The COVID-19 pandemic and the longevity of the public health and economic consequences surrounding the situation have pressured various medical experts to either find a long-term vaccine or preventive drugs to ease the ongoing battle. The governments around the world continue to pool in their best resources in the research and development of such preventive drugs and vaccines. With many countries racing ahead to launch vaccines and medical inventions, only a robust patent approval system will enable the true access of these medical discoveries to reach the masses. In the event of any invention to fight COVID-19, it is imperative to evaluate the existing patent infrastructure in India and the mechanism for fast track grant of patents, and adopt the breakthrough initiatives espoused by the international community.
Fast Track Patent Grant Mechanisms
A. International Jurisdictions
- United States
In May, 2020, the US Patents and Trademark Office (‘USPTO’) launched the COVID-19 Prioritized Examination Pilot Program for small and medium enterprises (including independent investors or companies with less than 500 employees, and non-profit groups). The Program forgave the payment of the standard fees required for such prioritized examination. This Pilot Program aims to apply to original, non-provisional applications with no priority claim and to applications with priority to one or more provisional or foreign applications. To avail the benefit of this Pilot Program, specified limitations on the number and type of claims have been imposed, and there is no provision for seeking an extension of time. It will only be applicable to 500 applicants in its first leg. These patent approvals will not include the time period required for the different approvals required by the Food and Drug Authority (FDA).
The USPTO had earlier in 2011 introduced the ‘Track One’ program which provided for an accelerated examination on the payment of the requisite fees and fulfilment of a certain requirements. The USPTO guaranteed the examination and issuance of the patent (if it is worthy) within a period of 1 year, instead of the average 3-year period. It eliminated the requirement of the performance and explanation during a pre-examination search which otherwise slowed the examination process. It also restricted and specified the number of independent and dependent claims allowed in such applications.
2. United Kingdom
UK Intellectual Property Office (‘UKIPO’) is yet to arrive at an acceleration mechanism for prioritized examination of patent applications related to COVID-19. However, the patent system of the UK consists various universal acceleration mechanisms.
The UK Government had introduced the Green Channel System in 2009 for accelerated processing of patent applications which have some environmental benefits. It is pertinent to note that the rationale behind adopting this accelerated Patent Process was to primarily enhance and support innovations in the fields of advanced manufacturing, life sciences, and low-carbon technologies. The question posed before the UK Government is whether the COVID related preventive drugs and vaccines can be included under the garb of life sciences and ultimately to allow fast track patent process for such drugs.
Another mechanism is the Patent Fast Grant System allows the applicants to request an expedited search and examination if adequate reasons are provided. Though the grant of such a request is at the discretion of the UKIPO, the existence of a potential infringer or a probable investment have been accepted as valid reasons. The Patents Fast Track Guidance provides applicants with three services in the nature of:
- Combined Search Examination
- Accelerated Search/ Examination
- Accelerated Publication
The UKIPO also offers accelerated patent examination under the Patent Prosecution Highway (‘PPH’) and Global Patent Prosecution Highway (‘GPPH’). The PPH initiative of the UKIPO offers the applicants with an opportunity of applying for an accelerated processing if the examination is already conducted in any other Intellectual Property offices located elsewhere around the world. An accelerated corresponding application can be accepted by the second intellectual property office if the application has been found acceptable. Through this process quick processing of application of COVID-19 related drugs and vaccines can be done with the highest degree of effectiveness and efficiency. The latter GPPH initiative was a 2014 Pilot Programme by the UK Government allowing an applicant to initiate accelerated assessment at any or all of the other intellectual property offices if the claims are accepted by the first participating office.
Both of these programmes will cater to the need of the hour and help the applicants of COVID-19 inventions to accelerate the process by filing corresponding applications.
Patent applications related to providing solutions to the COVID-19 will be eligible for fast track examination program by the Russian Patent Office. The applicant will receive a first office action within 2 months of filing an application for an invention related to anti-viral drug, diagnostic test systems, medical and protective equipment, and sterilizing and disinfecting agents.
B. under the Indian Patent Regime
The Patent Amendment Rules, 2016 previously provided an expediated examination of the patent application to only start-ups or, an application where India was indicated as the competent International Searching Authority (ISA) or elected as an International Preliminary Examination Authority (IPEA) in the corresponding International Application. Subsequently, the Patent Amendment Rules, 2019 created a new criterion benefiting the foreign applicants seeking an early disposal of their patent application. Essentially, an applicant shall be able to avail the option of filing a fast track patent application in India provided India has executed an agreement with the country of origin of the patent application, provided it meets the patentability requirements under the Indian patent system. Additionally, it created 7 more such categories to encourage the small entities and the government institutions.
The Bilateral Patent Prosecution Highway Program between the IPO and the Patent Offices of other interested countries was approved on 20 November 2019. The programme is likely to reduce the disposal time and the pendency of patent applications, while not compromising on the quality of the examination process. It aims to act as an opportunity for the Indian inventors (including MSMEs and Indian start-ups) to get an accelerated examination of their patent applications in other countries.
The IPO began its pilot programme with the Japan Patent Office and signed a joint PPH agreement for a period of 3 years, with an aim to modify the Indian patent architecture and attract more inbound investments and innovations from Japan, and also introduce newer technologies and increase employment opportunities. The examination time of a patent application is expected to be reduced to 12-16 months by March 2021 due to this program.
The success of this program will encourage other countries to enter into a similar bilateral agreement with IPO to avail the fast track benefits in the grant of patent. However, critics have raised the issue of harmonisation and simplification of the Indian patent laws with countries such as Japan which do not have strict standards of what is patentable or not, thus raising various public health concerns.
The Way Ahead
While the governments across the world gear up to fight the long raging war against the COVID-19 pandemic, one must not overlook that the establishment of a robust medical fraternity is complimentary to a stronger IPR system, especially one which provides ease of access and affordable services to people. While the Indian government has been shy to stand strong against the international pharmaceutical monopolies, a public health emergency demands the IPO to take inspiration from its US and Russian counterparts to devise a fast track patent grant mechanism for the various inventions awaiting approval to ease the demands caused by the pandemic. Additionally, the IPO can also contemplate the launch of temporary Bilateral PPH programs (till the end of the pandemic) with other countries, to ensure the availability of international patents in the country. The government must take note of the quintessential measures adopted by the World Intellectual Property Organisation (WIPO) including a separate WIPO Patent Scope COVID-19 Index providing all the necessary technical resources for improving the detection, prevention and treatment of diseases such as the novel COVID-19 in an expediated manner. Furthermore, WIPO also launched a new “COVID-19 IP Policy Tracker” which will help the member states to be informed about the changes implemented by the worldwide IP community. It is imperative for the IPO to necessitate such breakthrough measures taken by the global IP community and ultimately urge generic Indian drug companies to peruse the same. The constitution of an Indian Patent Taskforce can be considered which is actively involved in the formulation of various voluntary license agreements by international pharmaceuticals companies with the Indian generic pharmaceuticals companies to ensure fair and reasonable pricing. While granting patents expeditiously will foster innovation in the country, devising public welfare mechanisms to alleviate the insufficient supplies of the necessary pharmaceuticals will help the government eradicate the pandemic effectively. Hopefully, the accelerated assessment mechanisms for granting patents might help partially answering the most asked question in everyone’s mind owing to the current crisis – When will COVID-19 related preventive drugs or vaccines emerge and what process is best suited for a quick availment of the same?
ABOUT THE AUTHORS
Anuja Chaudhury is a final-year law student of the BA LLB (Hons.) course from ILS Law College, Pune (graduating in 2020). She loves to explore new facets of law in her writings, and is interested in Competition Law, Intellectual Property Rights laws and Technology Laws.
Kunal Saini is an undergraduate student pursuing BBA LLB (Hons) from School of Law, Christ University, Bangalore. He is an ardent reader and his areas of interest lie in Dispute Resolution, Intellectual Property Rights Laws and Information Technology Laws.