In a recent development, a compulsory license (CL) application
has been filed for the patent covering AstraZeneca's diabetes
management drug Saxagliptin. The CL has been filed by Lee Pharma
Limited (CL Applicant), a Hyderabad based pharmaceutical company
engaged in the manufacture and supply of pharmaceutical products,
pharmaceutical formulations, intermediates and active
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). BMS assigned the
ownership rights on the Patent to AstraZeneca AB on 3 April 2014.
Saxagliptin is adipeptidyl peptidase-4 inhibitor,used to treat Type
II Diabetes Mellitus by achieving glycemic controlwithout
accompanying weight gain.
The CL Applicant filed an application for grant of CL under
section 84(1) of The Patents Act, 1970 on the following
Reasonable requirements of the public
had not been satisfied: The CL Applicant had stated that the
quantity of Saxagliptin in the market fulfilled only 0.23% of the
market's needs and hence there was a shortage of more than 99%
of the drug in the market;
The patented invention was not
available to the public at a reasonably affordable price: The cost
incurred for the importation of Saxagliptin was only INR 0.80 -
0.92 per tablet, whereas it was being sold in the market for INR
41-45 per tablet; and
The patented invention had not been
worked in the territory of India: – Even after about 8 years
from grant of the Patent, no efforts had been taken to manufacture
Saxagliptin in India and the working of the patent was being
hindered by importation of the patented product from abroad.
The CL Applicant had further stated that they had made a request
to AstraZeneca for a voluntary license for the patent, in reply to
which, clarifications had been sought by AstraZeneca regarding the
CL Applicant's manufacturing capabilities. After providing the
clarifications, despite repeated reminders, AstraZeneca did not
reply regarding issuance/refusal of the license.
This is the third CL application to be filed in India so far.
The first CL application was filed by Natco Pharma Limited in
respect of patent no 215758, held by German drug major Bayer
Corporation for the cancer drug Nexavar and it was found that all
three conditions under section 84(1) of The Patents Act, 1970 had
been satisfied, leading to grant of the CL.
The second CL application had been filed by BDR Pharmaceuticals
International Private Limited in respect of patent no 203937 for
anti-cancer drug Dasatinib, patented by BMS. The CL application was
rejected in this case since BDR had failed to make out a prima
facie case for grant of a CL i.e., BDR had not made a sufficient
attempt to procure a voluntary license from the patentee.
In view of these precedents, it would be interesting to see the
outcome of this third CL Application.
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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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