This case is between US-based multinational Bristol-Myers Squibb and a mid-sized Mumbai based company BDR Pharma over 'Dasatinib', an anti-cancer drug. Bristol-Myers is the exclusive owner of Dasatinib and its derivative

This case is between US-based multinational Bristol-Myers Squibb and a mid-sized Mumbai based company BDR Pharma over 'Dasatinib', an anti-cancer drug. Bristol-Myers is the exclusive owner of Dasatinib and its derivatives by the claims of Patent No. IN203937 in India. The patent is valid and subsisting and has a term of 20 years from 12th April, 2000 in India. It enjoys patent protection in several other countries such as United States, Australia, New Zealand, Japan, etc. Chronic Myeloid Leukemia (CML), one of the most common forms of leukemia, arises from the excessive production of abnormal stem cells in the bone marrow which eventually suppress the production of normal white blood cells. The development of imatinib mesylate, a small-molecule tyrosine kinase inhibitor (TKI), was the first rationally designed drug for CML. Bristol-Myers product Dasatinib was approved by the US Food and Drug Administration on 28th June, 2006. It is presently sold in approximately 50 countries throughout the world. A marketing approval for Dasatinib was also granted by the Drug Controller General of India (DCGI) on 30th August, 2006. Apart from the above patent, Bristol-Myers also made a patent application in India for crystalline monohydrate form of Dasatinib. The said application is numbered 4309/DELNP/2006 dated 4th February, 2005 and is currently pending before the Indian Patent Office. The monohydrate form of Dasatinib has been granted patents in 45 countries and is an improvement patent of the Indian Patent No. IN203937. Cause of Action and Grounds In December, 2008, Bristol-Myers received information that Mumbai based company, BDR Pharma had applied to the DCGI for the marketing approval for Dasatinib. It sent a 'cease and desist' letter to BDR Pharma on 12th January, 2009 asking them to restrain from infringing its Patent No. IN203937. In view of the apprehension that the defendant may infringe the plaintiff's exclusive right of the patent, the plaintiff filed a suit in the nature of a quia timet action against the defendant on 3rd December, 2009 for the infringement of IN203937. The defendant has not launched the product in the market, hence, no loss or irreparable harm will be caused to BDR Pharma if it is restrained from doing activities that they have not yet commenced. BDR Pharma admitted that the defendant is intending to launch the generic version of Dasatinib only if the DCGI grants licence to the defendant to manufacture under the provisions of Drugs and the Cosmetics Act, 1940. Patent Licensing On 5th May, 2013 the Controller of Patents considered the compulsory licence application filed by BDR Pharma and opined that the BDR Pharma had not made out a prima facie case for grant of a licence as the applicant (BDR Pharma) did not make efforts to obtain a licence from the patentee on reasonable terms and conditions and relegated the applicant to approach the plaintiff for voluntary licence. By letter dated 13th March, 2012, Bristol-Myers, the patentee raised certain queries on BDR Pharma's application for voluntary licence such as 'facts which demonstrate an ability to consistently supply high volume of the API, Dasatinib, to the market', 'facts showing your litigation history or any other factors which may jeopardise Bristol-Myers Squibb's market position', 'quality related facts and in particular compliance with local regulatory standards and basic GMP requirement', 'quality assurance system due diligence', 'commercial supply terms', 'safety and environmental profile' and 'risk of local corruption'. BDR Pharma argued that the drug in question is important in the treatment of Leukemia and is exorbitantly priced at ₹1,67,000 for a month's course, putting it beyond the reach of majority of Indian population. Therefore, public interest lies in compulsory licences with royalty being given to Bristol-Myers. Blood cancer patients have a right to get the drug at low price. Ever since the launch of Dasatinib in India, Bristol-Myers has addressed the access and affordability needs of the patients by an aggressive commercial Patient Access Program (PAP) through which prices of the drug are reduced to a fraction of the MRP. This has evolved over time thereby consistently reducing the cost of drug to patients. The program is available through a third party service provider, for the self paying patients prescribed 'Dasatinib', by an Oncologist. The service provider through a centralised call center delivers the drug to the prescribed patients at their doorstep anywhere in India with no additional delivery cost. BDR Pharma Defense BDR Pharma claimed that Dasatinib patent is invalid as it doesn't pass the non-obviousness test and that in any event, the public interest lies in granting an alternative remedy such as ongoing royalties instead of an injunction. The arguments for invalidity of the patent were stated under section 3(d). Under section 3(d) of the Patents Act, 1970, BDR Pharma said that Dasatinib is a mere derivative of a previously-known compound and that Bristol-Myers is 'evergreening' the patents by patenting minor modifications to previously patented inventions. The other aspect is that of efficacy. The compound should display enhanced efficacy over the previously known compound. BDR Pharma further contended that it is a quia timet injunction, i.e., based on an expectation of harm rather than actual harm. A quia timet action is a bill in equity. It is an action preventive in nature and a specie of precautionary justice intended to prevent apprehended wrong or anticipated mischief. According to section 83 read with section 90(d) of the Patents Act, 1970, the patent has to be worked in India by manufacture and not by import. BDR Pharma submitted that same principles would apply in respect of the Indian law and thus, in the absence of definition of commercial scale, natural and ordinary meaning should be given to the expression. It said that in terms of the said treaties the general principles set out are that, a patentee must manufacture the product in that country and it should not also be mere improvement. Who grants patent? What is the role of Drug Controller General of India (DCGI) in the patent process, does it grant patents? While giving approval for marketing a drug, does it consider patent status?