Under the TRIPS agreement, the "black box" or "mail-box" clause gives a patent-holder five years of exclusive marketing rights (EMR) in a country like India for completely new drugs which are not in the public domain at the operative date and for which marketing approval is granted in India before the end of the 10-year transitional period (i.e. 2005).

Industry experts say that valaciclovir has been patented by the erstwhile Burroughs Wellcome as early as in 1989, and hence the very validity of the claim should be scrutinised. Valaciclovir has been patented by the Wellcome group in over 50 countries including USA, Germany and Japan.

"Glaxo's valaciclovir proposal may actually violate Article 70/3 as the product in question has fallen in publicdomain. Besides, the grant of EMRs cannot be granted for products/processes patented prior to January 1, 1995," sources allege.

Glaxo, on the other hand, while admitting that the molecule itself was known before January 1, 1995, says that its two pending applications in the mail-box are in respect of a new formulation/new form of valaciclovir. "Superior drug delivery of valaciclovir, by virtue of technology which is the subject of the applications and which is employed in the manufacture of the product, is therefore the issue here and not a patent for the bulk drug itself," the British healthcare giant says.

Under Article 70/3 of TRIPS, "there shall be no obligation to restore protection to subject matter which on the date of application of this agreement for the member in question has fallen in public domain". This means that neither existing products nor pipeline drugs with published patents (in public domain) can be protected in India.

Industry sources add that sometimes international firms developimprovements in drug delivery mainly with a view to extending the 20-year patent life of a product and the Indian government must handle all such cases carefully.

Significantly, Glaxo's spokesperson adds that the company has not yet actually sought EMRs on these or any other products. "In fact no decision has been taken on whether to apply for EMR in respect of a valaciclovir product. It should be appreciated that such a decision can only be made after there is some clarity with regard to appropriate new regulations which have not yet come into force. One cannot automatically assume that anything in the mail-box would automatically be granted EMR," the spokesperson said.

India has agreed to amend its patent act and put in place a mail-box, following a recent ruling by the WTO's Dispute Settlement Body (DSB) against it for not conforming to the rules under TRIPS. The cabinet has, however, reportedly deferred a decision on this.

Glaxo adds, "As of now mail-box applications are being lodged (and willcontinue to be lodged) in the hope that any new technological advances made shortly before and also after January 1, 1995 would be protected when the country's new patent laws emerge."

Meanwhile, certain Indian drug firms have even made applications to the ministry of health to manufacture valaciclovir in India. These are believed to be pending for some months now without any indication of their current status.

INSIGHT
Old wine in a new bottle

Glaxo Wellcome's "mail-box" applications for valaciclovir formulation, patented by Burroughs Wellcome in 1989, may be a case of old wine in a new bottle. By a change in the drug delivery system, the company may seek exclusive marketing rights for the formulation based on the same bulk drug.

If the product is granted an EMR, it could set a precedent for other older products. Glaxo's valaciclovir may be contrary to Article 70/3 of TRIPS as the product has fallen in the public domain. The government, while amending the patent act, must be carefulwhile allotting EMRs as there could be some borderline cases.