14 REPURPOSED DRUGS
LSIPR Newsletter 12:14
Patents—history and formats
In order to protect repurposed innovations, ‘second medical use’ patents are available in most territories, although notable exceptions exist including in India. Te precise wording of such claims is a matter of national laws, but a bewildering array of formats is used. For example, in Europe two claim formats have been permissible:
• Swiss form claim—Use of substance X in the manufacture of a medicament for the treatment of condition Y; and
• EPC 2000 form claim—Substance X for use in the treatment of condition Y.
Te Swiss form claim was first permitted in the landmark G5/83 decision by the European Patent Office’s (EPO) Enlarged Board of Appeal (EBA), which found that such claims could be granted “for a specified new and inventive therapeutic application, even in a case in which the process of manufacture as such does not differ from known processes using the same active ingredient”. As elsewhere, the patentability of Swiss form claims at the EPO
is predicated critically on the new “purpose” (or “repurpose”) of the known medicament.
Te EPC 2000 form claim was introduced in 2007, and was intended to match as closely as possible the scope of protection provided by a Swiss-type claim. Later the EBA decided that Swiss-type claims were in effect redundant in view of the new law, and would no longer be permitted in new applications. However, the very fact that the claims available to applicants are worded differently leads to uncertainty about their scope.
Te UK courts have, to date, treated Swiss form claims as process claims, whereas EPC 2000 claims are purpose-related product claims. Although in some respects the difference may be academic, for example because the product obtained directly from the process claimed under the Swiss form claim may be protected in the same way as the product claimed under the equivalent EPC 2000 claim, in other contexts there may be key differences.
For example it is questionable whether the Swiss form claim actually requires that the recited drug be present in the final medicament
(as is believed to be the case for the EPC 2000 form) or whether it could merely be present during the manufacture.
Te latter argument was rejected in one UK case, based on particular facts, but certainly remains arguable. Te complex relationship between the claims has also led, arguably, to confusing practice at the EPO regarding applicants pursuing protection for both types of claim. In one recent decision the EPO prohibited both types in the same application as the board of appeal was not persuaded that the claims were treated differently by national courts, whereas other appeal boards have said that the applicant had a legitimate interest in pursuing both types of claims, accepting that the protection offered was not identical.
Patentability
Irrespective of the format of the claim, a first hurdle for obtaining a patent for a new medical use for a substance is that the new use must be supported by evidence (in the application) that the substance is effective for the specified use. In some territories, such as the EPO, the burden
www.lifesciencesipreview.com
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20