19 Jul 2010

Claimant to establish enhancement of therapeutic effect for patent: High Court

In a recently reported decision [Glochem Industries Ltd. v. Cadila Healthcare Ltd. AIR 2010 Bom 76] the Bombay High Court has declared that the applicant has to establish that in terms of the Patents Act, 1970 in the application for patent that the discovery in the pharmacology field (the subject-matter of the patent application) has resulted in the 'enhancement of therapeutic value' so as to succeed in obtaining a grant of patent. The High Court being of the view that such an examination was not undertaken by the authority granting the patent, set aside the order and directed a fresh examination in order to ascertain whether there had been enhancement of any therapeutic effect by the application. 

The High Court inter alia observed as under;
11. 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. Reported in (2007) 4 Madras Law Journal 1153. In the said case while examining the question regarding the validity of the Amendment Act which amended Section 3(d) of the Act, the Court proceeded to examine the purport of the amended provision i.e., Section 3(d). It is held that from the language of Section 3(d) when considered along with the parliamentary debates, it was clear that Section 3(d) as it appears in the statute book is the result of parliamentary debates and not mere reproduction of the provision in the Ordinance. The Court then considered the validity of the provision on the touchstone of Article 14 of the Constitution. While doing so, it considered the purport of Section 3(d) along with explanation and in the first place held that the amended section not only covers the field of pharmacology but also other fields. In other words, it is a comprehensive provision covering all fields of technology including the field of pharmacology. It then went on to observe that the explanation would come in aid only to understand what is meant by the expression “resulting in the enhancement of a known efficacy” in the amended section. The Court has unambiguously held that the explanation would operate only when discovery is made in the pharmacology field. After referring to the reported decisions, it then went on to observe that the explanation creates a deeming fiction that all derivatives of a known substance would be deemed to be the same substance unless they differ significantly in properties with regard to efficacy. It has noted that it is clear from the amended Section and the explanation that in the pharmacology field, if a discovery is made from a known substance, the duty is cast upon the patent applicant to show that the discovery has resulted in the enhancement of the known therapeutic efficacy of that substance. The Court further opined that the explanation places emphasis on the expression ‘efficacy’. It held that it only means that the derivatives should contain such properties which are significantly different with regard to efficacy of the substance from which the derivative is made. It concluded that sum and substance of amended section read with explanation, it prescribes the test to decide whether the discovery is an invention or not, is that, the Patent applicant should show the discovery has resulted in enhancement of known therapeutic efficacy of that substance and if the discovery is nothing other than the derivative of a known substance, then, it must be shown that the properties in derivatives differ significantly with regard to efficacy. The Division Bench has observed thus:-
“... As we understand the amended section, it only declares that the very discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance, will not be treated as an invention. The position therefore is, 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 Respondents herein have not questioned the correctness of the above-stated legal position before us.
13. 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. 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.
18. We may once again clarify that although the Petitioners have raised several objections before the authority as also referred to in the present petition, however, confined the argument only in the context of Section 25(1)(f) read with Section 3(d) of the Act to the effect that the alleged invention of the Respondent No. 1 was not an invention as it does not result in the enhancement of the known therapeutic efficacy of the stated substance. Accordingly, we have confined ourselves only to the grounds pressed into service by the Counsel across the bar with reference to the said grievance. 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.

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