Long Division

Herceptin

IL 234696 to Genentech relates to the antibody that is the active ingredient in its blockbuster drug Herceptin.

The Application is a divisional application of IL 214084 which is itself a
divisional application of 136201.

Section 24 of the Israel Patent 1967 states that: (a) As long as the application has not been accepted, the applicant is entitled to demand that it be divided into several applications.”  (b) If the application includes more than one invention, then the Registrar may, as long as he has not accepted the application, direct the applicant to divide his application.”

Back in February 2010, in Circular MN 81, then Israel Commissioner Dr Meir Noam creatively interpreted this statute to mean that although a first filing into Israel may be divided into divisional applications, those divisional applications could not be further divided once the parent application had published. This new interpretation was a departure to 40 years of established practice and did not seem compatible with the wording of the Law.

As we noted back then, the logic for the new interpretation of the statute was that Israel was getting ready to automatically publish applications 18 months from priority and not just make allowed patents open to inspection. Nevertheless, the new interpretation issued in an Israel Patent Office circular and overturned common practice dating back to when the statutes were legislated. Back then I commented that

With the proposed amendment allowing for 18 month publication, this measure is clearly required. Nevertheless, I am not convinced that this is interpretation of the law, but rather amendment thereof.Arguably this measure requires a formal amendment to the Law by the Knesset and goes beyond the authority of the Commissioner. It should be included in the proposed amendment for 18 month publication (second reading) and it would be fun if someone challenges this Circular on procedural grounds.

It was a different and also timely circular, not to require publication of printed journals, but to rely on on-line publication, and subsequent Knesset criticism of this as beyond the legal competence of the commissioner, that caused Dr Noam to retire.

The current commissioner Asa Kling seems to be more wary about changing substantive law by creative interpretation and prefers to rely on the Knesset and Ministry of Justice.

After IL 234696 to Genentech was filed, Genentech challenged the circular and in January 2015 an ex parte hearing before the Current Commissioner of Patents and Trademarks was held. Genentech noted that the Circular did not institute a new law or regulation but merely provided a new interpretation to an old law.  Genentech argued that the new interpretation in the Circular was based on an untenable reading of Section 24a and was thus ultra vires.  If this was indeed interpretation of the Statute, it should apply retroactively and invalidate a number of issued divisional-of-divisional applications. If, however, the Circular was to be considered as new law, it was ultra-vires and thus void. Notably, the former commissioner himself postponed application of the Circular which was odd if it is to be considered as interpretation. Without needing to force the issue of the validity or otherwise of the Circular, Genentech asked for at least an exception to be made for their case, i.e. that their divisional be considered as a legitimate application despite being a divisional of a divisional.  In a ruling that issued in January of this year, the present Commissioner noted that in the U.S., In re Ernest Johan Jens Henriksen, 55 C.C.P.A. 1384; 399 F.2d 253; 1968 CCPA LEXIS 273; 158 U.S.P.Q. (BNA) 224 the Court of Customs and Patent Appeals found somewhat similar guidelines of the USPTO unlawful. The EPO who also initially banned secondary divisional applications, has changed its practice and reinstated the possibility of filing secondary divisional applications. Filing secondary applications is also allowed in Australia and Japan.

In conclusion, the present Commissioner has allowed Genentech’s 234696 filing as being a legitimate divisional application despite being a divisional of a divisional.

COMMENT

There was some justification in Dr Noam’s attempt to prevent parties from leaving a divisional application pending to claim around competition in cases of generic competition not literally infringing. I think that preventing this type of activity does indeed require primary legislation. However, what the Commissioner has apparently not done is to rescind Circular M.N. 81. It remains unclear whether Genentech is an exception to the rule, and why this should be so, or whether Patent Office Circular M.N. 81 is now void.

Either way, as the validity of both parent application (IL 214084) and grandparent application (IL 136201) were challenged in Opposition proceedings, we suspect that if the case is allowed, the claims will likely be challenged in a further Opposition and the correct interpretation of Section 24 and whether divisional applications of divisional applications are allowable will be challenged directly. If such an opposer remains unhappy, he may take it up with the courts.  Although I was wary of the original Circular, I consider a situation under which the Commissioner has the discretion to allow or reject the filing of a divisional of a divisional on a case by case basis even more problematic.

 

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