In the previous post I discussed the issue of amending granted US patents to include new dependent claims. In this post I look at the same question with regard to Israel.
The question of post-examination amendments was addressed recently during a pre-grant opposition to Schwarz Pharma’s IL 149567. The corresponding US 6858650 is the sole patent listed in the Orange Book for Pfizer’s Toviaz® (fesoterodine fumarate), used to treat overactive bladder. Claim 1 as allowed was a typical chemical compound claim, claiming a compound of the following structure:
in which R and X- were each defined as being selected from a closed group of choices. The other independent claims were directed to methods for making such compounds or certain intermediates thereto. The active ingredient in Toviaz® is such a compound in which R is isopropyl and the counterion X- is fumarate, and having (R)-stereochemistry at the chiral carbon atom.
After allowance of the claims (the same 17 claims granted in the corresponding EP 1481964 B1, which was granted without opposition) and their ostensible publication for pre-grant opposition, Teva opposed the granting of the patent. While the opposition was pending, Schwarz Pharma asked to amend the claims by (a) excluding chloride as X- throughout the claims; (b) restricting R to isopropyl throughout the claims, (c) canceling dependent claim 17 and (d) amending claim 6 – which by virtue of the amendments to claim 1 was now obsolete – with “Compounds in accordance with claims 1 to 5 in crystalline form.”
The amendment of claims in pending Israel patent applications is governed by §22 of the statute; applicants may freely amend their claims, as long as the amended claims are supported by the specification as filed. The amendment of claims in granted patents is governed by §§65-66 of the statute. By virtue of §29, the amendment of published but not yet granted applications is also governed by §§65-66. These two sections read as follows:
65. A patentee may request amendment [alternate translations: “correction” or “fixing”] of the specification of the patent for the sake of clarification or removal of an error that occurred therein or for the sake of reducing [alternate translations: “restricting”, “contracting”, “limiting”, “condensing”] his claims.
66. The Commissioner shall allow the amendment, if he is convinced that there is nothing therein to broaden the scope of the claims in the specification or to add to the specification things which were not in their essence mentioned therein a priori; notice of allowance of the amendment shall be published in Reshumot.
Teva opposed the amendment of claim 6 on the grounds that this amendment – in effect the addition of a new dependent claim – was not permissible under §65, as it did not fall into any of the three categories enumerated therein: clarification of the specification, correction of an error in the specification (which includes the claims), or for reducing the claims. Schwarz Pharma argued that since amended claim 6 did not broaden the scope of the claims, thus according with §66, the amendment should be allowed.
The hearing officer who decided the case first ruled that §65 establishes the criteria for potentially permissible amendments; only if a proposed amendment falls within the types of amendments under §65 does the Commissioner then turn to §66 to determine if the amendment is permissible. Turning to the criteria of §65, she then ruled that the inclusion of a new dependent claim did not constitute a clarification, and (similar to the statement made by the USPTO during the prosecution of Tanaka’s reissue application) that the failure to include dependent claims during ex parte prosecution was not the sort of error contemplated by §65. This left “reducing [the] claims” as the only possible basis for allowing new dependent claim 6, but, using reasoning very similar to that of the BPAI in Tanaka, the hearing officer concluded that new dependent claim 6 did not constitute a restriction of the claims:
“Restriction of claims” means claiming a smaller portion of the scope of monopoly that was claimed in the context of a claim or set of claims as originally presented. There is nothing in new claim 6 to limit the scope of the monopoly claimed in claim 1 or in the set of claims 1-5; for when the [substantive] opposition to the grant of the patent is addressed, these claims will be addressed in full (as would also happen in a suit for infringement, if the patent is granted), and the scope of the monopoly claimed therein will be unaffected by the addition of new claim 6. This implies that there is nothing in new claim 6 to restrict what is claimed in the patent application in accordance with section 65 of the patent statute.
Section 65 cannot be understood as instructing other than that the applicant must act to restrict his claims, i.e. to reduce the monopoly originally claimed, and not to add alternative lines of defense in the guise of new dependent claims.
Thus, per the hearing officer’s decision, once an application has been published for opposition, there is no way for the applicant/patentee to introduce new dependent claims.
Although the hearing officer’s take on §65 is not implausible, it is not the only interpretation of the statute possible; that’s why, in translating §65 above, I included several alternate translations of the Hebrew term “tzimtzum”. The hearing officer understood the phrase to mean “restricting the scope of the patentee’s claims”, but in the context of §65, “tzimtzum” could merely mean reducing the number of the claims. Support for this view comes from the fact that the word “scope” (“hekef” in Hebrew) doesn’t appear in §65, but it does appear in §66: the Commissioner must ascertain that the amendment won’t broaden the scope of the claims. To read “scope” into §65 is therefore to render part of §66 redundant; but interpreting statutes to create redundancy therein is generally frowned upon. If, however, “tzimtzum” in §65 is understood to mean reducing the number of claims, then there is no redundancy between §65 and §66 – and applicants whose applications have been opposed, or patentees, would be free to add a number of new dependent claims commensurate with the number of claims they are willing to cancel.
The absolute bar on the introduction of dependent claims is at odds with the situation in the USA, which, as explained in the previous post, enables the addition of new dependent claims (1) in the context of reissue proceedings, if at the same time (a) the scope of one of the independent claims is also being restricted or broadened or (b) the specification is being corrected, and (2) in the context of reexamination proceedings. In the present case, had claim 1 been granted in the USA and had Schwarz Pharma sought reissue to limit claim 1 by excluding Cl- as X- and limiting R to isopropyl, as it did in Israel, then new claim 6 could have been introduced.
Schwarz Pharma has until roughly the end of December to appeal the decision to one of the District Courts. In addition to appealing on grounds of statutory construction, Schwarz Pharma could appeal on the grounds that the application was not properly published per §26 of the statute (as discussed here and here), and therefore not only is the opposition to the grant of the patent premature (since the statute says oppositions cannot commence until after §26 publication), but in fact the applicable section governing the requested amendments is §22 rather than §§65-66. Inasmuch as Schwarz Pharma is represented by one of the larger Israel firms, Schwarz’s attorneys probably don’t want to rock the boat by raising this argument, as it could result in a declaration that thousands of ostensibly granted patents – including many of those held by other clients of those attorneys – weren’t really granted and still need to go through the §26 publication process, followed by the opposition period. But the argument has no worse a chance than the statutory construction arguments Schwarz Pharma might set forth
If the hearing officer’s decision is not overturned on appeal, the result will be that in most cases, applicants will only be able to obtain those dependent claims introduced during ex parte prosecution. To avoid this difficulty, in important cases applicants who can afford to do so should maintain the pendency of a divisional application. In the corresponding case in Europe, for example, the divisional EP 1690536 B1 claims crystalline fesoterodine fumarate as well as its use. However, the ILPTO in recent years has been making it difficult for applicants to delay examination of their applications; and as discussed in an earlier post, the Commissioner has (erroneously) taken the view that applicants cannot file divisionals of divisonals, which would be another obvious way to maintain pendency in the absence of an explicit continuation regime as in the USA.
Moreover, it’s not clear how the ILPTO would respond were an applicant to file a claim in a divisional that properly should have been included as a dependent claim in the parent case: the ILPTO might raise the Israeli equivalent of what in the US would be called a statutory double-patenting rejection. Although it’s my view that such an assertion would be incorrect, to the best of my knowledge the matter hasn’t yet been adjudicated.