Europe: patent protection of new medical uses of known active pharmaceutical ingredients

A 2010 decision by the Enlarged Board of Appeal (EBA) of the European Patent Office (EPO)ruled that for all patent applications filed later than 29 January 2011, new medical uses of known active pharmaceutical ingredient (API) should be claimed in the “substance for use in…” claim format; “Swiss Type” claim format (“use of substance for the manufacture of … for…”), previously permitted under the EPO practice, will no longer be allowed.

An EBA decision of 19 February 2010¹ , that was published a few months ago, dealt with some open-ended questions in the EPO regarding inventions of second and further medical uses of a known API, including their patentability and permissible claim language.

THE PAST: “SWISS – TYPE” USE CLAIM FORMAT

In the past, in order to protect new (second and further) medical uses of known API, the EPO accepted claim format known as the “Swiss Type”use claim format². Where the invention concerned the discovery that a known API “X” has a previously unknown therapeutic efficacy in the treatment of a disease “Y”, a “Swiss Type” claim would read:
   
   Use of X for the preparation of a pharmaceutical  composition for treatment of Y.

Since such wording of a claim indicates that the subject of the claim is actually the process of manufacturing a medicament from the known API “X” for an unknown disease “Y”, there were some ambiguity regarding the use of such language in “extreme” cases where the novel and inventive feature to be protected was not derived from the manufacture of a medicament or from the new therapeutic application, but rather, for example, from a new and inventive dosing regimen of known API’s in the treatment of known diseases.

On 13 December 2007 the so-called “EPC 2000”Amendment of the EPC (European Patent Convention) came into force, which stipulated, among other matters, that substances or compositions for use in a therapeutic treatment are patentable, provided the specific therapeutic treatment was not previously known. This followed from Articles 54 (“Novelty”)³ and 53 (“Exception to Patentability”)⁴. Thus, in the case of the invention that concerns the discovery that the API “X” has a previously unknown therapeutic efficacy for the treatment of disease ‎”Y”, the claim could now be drafted reading as follows:

           X for use in the treatment of Y.

At the time of enactment of the EPC2000amendments it was not clear, however, whether this “substance for use” format would be the only type of claim format permissible and the extent to which the “Swiss-type” claim format would continue to be permitted. It should be noted that there is a considerable amount of case law relating to the “Swiss-type” claim format and use of this claim format was considered by many to be a safer harbor than the new “substance for use” claim format now permitted.

THE PRESENT: DEMISE OF “SWISS TYPE” CLAIMS BY EBA DECISION G 2/08

In 2010, in its long-awaited, aforementioned decision, that dealt with the patentability of dosing regimen of known API’s, the EBA clarified the matter. According to this decision, where the subject-matter of a claim is rendered novel only by a new therapeutic use of a known substance, such claim may no longer have the format of the so-called “Swiss-type” claim. Consequently, EP patent applications having a filing date, or in case priority is claimed – an earliest priority date of 29 January 2011 or later, seeking second (or further) medical use protection of a known substance may only include claims in the “substance for use” format, now specifically permitted under the EPC 2000.

Additionally, the EBA noted in its decision that even in cases where it was already known to use a medicament to treat an illness, the requirements for novelty under the EPC (Article 54(5)) are not negated if the same medicament is claimed for its use in a different treatment by therapy of the same illness. The protection of such inventions is also not excluded where a dosing regime is the only feature claimed which is not comprised in the state of the art. It follows from the decision that in these cases EPO permitted claim language may read for example:

      X for use in the treatment of Y, wherein X is administered every morning for a 5 day period.

      X for use in the treatment of Y, wherein X is administered at a dosage of 20 to 50 mg/day.

However, the EBA indicated in its decision that it will be necessary for the dosage regime defined in the claim to provide a technical effect (such as an improvement or advantage) over the prior art to meet the requirements of novelty and inventive step.

THE FUTURE

While the EPC 2000 makes it clear that“substance for use” claims are not devoid of novelty where the claimed therapeutic use has not been previously known, in many countries such a claim is still regarded as lacking novelty.Consequently, while in the USA new medical uses of known APIs are protected by claims directed to therapeutic methods, in many other countries, following the past EPO footsteps, the solution adopted was use of the “Swiss-type”claim format. Therefore, claims in this format will continue to be utilized in the international patenting endeavors for this type of inventions.

It also remains to be seen how the national European Courts will interpret such claims and their scope in patent infringement cases.

1 Decision G 2/08
2 Instituted by EBA decision G 5/83
3 The relevant paragraphs of Article 54 read:
   Article 54 – Novelty
   …
   (4) Paragraphs 2 and 3 shall not exclude the patentability of any substance or composition, comprised in the state of the art, for use in a method referred to in Article 53(c), provided that its use for any such method is not comprised in the state of the art.
   (5) Paragraphs 2 and 3 shall also not exclude the patentability of any substance or composition referred to in paragraph 4 for any specific use in a method referred to in Article 53(c), provided that such use is not comprised in the state of the art..
4 The relevant paragraphs of Article 53 read:
   Article 53 – Exceptions to patentability  
   European patents shall not be granted in respect of:  
   ….
   (c) methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practiced on the human or animal body; this provision shall not apply to products, in particular substances or compositions, for use in any of these methods.