Strategies may be failing to ensure developing countries’ implementation of global trade rules for intellectual property protection does not squelch access to affordable medicines worldwide, according to a study presented this week.

The implementation of intellectual property protection for pharmaceutical products in developing countries have led to concerns on access to medicine and some countries, such as India, have tailored their legislation to limit the effect of IP rights, in particular to prevent patents on incremental innovations. However, this strategy might not be yielding the desired effect, according to a study presented at the World Intellectual Property Organization this week.

The study was presented on 13 December as part of the WIPO seminar series on “the economics of intellectual property.”

The 1994 World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) established minimum levels of intellectual property protection that each WTO member has to enforce. TRIPS [pdf] also prohibits excluding entire fields from patentability, such as pharmaceutical products, which a number of developing countries chose to exclude.

According to Bhaven Sampat, a professor at the School of International and Public Affairs at Columbia University in New York, India was an interesting case to study as it tried to prevent patents on modifications of existing compounds, so-called patent “evergreening.” This was done through section 3(d) of its 2005 patent law. It also made use of flexibilities to TRIPS rules, and it has a prominent role in the generic drug industry and is a main provider of such medicines to developing countries.

Section 3(d) [pdf] is an amendment to the Patents Act, in which a paragraph describes the limit of patentability: ” the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.”

The study, titled Institutional Innovation or Institutional Imitation? The Impacts of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) on India’s Patent Law and Practice [pdf], examined all patent applications during the transition period allowed under TRIPS before the implementation of the agreement. India employed what is known as a “mailbox” option, a transitional provision for developing countries that did not have previous product patent protection to hold patent applications from 1995 until their required implementation of TRIPS on 1 January 2005.

“The laws on the book do not map neatly with laws in practice,” Sampat said, as it appeared that the Indian patent office lacked resources and expertise to make the subtle determinations that would determine a patent falling under the scope of section 3(d).

The study looked at all pharmaceutical patent applications filed in India during the transition period, with a focus on two international patent classes commonly used to characterise drugs, and checked the status of those applications in July 2010 to find out which had been granted, were pending or had been rejected or withdrawn, Sampat said.

The author then compared the Indian grant rate to the European Patent Office for similar patent requests. It appears that “rejected applications at the EPO are much less likely to be granted by the Indian Patent Office, both because they are more likely to be rejected and to be pending.”

The study found that “despite much discussion about the novelty and international uniqueness of India’s patent laws, in practice … the 3(d) provision has little effect on patent prosecution,” which seems to have been highlighted by several scholars based on their observation on implementation of intellectual property rights in practice. In India, according to the study, “weak intellectual property rights on the books may be accompanied by strong ones in practice.”

The tailoring of the Indian patent standards to limit patents on incremental innovations, which “dominate drug patenting in the developed world,” can be seen as an “institutional innovation”, according to the study. However, in practice, resource constraints and “other pressures” may lead to “institutional imitation,” where the IPO would copy developed-country practices and standards. The “impacts of TRIPS in India will be determined by the extent to which India sticks to, or departs from, international patentability standards,” it said.

Empirical analysis presented by the study tends to suggest that “the pharmaceutical industry … may be overly concerned about 3(d),” and Indian policymakers not concerned enough “if its patent office is not enforcing its patent laws.”

According to the study, so-called incremental innovations at the EPO might be more difficult to obtain than in India, in particular because of obviousness or inventive step reasons that serve that purpose. Developing countries aiming at limiting patents on incremental innovations might consider implementing high inventive step requirements, Sampat said, and “might be a less politically inflammatory way for India” to achieve the same goals as 3(d) intends.