|
A large number of NGOs working in the health sector have demanded to the central government to withdraw from the MoU signed with Japan on the Patent Prosecution Highway (PPH) on fast-tracking of patents examination. The NGOs also asked the government to withdraw the proposed amendments to the Patents Rules, 2003 as these proposed amendments are a departure from India’s position on harmonization of patents.
In a letter to the Department for Promotion of Industry and Internal Trade, Ministry of Commerce & Industry, the NGOs stated that these amendments are aimed to facilitate the implementation of the India-Japan PPH. The PPH agreement/MoU between India and Japan not only goes beyond India’s obligations under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) but also compromises India’s strategy to make full use of the TRIPS flexibilities to address its socio-economic needs such as access to medicines. If the proposed revisions to the Patent Rules were accepted, it would lead to the functional harmonization of the scope of patentability and pose a major hindrance in exercising the safeguards against frivolous patenting under the Indian Patents Act.
Expressing deep concern on the recently proposed amendments to the Patent Rules, the NGOs further stated that the PPH may seem like an efficient way to accelerate patent examination in one country, based on the grant of a patent in the other country, by taking advantage of the examination results in the granted country. However, the process will squeeze TRIPS flexibilities available to India to tailor substantive patent laws. This is particularly troublesome because Japan follows lower threshold requirements for patentability criteria as against India's high threshold level requirements of patentability. Therefore granting a patent in Japan or any other country for an invention does not ipso facto make a case for fast- tracking of patent examinations in India.
Acceptance of PPH will create a negative precedence for developing countries who are under pressure to emulate PPH type of agreements in their intellectual property law and practice. Depending on the socio-economic conditions, developing countries have devised their patent laws to suit their domestic need especially health needs. For countries like India, a key producer of affordable generic medicines, PPH would dilute the public interest safeguards in the patent law and would have a deleterious impact
on access to medicines globally.
Further, PPH requires the patent office to expedite patent prosecution if the applicant’s claims have granted in the PPH- partner country. India has introduced an additional layer of scrutiny through pre- grant opposition, which allows third parties to object to frivolous patents claims from being granted in India. Implementing PPH would undermine this important safeguard aimed at strengthening examination and the application of the patentability criteria including section 3(d), the NGOs stated in the letter.
Moreover, unlike Japanese patent law, Indian Patents Act excludes patenting of software per se. Therefore, the PPH arrangement would seriously undermine the legislative intent behind the high patentability criteria prescribed in the Patents Act. Further, in their bid to speed-up the examination process, the patent office would invariably rely on search reports of other patent offices under the PPH or similar agreements, thereby grossly undermining the patentability standards under the Patents Act, 1970.
Thus, the PPH arrangement would lead to the functional harmonization of the lower patentability criteria of PPH founding countries such as Japan and neutralizes the safeguards provided under Section 3 of the Patents Act including Section 3 (d). In addition, expedited proceedings would also limit the time available to file pre-grant opposition which is a substantive statutory right provided by the Patent Act, 1970.
In the past India opposed the move towards the functional harmonization. For instance during the 19th Session of WIPO’s Standing Committee on Patents (SCP)(2014) India stated: “work sharing would create a dividing line, i.e., the offices of some countries would forever remain on the receiving side of the dividing line thus depending upon the product delivered by the other countries, enhancement of the competence of the offices would thus be a more preferred option.
Again, in 2018 June India opposed the proposal of outsourcing of patent examination under the Patent Cooperation Treaty (PCT). India may come under pressure from other developed countries for a similar arrangement and the bilateral arrangement with Japan would turn into a slippery slope. Finally the proposed amendments in India’s Patent Law are based on the demands of the Japanese Intellectual Property Association and will facilitate other countries like the United States which has long criticised India’s patentability criteria, demanding such agreements with their patent office. This gives the amendment very broad applicability. Therefore more consultation and analysis at the national level is required in initiating such an amendment as this will have strong repercussions on India’s future Patent Law, the letter said.
|