More Novartis Shenanigans

When an Israel patent application is finally refused by an Examiner, the Applicant can appeal the decision to the Commissioner. This recently happened with respect to IL 213926 to Novartis, titled “USE OF COMBINATION COMPOSITIONS COMPRISING VALSARTAN AND AMLODIPINE IN THE PREPARATION OF MEDICAMENTS FOR THE TREATMENT AND PREVENTION OF DIABETES ASSOCIATED WITH HYPERTENSION”. The Application is a divisional of IL 140665, which is, itself, a national phase entry of a PCT application from 9 July 1999. The divisional application is concerned with a combination of VALSARTAN and AMLODIPINE. The parent application was allowed on 31 December 2012, and an Opposition was filed on 24 March 2013. The Opposition was successful. See here.

The divisional application in question was filed on 4 July 2011, and, the Examiner refused it on 12 November 2015 on the grounds of double patenting, since there was very significant overlap between the claims of the divisional application and those of the parent. The Applicant appealed the decision and a hearing was scheduled before the Deputy Commissioner. However, this was postponed at the Applicant’s request.

On 10 October 2016 the Applicant requested that following the cancellation of the parent application (thereby removing double patenting grounds), the present (child) application should be returned to the Examiner for reconsideration.

On 13 October 2016, Ms Bracha ruled that:

The hearing on double patenting grounds is canceled. The Applicant shall submit a written summary of their claims and why, despite the parent being found obvious, there was still grounds for allowing the divisional application to issue. The Applicant was given 30 days to submit their claims in writing and to indicate if they wanted an oral proceedings prior to a ruling issuing.

On 13 November 2016 the Applicant submitted written summary and declined the oral hearing. Consequently the present ruling is based on the submissions and the summary in the file.

The Applicant’s Claims

In a laconic statement, the Applicant claims that the Divisional is a separate entity from the parent and should, therefore, be examined on its merits.

Since the Applicant was working on an Appeal against the opposition ruling to cancel the parent application, the opposition ruling is not final. Since the Examiner had found novelty and inventiveness in the claims of the divisional but had canceled it as significantly overlapping the parent application, there were no longer grounds of double patenting.

Ruling

The Applicant does not disagree that there is significant overlap between the claims of the parent and those of the divisional, but considers the overlap irrelevant due to the opposition against the parent application being accepted.

Although considering it superfluous to do so, Ms Bracha affirmed that the two claim-sets did indeed overlap. For example, claim 1 of the parent application deals with a pharmaceutical composition including VALSARTAN or a pharmaceutically acceptable salt thereof, AMLODIPINE or a pharmaceutically acceptable salt thereof, and a carrier that is pharmaceutically acceptable.  In the divisional application, the same active ingredients are claimed but there is no reference to treating high blood pressure. In the second claim of the divisional, specific quantities of VALSARTAN are claimed, and the scope of claim 2 of the divisional is that of claim 3 of the parent.

Claims 4, 9  and 11 of the divisional recite ranges for the active ingredients. There is thus significant overlap, although the claim-scope is not identical. See the ruling regarding IL 203972 also to Novartisthe ruling regarding IL 203972 also to Novartis, and also appendix (v) of the Guidelines for the Applicant 23.1 from 29 March 2015 which deals with sections 2, 9 and 19 of the Israel Patent Law 1967 and states:

“Overlap between the claims of a patent application under Examination and those of another patent application exists where the scope of the claimed invention as defined by specific claim(s) is identical, includes or has similar scope to those of the other patent application.”

Even if the patentability of each patent is to be considered separately, where the scope is identical, that determined with respect to one application will be applied to the second application. Thus having determined that the parent application is not patentable, the ruling binds the Examiner, whether because of the civil administration hierarchy under which commissioner rulings bind Examiners (See Zamir Civil Authority, Vol 2 pages 598 (1996)), or since the ruling is a critical review of the Examiner’s decision regarding the parent application.

In the theoretical case that the divisional application be returned to the Examiner and she allows the application, the ramification would be that the Opposer would have to initiate opposition proceedings against a divisional application having similar scope to the parent that they had already successfully opposed.  Apart from the waste of resources in such a scenario, the Opposer can be expected to claim a court ruling or at least consider all aspects of the ruling estopelling the applicant (see Nina Zeltsman, Court Rulings in Civil Proceedings, page 9, 1991. For application of court rulings to Patent Office proceedings, see Cancellation Proceedings Against Trademark No 245411 “Golden Pearl Camel Rice (stylized). Yoram Sasa vs. Yehusit Matock 25 March 2015.  https://blog.ipfactor.co.il/2012/03/27/trademark-for-rice-cancelled/ From this it is clear, that were the divisional to be allowed, it would subsequently be successfully opposed on the grounds used to oppose the parent.

The Applicant claims that they intend to appeal the ruling accepting the Opposition to the parent application.  If they do so, there are only two possible outcomes: either the appeal will be successful, the ruling will be overturned and the divisional application will be considered as double patenting and refused, or the decision will be upheld and the parent refused, in which case the divisional application will be refused.

From the above it is clear that examination of the divisional application is over. The divisional remains refused following the opposition to the parent.

Ruling Ms Bracha, 20 November 2016.

COMMENT

Last year, the Israel Patent Office issued a similar ruling for another Novartis patent and divisional with overlapping claims. It rendered this proceeding redundant.

There is so much riding on pharmaceutical patents that applicants will try anything to get them allowed. In this instance, the Deputy Commissioner’s reasoning seems so obvious that I am surprised she didn’t rule costs for wasting her time.

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