The Ahmedabad-based Cadila Healthcare may approach the Supreme Court seeking interpretation of the controversial Section 3(d) of the Indian Patent Act. The company has lost its case against the Hyderabad-based Glochem Industries Ltd to retain patent protection for its antiplatelet drug, clopidogrel besylate, it is learnt.

The High Court of Judicature at Mumbai in November, 2009, ruled against the decision of assistant controller of patent, the Patent Office of Mumbai to consider the patent application of Cadila Healthcare for the form of antiplatelet agent without paying heed to the objections of Glochem.

The chief justice Swatanter Kumar and justice A M Khanwilkar set aside the impugned order and directed assistant controller of patent to consider the matter afresh with the points raised by the rival parties. However, Cadila Healthcare has asked a stay on the order immediately seeking time to appeal to the Supreme Court, according to a source close to the development.

“The High Court has asked the patent office to give due consideration to our objections based on Section 3(d) before granting the patent. The order is under stay, as the Court has provided time for Cadila Healthcare to go for appeal in the Supreme Court,” said K Subbarao, chief promoter and managing director, Glochem Industries. However, he refused to comment more on the issue, as the matter is under sub judice. A query sent by Pharmabiz to the Cadila officials left unanswered.

Glochem, in its writ petition filed in January 2009, argued that the clopidogrel besylate is a salt of clopidogrel, used in the prevention of blood clotting and in the treatment of cardiac ailments, with known therapeutic effects. Clopidogrel bisulphate is the key ingredient in the known drug Plavix, marketed by the French drug major Sanofi S A.

The petitioner alleged that there was no legal and admissible evidence before the authority which would establish the claim of Cadila Healthcare that the alleged invention results in the enhancement of the known therapeutic efficacy of the stated substance as is the requirement of Section 3(d) of the Act and the assistant controller of patent has neglected the objection.

The patent office has considered that the crystalline clopidogrel besylate has more shelf life and is more free flowing and stable even after two months period. It has also agreed that the claim that the said salt is better and advantageous in matters of toxicity in comparison to solvated forms. However, Glochem argued that none of these factors which have weighed with the assistant controller of patent are germane to answer the core issue.

Cadila, on the other hand, argued that the Court cannot sit in appeal over the opinion of the patent officer on technical issues and the petitioner had fair opportunity in pursuing their objections and the assistant controller of patent has dealt with the objection as raised by the petitioner and decided the same on merits. The company also suggested that Glochem had alternative and efficacious remedies in the form of post-grant opposition under section 25 (2) or even remedy of seeking suo moto revocation of Patent under Section 64 of the Act can be resorted to.

Hearing the grievances of the petitioners, and referring the dictum of the Madras High Court in the case of Novartis AG v/s Union of India & others in 2007, the quorum ordered that the Respondent no. 4 – assistant controller of patent – has not dealt with the petitioner's questions as to whether the substance so discovered has a 'better therapeutic effect'.

“Considering the exposition of the Madras High Court, 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. These matters though crucial have not been examined by the Respondent No 4 at all,” said the Court.

If Cadila is going ahead with the case to the Supreme Court, the issues with the interpretation of Section 3(d) will again be a subject of discussion, according to a patent expert. The Glivec patentability issue, which has created much ado earlier, would again come into limelight with this, he added.