Following the decision by the Indian Patent Office:
- Boehringer Ingelheim will not legally contest the decision
- Generic manufacture of nevirapine for developing countries permitted since 2007

Ingelheim/Germany, 25 June 2008 - The Opposition Division of the Patent Office in New Delhi has allowed the opposition of an Indian patent organisation against Boehringer Ingelheim`s patent application for the suspension form of an HIV/AIDS drug nevirapine (trade name VIRAMUNE®). According to Indian law, this decision can be contested in the Indian courts.

Boehringer Ingelheim will not legally challenge this decision. In any case, the company had, in 2007, already permitted the generic manufacture of nevirapine in and for developing countries. Nevertheless, the decision not to contest this case does not constitute a precedent for subsequent decisions on other Boehringer Ingelheim drugs that are protected in India.

The basic decision to apply for a patent for the nevirapine suspension was important for Boehringer Ingelheim because without patent protection the company cannot prevent what may be poor-quality versions of the HIV/AIDS drug from Boehringer Ingelheim research from being produced and sent to industrialised nations or other countries.

Patents for pharmaceutical products are essential not just for securing the markets in the industrialised nations, but also for ensuring that all patients are supplied with innovative, high-quality drugs.

Nevertheless, the company accepts the proposition that patents should not prevent access to nevirapine in developing countries for their own needs. In order to strengthen this position, Boehringer Ingelheim is offering manufacturers of nevirapine products for developing nations special agreements (non-assert declarations) so that patents do not obstruct the supply of the drug in these countries. The selection criteria for countries with free access to nevirapine are broad, i.e. in addition to the low-income countries according to the World Bank classification, they include all countries with a low Human Development Index. A total of 77 countries will be able to make use of this concession. Boehringer Ingelheim is waiving any form of licensing fees for the production, distribution and sale of nevirapine in these countries. Nine manufacturers of generics, including seven in India, have already made use of this offer.

Drug donations
Since 2000 Boehringer Ingelheim has granted cost-free access to individual doses of Viramune® (nevirapine), used on its own or in combination with other drugs, for preventing the mother-child transmission of the HI virus during birth. The company currently donates the preparation in 59 countries in Africa, Asia, Latin America and Eastern Europe. To date, more than a million individual doses have been supplied free of charge to mothers and children.

Reduced prices for Viramune®
Another measure designed to ensure access to HIV drugs is the significant reduction in the price of Viramune® for continuous treatment in developing countries. As a founder member of the Accelerating Access Initiative (AAI)* Boehringer Ingelheim offers drugs in developing countries at a substantially reduced price.

New hope through new medicines
It was back in 1996 that Boehringer Ingelheim launched Viramune®, the first non-nucleoside reverse-transcriptase inhibitor, and for two years now the company has been supplying the protease-inhibitor Aptivus®, a drug for HIV-positive patients who fail to respond adequately to currently available anti-HIV preparations. Other antiviral substances are also in clinical development. For many years now Boehringer Ingelheim has been focusing strongly on virological research. Without this substantial investment by research-based drugs manufacturers such as Boehringer Ingelheim, advances in the drug treatment of illnesses such as AIDS would not be possible.

* AAI: A joint venture between pharmaceutical companies and WHO, UNICEF, UNAIDS, World Bank, etc.

Please be advised
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