Indian Patent Law Scares HIV & Consumer Advocates

Health campaigners fear stronger patent laws enacted by India in 2005 -- which Novartis is trying to shore up in the case of Glivec -- will jeopardise India's role as a source of cheap generic medicines for the most needy. The proceedings pit Swiss pharmaceutical giant Novartis AG against an Indian patent system that it says stifles innovation.

Medical aid agency Medecins Sans Frontieres estimates over half of AIDS drugs used in poor countries come from India. If Novartis wins its case, more medicines will end up being patented, making it very difficult for Indian firms to manufacture cheap copies, it says.

Stung by criticism from campaign groups, Novartis insists tighter intellectual property laws will, in fact, ensure future investment in new medicines by rewarding research.

"I'm convinced -- and I'm a scientist -- that patents save lives, because without patents you cannot discover and develop new drugs and get them to patients," Paul Herrling, Novartis head of corporate research, said in an interview in London.

The company points out that safeguards already exist in international trade agreements. These protect access to essential medicines by allowing for the export of drugs which are produced under compulsory licenses, issued for public health reasons.

Many companies also run access programmes, which offer affordable brand-name equivalents to cheap generics.

To follow this research, read on.

Essentialdrugs.org Reports Viraday may be too expensive to help

Viraday may still be too expensive

Generic versions of the new once-a-day FDC of TDF/FTC/EFV are being developed in India and their approximate market launch in India (to start with) could be expected within the coming months (see Times of India article below). This new combination is crucial as an improved first-line and alternative to the FDC containing d4T/3TC/NVP, which is commonly used in the developing world today. WHO recommends combinations containing TDF, as they have fewer side effects than those containing d4T.

Generic companies have already applied for marketing approval in India and therefore the generic equivalent of this new once-a-day FDC could be available within months of US FDA approval of Gilead/BMS’s version of the new FDC. The generic price of US$ 2,160 per patient per year as reported by the Times of India is much more affordable than the US market price of nearly US$14,000. The price is still very high compared to current first-line FDC prices, but when generic competition exists, prices can be expected to fall over time.

However, Gilead’s patent application on TDF is being examined in India. In May 2006, MSF supported PLWHA groups and the lawyers that represent them in filing a pre-grant opposition to this patent application. If the patent is granted on TDF, for which there was no generic production pre-2005, any generic production could be effectively blocke"

Cipla to Export Viraday to China

Per an article on CNBC-18:

Cipla has launched an HIV drug called Viraday. MD at Cipla, Amar Lulla says
that this drug is much needed because AIDS patients do acquire resistance to the
existing drugs and this is where it plays a significant role.

He adds that this drug will form a significant part of exports and they
are in the process of registering this new combination in various parts of
Africa.
Excerpts from CNBC-TV18's exclusive interview with Amar Lulla:
Q:
What does this launch mean and what kind of revenues are you looking at from
this launch?
A: More than revenues, this is an important combination. This is
a combination of three drugs that is Tenofovir, Emtricitabine and Efavirenz and
it’s a very important combination because it’s a new combination.
This is
the first time that this combination has been launched in India at
about one tenth the international price. This drug is important and it
is much needed because AIDS patients do acquire resistance to the existing drugs
and this is where it plays a significant role.
Q: Will this also form a part
of your export package to countries that require this drug, which may ask you
for it?
A: Yes, it will and it is an important part of the new therapy. This
will form a significant part of the exports and we are in the process of
registering this new combination in various parts of Africa.
Q: What kind of
ballpark revenues are you looking at in India and abroad and through exports
from this product for about the next three years?
A: In the next two-three
years this will be a significant addition on the topline, though we are right
now subsidising it and not having significant margins on it. But this could be a
part of the USD 50 million products.
Q: That is only in India or including
exports?
A: To begin with it will be in India, and then
exports.
Contd on pg 2...
Q: Any other product launches in this space,
that is in HIV drugs?
A: We have some more coming in and particularly we
are looking at immunity boosters and other additions in the opportunistic
infections. So we are looking at a complete package in treatment of
AIDS.
Q: When are you expecting to announce these launches, are they likely
to come within a quarter itself?
A: Some additional products are likely to
come in this quarter.
Q: In terms of distribution for this drug itself are
you looking at some acquisitions abroad, which will help you to distribute this
drug better or will it be largely through the government and World Health
Organisation kind of agencies?
A: This will be largely through government
fundings and through global fundings. This will be through the treatments
that are in programmes right now, being carried out by the governments
of various countries. So it will not be a private market distribution.