Glochem Industries Ltd v Cadila Healthcare Ltd (2009)

Summary

“This Writ Petition under Article 226 of the Constitution of India essentially takes exception to the order passed by the Assistant Controller of Patents & Designs-Respondent No.4 dated 7/1/2009 on the Petitioner’s representation by way of opposition against Patent Application No. 413/MUM/2003A.” (para 2) “The subject of patent application in the present case relates to Clopidogrel Besylate, a salt of Clopidogrel.” (para 2) The Assistant Controller had held that “the Crystalline Clopidogrel besylate of present invention compound is patentable and cannot be rejected under Section 3(d) of the Patents Act, 1970.” (para 4) At the hearing the petitioners’ counsel “confined his arguments mainly in the context of Section 25(1)(f) read with section 3(d) of the Act.” (para 5)

The Bench held that the availability of other remedies “by itself can be no basis to non-suit the Petitioners” (para 7), and that although “the enquiry contemplated at the stage of pre-grant opposition is a summary enquiry”, “the principles of natural justice will have to be adhered to even during that enquiry.” (para 9) The Assistant Controller had “not in the first place considered the plea of the Petitioners for discarding the said documents one way or the other” (para 9), and “The real question to be answered has not been dealt with by the Respondent No.4 in the impugned order at all.” (para 13) “In our opinion, the appropriate course is to set aside the impugned order and direct restoration of the representation by way of opposition filed by the Petitioners to the file of the Respondent No.4 to be reconsidered by the Respondent No. 4 on its own merits in accordance with law.” (para 17) “Accordingly, we allow this writ petition and make the rule absolute on the above terms with no order as to costs.” (para 19)

What the court decided

1. Procedure. The alternative remedies. “Although the Petitioners may have remedy of post grant opposition or of seeking suo moto revocation as well as filing of a counter claim as is suggested by the Respondents that by itself can be no basis to non-suit the Petitioners, if the Petitioners were right in their grievance that the authority has committed manifest or jurisdictional error while considering the representation by way of opposition or for that matter decided the objections on palpable misreading and misapplication of the relevant provisions of law.” (para 7)
2. The duty under section 25(1). “This is so because the law provides for remedy of pre-grant opposition by virtue of Section 25(1) of the Act. If such a remedy is provided, the authority is obliged to consider the representation by way of pre-grant opposition under Section 25(1) keeping in mind the parameters of law by observing principles of natural justice.” (para 7)
3. Procedure. Writ jurisdiction a matter of discretion. “Suffice it to observe that the preliminary objection raised by the Respondent No. 1 does not mean that this Court has no jurisdiction to entertain writ petition under Article 226 of the Constitution of India against the decision of the authority on the opposition under Section 25(1) of the Act. It is a matter of prudence and discretion as to whether the Court should entertain the writ petition or not.” (para 7)
4. Summary enquiry and natural justice. “There is no difficulty in accepting the argument of the Respondent No. 1 that the enquiry contemplated at the stage of pre-grant opposition is a summary enquiry. Nevertheless, the principles of natural justice will have to be adhered to even during that enquiry.” (para 9)
5. Section 79 in pre-grant opposition. “Moreover, keeping in mind the plain language of Section 79 of the Act, its application is not limited to enquiry under Section 25(2) of the Act. On the other hand, Section 79 postulates that the requirement specified under that Section is applicable in respect of ‘any proceeding’ under the Act before the controller. That expression would certainly take within its fold enquiry under Section 25(1) of the Act.” (para 9)
6. The applicant’s evidence. “Thus understood, the Respondent No. 4 even while deciding representation by way of opposition under Section 25(1) of the Act was expected to first ascertain as to which evidence produced by the applicant can be looked into to answer the point in issue. Moreover, the evidence produced by the applicant must be such that it would positively show that the alleged invention enhances the known efficacy of the stated substance and belies the contra stand of the objector.” (para 9)
7. Objections to the Enclosures not considered. “Indeed, the Respondent No.4 has answered the issue keeping in mind Enclosures 5,6,9,13 & 14, but has not in the first place considered the plea of the Petitioners for discarding the said documents one way or the other.” (para 9) “Even this aspect has not been dealt with by the Respondent No. 4 at all, though a jurisdictional fact.” “There is force in this grievance of the Petitioner.” (paras 9–10)
8. The Madras High Court’s dictum. “The Order impugned before us not only suffers from the above infirmity but we also find force in the submission of the Petitioners that the Respondent No.4 ought to have considered the dictum of the Madras High Court in the case of Novartis AG v/s. Union of India & ors.” Quoting that “if the discovery of a new form of a known substance must be treated as an invention, then the Patent Applicant should show substance so discovered has a better therapeutic effect”, the Bench recorded: “The Respondents herein have not questioned the correctness of the above-stated legal position before us.” (para 11)
9. Stability and toxicity not the test. “According to the Petitioners, none of these factors which have weighed with the Respondent No. 4 are germane to answer the core issue as to whether the substance so discovered has a ‘better therapeutic effect’. The real question to be answered has not been dealt with by the Respondent No.4 in the impugned order at all. We are in agreement with this submission.” “The Respondent No. 4 ought to have examined whether the factors noted in the impugned order had the effect of enhancement of known efficacy of stated substance in the context of ‘better therapeutic effect’ which is the legislative intent behind the amendment of Section 3(d) and not recognise the alleged invention merely because of its new form or some other advantages or is better in some respect.” (para 13)
10. Reliance on J. Mitra. “In that case, however, the problem considered was about the confusion arising on account of the postponement of in-part commencement of the Patents(Amendment) Act, 2005, in particular with regard to the remedy of appeal against an order rejecting the pre-grant opposition.” “Nevertheless, the law as it operates after the amendment has come into force is that it provides only one remedy of statutory appeal against the post-grant order. The ratio of this decision does not take the matter any further.” (para 14)
11. Disposition. “In our opinion, the appropriate course is to set aside the impugned order and direct restoration of the representation by way of opposition filed by the Petitioners to the file of the Respondent No.4 to be reconsidered by the Respondent No. 4 on its own merits in accordance with law.” (para 17) “Be that as it may, as we are relegating the parties before the authority, the Respondent No. 4 would examine the matter afresh confined to the grievance made before this Court and not on any other issues.” (para 18) “Accordingly, we allow this writ petition and make the rule absolute on the above terms with no order as to costs.” (paras 17–19)

What the court did not decide

“It is not necessary for us to examine the argument of the Petitioners that the remedy of pre-grant opposition is qualitatively different than the remedy of post-grant opposition.” (para 7) Of the submission that the evidence of efficacy was already part of the prosecution history: “We do not propose to examine the correctness of the above submissions with reference to the ground under consideration for the nature of relief that we intend to grant in the present petition. The same is left open to be decided by the Authority at the appropriate stage.” (para 16)

Subsequent treatment

• Followed — In Neon Laboratories v Troikaa Pharma (2010) the Bombay High Court, after reproducing the holding that “the enquiry contemplated at the stage of pre-grant opposition is a summary enquiry. Nevertheless, the principles of natural justice will have to be adhered to even during that enquiry”, held that “It is, therefore, clear that the opportunity provided in Section 25(1) is not an empty formality.” (paras 42–43)
• Distinguished — In UCB Farchim v Cipla (2010) the Delhi High Court held that “the settled law as explained in several decisions of the Supreme Court (which incidentally have not been adverted to by the Bombay High Court in Glochem) makes it clear that this Court should not entertain the writ petition, not because it does not have the power or jurisdiction, but because the petitioner has an efficacious alternative statutory remedy to exhaust.” (para 17)