In an order dated 19 January 2016 (Order), the Controller
General of Patents and Trademarks (CGPTM) rejected the application
for Compulsory License (CL), filed by Lee Pharma Limited (Lee
Pharma), for the patent covering AstraZeneca's diabetes
management drug Saxagliptin.
The drug, Saxagliptin, is protected and covered by Indian patent
no 206543 (Patent) titled "A cyclopropyl-fused
pyrrolidine-based compound", granted on 30 April 2007 to
Bristol-Myers Squibb Company (BMS) followed by assignment to
AstraZeneca AB. Saxagliptin is a dipeptidyl peptidase-4 (DPP-4)
inhibitor, used to treat Type II Diabetes Mellitus.
Lee Pharma filed an application for grant of CL under Section
84(1) of The Patents Act, 1970 (the Act). Following which, CGPTM
issued a notice to Lee Pharma stating that no prima facie case had
been made out on any of the three grounds under Section 84 of the
Reasonable requirements of the public
with respect to patented invention not satisfied;
Patented invention not available to
the public at a reasonably affordable price; and
Patented invention not been worked in
the territory of India.
In response to the notice, the Applicant requested and was
granted a hearing under Rule 97(1) of the Act and the Order is the
outcome of such hearing.
CGPTM considered each of the three grounds raised and made the
following observations while refusing the application of Lee Pharma
under Section 84(1):
Reasonable requirements of the public had not been
satisfied: This ground was rejected on the basis that
Lee Pharma failed to demonstrate what the reasonable requirement of
the public was with respect to Saxagliptin and further failed to
demonstrate the comparative requirement of the drug Saxagliptin
vis-a-vis other drugs which are also DPP-4 inhibitors.
The patented invention was not available to the
public at a reasonably affordable price: This ground
was rejected on the basis of comparison of the prices of the
various Gliptins available in the Indian market. The CGPTM held
that since all the DPP-4 inhibitors were in the same price ranges,
it could not be said that the prices of Saxagliptin alone was
unaffordable in India as compared to other DPP-4 inhibitors.
The patented invention had not been worked in the
territory of India: This ground was rejected on the
basis that manufacturing the drug in India is not a precondition to
establish working in India and since Lee Pharma had not shown the
exact requirement in India, it was difficult to hold whether
manufacturing in India was necessary or not.
This is the third CL application to be filed in India so far.
The first application for NEXAVAR was granted holding that all
three conditions under Section 84 had been satisfied while the
second one for DASATINIB was refused on the ground that no proper
attempt was made to procure a voluntary license. In this CL
application, CGPTM has not only passed an order refusing to grant
CL but has now laid down parameters for CL applicants to establish
a "reasonable requirement" especially where there are
other drugs in the market which treat the same ailment /
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This article enunciates the recent, much awaited, and landmark judgment delivered on September 16, 2016 by Hon'ble Delhi High Court throwing light on the important provisions of the Copyright Act, 1962.
The Patents Act 1970, along with the Patents Rules 1972, came into force on 20th April 1972, replacing the Indian Patents and Designs Act 1911. The Patents Act was largely based on the recommendations of the Ayyangar Committee Report headed by Justice N. Rajagopala Ayyangar. One of the recommendations was the allowance of only process patents with regard to inventions relating to drugs, medicines, food and chemicals.
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