A patent is a powerful intellectual property right that grants an inventor an exclusive monopoly for a certain period of time given by the government. It establishes a legally enforceable right to prohibit others from stealing the innovation. Patents may be divided into two categories i.e. product patents and process patents. A patent which is given for product protects the rights to the finished product, and anybody who is not a patent holder might be barred from producing it for a certain amount of time, even if they employ a different procedure. A process patent allows anybody, not just the patent holder, to make the protected product by altering specified production procedures. In the 1970s, India switched from product to process patenting, allowing it to become a major producer of generic medications on a worldwide scale and allowing businesses like Cipla to offer anti-HIV medications to Africa in the 1990s. However, owing to TRIPS Agreement requirements, India had to change the Patents Act in 2005 and transition to a product patents regime in the pharmaceutical, chemical, and biotech industries.
The waiver of intellectual property rights will eventually surrender ownership rights to the employer and function as a bill of sale. It is better to acquire a waiver to avoid a legal struggle. Moreover the IP waiver is not same as compulsory licence. The waiver should address the following points:
- Use that is permitted
- Royalties
- Other controversies
If exemptions are granted, vaccine developers will be required to share their expertise in the highly complicated manufacturing process. This is the first time a waiver of this nature has been approved. A decision that comes closest is from two decades ago, when WTO members approved a temporary waiver allowing impoverished nations to import low-cost generic medicines for HIV, TB, and malaria in the face of public health emergencies. That interim waiver was subsequently extended indefinitely.
At this critical time of Covid 19, the world is struggling to cope with the crisis. In order to meet requirement of vaccine, it is important that more number of companies get into vaccine manufacturing which is hindered to a large extent due to existence of patents. At this time, it is imperative to maintain balance between public health and patent rights and this has happened earlier also in the history. In this regard, India and South Africa presented an application to the World Trade Organization (WTO) in October 2020 for a patient waiver in connection to the prevention and treatment of Covid-19, including health items and technology. In May 2021, 62 co-sponsors, including India, South Africa, and Indonesia, presented a new plan. In June 2021, the European Union offered a counter-proposal proposing for a multilateral accord to promote Covid-19 vaccine manufacturing by licensing and abolishing export restrictions rather than suspending patents. New discussions will be based on that document and proposal from India and South Africa. On the revised proposal, the WTO’s TRIPs counsel agreed to begin text-based negotiations. The IP waiver might allow middle-income nations to produce Covid vaccines with emergency use authorizations (EUAs), such as those produced by Pfizer, Moderna, AstraZeneca, Novavax, Johnson & Johnson, and Bharat Biotech.
The majority of manufacturing is now concentrated in high-income nations, with middle-income countries relying on license or technology transfer agreements to produce. Pharmaceutical businesses argue that ramping up manufacturing capacity will take a long time, which is one of the reasons they oppose the move. The accord is likely to be the focus of the WTO’s next ministerial session, which will take place in late November.
India and South Africa have petitioned the World Trade Organization (WTO) in October 2020 to waive certain provisions mentioned in the “Trade Related Aspects of Intellectual Property Rights” (TRIPS) Agreement that might obstruct timely access to inexpensive medicinal goods to fight Covid-19. The nations had urged the Council for TRIPS in order to suggest a waiver on the implementation, execution, adoption of application, and enforcement of four articles of the agreement’s second part “as soon as practicable.” Copyright and associated rights, patents, industrial designs, and the protection of secret information are all covered in the section- 1, 4, 5, and 7. The proposal said that poorer nations “in particular” may confront institutional and legal challenges while utilizing TRIPS Agreement flexibilities.
Vaccine manufacturers like Adar Poonawalla of the “Serum Institute of India” (SII) stated that the DPA had prevented the export of plastic bags, filters, and specific media required in the creation of their version of the “Novavax vaccine”. The US had discovered sources of “particular raw material” that were “urgently” necessary for the development of Covishield, SII’s version of the “AstraZeneca vaccine”, and they would be “immediately” made available for India, according to the White House on April 25, 2021. Despite their continued resistance, the European Union, the United Kingdom, and Switzerland decided to participate in text-based negotiations for which a draft has been provided. Japan, Brazil, Australia, and a number of other countries agreed to participate in the negotiations in order to develop a means for adopting IP waivers as well as a deadline for doing so. However, the agreement is only for discussions. Because the WTO is based on consensus, any of the 164 member nations can veto a decision. Another question is whether the waiver would cover only vaccinations or will also include medications, treatments, and devices, as well as raw materials and inputs and technologies, in order to stop the spread of the coronavirus.
Other “serious obstacles” in scaling up manufacturing and marketing of Covid-19 vaccines, according to the “International Federation of Pharmaceutical Manufacturers and Associations” (IFPMA). These include trade obstacles, supply chain bottlenecks, raw material and ingredient shortage in the supply chain, and affluent countries’ reticence to share dosage with impoverished ones. The paucity of raw materials has become an increasing challenge when it comes to ramping up production; numerous firms rely on certain suppliers, and their options are restricted. Furthermore, utilizing rules like as the American Defence Production Act, nations like as the United States have prohibited shipments of essential raw materials required in the production of various Covid-19 vaccines. Some Indian businesses had to postpone the manufacture of Covid vaccines as a result of this. According to a story in the Financial Times, Mahima Datla who is the managing director of Biological E, which manufactures the J&J vaccine in India, US suppliers have advised worldwide clients they may not be able to fulfil their orders due to the Act.
A large number of nations are concerned about the sluggish rate of manufacturing, which they believe will not result in a large portion of the worldwide population getting immunized rapidly. The global economy would be unable to recover without effective immunization, affecting the lives and livelihoods of millions of people.
BY: Nikhil Verma, Kirit P. Mehta School of Law, NMIMS, Mumbai
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