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CLINICAL TRIALS


increasing benefit to patients and the possibility of seeking patent protection.


Clearly, there are still potential concerns. Te situation in the US is still evolving as to whether diagnostic methods constitute patentable subject matter. So far, it appears that it should be possible to find an acceptable claim format by careful consideration of the various strands of testing and treatment that make up a stratified or personalised medicine approach.


Accidental discoveries have always played an important role in the search for new drugs. Yet we subscribe to the maxim of Louis Pasteur that “in the field of observation, chance only favours the prepared mind”. Terefore, we recommend that a patent attorney is included as part of the team assessing clinical trial data to aid in determining whether a potentially patentable invention has been made. In the competitive world of the bio-pharma industry, patents provide a vital edge. Being prepared to seize every advantage provided by information arising from clinical trials is more important than ever.


Dr Richard Korn is a senior associate at Potter Clarkson LLP. He can be contacted at: richard.korn@potterclarkson.com


Dr Stephanie Pilkington is a partner at Potter Clarkson LLP. She can be contacted at: stephanie.pilkington@potterclarkson.com


Richard Korn, BSc, PhD, CPA, EPA, IPA, is a patent attorney qualified to practise in three jurisdictions. As a biotechnology specialist, Korn has significant expertise in preparing patent applications for complex medical and diagnostic


inventions, and co-ordinating


the patent prosecution worldwide. He also advises on IP strategy and handles oppositions and appeals at the EPO.


Stephanie Pilkington, MA(Cantab), PhD, CPA, EPA, has been working on IP aspects of personalised and stratified medicine for many years for both industrial and academic clients, building on her research and pharmaceutical industry background. She has extensive experience before the EPO and regularly advises on filing and prosecution strategy as well as oppositions and due diligence.


www.worldipreview.com


Life Sciences Intellectual Property Review 2011


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