The Unpatentability of a Dosage Claim is no Longer a French Exception

There is no doubt that substances or compounds used in medical treatments are explicitly recognised as meeting the criterion for patentability.

There is no doubt that substances or compounds used in medical treatments are explicitly recognised as meeting the criterion for patentability.

Thus, any claim concerning “substance or compound X for its use in the treatment of disease Y” for rights submitted under the EPC 2000, or concerning “the use of substance or compound X in the production of a medication for treating disease Y” for rights submitted under the EPC 1973, is patentable. Rights can be issued when the treatment method in question meets the requirements for novelty and inventive step.

In France however, doubt has persisted over whether a claim was patentable if the treatment was a specific dosage.

In the Finasteride case with Actavis Group v. Merck Sharp & Dohme, the Paris High Court, in its decision dated 28 September 2010, found that the claim reading use of [Finasteride] for the preparation of an orally-administered drug used for the treatment of androgenic alopecia in humans, where the administration dose is approximately 0.05 to 1.0 mg.

was null and unpatentable through its assimilation with a medical treatment method.

Since this decision, the INPI has rejected any “claim that concerns the dosage of a medication.”1

On 30 January 2015, the Paris Court of Appeal, faced with the same question, revised this point made in the 29 September 2010 judgement.

In its findings, the Court of Appeal recognised the patentability of a claim relating to the dosage of a medication;

provided that such a claim is submitted under the EPC 20002“from this decision [KOS, G2/08] it appears that treatment dosage claims are not unpatentable according to article 54(5) of the EPC 2000″or the EPC 1973:
“the patentability of a second therapeutic indication claim based solely on a dosage characteristic may be permitted, even for a patent filed under the EPC 1973”

However, the Court of Appeal issued a reminder that, to be valid, such a claim would have to “meet the requirement for evidence of technical skill”.

Continuing with its analysis, the Court concluded that the claim did not include a technical feature distinguishing it from the prior art. It therefore rejected the claims for lack of novelty.

This decision shows us that, when a dosage feature has underlying technology, it may be the subject of a patentable claim. As with all other treatment-related claims, it will then be necessary to determine whether this dosage feature is new and inventive compared to the prior art.

We can now hope that the INPI reviews its practices rapidly and amends its examination guidelines, so that it will be in line with the position adopted throughout the rest of Europe.

1 Taken from the Examination Guidelines, Title I – Section C – Chapter VII – 2b)
2 Strictly speaking, the actual date is January 2011, following the three-month grace period after the G2/08 decision was officially published

Published by

Anne Boutaric

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