[Ip-health] Economic Times: India rejects Lee Pharma’s compulsory licence plea

Thiru Balasubramaniam thiru at keionline.org
Tue Aug 18 05:29:46 PDT 2015


http://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/india-rejects-lee-pharmas-compulsory-licence-plea/articleshow/48521191.cms

By Ruchika Chitravanshi, ET Bureau | 18 Aug, 2015, 04.41AM IST
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NEW DELHI: India has decided against giving the compulsory licence for
Anglo-Swedish drugmaker AstraZeneca's key antidiabetes compound Saxagliptin
sought by Hyderabad-based Lee Pharma. The Controller of Patents office
rejected the application on the grounds that substitutes to the drug are
readily available in the market and Lee Pharma's claim that requirements of
public with respect to the patented invention are not being satisfied has
not been proven.

Saxagliptin, sold under the brand name Onglyza and Kombiglyze, is
prescribed for type-II diabetes mellitus, which occurs when the pancreas
does not produce enough insulin or when body does not effectively utilise
the insulin produced.

The patent for manufacturing and selling Saxagliptin compound was granted
to Bristol Myers Squibb on April 30, 2007 and then transferred to
London-headquartered AstraZeneca. The renewal fee for the patent has been
paid till March 5, 2016.

Section 84(1) of Patents Act 1970 states that after the expiration of three
years from the date of grant of patent any person may make an application
for grant of compulsory licence on three grounds - the reasonable
requirements of the public have not been satisfied or the patented
invention is not available to the public at an affordable price or the
patented invention is not worked in the territory of India.

The Controller of Patents office turned down Lee Pharma's application on
all the three grounds. Rajiv Aggarwal, controller of patents, said that
manufacture in India is not a necessary precondition in all cases to
establish working in India.

"The applicant has failed to prima facie show that the patented invention
is not worked in the territory of India...I am therefore of the view that
case has not been made out for the making of an order under Section 84,"
Aggarwal said in his order, a copy of which was seen by ET.

Although Lee Pharma had contended that AstraZenecaBSE -0.05 % had fixed a
high price for tablets of the two medicines, Onglyza and Kombiglyze, the
controller of patents found Lee Pharma's proposed selling price several
times the import cost and only marginally below that of AstraZeneca. This
also prompted the controller to turn down the application



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