EXCLUSIVE MARKETING RIGHTS
&MAIL-BOX APPLICATIONS
BYManish Kumar Prusty
T. Harish
Origin• Dunkel Draft of WTO- Countries not offering
patents - 1st Jan 1995- provision for pipeline system
– accept patent applications (‘mailbox provision) –
grant EMR
• Article 65.4 – TRIPS – Developing Countries –
Introduce – PPR – 10yrs - 2005
• 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 1999.
• 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 1.1.1995 and patent be
issued Invention to be filed in India after 1.1.1995 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 1.1.2005
• 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 21 2005
•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 1st 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
120000/-,whereas Indian counterparts were selling @ 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 06.08.2007
made by Novartis on a provision in IPA sec 3(d).