Patent Rules Amendment And PPH Program Scrutinized!
A little time back, a draft rule amending the Patent Rules, 2003 was proposed by the Department of Industrial Policy and Promotion (DIPP) through a notification in the Official Gazette. The said draft, basically, aimed at changing the procedural rules relating to pre-grant opposition and increasing and expanding the applicant’s list who can easily apply for an accelerated and fastened examination of the patent application. The Patent Rules not only provides procedures that are to be followed while implementing the provisions of the Patent Act of 1970 but also aids the Indian Patent Office in deciding over the applications for a patent made under the said Act. For the reason that amendment of rules is easier as compared to amendments of the legislature, the rules are amended frequently to synchronize and validate the policies made by the government. As of today, seven amendments have already been made to the Patent Rules.
Accelerated and speedy examination of the application
The Patent (Amendment) Rules, 2016 introduced a procedure for speedy and expedited examination of applications that are filed under the Patent Act. This procedure was introduced with an aim of fast track disposal of patent applications. The process reduces the time so taken in examining an application and also issues a‘ first examination report’ which also adds on to the acceleration of the entire process. However, as per the Rules 2016, this speedy examination can be requested only in either of the two below-mentioned conditions:
“(a) that India has been indicated as the competent International Searching Authority or elected as an International Preliminary Examining Authority in the corresponding international application; or
(b) that the applicant is a startup.”
The above-mentioned provisions were considered as a step taken by the Government to familiarize India as a hub for patent filing. Not only that, but it also was a step considered as a method to provide a strong base and ecosystem to the start-ups. This proposed draft rules by DIPP tries to add certain categories of applicants to the list of applicants who can apply for an expedited examination of the application. Such certain categories are:
1. Small entities
2. Female applicants
3. Government undertakings
4. Applicants eligible for an arrangement for processing an international application pursuant to an agreement between IPO with another participating patent office.
With such additions to the list, it is clear that the intention of DIPP by widening the list of applicants is to reduce the application pendency at the IPO and also to reduce the total time needed for a patent to be granted. Emphasizing the last category of the applicants so proposed in the draft, it seems to be a step towards harmonizing the examination of patents across the globe.
It is further important to see these amendments in connection with the recently signed agreement between India and Japan for Patent Prosecution Highway (PPH), which looks more like a haste decision by the government.
Patent Prosecution Highway (PPH) is a method effective enough for expediting procedures for patent prosecution by sharing patent searches and examination results between some of the Patent Offices. It is an administrative collaboration between various Patent Offices, in order to implement fast disposal of patent applications in one country based on the patent grant in another country, done by using the search and examination reports of the office. On the first look, PPH may look an efficient and easy method to fast track examination and issuance of a patent, but when read thoroughly, it might be deeply concerning as it seems that this process might restrict the flexibilities provided by TRIPS to countries to change or amend the patent laws in accordance to the local needs. It is now important to mention that the draft rules do not specifically talk about the PPH program but it, however, suggests that a legal framework must be provided for the expansion of PPH to all types of technology which includes pharmaceuticals.
This draft amendment can be said to be the outcome of the 1st JPO-DIPP Review Meeting which was held in September 2017. It was in this meeting that the Japan Patent Office (JPO) triggered and encouraged India to widen the grounds that enable fast track patent application disposal. This agreement thus provides leverage to amend substantive patent laws and its examination standards. It is further important to note that this agreement was made without any discussions with the lawmakers or the stakeholders so concerned. As per the current situation, there are no such obligations over India that mandate it to harmonize criteria for a patent, its procedures, and decisions.
Countries that are backed up by multinational pharma corporations like the developed nations such as Japan, United States, and European Union have effectively adapted to the PPH program in order to make suitable changes to their examination and issuance procedure and standards in the developing countries like India, and this has become a point of concern for the remaining world. It is also to be noted that this agreement signed between India and Japan will not be restricted only between the two countries but will lead to an implied agreement with various other countries and pharma corporations. This current agreement between India and Japan is not free from loopholes and problems. The present agreement does not consider the vital role played by India in the production of generic medicines and it also fails to acknowledge the need of lesser developed nations to increase the access and use of affordable medicines.
The present draft provides for an out-of-turn application examination which is possible by sharing of patent search and examination reports along with details of examiner training, etc. The proposed speedy process is likely to skip an extra-layer of scrutiny which is generally provided by the pre-grant opposition. This can be said because the process will make it difficult for the opposition/ opponent to oppose such a short time span. Adding on, the draft amendment has a codicil stating that the patentability of the applications filed on the basis of this agreement shall be scrutinized and examined as per the provisions of and in accordance with the Act, but considering the present patent market mere assurance is not a solution enough. PPH further fails to consider the need to access affordable medicines in India.
The rules made under the Patent Act can turn out to be positive or negative on access to public health, medications, and the right to health of the citizens. For the reasons of biased assistance in the technical field from developed countries, regular pressure, and free trade agreements with TRIPS, many developing countries tend to amend their patent policies. In the year 2017, there was a 50% hike on the patent granted by the IPO. With the coming up of the agreement between India and Japan, it can be expected that there will be an even further hike in the number of patent grants which might lead to depreciating the quality of the patents. This statement can be supported by the fact that about 72% of patents granted in the pharmaceuticals were granted on mere slight improvements on already known drugs for which patents already existed.
Considering the above facts and figures, it is suggested that IPO should consider granting patents as per quality and not quantity. Also, different health and development needs of the country should not fade away from certain practices and safeguards to public health provided under the patent laws of India.