EXCLUSIVE MARKETING RIGHTS & MAIL-BOX APPLICATIONS BY Manish Kumar Prusty T. Harish

Origin Dunkel Draft of WTO- Countries not offering patents - 1 st Jan provision for pipeline system – accept patent applications (‘mailbox provision) – grant EMR Article 65.4 – TRIPS – Developing Countries – Introduce – PPR – 10yrs Provide pipeline protection – to bridge gap

TRIPs and the adoption of EMR TRIPs came into force as per first amendment of Indian Patents Act (1970) in Section 5(2) provided for mailbox provision Chapter IVA introduced EMR with 5yr validity EMR precedes a patent. Conditions to satisfy for grant of EMR  Invention to be filed in ‘Convention country’ after and patent be issued  Invention to be filed in India after and patent be issued for the same &  Marketing approval is obtained from appropriate authority - IPO, CGPDTM

EMR Claim Grant of EMR did not guarantee grant of patent EMR - claimed for any invention – related to drug for medicinal or agro purpose – after EMR cannot be claimed for inventions based on traditional system of medicine. The applicant has the exclusive right to sell or distribute the product

Mail-box  ‘Mail-box’ provision implies that inventors be allowed to file patent applications for pharmaceuticals and agricultural chemicals from 1 January 1995, even though the decision on whether or not to grant any patent itself need not be taken until the end of the transition period  The date of filing is significant, which is why the mailbox provisions were set up  It is used for assessing whether the application meets the criteria for patenting, including novelty (“newness”)  These applications are filed under section 5(2) of the Indian Patents Act

The Mail-box system  Product patent application  Applications stored separately (with allotted filing date, serial number & title)  Are only examined after the amendment of Indian Patent Act of 1970  Priority is given in granting patents –product patent regime

Applications Source: The Financial Express, March Since, 20th May 2003, India has adopted a three-phase system of patenting. In the first phase anybody can file an application. The second phase involves the eighteen- month publication from the date of filing the application or the priority date. All mailbox applications qualify for eighteen months publication. The mailbox applications have been published by the Indian Patents Office in the ‘Patent Journal’, a public document, available in printed and electronic formats. There are 7100 applications and nearly 80% are foreign applications

Only a minority of these relate to products patents, while the rest relate to process patents, different forms of an already known product, combinations of already known drugs, different use or dosage patent applications, and different drug deliver forms Product Patent

Madras High Court vs Novartis A.G. Novartis A.G., filed a patent application for Glivec in 1998 and was granted 1 st ever EMR in the country during November 2003 by CGPDTM Novartis then filed infringement suits at Bombay High Court – got injunction orders in Jan 2004 against 5 generic companies against manufacturing, selling, distributing or exporting the drug. After the injunction, the price of the drug shot up from 10000/- to /-,whereas Indian counterparts were 8000/- Generic manufacturers such as Cipla & Ranbaxy filed a representation under IPA 1970, Section 3(d) against Novartis.

In 2006, Chennai Patent Controller rejected Novartis Patent for Glivec saying that the application was insufficiently innovative - Sec 3(d) Novartis challenges provision –Sec 3(d)- Indian Patents Act- which denies patents for minor changes in known drugs – allowing cheaper drugs to be made available Indian Patent law allows provision for making affordable drugs, especially antiretroviral. MSF – argued – this provision would affect access to medicines by poor – like AIDS patients who depended on less expensive, good quality drugs made in India. Madras High Court rejected the challenge on made by Novartis on a provision in IPA sec 3(d).