Out-of-Sight RCEP Negotiations Threaten Public Health and Access to Medicines

Although the draft text of the RCEP agreement is not public, leaked documents show that the deal could undermine India's patent system.

This week, officials from 16 countries will gather in Hyderabad’s International Convention Centre for negotiations related to an expansive trade deal that endangers hard-won public health safeguards in India’s national intellectual property laws.

The known as the Regional Comprehensive Economic Partnership (RCEP) involves 16 nations, including the ten ASEAN member-states, as well as India, China, Japan, South Korea, New Zealand and Australia.

Draft texts of the trade agreement are being concealed from the public and negotiations have been ongoing without transparency or opportunity for public engagement. Despite the absence of democratic oversight or input, the outcome of RCEP’s negotiations will require member countries to amend their national laws to meet its obligations or face severe economic penalties.

Leaked text from a 2015 draft of the RCEP agreement revealed that Japan and South Korea are seeking significantly ramped up protections for intellectual property, which, if adopted, would have devastating consequences for public health and access to medicines in the region and beyond.

Currently, countries involved in RCEP negotiations must provide protections for intellectual property in line with the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and other trade agreements of which they are part.

To date, India has been a global leader in adopting and utilising TRIPS health safeguards to balance rights of inventors with health rights. These safeguards have helped ensure the refusal of unmerited pharmaceutical patents that have been filed in India. Indeed, the refusal of unmerited patents on three HIV drugs alone in India has resulted in over half billion dollars in cost savings in five years for global purchases of these medicines – money that can be reinvested to treat over one million patients.

Yet, intellectual property provisions contained in RCEP seek to remove or undermine the ability of India and other member countries to adopt and utilise TRIPS health safeguards, while simultaneously seeking to extend the length of patent monopolies and expedite and expand mechanisms to enforce them.

Critical safeguards provided under TRIPS to protect public health include (among others) the sovereignty of countries to adopt stringent patentability criteria to guard against the granting of unmerited patents, as well as opposition procedures that allow third parties (including civil society and patients) to oppose patent applications and granted patents.

The majority of pharmaceutical patents filed globally are for minor modifications of existing compounds or for secondary claims. Very often, these types of patents do not provide any additional therapeutic benefits to patients and/or use commonly practiced scientific techniques that are in the public domain.

As each new patent is granted 20-years of monopoly protection, secondary patents in particular are used as a business strategy by branded companies to delay generic competition (and its downward pressure on prices) for decades after the original patent has expired. Simultaneously, industry pursuit of secondary patents on profitable products has incentivised R&D investment towards the extension of commercial monopolies, rather than addressing unmet health needs.

Provisions contained within the leaked RCEP text threaten to undermine India’s domestic efforts and sovereignty to guard against poor-quality patents. RCEP introduces language that may force India to limit eligibility to oppose patents and reduce the grounds on which patents can be opposed.

RCEP further seeks to extend and standardise the grace period allowed to patent applicants when assessing the novelty of an invention claimed in a patent application. This extended grace period would mean that a prior publication that would otherwise show the lack of newness of an invention claimed in a patent application would not be permitted as part of the examination or opposition evidence. Such an extended grace period is designed to make patenting easier for companies.

Yet, while simultaneously expanding the complexity of patent examination and limiting opposition procedures, RCEP seeks to establish obligations on countries for expedited patent examination. Patent offices are too commonly judged on the speed with which they grant patents, rather than the quality of patents that they grant. Expediting patent examination would lead to an increase in the granting of poor-quality patents that undermine countries abilities to protect public health rights.

India must oppose any demands in RCEP that calls for expedited patent examination, limiting the grounds and eligibility for filing patent oppositions and examination standards that benefit patent applicants. Any language that seeks to limit extension periods for least developed countries, requires data exclusivity and patent term extensions (“restoration”) also needs to be removed.

To date, India has been a global leader in creating a patent law that balances the rights of inventors and public health. The country must defend its progressive patent law.

And, if trade negotiations are truly meant to benefit society then they must be freed from their shrouds of secrecy and brought into the public domain. In this vein, a process for public oversight and input into RCEP’s negotiations must be urgently established. Otherwise, like many trade agreements before, RCEP will amount to corporate capture of India’s patent system.

Tahir Amin is co-founder and director of Intellectual Property at Initiative for Medicines, Access & Knowledge.