[Ip-health] GSK lapatinib patent decisions in India update

leena menghaney leenamenghaney at gmail.com
Mon Aug 5 02:35:01 PDT 2013

Lapatinib- Cancer Drug

There is considerable media coverage on the decisions of the
Intellectual Property Appellate Board (IPAB) on the revocation cases
related to the cancer drug - Lapatinib - in India. The patented drug
is sold under the brand name Tykerb by GSK in India and is quite
expensive. Some media reports have portrayed that after the IPAB
decision, companies can now easliy launch the generic versions of this
drug w/o facing patent infringement suits. This is not true. It is
also being used to further attack India's pro public health IP regime
without looking at the actual facts of the case.

See for example - "Blow to another MNC as patent for GSK's drug
revoked, Prices to come down, say patient associations", Business
Standard, 3rd August, 2013.

But these news reports are not fully accurate. There were two cases
and two patent decisions related to the drug. GSK's Lapatinib compound
patent is that expired in 2019 was upheld by IPAB in its decision and
what has been revoked  in a second decision is a secondary patent
related to the salt/crystalline form of the same drug Lapatinib. In
GSK's own statement to WSJ, they have stated - "The decision wasn't
all bad news
for Glaxo, as the company noted in an email. Even as the appellate
board refused to give Glaxo an additional 2½ years in patent
protection for Tykerb, the board allowed the company to hold on to its
patent on the underlying compound, Lapatinib, until January 2019. "

See article here: India Deals Blows to Drug Makers, 4 August 2013,
WSJ, http://online.wsj.com/article/SB10001424127887324635904578644100746473088.html)

India Patent landscape:

Patent that covers the compound  (WO9935146) - The patent application
IN/PCT/2000/130/KOL was granted (IN221017) and published on
13/06/2008. On 27 July, 2013, Intellectual Property Appellate Board B
held that the main compound patent IN221017 was valid on the grounds
that the invention was non-obvious. This patent will expire in 2019
and blocks generic entry till the patent expires or is revoked (if
another company files another revocation and wins) or a license
authorizing generic production is issued to a generic company.

Patent of salt/crystalline form - Ditosylate salt application
IN/PCT/2002/1457/KOL(WO2002002552) was granted as IN221171 on 20 June
2008. This patent would have expired more than 2 years after the
compound patent in 2022. This was challenged before the Intellectual
Property Appellate Board. On 27 July 2013 the IPAB held that that the
invention is obvious and is hit by S.3(d) and Patent No 221171 is
revoked. This decision can be accessed at

This is a classic case of attempted evergreening by GSK in India and
that is why patent law safeguards on patentability are important as it
creates an opportunity to address this problem. Therefore, the IPAB
decision rejecting the crystalline/salt form patent should be
welcomed. In this case more than 2 years of patent extension -
blocking generic entry in 2019 -was avoided. Indian law unlike other
countries like the US addresses evergreening and provides clarity to
generic producers as to when the generic can be launched is now being
criticised by big pharma as creating 'uncertainity and

For example, In the above 3rd August, Business Standard article Tapan
Ray, director-general, Organization of Pharmaceutical Producers of
India (OPPI), the largest body for MNC drug makers in India, said:
“Such incidents are indeed very disappointing. Revocation of patents,
especially of globally acclaimed molecules, not only creates
uncertainty and unpredictability in the intellectual-property (IP)
ecosystem of a country but also invites doubts on its IP machinery.
Such revocations in India, close on the heels of one another, further
strengthen apprehensions of innovator companies and will not help
patients, either.”

Most importantly the Ministry of Health (Indian government) needs to
set up a monitor such drug patents which lead to exorbitantly high
prices in Indian market making them unaffordable for the majority in
India, except for the wealthy or those public sector employees who are
covered by Central government Health Scheme.

Leena Menghaney
Tel: 46573730/1, 9811365412

Leena Menghaney
Tel: 46573730/1, 9811365412

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