By Shivani Pandey
Introduction
India and South Africa in recent times have emerged as the 2 nations who strongly advocate waiver on patent of Covid -19 Vaccines in order to provide for equitable access to the middle income and developing nations who have the required infrastructure, technology and sufficient resources to produce the vaccine but are unaware of the method and the process involved.
This move of the 2 nations which was moved in October last year acquired considerable support at the G7 summit concluded recently in the UK.
Thus, this article deals with the concept of patent and the conditions needed for a waiver.
What is meant by Patent?
Patent originates from a latin term “patere” which means “to lay open”. WTO defines Patent as a right granted for an invention in any field of technology, which is new, involves an inventive step and is susceptible of industrial application.[1]
It is a kind of Intellectual Property Right that guarantees the creator the legal right to prevent others from making, using or selling his creation for limited but justified period of time frame. In America this period normally lasts for 20 years.
This benefits the creator as it completely negates the chances of Competition and is seen as a huge competitive advantage limiting others in the market from creating something of a similar kind thus safeguarding the Interest of the creator in the best possible way.
A patent does not necessarily authorize anyone to sell an invention rather than within safe ambit of protection of law it prevents others (except for the creator of this IPR) from making, using, selling, offering to sell, or import the patent invention for a period that usually extends to 20 years from the date of filing contingent upon the payment of maintenance fees.
Like any other property right, Patent can be sold, mortgaged, licensed, assigned or transferred given away or simply deserted depending solely upon the discretion of the creator.
What are Patentable Inventions?
As per WTO the subject matter of an invention protected by a patent may be a product (e.g. a device, substance, composition, biological material) or a process.
The subject matter protected by a patent may also be related to:
- A product consisting of or containing biological material;
- A process by means of which biological material is produced, processed or used;
- A biological material isolated from its natural environment or produced by means of a technical process, even if it previously occurred in nature.
For the purpose of this Law, biological material shall mean any material containing genetic information and capable of reproducing itself or being reproduced in a biological system (e.g. micro-organisms, plant and animal cell cultures, sequence of genes).[2]
Can a Patent be Challenged?
A Patent is not something absolute and can be challenged on different grounds in court ranging from:
- The claimed topic was not a patentable subject in 1st place.
- The claimed subject matter wasn’t de novo.
- It was very evident for a gifted individual in that stream/workmanship at the hour of petitioning for a patent.
- Some sort of misrepresentation was included during the filing of patent concerning reference of creators or other significant individuals involved in the process or at the time when things were discovered, etc.
Patents can be declared as invalid on grounds of any of one mentioned above, a blend or all.
Enforceability of Patent
Patents are generally enforced through civil lawsuits where the patent owner is entitled to monetary compensation and injunction prohibiting others from making something of a similar kind.
Patents are enforced on a national basis for example the making of an item in India, that would infringe U.S. patent, would constitute infringement under U.S. patent law only if the items are imported into the U.S
Does huge Royalty or Compensation allure the Patent Owner?
When the owner of the patent agrees to provide the licensee the allowance to make, use, sell or import the claimed invention generally in return of a heavy “royalty or compensation” a patent licensing agreement is said to take place it is seen quite often in complex technical fields.
It also helps build a mutual beneficial “business relationship” where both parties benefit from the agreement. When without authorization from the patentee a third party makes, sells or uses a patented invention he is said to commit patent infringement.
Laws on Patent by the World Trade Organization
According to the TRIPS (The agreement on trade related aspects of Intellectual Property Rights) all the 159 member countries should have patent available at their disposal in all fields of technology provided that they are latest, involve a creative step and are efficient enough for Industrial application.
TRIPS provides exclusively that the term of protection should be a bare minimum of 20 years.
The status quo with reference to patent waiver for Covid-19 Vaccines
The proposal moved by India and South Africa requesting Patent Waiver ie relaxation in the patent norms has garnished support worldwide in the recent times in order to ensure availability to the world at large and wants for the waiver to remain valid for a bare minimum period of 3 years from the date of the decision.
The present secretary general of the United Nations Antonio Guterres although stands in favour of the patent waiver but has warned on the fact that “technology transfer must be backed up by technical support”.
The United Nations has continuously highlighted the fact that “the existing discripancies in vaccination between nations has allowed for the virus to mutate and develop new and even deadlier variants”. While the diplomats negotiate the virus mutates.
The Biden Administration came into intense pressure when it came to deciding their stand whether they supported waiver on patent for the covid vaccines or not despite the big pharmaceutical companies constantly lobbying against the government on supporting the stand of granting Patent Waiver Biden administration stands in the favour of Patent Waiver.
Surprisingly, Bill Gates who is known worldwide for his Philanthropic initiatives strongly condemned granting of patent waiver owing to his personal interest in Pharmaceutical Industry.
Wealthier Nations Exploiting the Global Power Dynamics?
United Nations has stood out as a big supporter of temporarily putting a hold on Intellectual Property Protections for COVID -19 Vaccines, in the backdrop of recent fall of events the need for ramping up the production of Vaccine shots has gotten even stronger.
Brazil fears lifting of patent as the country does not have the required resources to produce the vaccine and wavering of patent protection could hamper Brazil’s efforts of purchasing doses from pharmaceutical companies.
France was among one of the earliest nations to permit patent waiver but Emmanuel Macron in light of the statement of big pharmaceutical companies stated that waiver on the Patent will not solve the burning issue of access to vaccine for low income nations countries like Africa are not equipped with the required resources and infrastructure to develop vaccine therefore for such nations donation of vaccines should be given a priority instead.
The stand of China and U.K are open to discussions.
Germany unequivocally stands firm against waiver of Patent a statement released by Angela Markel German Chancellor’s Office stated that “The protection of Intellectual property is a source of Innovation and must remain so in the future”
The licensed companies for COVID-19 Vaccines which are: Pfizer, Johnson and Johnson, Moderna and AstraZeneca. Moderna byfar has emerged as the only company who stated that it would not go about rivals for patent infringement in the ongoing pandemic.
The big pharmaceutical companies have stated that these protections have allowed them to develop the vaccine in a jiffy and kept their morals high.
The International Federation of Pharmaceutical Manufactures and Associations in recent statement stated that “A waiver is simple but the wrong answer to what is a complex problem. It will neither increase production nor provide practical solutions needed to battle Covid-19”
What is the need of Patent Waiver?
It would be an essential 1st step but not the ultimate solution
The disappearance of legal barrier would help the governments of middle and low income countries to involve 3rd party manufactures and speed up production and save lives.
Wealthy nations have already bought huge amount of vaccines from the pharmaceutical companies aggravating the situation for the low and middle income countries by robbing them of opportunity to procure vaccines and safe lives. As of now the waiver if granted is only expected in 2022
Will granting of Patent Waiver solve Problems?
Granting of Patent Waiver wont miraculously solve the problem of vaccine deficit and produce vaccines. The shortcomings are as follows:
- Technology
- Infrastructure
- Resources (mainly in low and middle income countries)
- Manufacturing Capacity
Lawrence Gostin, director of the O’Neill Institute for National and Global Health Law at Georgetown Law, said “the waiver is essential yet scarcely adequate.” It will probably require a long time of worldwide infighting before the proposition would produce results, he said, months during which would-be makers would not have the right to produce vaccines.
There are at the moment no conventional vaccines essentially on the grounds that there are many cycle steps engaged with the manufacturing of vaccines, and a large number of designated spots for testing to guarantee the quality and consistency of manufacturing.
One may transfer the IP, however, the exchange of skills isn’t excessively simple and possible,” said Norman Baylor, who previously headed the Food and Drug Administration’s Office of Vaccines Research and Review, and who is currently leader of Biologics Consulting.
Using messenger RNA technology requires exceptional expertise in the field difficult for even the established manufacturers to use.
Conclusion
The last Pandemic to hit us was The Spanish flu which lasted for about 2 years (February 1918- April 1920) and shook the world in 4 consecutive waves but no vaccine could be developed to counter the effect rather traditional medicines and all sorts of random medicines like epsom salts, castor oil, digitalis, asprin were resorted to.
Fast forward a hundred years another Pandemic shook the world but thanks to the technological advances and new heights humans have achieved in the field of science and technology we have been able to develop vaccine to counter the effect of the deadly Corona virus that is mutating at a fast rate and turning even deadlier every single day.
But of what use is the vaccine of it cannot not be distributed equitably? The debate over relaxing the Patent rights internationally has gained considerable momentum since the question now has come down to survival. The huge Pharmaceutical companies are lobbying against the grant of such Patent waiver as it would stand in the way of the economic Prosperity the Vaccines they have developed come along with.
Nations are buying vaccines despite the possibility of political entanglements interfering and exacerbating this international public health crisis, access to a life-saving vaccine should be determined keeping equity and medical necessity in mind rather than national wealth or international influence.
The Patent Waiver will have a great impact on countries like India as it could open new doors towards the development of Vaccine on home grounds and save lives. Who knows what tomorrow will bring and this Patent waiver could be a breakthrough in the field of medicine for developing nations like India.
References
- Patent Laws from WTO Available at: wto.org/english (Last visited on 3rd July 2021) ↑
- Patent Laws from WTO Available at: wto.org (Last visited on 3rd July 2021) ↑