Yesterday I noted that the ILPTO had published draft "circular notices" and requested comments on them. Today we continue with discussion of the first of these draft circulars, “Draft Circular 34/2016”. Part B of this draft circular is directed to "use" claims.
“9. Section 3 of the statute establishes that a patentable invention must be a product or process. Therefore claims of the form “X for use as a paint” are not allowable.
“10. In claims for a process it is required that the novel and inventive steps for effecting the process be recited. Therefore claims of the format “Use of X in the manufacture/preparation of Y” will not be allowed unless they recite novel and inventive steps.
“11. Claims for the new use of a known product may be worded “Product X for use as a medicament”.”
A word of background: Israel, like most countries, has an anachronistic provision in the patent statute that prohibits claims on methods of treatment of humans, and, like many countries, has until now allowed both “Swiss-type claims” (Use of X in the preparation of a medicament [for the treatment of Y]” and purpose-directed product claims (X for use as a medicament [for the treatment of Y]). It appears that these proposed sections will obfuscate rather than clarify anything in this regard, and consequently, in the tradition of “if it ain’t broke, don’t fix it”, it would be prudent to omit these sections.
Proposed sections 9 and 11 reiterate statements made in earlier circulars, most notably circular MN 30 of August 17, 2004, which these sections are evidently meant to replace. But why replace those earlier statements? MN30 seems to have operated just fine for the past 12+ years. Moreover, the proposed replacement sections 9 and 11 seem to contradict each other: what’s the difference between, for example, a claim reading “AZT for use as a medicament [for treating AIDS]” (wording per proposed section 9 and apparently not permissible) and “The product AZT for use as a medicament [for treating AIDS”? (wording per proposed section 11 and hence permissible). What’s magic about the inclusion of the word “Product” at the beginning of the claim? Introduction of these new sections will only sow confusion.
Section 10 also appears to muddy the waters rather than provide clarification, as it seems to imply that process steps need to be included in Swiss-type claims. But if we’re already going to avail ourselves of the fiction that this type of claim describes a process – and in every country that accepts Swiss-type claims, it is that fiction that makes that claim format acceptable – then why require the recitation of process steps? Only two possibilities exist for Swiss claims: they recite the use of a compound as a medicine, period (i.e. either the compound itself is new, or its use as a medicine is new), or they recite a new use of a compound already known as a medicine. In the first case, the novelty of the compound per se, and/or the novelty and inventiveness of using the compound in preparing a medicine, would seem to be sufficient to confer novelty and inventiveness to the claim as a whole. Yet I can foresee some examiners saying that the claim must nevertheless include process steps for formulating the medicine. Likewise, in the case of a known pharmaceutically active compound, hitherto the addition of the words “for the treatment of Y” have been considered by the ILPTO to be sufficient to confer novelty and inventive step. It’s not clear if section 10 is meant to change that or be a restatement of existing practice. Aside from pointing to the ridiculousness of proposing such statements without explaining what the office’s goal in proposing the statements, it again leads to the question, “If it ain’t broke, why fix it?”
There is also a more subtle point here: do Swiss claims and purpose-directed product claims reciting the same material for the same use (e.g. “Use of azithromycin in the preparation of a medicament” and “Azithromycin for use as a medicament”) have the same scope? Rightly or wrongly, for roughly 25 years, the position of the ILPTO has been yes: in the early 1990’s, in a case involving the use of the already-known AZT to treat AIDS, the commissioner ruled that while both forms of claim are permissible, in the case before him they were of the same scope and therefore could not be allowed in separate applications due to double-patenting concerns. If process steps need to be explicitly incorporated into Swiss claims, but not into purpose-directed product claims, then adoption of this circular as proposed would seem to change the ILPTO’s position, with concomitant effect on double-patenting determinations.
FWIW, I think a better approach would be to get the Knesset to rescind section 7(1) of the statute, the section that prohibits the patenting of methods of treatment of humans. The world-wide use of Swiss claims and purpose-directed product claims shows there is a need to provide patent protection for such methods, and that forbidding claims on methods of treatment of humans is dumb. Repeal of section 7(1) would obviate the need to engage in legal and semantic gymnastics in order to provide such patent protection. Inasmuch as the MOJ is currently considering legislation that would amend other parts of the patent statute, repeal of 7(1) should be a goal.