Patent Case Summary: Pfizer Products Inc. v. Controller of Patent & Designs

IMPORTANT ISSUE

• Whether the Controller General erred in rejecting the patent under Section 15 of the Indian Patents Act, on the grounds of non-patentability under section 3(d).

SUMMARY

Short description of Patent: The claimed compound of IN’991 is 3-{(3R, 4R)-4-Methyl-3-[methyl-(7Hpyrrolo[2,3-d]pyrimidin-4-yl)-amino]-piperidin-1-yl}-3-oxo-propionitrile and pharmaceutically acceptable salts thereof. The claimed compound is called TOFACITINIB and the commercialized pharmaceutically acceptable salt is TOFACITINIB MONOCITRATE.

FACTUAL MATRIX

1. The Appellant filed a national phase application in India with respect to the PCT application no. PCT/IB2002/01905 on 27th October 2003 as “mailbox application” under Section 5(2) of the Indian Patents Act.
2. The Appellants submitted their response to the first examination report on 2009 by amending their claims. The hearing for the same was scheduled in 2011 and in response to the objections raised; only two claims remained before the Controller (pharmaceutical composition of the compound claimed). Following this the Controller in their order dated 9th June 2011 rejected the application for patent IN ‘991.
3. Further, the Appellant filed a review petition under Section 77(1)(f) of the Indian Patents Act which was eventually dismissed. Aggrieved by the order of the Controller dated 9th June 2011 and refusal, the Appellants filed an Appeal. On hearing the Appellant’s, the IPAB held that the order of Controller was against principles of natural justice and ordered that the Controller hear the Applicant’s case afresh.
4. On recommendation of the IPAB, the hearing was conducted and after 7 months the Controller rejected the present application vide impugned order dated 03.09.2015 on grounds of anticipation by prior claim and non-patentability under section 3(d).
5. Aggrieved by this order, the present Appeal was filed.

SUBMISSION BY APPELLANTS

• According to the appellant, section 3(d) is not applicable to the present case as there is no “known compound”. The prior art (D1) was not publicly available at the priority date of the present application. Further, even if Section 3(d) is applied without prejudice, by evidence there is enhanced efficiency when compared to D1.
• It is against the principles of natural justice that an application is rejected without clearly communicating an objection under Section 14 of the Patents Act. In the absence of a citation, and a known substance being identified, the applicant must be aware as to what the known substance is, and against which an enhancement of efficacy is to be shown to show patentability.
• The controller was  incorrect in holding that the patent application is anticipated by prior claiming and establishing superiority of unexpected results is required to overcome the objection of anticipation be it anticipation by prior claiming or anticipation by prior publication

SUBMISSION BY RESPONDENTS

1. When the appeal was taken up for hearing, it was noticed that no counter – affidavit had been filed on behalf of respondents, who also failed to file written submissions. No one appeared on their behalf.
2. The main grounds relied on by the respondent for rejecting the present application include that the application is anticipated by prior claiming and is not patentable under section 3(d).

HELD

• The court opined that section 3(d) is not applicable to the present case as there is no “known compound”. D1 (prior art) was not publicly available at the priority date of the present application. Further, even if Section 3(d) is applied without prejudice, the applicant by evidence has established the superiority of claimed form over and other enantiopure forms of compound of D1.
• The court explained that in anticipated by prior claiming requires only claims to be checked from prior art and establishing superiority of unexpected results is not required to overcome the objection of anticipation be it anticipation by prior claiming or anticipation by prior publication
• Court in consideration of delay in prosecution opined that practice of filing of Benami opposition by the Benami opponent and crooked imposter has to be stopped. It is the duty of the respondent that such person(s) may not be allowed to take the advantage of multiple layers of opposition

Therefore, the Controller’s order was set aside and it was directed that the patent be granted.

Copy of judgement

Citation OA/2/2016/PT/MUM