Over the last decade, plausibility, polymorphs and purity have been recurring themes in the EPO’s Board of Appeal decisions. These topics can underpin a pharmaceutical company’s filing and life cycle management strategy.

For example, with respect to plausibility, it is established practice that, for a therapeutic use of a product to be patentable, a patentee has to demonstrate that his/her product is suitable for that therapeutic application at the time of filing. The question, however, is how much evidence is required to render the therapeutic use plausible. Can the application be filed on a hunch to secure an early priority date, or are clinical data required, which will invariably delay when you are able to file? What the EPO is likely to consider “plausible” may influence your IP strategy, particularly if patent protection in Europe is key to your business.

As for the concepts of polymorphs and purity, medically active molecules can exist in different solid-state forms (polymorphs) or can be isolated to different levels of purity. Pharmaceutical researchers typically screen for polymorphs and purify their pharmaceutical actives as a key part of their research and development activity in the hope of improving properties, such as stability or efficacy. Can you get a patent for the fruits of such routine labour? The EPO’s decisions have been mixed and, in the last year, the Boards have yet again pronounced on these topics in a number of decisions.

In this session, we shall review and discuss the key features of these decisions.

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