[Ip-health] Patent denied in US, but granted in India

[Adrienne.MacDONALD@geneva.msf.org]

Patent denied in US, but granted in India=0D
=0D
New questions arise on Chennai Patent Office's decision to okay a key=0D
patent without hearing pre-grant opposition=0D
=0D
http://www.livemint.com/uspto.htm=0D
=0D
C.H. Unnikrishnan=0D
=0D
Mumbai: Adding significant ammunition to an ongoing government=0D
investigation involving drug giant Roche and a key patent granting office=
=0D
in India, there is now new evidence that an India patent was approved for=
=0D
the drug some three years after a similar application was turned down in=0D
the US by the US Patent and Trademark Office.=0D
=0D
The office of India=E2=80=99s controller general of patents, based in New D=
elhi, is=0D
conducting an inquiry whether the decision of the Chennai Patent Office to=
=0D
grant Roche a patent for its anti-infection drug, valganciclovir, violated=
=0D
Indian rules.=0D
=0D
Roche executives insist the US and Indian decisions cannot be linked=0D
because of different laws.=0D
=0D
=E2=80=9CThe patent for this product was granted fully in compliance with t=
he=0D
Indian law,=E2=80=9D says Roche India managing director Girish Telang.=0D
Arrayed against F Hoffmann-La Roche Ltd=E2=80=99s India unit is Mumbai-base=
d=0D
non-profit, Lawyers Collective, which had opposed the patent in 2006, 11=0D
months before Roche=E2=80=99s Indian unit eventually got the patent in June=
 2007,=0D
without a pre-grant opposition being heard.=0D
=0D
It is quite unclear how Roche has been able to obtain the patent. Most=0D
multinational drug companies in India have had the opposite problem=E2=80=
=94they=0D
claim drugs for which the rest of the world gives patent protection are not=
=0D
being protected in India.=0D
=0D
A review of a US PTO document by Mint shows that a key patent application=
=0D
for the same drug was rejected by that office back in 1994 because the drug=
=0D
had been in the so-called public domain for three years.=0D
=0D
The document also shows that while the original Roche claim for a=0D
comprehensive patent was indeed rejected, a patent was granted to the=0D
crystalline form of the drug based on findings that a modification eases=0D
the manufacturing process for the drug. But, in India, the Roche patent=0D
covers both the basic compound as well as a crystalline form, giving the=0D
drug maker a much more formidable patent.=0D
=0D
=E2=80=9CBoth these findings show that the Chennai patent office has not co=
nsidered=0D
the fact that the invention of this product was prior to 1995 and the=0D
already granted patent in the US was for a modification, which does not=0D
claim any treatment efficacy aspects,=E2=80=9D says Chan Park, a senior tec=
hnical=0D
and policy adviser at Lawyers Collective.=0D
=0D
An email query sent to V. Rengaswamy, chief patent controller at the=0D
Chennai office, received a cryptic reply late on Monday.=0D
=E2=80=9CSince your query relates to a published patent, you can purchase a=
 copy of=0D
the specification and get clarified,=E2=80=9D he wrote, while ignoring the=
=0D
questions about whether the drug, which Roche sells as Valcyte brand, was a=
=0D
pre-1995 drug or not.=0D
=0D
This is an important distinction in India as the country=E2=80=99s laws all=
ow drugs=0D
to be patented on the condition that they don=E2=80=99t pre-date a crucial =
2005=0D
amendment by more than 10 years. The Indian law also restricts patent=0D
grants to any modifications of known substances unless the same is shown=0D
improving the treatment substantially.=0D
=0D
Some patent experts see the Roche application, which claims that its=0D
first-ever patent application for the drug was dated 28 July 1994, as=0D
making valganciclovir the first pre-1995 drug compound to be patented in=0D
India, giving it renewed ammunition to try and claw back the patent.=0D
S.M. Laud, company secretary and director of Roche Scientific Co. (India)=
=0D
Pvt. Ltd, agreed the Valcyte patent application in India made identical=0D
claims as in its 1994 US application, but insisted no rules had been=0D
violated.=0D
=0D
=E2=80=9CThe company=E2=80=99s patent filing was strictly in line with the =
patent law in=0D
India, which allows an application to be filed within 12 months from the=0D
priority date (the date of the first patent application for the product=0D
anywhere in the world). Roche=E2=80=99s first application in the US was in =
July=0D
1994, and the filing in India was within the 12 months from that date. It=
=0D
is irrelevant to compare the same with the US patent as each country has=0D
its own law.=E2=80=9D=0D
=0D
Roche had applied for 28 claims in its US patent application in 1994 and=0D
repeated them in India. However, the US patent office had rejected all but=
=0D
six of them as they were not =E2=80=9Cnew=E2=80=9D and =E2=80=9Cobvious=E2=
=80=9D. But the Chennai patent=0D
document shows that it had admitted at least 12 of Roche claims that had=0D
previously been rejected by US patent office.=0D
=0D
=E2=80=9CThis is extremely puzzling,=E2=80=9D insists Park. =E2=80=9CThe Ch=
ennai Patent Office must=0D
have been aware of the fact that the Indian law requires the patent=0D
applicant to keep the patent office informed about the status of equivalent=
=0D
foreign applications under Section 8 of the Indian Patents Act.=E2=80=9D=0D
=0D
The Lawyers Collectives=E2=80=99 petition was made on behalf of two patient=
 groups,=0D
the Indian Network for People Living with HIV/AIDS and Tamil Nadu=0D
Networking People with HIV/AIDS, in July 2006. The collective is a=0D
non-governmental organization that works for AIDS patients=E2=80=99 access =
to=0D
medicine in India as also civil and women=E2=80=99s rights.=0D
=0D
The Roche drug is prescribed for infections related to HIV/AIDS and also=0D
organ transplantation.=0D
=0D
+++++++++++++++++++++=0D
Adrienne MacDonald=0D
Communications Officer=0D
M=C3=A9decins Sans Fronti=C3=A8res=0D
Campaign for Access to Essential Medicines=0D
Rue de Lausanne 78=0D
1211 Geneva, Switzerland=0D
+ 41.22.849.8909=0D
+ 41.79.293.0270 (m.)=0D
www.accessmed-msf.org=0D
+++++++++++++++++++++++