By Bradley Crawford —

In 1998, the Administrative Council of the European Patent Organisation, seeking to update the European Patent Convention (EPC), agreed on a catalog of potential revisions (see "EPC 2000").  A Task Force was then formed to prepare detailed proposals for revision of the EPC, which were examined and refined in meetings of the Organisation’s Committee on Patent Law.  The Committee produced nearly one hundred changes to the EPC, which were collected in the Basic Proposal for the Revision of the EPC.  The Administrative Council adopted the Basic Proposal in September of 2000, and submitted it to the Conference of the Contracting States, which adopted the changes as EPC 2000 two months later.  Following ratification of the EPC 2000 by Greece on December 13, 2005, the date by which the EPC 2000 would enter into force was set (see "Status of accession and ratification").  Thus, the EPC 2000 will take effect by December 13, 2007, at the latest.

Many aspects of European patent law will be impacted by the EPC 2000, some significantly.  The actual changes to all of the EPC Articles may be found here, while the completely revised articles (in German, English, and French) may be found here.  Since there are so many changes, we are starting a multi-part series in which we will highlight – from a U.S. patent practitioner’s perspective – some of the changes that will take effect.  In the first installment of this series, we will discuss the changes to "use" claims.

As a preliminary matter, first medical use claims, which may be written as follows, are allowable in EPC member states:

The use of a compound or pharmaceutically acceptable salt thereof as a medicament.

Of course, other formats for first medical use claims are also perfectly acceptable.

While the patentability of first medical use claims has long been recognized, there was some question regarding the status of second medical use claims, i.e., claims directed towards a specific medical use.  This problem was addressed by the Enlarged Board of Appeals in G 5/83 (OJ EPO, 1985, 64), where second medical uses were approved when applicants use the "Swiss" format, which gets its name from the Swiss Patent Office, where it originated.  A "Swiss" claim has the following general format:

The use of X for the preparation of a medicament for the treatment of Y.

Second medical use claims, however, are not expressly authorized by the EPC articles.  In order to clarify the status of second medical use claims, amendments were made to Articles 54(4) and 54(5) EPC, the new text of which appears below:

    (4)  Paragraph 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)  Paragraph 2 and 3 shall also not exclude the patentability of any substance or composition referred to in paragraph 4 for any specific use in any method referred to in Article 53(c), provided that such use is not comprised in the state of the art.

It is now clear that second medical use claims are patentable.  In light of these amendments, "Swiss" claims are being phased out as redundant, and therefore, unnecessary.  Of course, first medical use claims are still patentable.

One way to draft first and second medical use claims is:

10.  The use of a compound or pharmaceutically acceptable salt of claim 1 as a medicament.

11.  The use according to claim 10, wherein the medicament is suitable for use in treating condition Y or is suitable for use in patients who are at risk of developing condition Y.

(The claim numbers are chosen at random.)  As a result of these changes in the EPC, the use of "Swiss" claims can be expected to cease, not because they are not valid but because they are no longer necessary.

Mr. Crawford is a registered patent attorney at the law firm of McDonnell Boehnen Hulbert & Berghoff LLP, where he focuses on chemical and pharmaceutical patent preparation and prosecution.  He has a master’s degree in organic chemistry from the University of Illinois, has worked as a bench chemist in the pharmaceutical industry, and is a named inventor on three U.S. Patents.

As noted here, Mr. Crawford will be giving a presentation on "International patent protection and strategy" at the American Chemical Society Spring 2007 meeting in Chicago, IL on March 28th.

Additional Disclaimer:  This article, like all articles on Patent Docs, is intended for informational purposes only, and does not contain any legal advice whatsoever.  Moreover, Mr. Crawford is not a European patent attorney.  Readers having questions about the impact of the EPC 2000, therefore, should seek the advice of European patent counsel.