BMS’ PATENT FOR DASATINIB PRIMA FACIE VALID, UPHOLDS HIGH COURT

By a recent decision, the Delhi High Court seems to have put a long drawn battle between US incorporated Pharma giant Bristol-Myers Squibb (BMS) and Mumbai based Indian Drug Company BDR Pharma (previously MJ Chempharma Private Limited) over anti-cancer drug Dasatinib to a temporary halt. By this decision the High Court prima facie upheld the validity of the BMS’ patent (IN 203937) for the said drug and maintained the order of interim injunction against BDR Pharma.

The genesis of the entire controversy was as early as December 2008 when BMS received the information that BDR Pharama had applied to DGCI for marketing approval of Dasatinib. Apprehending that BDR may infringe its exclusive right under Section 48 of the Patents Act, BMS initiated an action against BDR by filing a civil suit in December 2009 for infringement of IN 203937. This was followed by another suit in the year 2013, on a fresh cause of action, when BDR advertised and offered for sale, Dasatinib tablets under the head ‘Finished Formulations’ on its website. Both these suits were in a nature of quia timet action for infringement of BMS’ patent. In both these suits, BDR had moved the application for temporary injunction, the fate of which the High Court was called to decide by this decision. In defence, BDR challenged the validity of the BMS’ patent on various grounds such as obviousness of patent in terms of prior art, lack of utility, non-workability of patent, lack of bonafide etc. It was also contended by BDR that its product does not infringe BMS’ patent and the public interest mandated grant of an alternate remedy instead of injunction.

The Court was not convinced with any of the contentions of BDR, which according to it were not sufficiently established at the prima facie stage to deny the relief to BMS. The Court rejected the contention of obviousness noting that it is common in the field of medicine that the chemical compounds are pre-existing and there are further improvements upon treatment and working on the compounds so as to increase their efficacy by reacting with chemical compounds and group of the reactants. Referring to the earlier decision in Hoffman La Roche v. Cipla Ltd. the court to reach to a conclusion, “mere some similarity of the structure would not lead to inference as to obviousness unless it is shown that the said selection was arbitrary one without application of mind and thereafter the working done was also inconsequential result which leads to workshop result and not further new improvement.”

The Court also negated the objections of lack of utility and Section 3(d) of the Patents Act respectively by holding that plea was not prima facie established and the Section cannot be pressed into service till the compound involved in the patent is efficacious. It is worth mentioning here that the approach taken by the court in interpretation of Section 3(d) seems to be not in tandem with the words, “enhancement of known efficacy” in contra distinction to “efficacy”. It seems here that while reaching the said conclusion the court was slightly swayed away by its earlier finding on the point that the invention was not obvious ignoring the fact that the finding was to be reached under the presumption that the suit compound was a mere derivative of known elements/ integers.

Further the court held that the question of public interest for the purposes of infringement proceeding in the form of deciding the interim application has to be only seen from the prima facie view of credibility of the defence of the defendants. The Court found this plea BDR to be non-credible in the instant case and directed that if BDR intended to have license from BMS it should come out with a concrete proposal and discuss it with BMS.

Undoubtedly, BDR had an option to avail compulsory license from BMS for Dasatinib and the talks for voluntary licensing did commence in the present case in the year 2012, however, BDR did not proceed with the negotiation proceedings nor did it reply to the enquiries made by BMS in reply to its request for fourteen months. It seems quite puzzling why BDR would not follow the course of compulsory licensing as already envisaged by Novartis v. Cipla and would introduce its product in market and claim public interest and royalties instead of infringement to justify its actions. Clearly, allowing such an attempt would have amounted to negating the express of provisions of law against patent infringement and rendering the judgment in Novaris otiose.

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