By Invitation . India’s patentability criteria: Do it our way, not the highway

India’s medicines patent law is under tremendous pressure from the multinational pharmaceutical lobby, which enjoys considerable clout as powerful governments like the US and Japan are seen espousing its causes.

But at stake here are public health safeguards that go to the heart of what merits a patent.

The amendment to India’s Patent Law in 2005 makes it tougher to patent new forms of existing medicines, a common abusive practice of ‘evergreening’ by pharmaceutical corporations to block price lowering competition. The step taken by the Indian Parliament in 2005 to curb evergreening, in line with international rules, has kept generic competition alive and dramatically driven down prices of HIV, Hepatitis C and cancer medicines that are patented and priced out of reach elsewhere.

The US has been relentlessly critical about India’s strict patentability criteria for pharmaceuticals, evident from India’s continuous presence in the Special 301 Watch List and demand that India adjust its patent system to the interests of the US pharma industry. And it’s not just the US, but allies like Japan too who push the agenda of harmonising patentability standards that undermine India’s anti-evergreening safeguards.

More recently, while the media’s attention was on Prime Minister Modi’s visit to the US, India quietly amended its Patent Rules, allowing pharmaceutical giants to fast track examination of their patent applications in the presence of an agreement between the Indian patent office and its foreign counterparts.

Proposals to harmonise patent laws are not new and were first made at the World Intellectual Property Organization (WIPO), which was put on hold in 2006 amidst strong objections from developing countries like India. Presently, there is no international agreement in force that obligates countries to harmonise substantive patent law, including patentability criteria.

The proposal, however, has not gone away. Over the past two years, the Japanese Intellectual Property Association has been aggressively seeking harmonisation through a bilateral patent prosecution highway (PPH) between Japan and India. In a nutshell, if claims have been determined to be patentable in Japan, pharmaceutical corporations can request for expedited examinations before the Indian patent office to acquire patents swiftly and expand their monopolies in India.

In the first half of 2019, India succumbed and signed a PPH agreement with Japan. The present amended rules legitimise this arrangement between both the patent offices. Unfortunately, this will not be restricted to Japanese pharmaceutical corporations in India but will lead to fast track examination of patent claims from other multinational pharmaceutical corporations as Japan has bilateral arrangements with 48 countries, including the US.

Safeguards at risk

The PPH may seem like an easy and quick way to accelerate patent examination and reduce pendency of applications, but the process will squeeze flexibilities available to countries under international law to tailor patent laws according to local developmental needs.

Second, India — unlike Japan and the US — has stricter standards for a grant of patent. Any reliance for examination on Japan’s patent office through PPH could dilute India’s safeguards against ‘evergreening’ and pave the way for unmerited monopolies in pharmaceuticals.

Third, fast-track examinations are likely to miss the extra-layer of scrutiny provided by pre-grant oppositions as the opponents will find it difficult to oppose an application in such a short period. Although the amendment has a rider that the patentability of the applications filed based on such an agreement will be in under the Indian law, the assurance is not enough, especially at a time when India is already seen to be diluting the patentability criteria by allowing ‘evergreening’ of patents like never before.

The amended rules — notified without due consultation among patient groups and academia — are a setback to India’s efforts to balance the patent system with its role as a significant manufacturer of generic medicines that drives access to affordable treatment in India and globally.

India, being a developing country and key producer of generic medicines, should roll back the rules and actively defend its position as the pharmacy of the world.

The writers are lawyers and work with the Access Campaign of Médecins Sans Frontières (MSF), or Doctors without Borders. Views expressed are persona l

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