America-Israel Patent Law

Examination under Section 17(c): Be Careful What Statutes You Wish For

This is a story about how a good idea that originated in the Israel PTO tripped over its own shoelaces (in a manner of speaking) when it was eventually enacted into law.

The story begins in the late 1980’s, when the Israel PTO had a significant backlog in the examination of patent applications.  The Commissioner at the time had (or had suggested to him) a bright idea: why carry the load all by yourselves when there are other patent offices examining related applications? 

Thus was born Commissioner’s Circular no. 9, which said that if applicants for Israel patents amended their claims to correspond to claims granted in corresponding patents in certain other jurisdictions, notably the USA and the EPO, then the ILPTO would view those claims as meeting local criteria for novelty, inventive step, unity of invention, sufficiency of description and clarity of the claims.

The idea proved to be so good that in 1995, during major round of statutory amendments, this policy was written into the statute as §17(c). 

Neither Circular no. 9, nor §17(c) after it, solved all of an applicant’s problems, however.  In particular, section 7 of the Israel statute forbids the patenting of methods of treatment of the human body.  So those granted US claims reciting “A method of treating X, comprising administering to a patient in need thereof drug Y…” can’t be granted in Israel.

Under Circular no. 9, the ILPTO was willing to allow applicants to convert such method of treatment claims to “Swiss” style claims or purpose-directed product claims, and to proceed in accordance with the Circular.  This was true as well for many years under §17(c). 

More recently, however – perhaps as a result of the ILPTO’s effort to draft written examination guidelines, perhaps due to changes over time in senior ILPTO personnel, perhaps owing to both – the ILPTO has taken a stricter view of the application of §17(c) with respect to method of treatment claims.  In particular, sub-section 4 of §17(c) states that one of the requirements is that:

“(4) the claim or claims in the application are identical to the claims in the parallel patent, but the application can include fewer claims that those in the parallel patent;”

In recent years, the ILPTO has taken this literally, and will not allow applicants seeking to invoke §17(c) to amend method of treatment claims to “Swiss” or purpose-directed product format.  If such method of treatment claims appear alongside claims on compounds and/or pharmaceutical compositions, the method of treatment claims will need to be cancelled if §17(c) is to be used, and a divisional with the claims rewritten in an acceptable format filed.  The divisional will not be able to benefit from §17(c). 

When this practice was initiated by the ILPTO, the Office maintained flexibility in the application of the practice with respect to method of treatment claims – Circular no. 9 was simply a way for the Office to say, “We’ll accept the word of the USPTO or the EPO regarding these claims and this application if you, the applicant, want us to. To the extent this may call the validity of the patent into question, caveat emptor.”  And that was the way the statutory provisions were viewed by the PTO in the years after their enactment, likely because the same Commissioner who issued Circular no. 9 was in office for several years after §17(c) was enacted. 

It’s ironic that the ILPTO now views itself as constrained by a statutory provision that was intended to enshrine in the statute the practice that the ILPTO itself initiated and applied with a greater measure of flexibility than is presently the case.

So when making statutory amendments, as in many other things, be careful what you wish for.

Final Versions of New Circulars: Is the ILPTO Ignoring Court Precedents?

Last month the ILPTO published final versions of two circular notices; the drafts of these notices were discussed at length here, here, here, here and here.  The final versions aren’t terribly different from the draft versions, with the most noticeable change coming in the parts that relate the claiming of nucleic acid or protein sequences, but that’s a topic for another post.

One of the things that didn’t change from the proposed circulars was the announcement by the ILPTO that it would limit the use of “Swiss”-style claims (but continue to allow purpose-directed product claims).  This particular change in ILPTO policy is interesting in two respects.  First, it’s not clear that it accords with case law. And second, if not, it evinces an inconsistency between the ILPTO’s position on Swiss claims and its position on “overlap” between claims.

First, a word on “Swiss” claims.  As is well-known to practitioners who prosecute pharma patents, few countries allow claims on methods of treatment of people, the USA being the most notable exception.  In those jurisdictions where such claims aren’t allowed, a common practice that developed over the years was to allow claims of at least one of two formats: purpose-directed product claims, and “Swiss claims”.  The former are of the format, “Compound X for use as a medicament [for the treatment of disease Y]”.  The latter are of the format, “Use of compound X in the preparation of a medicament [for the treatment of disease Y]”.

Hitherto, the ILPTO has allowed claims of both formats; in the case where a medical use for the compound had never been suggested before, it wasn’t even necessary to include “for the treatment of …”.  The justification for “Swiss” claims was that they recited a process.  Indeed, in ex parte proceedings from the early 1990’s, the ILPTO ruled that the claim “Use of 3’-azido-3’-deoxythymidine in the preparation of a medicament for the treatment or prophylaxis of a human retrovirus infection” was, in substance, the same claim as “A process for the preparation of a formulation according to any one of claims 1 to 14 which comprises bringing 3’-azido-3’-deoxythymidine into association with the said pharmaceutically acceptable carrier”.  Upon appeal to the Tel-Aviv district court, the court upheld that finding – thus implicitly giving its imprimatur to the “Swiss” claim format.

Such claims have likewise been found in numerous patent applications that were subject to opposition proceedings before the ILPTO, and in numerous patents asserted in infringement proceedings in District Courts (some of which were subsequently appealed to the Supreme Court).  At no point has a court in Israel held that “Swiss” type claims are per se deficient.

In the new circular, however, as in the draft, the ILPTO states,

“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”.”

As I noted when commenting on the draft circular, sections 9 and 11 just re-state what has been long-standing policy, and section 10 introduces serious mischief potential.  As I said previously:

Section 10 … 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 compound as a medicine, period (i.e. either the compound itself is new compound, 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. 

If section 10 is meant to be a deviation from existing practice, then on what basis has the ILPTO arrogated to itself the authority to ignore court rulings?  Well, there’s a possible answer to that: the AZT case the case where the question of the validity of “Swiss” claims per se came closest to being front-and-center.  But that was a district court case which wasn’t appealed, and the ILPTO is only bound by district court decisions in the particular matter hand; district court decisions don’t create binding precedent on the ILPTO.  Only Supreme Court decisions do that.

But if that’s so, then the ILPTO is being pretty selective about when it chooses to ignore district court instructions as being limited to the particular case, and when it enshrines such rulings as if they’re Torah-mi-Sinai.  Because that same district court decision was the one where the judge said an applicant can’t have “overlap” between two applications, and the ILPTO, as we’ve noted several times on this blog, has turned that particular molehill into a large mountain that needlessly consumes significant amounts of examiner and applicant time. 

Why the inconsistency?  I don’t know.  Maybe there isn’t any, and section 10 of the circular cited above really doesn’t change anything.  But if section 10 is now viewed by the ILPTO as requiring the recitation of process steps in Swiss claims, then the ILPTO is being intellectually dishonest.