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Sufficiency of Second Medical Use Claims – T 2015/20

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An examining division (ED) at the European Patent Office (EPO) refused European patent application no. 15173011.6 on the grounds that the patent application did not sufficiently disclose the claimed invention. In particular, the ED found that there was no evidence in the patent application showing the claimed therapeutic application.

As background, Article 83 of the European Patent Convention requires that a European patent application discloses an invention “in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art.” According to EPO case law, a lack of sufficiency objection “presupposes that there are serious doubts, substantiated by verifiable facts, on the possibility for a skilled person to carry out the invention as claimed.” This is a high bar.

This case considered “how much” evidence is needed to meet the sufficiency threshold in the context of second medical use claims.

Examining Division

Claim 1 of the patent application related to a pharmaceutical composition comprising a pharmaceutically acceptable salt of aclidinium in the form of a dry powder with a dry powder carrier, which provides a metered nominal dose of aclidinium equivalent to 400 μg (plus/minus 10%) aclidinium bromide for use by inhalation in the treatment of asthma.

According to the ED, the application did not provide evidence which made it credible that asthma could be treated with a metered nominal dose of 400 μg aclidinium by inhalation. The ED accepted that the application did provide evidence of the treatment of chronic obstructive pulmonary disease (COPD). However, the ED referred to prior art to argue that the underlying mechanisms of COPD and asthma were different. There was additional prior art which suggested that aclidinium could not be used in the treatment of asthma.

Board of Appeal

The applicant appealed against the refusal and argued that, in the context of the claim, all that is required for the sufficiency requirements to be met is that the skilled person should be able to prepare the product and administer it to a patient suffering from asthma.

The Board looked at the prior art and found that it was common general knowledge that asthma is influenced by cholinergic mechanisms, be it to a lesser extent than COPD. Therefore, the statement in the application that aclidinium bromide could treat asthma was not called into doubt.

The Board found that the defined utility of aclidinium in the treatment of asthma did not go against any prevailing opinion in the prior art. Therefore, the statements of effect in the description which were not supported by a working example did not lack plausibility. The opponent was found not to have raised serious doubts on the effect of treating asthma with aclidinium. Therefore, sufficiency was acknowledged.

The Board went on to find that the prior art did not teach in the direction of the claimed invention and found in favour of inventive step.

Conclusion

The Board found that the application should be granted.

In reaching their decision, the Board commented that claims in patent applications typically involve generalisations which inherently include an aspect of speculation. Patent applications in the field of medicine are no exception.

This decision is of assistance to applicants facing sufficiency objections against second medical use claims when there is no, or limited, evidence in the specification for the treatment of the claimed indication(s).

 

This article is for informational purposes only and does not constitute legal advice. Please, therefore, get in touch with your usual Forresters Attorney if you need further advice.

If you have any questions about this topic please contact Chris Bond cbond@forresters.boldtype.website or your usual Forresters contact.

Chris Bond