On ‘Patent Linkage’ – a rational argument on an emotive debate

WTO TRIPS Article 28.1a says that the member countries agree to ensure exclusive rights to patent holder for a specific time period. In case of India, like most other countries, this time period is for 20 years.During this period the member countries agree to prevent third parties from making, using, offering for sale the patented product without the owner’s consent.In India, during last twelve months, at least 4 patents were infringed by the local generic companies. All these cases are currently under litigation. No one at this stage will possibly be able to hazard a guess as to when will these cases ultimately get resolved. If it takes another two to three years to get the final verdict from the honourable High Courts, the revenue of the innovator companies who have already launched their patented products in India will get shaved off, at least for this period, leaving a very adverse commercial impact on them. There is a theoretical possibility that it may take even more time for the honourable High Courts to resolve these cases and during the remaining period of limited patent life of these products the cases may not get resolved, at all.

Moreover, in India there is no known strong deterrent for patent infringement. In absence of which, the opportunity to make significant commercial gain through patent infringement, on the pretext of extending benefits to patients could indeed be, many a times, difficult to resist. Media reports that the National Pharmaceutical Pricing Authority (NPPA) has raised huge demand in crores of rupees for overcharging the common man, flouting the drug pricing norms, by some of these large companies involved in patent infringement litigations, vindicates the point of their basic overall intention of significant commercial gain over extending pricing benefits to the patients. The moot question that follows is who is responsible to ensure the sanctity of the product patent system in India?

The prevailing situation warrants a strong regulatory system which could prohibit marketing approval of generic equivalents of patented molecules during their patent period.

The question that is often raised in this context is who exactly be held responsible for implementation of such a system in our country? While addressing this question one should realize that it is the Government in its entirety and not just the Patent offices or any particular ministry or ministries of the Governments is bound by the WTO TRIPS Agreement. Therefore, it is justifiably the responsibility of all Government departments/ministries to ensure that TRIPS obligations of the Government on proper enforcement of patent are properly met.

The process of granting marketing approval for patented molecules, in general, rests on the Ministry of Health (MoH) of WTO member states. Thus for WTO member states to meet TRIPS obligations effective communication between the MoH and the Patent offices of the country is absolutely essential. Such a system will help prevent approval of generic versions of patented molecules before expiration of the product patents.

Establishing this communication process will ensure that one department/ministry of the Government (say DCGI) does not impair the efforts of another Government department/ministry (say IPOs) to provide effective intellectual property protection as articulated in Article 28.1 of the WTO TRIPS Agreement.

This system will ensure that Health Regulatory Authorities do not, even unintentionally, undermine the commitment of the Government to conform to the TRIPS Agreement.

My experience of the last three years of post product patent regime in India prompts the need for establishing a “Patent Linkage” system without further delay, not only for effective patent protection but also to encourage innovators to get more involved and engaged in the process of innovation in India.

Will India be the unique country if such a system of “Patent Linkage” is put in place? The answer is obviously ‘no’.

In the largest market of the global pharmaceutical industry, the USA, such a system exists. US FDA maintains a listing of pharmaceutical products known as the ‘Orange Book’. The soft copy of the ‘Orange Book’ is also available through internet at: http:/www.fda.gov/cder/ob/.

US FDA does not authorize marketing approval of generic versions of patented molecules listed in the ‘Orange Book’.

What then happens in the second largest market of the global pharmaceutical industry, the European Union (EU)? In the EU, sanctity of the product patent is ensured by granting 10/11 years data exclusivity. Thus, if any company intends to introduce a generic version of a patented molecule, it will have to generate its own sets of entire regulatory data through a very long and expensive process, which may take several years. Even after spending huge amount money and time towards generation of their own clinical data, there is no guarantee that such companies will be able to market the product without getting involved into expensive patent infringement litigation. Thus in the EU, the deterrent to make such an ambitious attempt is humongous.

Various types of ‘Patent Linkage’ system also exists in Australia, Canada, Mexico, Jordan, UAE, Singapore, China etc. While putting in place of such a system is reportedly in progress in countries like, Chile, Dominican Republic – Central America, Bahrain, Morocco, Oman etc.

To conclude, in my view, when the Government of India is the sole authority to grant product patents in India, it is the responsibility of the same Government to protect those patents through its Health Regulatory System i.e. DCGI’s office. I reckon, such a system already exists in India. The procedure of (‘Patent Linkage’) checking the patent status before granting marketing approval already exists in FORM 44, which is an application to the DCGI for grant of permission to import or manufacture a New Drug or to undertake clinical trial in India. In the first page of FORM 44 (available in the website of the DCGI) under ‘Particulars of New Drug’ in point 8, it seeks details of the ‘Patent Status of the drug’. Can this information be not effectively utilized to justifiably deny marketing approval of a generic version of a patented molecule during its patent life in India? If not, it is difficult to make out what purpose will the DCGI utilize this information for?

Thus in my view, the procedure to be followed for ‘Patent Linkage’ in India is already in place. There is hardly any need to reinvent this wheel either. The Health Regulatory Authority of India should now make this procedure work effectively in its obligation to adhere to the commitment of the national Government to honour Article 21.1 of WTO TRIPS Agreement.

By Tapan Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.