[Ip-health] India Legitimises Patent Prosecution Highway: Amends Patent Rules

Roshan JOSEPH Roshan.JOSEPH at geneva.msf.org
Tue Sep 24 05:29:18 PDT 2019

The Department of Industrial Policy and Promotion (DIPP), the department that governs the Indian Patent Office last week notified the 2019 amendment<http://www.ipindia.nic.in/writereaddata/Portal/News/569_1_The_Patent_Amendment_Rules_2019_.pdf> (http://www.ipindia.nic.in/writereaddata/Portal/News/569_1_The_Patent_Amendment_Rules_2019_.pdf) to further amend the Patent Rules, 2003. The Draft Rules seek to expand the list of applicants who can apply for an expedited examination of patent application. The Patent Rules details the procedure to be followed while implementing the provisions of the Patents Act, 1970 and guides the Indian Patent Office (IPO) in considering the applications made under the Act. Being a comparatively easier process than legislative amendments, the Rules are often amended (seven times so far) to validate the policies of the Government.
Expedited Examination of Application
More recently, in 2016, the Patent Rules were amended to introduce a procedure relating to expedited examination of the application-a process aimed at fast track disposal of patent applications. It cuts down the time taken to examine a patent application and issue a first examination report, which in turn expedites the entire process. After the amendment last week, a request for this service can only be raised if any following grounds are satisfied:

1.       That India has been indicated as the competent International Searching Authority or elected as an International Preliminary Examining Authority in the corresponding international application

2.       That the applicant is a startup;

3.       Small entities;

4.       Female applicants, in case of natural persons;

5.       Government undertaking;

6.       Applicants eligible for an arrangement for processing a patent application pursuant to an agreement between IPO and a foreign patent office.
The proposed amendment, specifically the inclusion of the last category of applicants is deeply concerning as this looks like a step towards harmonizing patent examination globally. It is critical that the amendments be seen in the light of India's recent agreement with Japan on having a patent prosecution highway (PPH) program, which is nothing but a hasty policy decision.
Patent Prosecution Highway Program
PPH are administrative collaborations that fast track patent applications in one country, based on the grant of patent in the other country, by taking advantage of the search and examination results of the office of first filing. The PPH may seem like a relatively easy and efficient way to accelerate patent examination and issuance, but the process shall squeeze the TRIPS flexibilities available to countries to tailor substantive patent laws according to local needs. Though the amended Rules don't explicitly mention PPH, but they suggest providing a legal framework and expansion of PPH to all forms of technology, including pharmaceuticals.
The amendment is clearly a result of 1st JPO-DIPP Review Meeting<https://www.meti.go.jp/english/press/2017/0904_003.html> (https://www.meti.go.jp/english/press/2017/0904_003.html), where the JPO had encouraged India to expand the grounds for requesting expedited examination of a patent application. Moreover, this amendment was notified amidst the Indian Prime Minister's visit to the US when there were reports which suggested pressures from the US to change local policies on IP and medical products.
Developed countries like Japan, United States, and European Union backed by multinational pharmaceutical corporations are effectively using joint PPH program to adjust the patent system and examination standards in developing countries like India. It is important to understand that India-Japan PPH will not be restricted between these two countries. This will lead to an implied agreement for fast track examination from pharmaceutical corporations from other countries including the United States which is aggressively pursuing an IP enforcement agenda without consideration on the negative impact on generic competition and access to medicines. It should be borne in mind that within its existing framework, the India-Japan PPH program fails to take into consideration, particularly the role India plays as a key producer of generic medicines, as well as the greater need of least developed members to increase access to affordable medicines.
The proposed amendment proposes for a quick out of turn examination of patent applications, which can only be made possible by sharing search and examination results, having combined examiner training etc. In the context of medicines, training to patent examiners supported by developed countries such as Japan rarely emphasize on a stricter patentability criteria. More importantly, the fast track examinations shall most likely 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 on the basis of such an agreement will be in accordance with the Act, but the assurance is not enough, especially at a time when India is granting patents like never before. India being a developing country and a key producer of generic medicines, PPH fails to ensure its needs for access to affordable medicines.

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