PHARMACEUTICAL PATENTING IN INDIA - BREAKING MYTHS

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

AJANTA PHARMA LIMITED vs. ALLERGAN INC., ALLERGAN INDIA PVT. LTD. AND THE CONTROLLER OF PATENTS[9] 

 

In a revocation petition filed by Ajanta Pharma Limited before the IPAB, against the granted patent of Allergan Inc. bearing patent no. 219504, the provisions of Section 3(d) of the Act were discussed at length by both parties. The IPAB agreed with the perspective of the patent holder and clarified a distinct line between an attempt to claim derivatives of compounds vis-à-vis an invention comprising of a combination of compounds. The IPAB held as follows:

 

“The section explained that a mere discovery of which is not to be considered as an invention if it is a new form of a known substance, new property of new use of known substance or a known process or the use of a known process, machine or apparatus. But this discovery would be considered as an invention if the new form results in enhancement of known efficacy of that substance and so on as described in the section. The explanation to the section enumerates various derivatives of the known substance which shall be considered to be the same substance unless, there is significant difference in therapeutic efficacy. Therefore all forms of the known substance that are mentioned are derivatives of the known substance which could be salts, esters, ethers and so on. Combination is also mentioned here. The respondent (patent holder) had argued that this cannot be considered as a form of a known substance. The respondent is right. This invention is a combination of Brimonidine and Timolol. The applicant perhaps wants us to consider it either as a derivative of Brimonidine or as a derivative of Timolol. It is not a derivative. The combination mentioned in the Explanation can only mean a combination of two or more of the derivatives mentioned in the Explanation or combination of one or more of the derivatives with the known substance which may result in a significant difference with regard to the efficacy. A combination of two active drugs like Brimonidine and Timolol cannot be considered derivatives of each other. This ground is rejected.”

 

It is significant to note that the IPAB protected Allergan’s patent from the ambit of non-patentability under Section 3(d) of the Act by going to great lengths to understand and give justice to the scope of the invention and the true intent of the patent holder with respect to the compounds claimed in the invention. The efforts undertaken by IPAB to thoroughly discuss the facts of the case and the merits of the arguments presented by both parties, is appreciable. No stone was left unturned by the Appellate Board as it conducted an in-depth discussion and thorough review of the complete specification of the patent to understand the scope of the invention.

 

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[9] ORA/21/2011/PT/KOL and MP. Nos. 60/2011, 2/2012, 59-61/2012, 72/2012, 73/2012, 127/2012, 128/2012, 134/2012, 135/2012, 12/2013 and 15/2013 in ORA/21/2011/PT/KOL

 

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