From the Desk of Patent Circle: Delhi HC Dasatinib Order

A patent has no value if it cannot be monitored and enforced under the law and Indian patent is no exception to it. Though the Indian Patent Office (IPO) has started granting patents for drug compounds but industry runs serious concerns about their enforceability. Enforcement is not possible without proper and regulated monitoring which is already a major problem in fragmented Indian drug industry and the gravity of which can be gauged by the fact that about 20 percent drugs marketed in India are spurious drugs despite having both Central and State drug regulatory agencies. Both domestic and foreign companies are constantly struggling to tackle and raid counterfeit and spurious drugs in India. Even the government has shown serious concern over spurious drugs and has brought the Drugs and Cosmetic (Amendment) Bill, 2008 which is already been passed by both the Houses of Parliament and lately got approval of the President. However, the issue of spurious drug is not our main concern of discussion here it is just to give an idea about what extreme damage lack of proper monitoring policies can bring to Indian drug industry and consumer. Our focus of discussion is a recent order of the Delhi High Court (HC) restraining generic Dasatinib. Albeit we are bit late in reporting on this but still personally believe that the Delhi HC order got invariably distorted in the news media. So we thought running a post on the Delhi HC Dasatinib Order.

Dasatinib is an anti-cancer drug belonging to the class of tyrosine kinase inhibitors first approved in the United States on June 28, 2006 and marketed by Bristol-Myer Squibb (BMS) under the brand name Sprycel. BMS has a granted Indian patent (IN203937) for drug compound dasatinib conferring BMS the exclusive right under Sec. 48 of the Patents Act, 1970 to prevent third parties, who do not have his consent, from the act of making, using, offering for sale, selling or importing dasatinib in India. Regardless of patent protection, Hyderabad-based generic manufacturer Hetero Drugs submitted an application with the Drug Controller General of India (DCGI) for a grant of license to manufacture and distribute generic dasatinib tablets in India. Although BMS said to inform Hetero about the dasatinib patent but Hetero kept unanswered to BMS and continued to pursue its application before the DCGI. Clearly, the DCGI approval of license for generic dasatinib would have been a blatant violation of BMS right under Sec. 48 of the Patents Act, 1970. What is important to note that patent is a statutory right created by the legislature and it is duty of the executive (government) to enforce the right of the patentee. Also, it would be a complete mockery of jurisprudential aspect of ‘right’ if one government body (Indian Patent Office) confers BMS the exclusive right to prevent third parties from the act of making, using or selling dasatinib in India and the other government body (DCGI) dilutes, in fact, ignores the same right by issuing license to third party for making and selling dasatinib in India.

In law, there is a well-established legal maxim that says “ubi jus ibi remedium”: where there is a right, there is a remedy. Now in absence of any legal provision which would have prevented Hetero from pursuing application before the DCGI or would have authorized the DCGI to stop regulatory approval for generic version of patented drug, BMS had valid grounds and reason for approaching the judiciary for remedy against its right under Sec. 48 of the Patents Act, 1970. To make an appropriate case, BMS sought a legal recourse under Sec. 151 of the Code of Civil Procedure (CPC) from the Court to pass an ex parte ad interim order to restrain Hetero from manufacturing, selling, distributing, advertising, exporting or offering for sale generic dasatinib, and also an ex parte relief to restrain Hetero from pursuing their application before the DCGI. Sec. 151 of CPC triggers inherent powers of Court particularly in cases where there is no specific provision provided under the law. The Court is open to pass an appropriate consequential order under Sec. 151 of CPC as may as necessary for ends of justice.

After hearing BMS counsel and considering a prima facie case for grant of ex parte ad interim order, the Court restrained Hetero from manufacturing, selling, distributing, advertising, exporting or offering for sale generic Dasatinib. While referring BMS ex parte relief of restraining Hetero from pursuing their application before the DCGI, the Court added that it is expected that the DCGI while performing statutory functions will not allow any party to infringe any laws and if the drug for which approval has been sought by defendants (Hetero) is in breach of the patents of plaintiffs (BMS), the approval ought not to be granted to the defendants (Hetero). The Court further instructed BMS to make a representation to the DCGI within one week making out a case that Hetero generic drug for which approval has been sought being in breach of the patent granted to BMS.

Important to note that the learned Judge knowing that there is no legal provision to restrain the DCGI from approving the application for generic Dasatinib, has diligently and aptly used the word ‘ought’ while referring BMS ex parte relief of restraining Hetero from pursuing application before the DCGI. In fact, the Delhi HC order finds reasonable support in Sec. 2 of the Drugs & Cosmetic Act, 1940 (DCA) which states that the provisions under DCA shall be in addition to and not in derogation of any other law for the time being in force. Further it is important to note that this is just a temporary order which is passed to stop Hetero generic dasatinib during the pendency of the trial and also the order is restrictively limited to Hetero case. Till here, both the Delhi HC and BMS acted within the periphery of the law. The order nowhere creates any ‘patent-drug regulatory’ linkage or authorizes the DCGI to monitor drug patents and framing such an opinion at this moment when the Delhi HC has not even started hearing on the issue (just made a temporary order) and judgment still awaited is completely irrational. The issue is been unnecessarily sensationalized by the newspaper media, further creating more confusion and chaos among the domestic pharma companies and patent practitioners, however, the whole dasatinib episode has surely left us with few questions that now need utmost attention.

(1) Whether approval of generic version of a patented drug violates the exclusive right of the patentee under Sec. 48 of the Patents Act, 1970?

(2) Is there a need to formulate substantive and procedural laws under Drugs & Cosmetic Act, 1940 regarding approval of generic version of a patented drug?

(3) How enforcement of drug patents feasible in India?

(4) Is ‘patent-drug regulatory’ linkage a necessity?

(5) Importantly is India really serious about drug patents or possibly we are moving toward creating more chaos?

The Delhi HC order has surely opened a wide platform for policy discussions, particularly related to ‘patent-drug regulatory’ linkage and enforcement of patent right.