Enzalutamide - India

On May 16, 2019 The Delhi High Court set aside the order issued by Controller & remanded the case back to patent office for fresh consideration.

The Regents of the University of California’s (Petitioner) filed Indian patent application, 9668/DELNP/2007 on Dec 13, 2007. The invention relates to ““Diarylhydantoin Compounds” & specifically claims compound Enzalutamide. On May 13, 2009, the petitioner filed a request for examination. The Controller issued the First Examination Report (FER) on May 24, 2013. Multiple Respondents filed pre-grant oppositions to said patent application. Different oral hearings with respect to different respondents were held in Jul 2015 & in Jul 2016 before Controller. The Controller passed the order on Nov 08, 2016 & rejected the patent application. Petitioner filed petition before Delhi high court.

Petitioner advanced their contentions, essentially, on three fronts.

First, it was submitted that no evidence was filed by respondent nos. 3 to 7 in support of their oppositions. Second, they contended that the petitioner had no effective opportunity to deal with the “Bohl” document. Third, they submitted that the evidence of the inventors filed by the petitioner was not considered by the Controller. In addition to the above arguments, it was also contended that the Controller had erred in applying an incorrect test for adjudicating whether there were inventive steps. As is apparent from the above, the petitioner’s challenge to the impugned order is of twofold: the first relates to the decision making process and the second relates to the merits of the decision. Thus, petitioner contended that principles of natural justice have been violated.

With respect to first contention, Court said that it is apparent from the plain reading of Section 25(1) of the Patents Act that a representation to oppose grant of a patent is required to be in writing. There is no requirement that any such opposition is to be supported by an affidavit. In terms of Rule 55(1) of the Patents Rules, the pre-grant opposition is required to be accompanied by a statement of evidence. It is not necessary that such evidence be accompanied by an affidavit. The principal object of requiring the opposition to be in writing is, plainly, to enable the Controller to examine the grounds stated therein and to provide an opportunity to the applicant to meet such opposition. In the instant case, there is no dispute that the respondents had submitted their respective representations. The Controller had issued a notice with regard to the same, thus enabling the petitioner to file a statement and evidence in support of its application. The parties were also heard. Thus, as far as this stage is concerned, there is no dispute that the principles of natural justice were complied with.

With respect to second contention, Petitioner argued that respondent no.3 had produced the “Bohl” document during the course of hearing, and the written submissions filed by respondent no.3 had further expanded the submissions made on its behalf during the course of the oral hearing. Petitioner thus contended that this was, essentially, a new argument and the petitioner had no opportunity to deal with the same. Court, however, said that although Bohl document was produced at the belated stage, it cannot be disputed that the petitioner was given full opportunity to make submissions with regard to the said document. The petitioner had not only made oral submissions with regard to the said document but had also filed written submissions at a later date. Also the consideration of the representation filed to oppose grant of patent is an intrinsic part of the decision making process whether to accept the claim and, therefore, cannot be viewed as a completely independent proceeding. Thus, the Controller cannot ignore any document or material produced, which may have a bearing on whether the patent ought to be granted. Thus the essential requirement of providing the petitioner an opportunity to deal with the said document was, thus, duly met.

But with respect to post hearing submissions, Court said that such submissions are clearly meant to record only the oral submissions made at the hearing in order to assist the decision maker & cannot expand the scope of submissions made in the oral hearing. There is no scope for entertaining additional arguments after the oral hearing is concluded. If the Controller intends to take into account any additional arguments raised after oral hearing is concluded, he is, obviously, required to put the applicant to notice regarding the same. In the impugned order Controller accepted the arguments raised by respondent no.3 after conclusion of the hearing without providing notice, & therefore cannot be sustained.

With respect to third contention, Petitioner argued that impugned order is vitiated as the Controller had failed to consider the affidavit submitted by its experts. There is no reference or discussion regarding the affidavits of the experts submitted by the petitioner in the impugned order. The respondents contended that the evidence of experts had been considered and dealt with by the Controller in the impugned order. In support of its contention, respondent no.3 had, in its written submissions, set out a tabular statement referring to the extracts of the affidavit and the impugned order. But Court said that whilst it is correct that the conclusions drawn by the Controller dealt with the issues referred in the impugned order, however, a careful reading of the affidavits and the conclusions drawn by the Controller clearly indicate that observations made in the impugned order are not directly relatable to the issues raised by Experts in his affidavit. The Controller has selectively culled out certain sentences from paragraphs 41, 42 and 44 of the affidavit filed by one of the Expert, Mr Jung to indicate that the said issues had been considered in the impugned order. However, a plain reading of Mr Jung’s affidavit indicates that the conclusions drawn are not directly in reference to the said affidavit. Court also denied respondent’s argument that said affidavits are not relevant to subject matter of claims since it is related to clinical trials & marketing approval.

Court thus set aside the order & remanded the matter to the Controller to decide afresh.