PROCESS FOR REGISTERING CORONA VIRUS VACCINE UNDER IP LAWS

“This outbreak is a test of political, financial and scientific solidarity for the world to fight a common enemy that does not respect borders… what matters now is stopping the outbreak and saving lives.”- Dr Tedros, Director General, WHO

Being declared a Public Health Emergency of International Concerns, COVID -19 has unleashing effects on life, health, property, business and indirectly everything. Due to it’s rapid spread, the virus has led experts to declare that it will continue to spread if it is not well contained. In such a scenario it has become imperative of the world leaders to develop a vaccine which serves as a bullet proof treatment to this fatal disease. This paves an entirely new way in patent and intellectual property rights since it is a major concern that what shall be the guidelines for patenting the vaccine for COVID -19.

The laws related to IPR and patenting vary significantly from place to place and are usually dependent on the laws of the land. However, they are coherent with the TRIPS agreement for those countries which ratified it.

Being considered as the most important necessity of this time, the patent rights for the formula and the process for the development of vaccine cannot be absolutely governed by the TRIPS agreement since it prevents other companies from using the same formula for the successful development of the drug for certain time period. However, it is also important to give due recognition and monopoly to the pharmaceutical company which makes the most important invention of the time. Therefore, a balance should be struck between IP laws and doing public good.

Many companies world wide are racing for the successful development of the vaccine witht the hope that they might be the company to own the rights over the production and sell of the vaccine by way of a patent. In the context of pandemic, the provision of exclusive rights to any one party poses a conflict with the state’s public health commitment to immunize as many people as possible.

WHY ARE PATENT RIGHTS PROVIDED FOR DRUGS AND VACCINES?

A patent is a government endorsed, limited term monopoly to a certain company on an invention that excludes others from manufacturing and selling it. The monopoly and recognition by a patent encourage innovation which in turn benefits the wider public as the invention passes on to the public domain. It is though that without these incentives, the inventors will not be interested to invest their time, money and efforts on new ideas. This patent economics is equally applicable to pharmaceutical industry which is responsible for manufacturing drugs and vaccines. By preventing the pharmaceutical company from receiving their due rewards, the state as well it’s citizen run a risk of obtaining quality cure to suddenly occurring disease.

CRITERIA FOR REGISTERING FOR PATENT OF A VACCINE.

1. PATENTIBILITY CRITERIA

Inventions claiming biological entities like antigens/ antigen binding fragments without any modifications, isolated antibody, host cells, cell lines comprising novel nucleic acids, virus like particles, etc. are considered to fall within the scope of section 3(j) and hence, not patent eligible subject matters. The three statutory requirements for the patentability are: Novelty, Non-obviousness and Industrial Applicability. Further, Sections 3 and 4 of the Indian Patents Act determine whether the invention relates to a patentable subject-matter. Drugs and vaccines are non-biological entities. Therefore they come under the purview of patenting.

2. Novelty

Novelty is an important criterion in determining patentability of an invention; novelty or new invention is defined under 1Section 2(l) of the Patents Act as “any invention or technology which has not been anticipated by publication in any document or used in the country or elsewhere in the world before the date of filing of patent application with complete specification. For the Novelty, the vaccine must be new, i.e., shall not have been disclosed or made available to the public by any means prior to the filing date of the patent application. This implies that patent protection will not be granted if, for example, it was previously deposited in a public collection.

3. INVENTIVE STEP

Inventive step is defined under Section 2(ac) of the Patents Act as “a feature of an invention that involves technical advance as compared to the existing knowledge or having economic significance or both and that makes the invention not obvious to a person skilled in the art”. The development of vaccine must contain inventive step and must not be obvious to a person skilled in the same field, which means that, having regard to the state of the art, it must not be obvious to a person skilled in the art.

4. INDUSTRIAL APPLICATION

Industrial applicability is defined under 1Section 2(ac) of the Patents Act as “the invention is capable of being made or used in an industry”. This essentially means that the invention cannot exist in abstract. It must be capable of being applied in any industry. The strain of the virus must be capable of industrial application, i.e., it can be used in any kind of industry. If the virus is defined by its genomic sequence, the patent application must describe a specific, substantial and credible utility for this sequence, for example, for the production of a vaccine. It is not enough to make a speculative reference regarding its possible uses. When a gene sequence is used to produce a protein, it is necessary to specify which protein is produced and what function it has.

GENERAL PROCESS OF USING PATENT PROTECTED VACCINES

The most common way of using a patented vaccine is to licence the invention to a third party on a non-exclusive basis such that they may also produce the invention and procure financial gains from it. Most often, this licence is provided in exchange of a royalty fee which is decided by the inventor. However, sometimes the company donates it’s patented drug for public good as was done by Volvo which believed that it’s three-point seat belt was such a significant contribution to the society that they should not keep it to themselves. The patent lapsed in 1970 but this commercial sacrifice demonstrates that the right to exclusion can be waived at the discretion of the inventor.

For a vaccine, as important as this, given the number of people that require the immunization, it is not practically possible for any one drug manufacturer to produce the required quantity in short span of time. Therefore, the inventors would license their biologics to several manufacturers who may fulfil the requirement at local level. A state can also select its own licensed manufacturers of the vaccine which hallows for lower cost per unit or more responsive supply of this vaccine to meet the domestic needs.

Governments may encourage such an approach and reward fair monetary incentives for the inventor to continue the development of research.

PROCEDURE SUGGESTED SPECALLY FOR THE PATENTING OF VACCINE FOR CORONA VIRUS

In response to the global race to combat the Covid-19 pandemic, the World Health Organization along with European Union embraced a proposal to create a voluntary pool to collect patent rights, regulatory test data, and other information that could be shared for developing drugs, vaccines, and diagnostics. The notion was raised several weeks ago by Costa Rican officials amid mounting concern that some Covid-19 medical products may not be accessible for poorer populations. By establishing a voluntary mechanism under the auspices of the WHO, the goal is to create a pathway that will attract numerous governments, as well as industry, universities and non-profit organizations. This movement calls on organisations to freely make available their existing patents and copyrights associated with vaccine research to create an open patent pool to solve a global problem

“the idea is to make available for everybody around the world the different advances and innovations and put those into service at lower costs to protect people. This is a call for solidarity and a call for global alliance.”

– Costa Rican

CONCLUSION

In a race among countries to develop the vaccine, issue of pharmaceutical patent protection has been raised to the heights of the global discussion on future of free trade initiative. It is important for the vaccine community to provide technical support to developing country governments in the creation of IP laws that not only support innovation and respect international law but also safeguard public health access against unmerited patents. Indeed, as has been demonstrated in other disease areas where patents have posed problems to access, creating patent laws with stricter patentability criteria that weed out low quality patents can help remove some of the barriers. It is suggested that improved transparency around patenting of vaccine technologies, stricter patentability criteria suited to local needs and strengthening of IPRs management capabilities where relevant, may be necessary in order to reduce patent related impediments. Greater attention to these issues through technical support in IP management and FTO analyses, monitoring developments in the industry and sustained engagement with stakeholders for systematic need assessment and identifying solutions can help encourage a competitive supplier base for quality vaccines at sustainably low prices.