[Ip-health] Eli Lilly withdraws Forteo patent claim in Kolkata

[Adrienne.MacDONALD@geneva.msf.org]

Eli Lilly withdraws Forteo patent claim in Kolkata=0D
Its previous request had been rejected in August; decision follows similar=
=0D
move by Novartis and GlaxoSmithKline=0D
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http://www.livemint.com/2007/12/16220111/Eli-Lilly-withdraws-Forteo-pat.htm=
l=0D
=0D
C.H. Unnikrishnan=0D
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Mumbai: US drug multinational Eli Lilly & Co. has voluntarily withdrawn its=
=0D
application at the Kolkata patent office for a crystal form of its=0D
osteoporosis drug, sold under the Forteo brand.=0D
=0D
Lilly, which lost an earlier patent claim for another form of the same drug=
=0D
following a pre-grant opposition from a local rival drug maker USV Ltd in=
=0D
August, had filed three patent applications in India for different forms of=
=0D
this biotech drug. Another form of the molecule, which the firm has applied=
=0D
a patent for, is not revealed.=0D
=0D
Forteo, a new generation drug for osteoporosis, generates about $600=0D
million (Rs2,364 crore) in annual sales for Eli Lilly.=0D
Eli Lilly=E2=80=99s application for a crystalline form of the drug teripara=
tide has=0D
been withdrawn by the applicant under section 11B (4) of the Indian Patent=
=0D
Act last fortnight, according the patent office. Teriparatide is the=0D
generic name of Forteo. The company has already launched this product in=0D
India anticipating patent protection.=0D
=0D
An Eli Lilly and Co. (India) Pvt. Ltd spokesman said he couldn=E2=80=99t=0D
immediately comment.=0D
In August, after hearings on a pre-grant opposition filed by USV that=0D
lasted a year, the Kolkata patent office had rejected Eli Lilly=E2=80=99s f=
irst=0D
patent application, on grounds of prior knowledge, incremental innovation=
=0D
and failure to establish enhancement of known efficacy.=0D
Forteo is the only biotech drug=E2=80=94medicines that are developed from l=
iving=0D
forms=E2=80=94available in India for osteoporosis treatment. It is a synthe=
tic form=0D
of parathyroid hormone, which is naturally found in the body.=0D
=0D
This hormone is to be given by injection for the treatment of osteoporosis=
=0D
in men and post-menopausal women, who risk fractures as their bones become=
=0D
brittle due to loss of calcium.=0D
=0D
It is also supplied in a disposable pen device that can be used for up to=
=0D
28 days in once-a-day, self-administered injections.=0D
However, at least two companies, including USV, are now expected to launch=
=0D
the generic version of this drug in the local market soon.=0D
Eli Lilly=E2=80=99s decision to withdraw its patent application in India fo=
llows a=0D
similar move by other two multinational giants Novartis AG and=0D
GlaxoSmithKline Plc. (GSK) in India early this year.=0D
=0D
While GSK had withdrawn its Indian patent applications for two of its=0D
antiretroviral combination drugs, combivir and trizivir, used to combat=0D
HIV/AIDS, Novartis=E2=80=99 filing for patenting its HIV/AIDS drug atazanav=
ir in=0D
India lapsed earlier this year as the company did not pursue the=0D
application.=0D
=0D
India is likely to see many such patent withdrawals amid fierce opposition=
=0D
for local companies and some patient activist groups.=0D
Patient groups and generic drug companies have been aggressively opposing=
=0D
patent claims, especially after successfully opposing a patent filing by=0D
Novartis on its cancer drug Glivec at the Chennai patent office early last=
=0D
year.=0D
=0D
Indian patent rules do not permit patent protection for drugs here if it=0D
has been patented elsewhere before 1995, and its claims of innovation are=
=0D
only incremental, under the provisions of Section 25(1)(b) and Section 3(e)=
=0D
of the Indian Patents Act.=0D
=0D
The drug also cannot be patented if its efficacy is not significantly=0D
superior to an already known molecule under Section 3(d) of the law.=0D
Novartis=E2=80=99 appeal against Section 3(d) was rejected by the Madras hi=
gh court=0D
in August this year, but an appellate panel is separately hearing an=0D
appeal, which is being closely watched by the global pharmaceuticals=0D
industry, against the patent rejection by the Chennai patent office.=0D
Because decisions at India=E2=80=99s four patent offices=E2=80=93at Chennai=
, Kolkata,=0D
Mumbai and New Delhi=E2=80=94are independent of one another, drug patent ap=
plicants=0D
often make more than one filing at two or more of such offices in the hope=
=0D
that one of them will approve the application even if it is rejected=0D
elsewhere.=0D
=0D
=E2=80=9CSince these offices operate without a coordinated single system to=
 process=0D
these applications, many such patent applications on incremental=0D
innovations have already been granted patents,=E2=80=9D said Anand Grower, =
a senior=0D
lawyer with Lawyers Collective, a Mumbai-based non-governmental=0D
organization that deals with issues related to health care and access to=0D
medicine.