India Would Be Wise To Ensure Boehringer's Continued Investment in the Country By Overseeing the Just Application of its Patent Laws

http://timesofindia.indiatimes.com/Business/India_Business/India_rejects_Boehringers_AIDS_drug_patent_plea/articleshow/3146786.cms
India rejects Boehringer's AIDS drug patent plea


By Rupali Mukherjee


The Times of India


20 Jun 2008


NEW DELHI: In one of the landmark judgments on patents which would benefit HIV patients, Indian Patent Office on Thursday rejected a patent application filed by multinational pharma company Boehringer Ingelheim on paediatric form of anti-AIDS drug nevirapine.

The company was trying to claim a patent on the syrup form of nevirapine, which is particularly important for children living with HIV who are unable to swallow tablets.

[THE INDIAN GOVERNMENT MUST REMEMBER HOW, EARLIER THIS YEAR, BOEHRINGER REFUSED TO LAUNCH & REGISTER ITS ANTI-AIDS DRUG TIRANAVIR IN BRAZIL BECAUSE THE MANNER IN WHICH THE BRAZILIAN GOVERNMENT HAS IMPLEMENTED ITS PATENT LAW WOULD LIKELY RESULT IN THE BREAKING OF THE DRUG PATENT. "...the decision was taken already in the middle of 2006, before the compulsory license of other medicine against aids, efavirenz, that took place in May last year. Nevertheless, this decision was never turned public. Partners of the company, nevertheless, affirmed to the newspaper that the compulsory licensing buried the possibility of the medicine be made available in Brazil." See German Pharmaceutical Company Chooses NOT to Register Drug in Brazil Due to Risk of Patent Expropriation, ITSSD Journal on Intellectual Property, at: http://itssdinternationaliprights.blogspot.com/2008/01/german-pharmaceutical-company-chooses.html ].

This is the first decision from the Patent Office on the 13 patent oppositions filed by public health groups against AIDS drugs, and will set an important precedent for the pending patent applications, industry expert pointed out.


If the patent had been granted, price would have increased for children suffering from AIDS. In May 2006, the Indian Network of People Living with HIV/AIDS (INP+) and the Positive Women's Network (PWN) had filed a pre-grant opposition against the company's application.


[THESE GROUPS ARE TRYING TO ENSURE THAT INDIA RETAINS A STRONG 'PUBLIC INTEREST' EXCEPTION TO PATENTABILITY, CONSISTENT WITH AN OVERLY BROAD READING OF THE WTO TRIPS AGREEMENT].


"We opposed the patent application on nevirapine hemihydrate (syrup) to ensure that it remains available for our children and to make sure that the government doesnt say it is too expensive to provide," said, P Kousalya, president of PWN.


Nevirapine is an important anti-retroviral drug, invented in 1989, and was not patentable in India.


"Accessing appropriate paediatric formulations of AIDS drugs has been a particular problem around the world, and we hope that this decision can be a step towards making them more available," she added.


The Indian Patents Act contains some important safeguards designed to ensure that ‘‘frivolous patent applications are not granted at the cost of public health. These include section 3(d) of the Patents Act, which prevents many "new forms" of known substances from being patented unless there is a significant improvement in efficacy, and section 3(e) of the Act, which prevents "mere admixtures" of substances from being patented.

Brazil Opposes India's Emerging Pro- Patent Policy as Part of its Global Universal Access to Healthcare Strategy?

http://timesofindia.indiatimes.com/Brazilian_group_opposes_Gileads_AIDS_drug_patent/rssarticleshow/3169835.cms

Brazilian group opposes Gilead's AIDS drug patent


By Neelam Raaj


Times of India


June 27, 2008



India's generic drug industry is a lifeline for millions of AIDS patients in developing countries. Now in a bid to protect access to this lifeline, a foreign patient group has for the first time filed an opposition against the grant of a patent in India to US-based Gilead Sciences for the key AIDS drug tenofovir.


Brazilian AIDS advocacy group ABIA (Brazilian Inter-disciplinary AIDS Association), which filed the opposition along with Indian NGO, Centre for Residential Care & Rehabilitation), says the step was necessary since a patent in India would have a direct impact on ability of Brazil to produce and access affordable generic versions of tenofovir.


The patent has been opposed on the grounds that the drug is only an addition of a salt (fumaric acid) to an existing compound (tenofovir disoproxil) and not a new invention. India's Patents Act includes a provision against patenting of minor improvements of known medicines: Section 3(d)).


The law allows any party to oppose patent applications. In 2006, Indian patient groups had also registered their pre-grant opposition to a patent on tenofovir.


Now, Brazil has entered this patent battle. An opposition to Gilead's patent application on tenofovir has also been filed in Brazil. The patent offices in both India and Brazil will be reviewing the case in July.


Tenofovir, a second-generation drug with fewer known side effects, has emerged as an important option for patients starting AIDS treatment for the first time, and those who have been on anti-retroviral treatment therapy (ART) for some time and require access to newer drugs due to occurrence of toxic effects or as they develop resistance to first-line drug regimens.


The drug is recommended under the updated World Health Organization (WHO) ART guidelines.


[FREE] Access to affordable tenofovir is particularly important for Brazil, as by the end of 2008, an estimated 31,000 people living with HIV will receive the drug through its national treatment program.