Israel Patent Office Claims Practice In Materials, Chemical And Pharmaceutical Cases ~ Part II
Contributor
Use claims, and claims relating to first and further medical uses. The following practice directives of the Registrar, made in 1993, are still in force at the present time: (a) (Directive No. 38:)
(1) A claim in the form
"Use of X in the manufacture/preparation of Y"
is essentially a process claim and as such complies with the Section 3 of the Patents Law (which inter alia appears to define an invention as a product or a process), provided that such a use claim includes adequate detail as to how the steps of the manufacture/preparation are carried out.
(2) However, the stated proviso in paragraph (1) is not essential, if the claim makes reference to the specification, in which the process in question is described, detailed and defined. By way of illustration, such a claim could read:
"Use of X in the manufacture/preparation of Y as described in the specification".
(b) (Directive No. 40, complementary to Directive No. 38:)
(1) For a first medical use, the following form of claim would be prima facie acceptable:
"Use of X in the manufacture/preparation of a medicament substantially as described in the specification".
(2) For a second medical use it is necessary to specify such new use embodying the inventive step, for example:
"Use of X in the manufacture/preparation of a medicament having anti-inflammatory activity substantially as described in the specification". Note that the italicized part of this illustrative claim is not mandatory in practice, insofar as the second (or further) medical indication embodying the inventive step could be expressed in some other way, compare the "Swiss-type" claims acceptable in Europe in this context (except that in Israel practice reference to the specification is necessary if details of the inventive medical application are not recited), e.g.:
"Use of X in the manufacture/preparation of a medicament for use in a method for the treatment of Aids substantially as described in the specification".
(3)(a) For a first medical use, the following additional form of claim would also be prima facie acceptable:
"Compound X for use as a medicament". (It is of interest in this context to compare Art. 52(4), EPC: "Methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body shall not be regarded as inventions.......This provision shall not apply to products, in particular substances or compositions, for use in any of these methods." In contradistinction thereto, the methods prohibited under Art. 52(4), EPC are in fact allowable in Israel when applied to non-human animals, and Israel patent applications can claim such methods.) (3)(b) The corresponding illustrative additionally allowable form of claim in respect of a second medical use would be: "Compound X for use as an anti-inflammatory agent", or "Compound X for use in the treatment of Aids".It should be noted that similar claims in which "compound X" is replaced by "composition comprising components A, B and C", for example, would be equally acceptable.
(4) However, use claims which do not properly define a novel and inventive product or process are unacceptable, an example being: "Use of X as a lubricant".
(5) The following type of claim: "Use of X in the treatment of Aids".
would however be unacceptable, being regarded as a process for medical treatment and therefore unpatentable in accordance with Section 7(a) of the Patents Law.
Note. A second medical use claim along the lines: "Process for the manufacture of a composition having activity X, characterized in that there is employed as active ingredient substance Y, substantially as described in the specification" (or alternatively reciting the essential steps of the process) has not been tested in a Hearing before the Registrar, or in the Courts, to the best of the author’s knowledge, but would possibly be allowable, based on reasons similar to those stated in EPO Decision T0958/54 of September 30, 1996, reported in "EPC - Today" published by Albihns GmbH and since published in Official Journal EPO 6/1997, 241-250. We thank Mr. Michael Harrison, editor of "EPC - Today" for sending us a copy of this decision.