Drug controllers to analyse patents while patent controllers analyse efficacy

Following on from this week’s IP Think Tank podcast which analysed the BMS v Hetero case.  We thought it would be instructive to have Vandana Mamidanna, our Indian team member give some of her thoughts on the case.

Just to recap then, the High Court of Delhi recently granted an ex parte restraining order in favour of Bristol Myers Squibb restraining the defendants, Hetero Drugs (an Indian generic firm) from manufacturing, selling, distributing, advertising, exporting, offering for sale or in any manner dealing directly or indirectly in any product infringing the plaintiffs product patent covering Dasatinib, a drug used in the treatment of Chronic Myloeid Leukemia. The Delhi High Court also noted that

"The plaintiffs have also sought ex parte relief of restraining the defendants from pursuing their application before the DCGI. It 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 the defendants is in breach of the patent of the plaintiffs, the approval ought not to be granted to the Defendant.

The plaintiffs to within one week make a representation to the Drug Controller General of India making out a case for the drug for which approval has been sought by the defendants being in breach/violation of the patent of the plaintiff.

The decision has created unrest amongst various generic companies, essentially raising the question whether this is a judicial manner of enforcing the much debated patent-linkage system linking the patent and the drug regulatory approval process. While, not getting into the nitty-gritty of whether the High Court has acted hastily in granting such an order; it may be worth considering the various approaches now available to the DCGI’s office to act on the order.

A first and a reasonable approach may be that the DCGI’s office treats this matter with specificity and strictly on a case-to-case basis. While it is expected of any Government office and its Office bearers to abide by the orders of the court; it is not expected that the Government Office relies on this as a precedent to grant, reject or stay other generic approvals. This is particularly true in this case where the DCGI’s office is not mandated by the law to grant or refuse approvals on the basis of patent status. Infringement is a case by case issue and the DCGIs office neither has the jurisdiction nor the expertise to determine infringement of patent rights by other generic applicants. In view of this, some might say that it may be appropriate for the DCGI to confine to this order only to an extent of not granting an approval to Hetero’s application pending a final hearing of the suit. Speaking further, one needs to wait and see if the order in fact is even extendable to other generic applicants of Dasatinib who are not defendants to the suit. However, a realistic approach suggests that in view of the patent in question being a product patent as well as the duty of a government office to exercise due diligence in conducting its activities, it is likely that the DCGIs office does extend this order to other generic applications of Dasatinib instead of expecting BMS to approach the court each time for each generic applicant.

It is worth noting that the DCGI’s Office in some cases asks the innovator company to submit Patent Data related to the New Drug Application. Such a requirement is not mandated by Schedule Y of the Drugs & Cosmetics Act (which deals with Applications for a New Drug Approval) and is merely a practice adopted by the DCGI’s office. However, there is neither any consistency in this practice; nor is the approval dependant on the patent data submitted. A second approach could therefore be that the DCGI’s office adopts a practice of requesting such information from the innovator and bases subsequent generic approvals on the patent data submitted. However, this approach oversteps the statutory limits since there is no mechanism by which the DCGI can refuse a generic approval on the basis of a patent granted to a similar product. Secondly, such an approach will also lead to a highly impracticable situation because of the lack of legal expertise or resources at the DCGI’s office in dealing with patent infringement issues.  Adding a burden to the DCGI’s office to determine infringement will only cause disorder and further delay marketing authorizations. This is particularly so, given DCGI’s lack of expertise in patent matters.

On a lighter note; Should this approach be adopted; it would be highly absurd that the while the patent controller needs to determine matters related to efficacy (a regulatory matter) for compliance with Section 3(d); the DCGI will now be expected to determine matters of patent infringement!

A third approach; and an extra ordinary interpretation of the order could be to determine the patent status of every drug before granting any approval irrespective of whether its filed by the innovator company or the generic manufacturer.  The approach is however too whimsical to even consider since it serves no purpose and will only result in further delay to the process of obtaining marketing approvals.

In conclusion, it is to be understood that the question of Patent-linkage needs to be treated solely as a statutory subject. The advantages and disadvantages of such a system need to be weighed in the Indian context and a system balancing the interests of all stake holders needs to be designed. For example, a patent-linkage system without any guidance regarding the types of patents to be considered, provisions for tentative approvals, limited stay period etc. can only do more harm than good. It is highly inappropriate to burden the DCGI’s office with an additional responsibility of ensuring that patent rights of innovator companies are preserved based on a single order of the High court against a single defendant company.


One Comment on “Drug controllers to analyse patents while patent controllers analyse efficacy

  1. It  is almost 4 years now that the Patent’s Act has been ammended and India is a signatory to the WTO and GATT international agreements. Why this debate now? What is the difference then between the pre 2005 and post 2005 scinario? In fact all new drug applications in India should automatically be disapproved if the active substance in them is under an active patent protection in any of the 150 odd group of countries. How it is donre is the problem of the DCGI and not the copiers of patented drugs. The DCGI cant escape by pretending ignorance of patent status of new drugs. Though the onus of protecting a patent right lies with the patent holder, regulatory agencies also have an obligation to ensure that the products they approve are not “illegal” , since one of their own departments have granted the patents. The larger picture is however much different. The very purpose of ammending the Indian Patent’s Law was to facilitate drug research capabilities of the Indian Pharmaceutical Industry. Continuing with the pre-2005 policy of granting approvals to copies of patented drugs will effectively kill all research activities of the Indian Pharmaceutical Industry, whatever little worth it is as of today.

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