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.