Update India: Abbott Files a Divisional Application for its Heat Stable Ritonavir/Lopinavir Formulation

Press Release 23 May 2009

In our earlier post, we informed you that the hearing on our opposition against Abbott’s patent application in India for heat stable ritonavir, ritonavir/lopinavir formulation (Application No. 339/MUMNP/2006) took place on 15 April 2009.

It has now come to our attention that on the day of the hearing, Abbott filed a divisional application to 339/MUMNP/2006. The new application number for the divided application is 726/MUMNP/2009 (‘726) A and was published in the Official Journal of the Indian Patent Office on 22 May 2009. A copy of the publication can be downloaded here.

Section 16 of the Indian Patents Act permits an applicant at any time before grant to file a further application in respect of an invention disclosed in the first/parent application i.e 339/MUMNP/2006 (‘339). As required under sections 16(2) and (3) of the Act, the newly divided application cannot include any matter that was not disclosed in any substance in the parent application. The Controller may also require an amendment that the newly divided application does not include a claim that has already been claimed in the parent application.

Typically, applicants will seek to divide an application in order to overcome an objection during examination that the claims of the complete specification relate to more than one invention. In this case, such an objection does not exist against ‘339. Indeed, at no point in the hearing did the Controller make such a request.

So what will the new divisional application cover?

We are still waiting to see the complete specification for ‘726. Interestingly, as highlighted in the publication notice, ‘726 consists of 27 pages and 37 claims. This is the same number of pages and claims as originally filed in ‘339. It would appear that Abbott has re-filed the original application and will wait to see if the patent office will request an amendment to the claims in ‘726 so that they do not claim the same matter in ‘339. Alternatively, Abbott could amend the claims so as not to overlap with ‘339.

However, given that Abbott already amended its claims during the prosecution of ‘339, but which still cover all relevant subject matter relating to the claimed invention disclosed in the specification, it is difficult to see what claims ‘726 will cover. This is especially so given that ‘339 is still pending the outcome of the pre-grant opposition hearing.

To add another twist to this case, Abbott has yet to file its final written submission following the hearing of ‘339, which was due at the beginning of May. It is possible that Abbott may simply abandon ‘339 in the face of the oppositions against it and start over again with ‘726 in the hope for a different examiner or simply that potential opponents may miss the new application. This scenario is not unheard of in patent practice, especially given that Abbott took the unusual step of filing ‘726 on the day of the hearing.

We’ll have to wait to see what Abbott is attempting with the divisional application. What is apparent from this case is that section 16 essentially allows applicants to file what are akin to continuation applications of existing applications where the original application is facing difficulties.

It would seem this is a loophole within the Act that could lead to applicants abusing the patent system. Such permitted practice leads to uncertainty in the market place as it delays the outcome of whether a patent will be granted or not. Uncertainty and delay is a criticism that the originator industries have directed at the Indian Patent Office’s backlog in examination and the pre-grant opposition system. Yet, in this case it is the applicant that creates uncertainty and delay. Indeed, the recent EC Competition Report on the Pharmaceutical Sector discusses how originator companies use divisional applications to foster uncertainty and keep generic competitors off the market as long as possible.

In the current situation, Abbott is littering the patent office with applications that are overlapping in claims and which warrant investigation of double-patenting. Aside from ‘339 and now ‘726, Abbott’s application numbers 676/MUMNP/2007 and 6733/DELNP/2007 cover subject matter already claimed in ‘339 (and ‘726).

We trust that the Indian Patent Office will remain vigilant of such overlapping patent applications and how section 16 is used.

We’ll be sure to keep you informed of any developments as they happen.

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