select test compounds for trial in particular patients taking into account the genetic profile of their cancer.


How feasible is it to protect innovation in this sector? Divergence between approaches in the US and in Europe, for example, provides a challenging environment for those seeking to protect and develop their assets, but with care, it is possible to capture significant value in this clinically and commercially important area.


Te US Patent and Trademark Office (USPTO) memorandum to examiners issued in March 2014 (http://www.uspto.gov/patents/law/exam/ myriad-mayo_guidance.pdf) presents a significant challenge to obtaining protection and explaining its commercial value. Te USPTO guidance seeks to ensure that all applications of a particular biological finding are not monopolised; a patent applicant, on the other hand, might typically seek to ensure that all commercially important aspects are encompassed.


A challenge for obtaining protection, therefore, is to be able to focus on those commercially important aspects while leaving open a sufficient number of other applications to satisfy the USPTO. A range of options of varying scope is likely to


be needed to accommodate developments in how the USPTO and courts interpret these provisions. A strong plan for follow-on research, development and patent filing to build on the company’s expertise and market position will give the most commercially robust protection.


At the EPO


In Europe, the challenges are different. Although ways of using known medical devices may be difficult to protect at the European Patent Office (EPO), the EPO generally takes a less restrictive view of the types of invention for which protection is possible. Particular claim formats are required and the EPO’s very strict approach to amendments and entitlement to priority means that options may be unnecessarily limited unless bases for those claim formats are included in priority and international (Patent Cooperation Treaty) applications, for example.


At the EPO, a method claim relating to an invention linking a particular biomarker to a


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