[Ip-health] USPTO TDF Patent Rejection - Reactions in India (2 news reports)

[Kajal Bhardwaj]

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[ Picked text/plain from multipart/alternative ]
Gilead patent case to help Indian firms
25 Jan 2008, 0027 hrs IST,Rupali Mukherjee,TNN

              NEW DELHI: The US Patent & Trademark Office's rejection of fo=
ur patents held by Gilead Sciences on a key HIV drug Tenofovir, paves the w=
ay for a more affordable treatment for millions of patients suffering from =
AIDS.

The US patent office decision strengthens the pre-grant opposition filed in=
 2006 by Indian Network for People Living with HIV/AIDS (INP+) to several p=
atent applications filed by Gilead on tenofovir disoproxil fumarate (TDF) i=
n India, on the ground that they did not meet the country's patentability s=
tandards.

For the domestic generic industry, the development encourages production of=
 the drug in the country, and gives them opportunities to export to develop=
ing countries.

US public interest organization, Public Patent Foundation (PUBPAT) challeng=
ed the patents in the US patent office, saying that Gilead's patent on TDF =
did not fulfil the criteria of novelty.

With this rejection, Gilead Sciences faces an uphill task to get a patent i=
n India, and other developing countries. Legal experts say, Gilead will now=
 have to share this information with the Indian patent office, which is in =
the process of examining patent applications on TDF by Gilead.

TDF is important for people suffering with AIDS as a first line treatment, =
and also for those who have developed resistance to first-line antiretrovir=
al therapy. WHO treatment guidelines include TDF in first and second-line a=
ntiretroviral regimens.

INP+, which filed a pre-grant opposition in India is concerned that if pate=
nts on TDF are granted access to affordable generic versions of the drug wi=
ll be affected. Patents granted on TDF by other countries denied people liv=
ing with HIV/AIDS access to this important anti-retroviral. In fact, Brazil=
 who has granted the patents on TDF has not been able to produce the generi=
c version and has been forced to pay high prices to Gilead to provide the d=
rug to its patients.

The lowest price that Gilead offers TDF (300 mg) in Brazil is $2766 per pat=
ient per year, which was nearly halved at $1400 after it threatened invokin=
g a compulsory licence.

The cost of treatment would be one-seventh of that price, if an Indian gene=
ric such as Hetero Drugs, Cipla and Matrix offers the drug =97 at $195 per =
patient per year.



  http://timesofindia.indiatimes.com/Gilead_patent_case_to_help_Indian_firm=
s/rssarticleshow/2729348.cms

  ---------------------------------------------

          US body denies Gilead HIV drug patent          BS Reporter / New =
Delhi January 26, 2008

                    US-based drug maker Gilead Sciences has found four of i=
ts US patents on Viread being turned down by the US Patent and Trademark Of=
fice (USPTO).          The company entered into non-exclusive license agree=
ments with Indian drug companies such as Ranbaxy and Hetero for supply of t=
he generic versions of its patent-protected AIDS medicine Viread (tenofovir=
) in over 90 developing countries.          The rejection of patents, a dec=
ision that can be appealed against, was based on the post-grant opposition =
filed by a US-based NGO Public Patent Foundation (PUBPAT).          The ini=
tial set back to Gilead has strengthened the case of Indian patient groups =
and health NGOs who have filed pre-grant oppositions against similar patent=
 applications of Gilead in the Indian patent office.          If the US dec=
ision is to have an impact on Indian patent office=92s verdict, the license=
 agreements, which called for restricted supply of the medicines on a royal=
ty basis may
 turn redundant, experts feel.          It was in 2006, that the Indian Net=
work for People Living with HIV/AIDS (INP+) filed pre-grant oppositions to =
several patent applications on Gilead=92s Viread on the ground that they di=
d not meet the Indian patentability criteria.          Months later, PUBPAT=
 approached the US patent office challenging the patent grants on the medic=
ine. Both oppositions were based on the premise that the patents granted in=
 the US and the ones sought in India are not patentable.          According=
 to a PUBAT announcement on January 24, the USPTO has rejected all four pat=
ents on the drug. The decision, subject to challenge by Gilead, is likely t=
o have an international impact on Gilead=92s patents on tenofovir in other =
countries, PUBAT stated.          Indian patient groups said that Gilead wi=
ll now have to share the US patent office decisions with the Indian patent =
office.          Interestingly, Gilead had almost succeeded in stalling pro=
bable patent
 oppositions from Indian generic companies such as Ranbaxy, Strides Acrolab=
, Emcure, Hetero Drugs and Matrix Laboratories by entering into licensing p=
acts with them in August 2006.          The agreement allows its partners t=
o manufacture and sell these products in over 90 developing countries, whic=
h accounts for 95 per cent of AIDS population, on payment of a nominal roya=
lty.          However, INP+ went ahead with the patent opposition as it fel=
t that if patents on tenofovir are granted in India, it will affect the acc=
ess to affordable generic versions of the medicine in the country.

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