The goal of the project is to prevent or remove low quality patents – one of the main market entry barriers for generic medicines – by filing patent oppositions for medicines of HIV, TB and Hepatitis C in India.
India is a major supplier of affordable generic medicines of assured quality, and most ARVs that are procured with donor funds are sourced from Indian generic companies. The availability of affordable first-line ARVs has been a key factor in providing and expanding treatment for millions of people living with HIV in low- and middle-income countries.
One of the main reasons for the prominence of Indian companies in supplying affordable generic ARVs is that, until 2005, India did not grant product patents on pharmaceuticals. This enabled Indian companies to develop, manufacture and supply generic versions of medicines that were still patented elsewhere.
After India joined the World Trade Organization and had to comply with the Trade-related Aspects of Intellectual Property Rights (TRIPS) Agreement, India had to revise its law and introduce product patent protection for a period of twenty years for all inventions including pharmaceutical inventions. Thus, since 2005, product patents can be granted on new medicines – including new ARVs, new medicines for TB and direct acting antivirals (DAAs) for the treatment of hepatitis C – in India.
When product patents are granted on such new medicines, generic companies are not allowed to manufacture generic versions of them until the relevant patents expire (unless they have a license). This means there may be no generic competition and – since generic competition is a key factor in reducing prices – prices are likely to remain high. As a result, access to such new medicines may be limited.
When India’s Patents Act was amended in 2005, certain flexibilities were included that can be used to mitigate the potential negative impact on access to medicines – which is allowed under the TRIPS Agreement. Flexibilities in India’s Patents Act include stringent standards for patentability (disallowing patents on, for example, new forms or different formulations of know medicines) and provisions that enable third parties to file patent oppositions.
The Lawyers Collective will strategically use the patent opposition mechanism to try to prevent that low quality patents – which fail to satisfy the patentability standards under the Indian Patents Act – will be granted on medicines that are important for public health. By removing or reducing such patent barriers, the Lawyers Collective project will help to open the way for early market entry of generic versions of new ARVs, DAAs and new TB medicines. This, in turn, would encourage competition and lead to more affordable prices of such medicines.
By preventing patents on certain formulations or combinations of known medicines, the project would also pave the way for the development of improved formulations, such as pediatric medicines and fixed-dose combinations (FDCs) by generic companies.