Indian Company bears the brunt of Section 3(d)

After a series of overseas pharmaceutical companies, it is now the turn of an Indian pharmaceutical company to bear the brunt of Section 3(d). The relevant patent relates to Clopidogrel Bisulfate claimed by Cadila Healthcare, a pharmaceutical company based in Ahmedabad. A pre-grant opposition was filed by Glochem Industries, a Hyderabad based pharmaceutical company. The instant writ petition has been filed by Glochem Industries alleging misconstruction and misapplication of the law. The judgment followed the interpretation of Section 3(d) in the Novartis judgment and laid down some procedural guidelines in relation to the opposition procedure. The series of posts on Section 3(d) can be found here.

Clopidogrel (the image is the molecular structure of clopidogrel and it is from here) is an antiplatelet agent used in the prevention of blood clotting and in the treatment of cardiac ailments. Clopidogrel Bisulfate, a salt of Clopidogrel is marketed by Sanofi as Plavix. The instant patent application is with respect to Clopidogrel Besylate. The application was filed by Cadila Healthcare (respondent in the writ petition) in April 2003.

Glochem Industries (petitioner in the writ petition) filed a pre-grant opposition to the patent under Section 25 (1) of the Patents Act (henceforth the Act). The Assistant Controller ruled in favour of granting the patent. The writ petition was filed by the Petitioner, Glochem Industries alleging misconstruction and misapplication of the law in the context of Section 3(d) read with Section 25 (1) (f) of the Act by the Assistant Controller of Patents and Designs.

The Petitioner, Glochem Industries claimed that,
i) The respondent (Cadila Healthcare) failed to produce legal and admissible evidence.
ii) The respondent has failed to show enhancement of the known therapeutic efficacy.
iii) The Assistant Controller of Patents and Designs (Respondent No. 4) has misconstrued and misapplied Section 3(d).

The Respondents however argued that,
i) The Court cannot sit in appeal over the opinion of the Assistant Controller on technical issues.
ii) The Petitioners had a fair opportunity to pursue their objections before the Assistant Controller.
iii) The Petitioner had alternative and efficacious remedies in the form of post-grant opposition under section 25 (2), suo motu revocation under Section 64 and remedy under section 104.

The Court allowed the petition as the matter related to alleged misapplication and misreading of provisions of law.

The court held that even if the enquiry at the stage of pre-grant opposition is a summary enquiry as prescribed by Rule 55, adherence to principles of natural justice cannot be dispensed with. It was held that section 79 is applicable to all proceedings under the Act before the Controller and not limited to post – grant opposition proceedings. Section 79 provides that the Controller has powers to admit oral evidence in addition to or in lieu of evidence by affidavit. However the court said that since section 77 confers upon the Patent Controller the powers of the Civil Court, the Controller needs to first ascertain as to which evidence produced by the applicant can be looked into in order to answer the issue in question.

Moreover, the court observed that the evidence produced by the applicant should serve to show that the alleged invention enhances the “known efficacy” of the substance. In the opposition proceedings, the Petitioners objected to the consideration of the certain document as evidence. The Petitioners claimed that the comparative data produced by the Petitioners compared the pharmaceutical characteristics of Clopidogrel Besylate vis-a vis toluene solvate and dioxane solvate and not vis-à-vis solvated forms of Clopidogrel Bisulphate salt. The Court noted that these objections have not been considered by the Assistant Controller. The Controller had also refused to consider the averments of the Petitioner that there was no evidence to establish enhancement of therapeutic efficacy as required by Section 3(d).

The judgment then noted that the Assistant Controller had refused to apply the interpretation of Section 3(d) laid down by the Madras High Court in the Novartis case. Keeping aside the fact that the Assistant Controller had not considered comparative data with respect to Clopidogrel Bisulphate salt; the Assistant Controller had ruled that Clopidogrel Besylate constitutes patentable subject matter owing to increased stability, increased shelf life (over the bisulphate salt) and lesser toxicity in comparison to solvated toluene and diozane. The Court ruled that these factors however as per the Novartis judgment do not lead to enhancement of known efficacy in the context of “better therapeutic effect”.

The Court set aside the impugned order and directed the Assistant Controller to consider the arguments afresh.


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13 thoughts on “Indian Company bears the brunt of Section 3(d)”

  1. It would be better know Indian application no. on the patent on Clopidogrel besylate filed by Cadila healthcare, accordingly one can really dwell on the facts of the case.

  2. The court is doing nothing but indirectly converting Article 226 into some sought of an appeal-provision for pre-grant orders. There is no clear violation of natural justice that appears from the Bombay HC order. Applciants cannot be asked to prove documents as a pre-requisite for granting patent before the controller. If that was the case there would have been elaborate provisions similar to rule 55A-62 in the place of Rule 55. The discretion should be left with the controller. The court must see as to why the legislature did not incorporate a provision for appeal from pre-grant orders. Anand Grover has succeeded in busting another patent!

  3. AR,

    A) Anand Grover did not ‘bust’ another patent, simply because this was a pre-grant application – no patent was granted as yet;

    B) While I accept that the Court’s remedy seems a bit over arching, I have read the actual court order and it is clear that Controller had not considered very relevant evidence. Cadila had tried [and almost] succeeded in a ‘smokes and mirror’ evidence situation. Do read the order and you will realise that Cadila compares different aspects… not exactly and apples to apples comparison.

    C) I personally have a problem with the remedy mechanism for the pre-grant opposition.
    Where should the Applicant go, if his application is rejected by the Controller in a pre-grant? We are seeing cases where Applicant’s are approaching the HC as a matter of writ jurisdiction.

    Freq. Anon.

  4. The Patent Application Number is 413/MUM/2003A. I am awaiting the decision of the controller on the same. Clopidogrel bisulfate, another salt of clopidogrel is patented and is a popular medicine.

  5. @ anon
    i agree with you. the controller has absolutely not considered the objections raised by cadila. a writ would not have been the right course had the Controller considered the objections and rejected them after citing reasons. even a summary procedure in a pre grant procedure cannot do away with principles of natural justice.

  6. Prakruthi,

    I presume that you meant ‘objections raised by Glochem’, right?

    My second question is general.
    How legally appropriate is it for a patent applicant [whose patent application has been rejected in a pre-grant opposition] to use the High Court/ Write route?

    Freq. Anon.

  7. @anon and prakruthi

    i have read the entire order myself…i stand corrected to the extent that Anand Grover might not have busted a patent…there is a thin-line of difference btw non-consideration of materials on record and non-application of mind on the one hand and faulty appreciation of evidence on the other…the former might warrant interverntion of courts in writ jurisdiction (i.e. if post-grant and revocation are not considered alternate remedies)…in any event i think the controller has considered evidence, how so ever faulty the manner in which he has done may be…There might be cases where controllers have not compared apples to apples…you simply cant deal with it in writ jurisdiction. If you have a problem with the remedy against pre-grant opposition orders then the act ought to be amended. I repsectfully disagree.

  8. This is a pre-grant opposition stage. In case this does not get opposed, appellant have an option to go for post-grant opposition once the patent gets granted. High court route is only available when there is suit of infringement against the infringer by the patent holder. In that case as defence strategy, infringer can counterfile for revocation of patent on grongs specified under IPA.

  9. @ anon

    Yes. I was referring to objections raised by Glochem.

    As Mr. Garg has pointed out, the option of a writ or a revocation counter claim in a High Court is not available as an appeal option after the rejection of a pre or a post grant opposition. Revocation can be a counterclaim in a suit for infringement. An appeal however lies to the IPAB. From the IPAB an appeal lies to the Supreme Court and a writ to the High Court.

    With respect to a writ, it can be resorted to only when there is a question of interpretation of law involved. This case involved a misinterpretation or misapplication of Section 3(d). The writ jurisdiction of the High Court could not have been invoked if the Controller had “applied the interpretation of Section 3(d) as laid down in the Novartis judgment.”

    @ reddy
    I agree with you when you pointed out there is in fact a very thin line between non-consideration of material and non – application of mind.

    Please correct me if I am wrong.

  10. Prakruthi/ MG,

    Please read my ‘general comment again.
    I am asking on the use of High Courts, by the APPLICANTs, not the Opponents.

    Freq. Anon

  11. In case of APPLICANTS, the road for using High Court can only be used when the patent gets granted.Till then, they cannot file any suit of infringement against infringers.

  12. Manish,

    You never got the gist of my question.
    Please read the entire comment set, once again.

    In any case, I would rather advise you that you read today’s post on SpicyIP regarding Gilead.

    That was precisely my question, which I had been having a debate with Shamnad [hence the later article].

    Freq. Anon.

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