The debate on intellectual property rights (IPR) is reaching a tipping point in India as the country begins to work around its existing laws governing patents. India’s revisit to the IP rights comes in the wake of mounting concerns from the stakeholders, especially the innovator pharma companies, that the patent environment in the country is becoming increasingly hostile. Courts in India are flooded with litigations challenging the granting or rejection of product patents.

At the heart of the controversy is the eligibility criteria defined in the patent rulebook for products seeking patent protection. Section 3(d) in India’s Patents Act says that novelty and inventive step should be the basis for a pharmaceutical product to secure patents.

However, actual improvement in therapeutic efficacy of the new product should also be a criteria for patenting incremental inventions. Companies find this additional filter in the section gets in the way of a large number of patents and is often interpreted improperly, leading to refusal of IPR.

Examining the anomalies in the patent legislation is high on the agenda in front of the newly constituted expert panel to draft National Intellectual Property Rights Policy. The six-member IPR Think Tank, set up by Department of Industrial Policy and Promotion (DIPP) under the Ministry of Commerce and Industry, has a nine-point checklist with the task of charting out the national IPR policy as item number one.

Going Slow on CLs?
The other points of reference include tracking down IPR areas that require more studies, preparing reports on best practices followed in foreign countries, suggesting ways to improve infrastructure in IP offices and tribunals and so on, besides highlighting the inconsistencies in the present IPR legislations and advising possible solutions to the government.

The review panel will also look into the current issues raised by industry associations and provide views on the implications of demands placed by the negotiating partners.  

Another contentious issue is the way India revokes patents for granting compulsory license (CL) for proprietary products. Provisions in the Trade Related Intellectual Property Rights under WTO agreement, CLs are supposed to be invoked in extremely urgent situations like national emergencies. In such a case, a CL can be permitted by breaking the patents granted and paying a royalty to the patent owner.

To date, India has issued only one CL in 2012, allowing the generic firm Natco Pharma to make and commercialize a generic version of Bayer’s sorafenib to treat cancer affecting the kidneys and liver.

But considering the country’s strong generics background, companies fear that India could permit more CLs in the days to come paving the way for unfair commercial use of their patented products.

The commerce ministry, reportedly, has initiated certain steps to restrain unfettered access to CLs, as well. Urging caution while exercising the option of these patent-disabling measures, DIPP has asked the authorities to ensure that such licenses survive possible judicial scrutiny before granting them. Compulsory licensing on frivolous grounds can entail litigations, which could eventually lead to it being revoked. In that case the government should be able to safeguard its turf by fully justifying the provisions for permitting a CL.

NGOs See Red
The new proposal could throw a spanner in the works of a new line-up of potential candidates meant to pursue the CL route. The health ministry is considering CLs for BMS’s dasatinib (Sprycel) and Roche’s trastuzumab (Herceptin) to local firms in order to make them affordable for the needy public, reports indicate.

Affordability to most of the public is often touted as legitimate ground for breaking patents of drugs in India. But the affordability plank may fail as a valid explanation for justifying the invoking of this emergency clause.

Even as the commerce ministry—one of three various ministries of the government involved in the policy and regulation of pharmaceuticals—embarks on the process of overhauling the patent system, health activists and other consumer forums start seeing red in the motive. They warn against any attempt to weaken existing patent laws of a country considered to be the pharmacy of the developing world. Bowing to pressure would hurt the interest of patients not only in India but millions of people across the globe. 

Meanwhile, experts from the more developed markets view the ongoing review of IPR policy as a sign that India is demonstrating its boldness in dealing with the challenging issues like patents, copyright, trade secrets and compulsory licensing.

Industry is watching how India strikes a fine balance between its commercial obligations and patient needs against the backdrop of rising tensions within an industry driven by generics and conflicting interests among its various ministries on IP rights.