Patent waiver alone is useless

There are three ways to overcome the problems we face in our anti-COVID battle

One of my close friends called me a few days ago to discuss his refurbishment amid a surge in demand for vaccination. Indian policymakers are looking for all possible options to increase supply. The main obstacle to this method is intellectual property rights (IPRs) related to new drugs that are primarily discovered and developed by multinational pharmaceutical companies. For example Kobi Shield Discovered and developed by AstraZeneca in collaboration with Oxford University. The license for its manufacture was granted to the Pune-based Serum Institute of India (SII).

The most important of these rights are related to patents. A patent granted to an innovator for a new drug provides a period of “market exclusivity” in which no other company can manufacture or sell the drug without the prior consent of the patentee. In the case of Covishield, only SII has a production license and the royalties are quite high. There are three ways to overcome these barriers. First, Compulsory License (CL) —the flexibility available to developing countries under the TRIPs Agreement — allows generic companies to manufacture and sell patented products without the prior consent of the patentee. I will. CL under the Indian Patent (Amendment) Act of 2005 is if the patentee has not taken steps to ensure that the product is available in “sufficient” quantities, or the claim price is “affordable”. In some cases, it can be issued for “private commercial use”. The government may also issue a CL citing the situation of “national emergency or public non-profit purposes”. However, this alone does not guarantee that they will be able to produce. Unlike generic drugs, vaccines are organic and making them is a completely different ball game. Even simple proteins (AstraZeneca vaccines are much more complex, including bioengineered adenoviruses that express the Sars-Cov-2 peplomer) are much more sophisticated and complex than drugs such as paracetamol, for example. ..

Generic manufacturers don’t give details about the ability to copy products and methods, so just looking at patents can’t give you a clue. Issuing CL allows governments to overcome patent barriers, but generic manufacturers still need to go to innovators to access their know-how. In addition to this, there is the issue of procuring the raw materials and other components needed to manufacture the vaccine. In the case of Covishield, we have already seen in the early stages how production was hampered by problems with raw material imports. This is when SII is licensed from AstraZeneca. What happens if I enter the inevitable conflict mode when a CL is issued?

The second option is to seek a temporary exemption from the TRIPS clause to deal with public health emergencies. India submitted a proposal with South Africa in October 2020 and has already received the support of the majority of member states, including the United States. If approved, this will give some companies global legitimacy for manufacturing vaccines without asking for innovator nods. But for now, the big question is whether the proposal will be completely cleared. The third option is “Voluntary License” (VL). This is a permit given by the patentee to a generic company to permit the manufacture of patented medicines. The license sets quality requirements and defines the market in which the licensee can sell the product. In the current crisis situation, VL provides the best way for Indian companies to not have to worry about technical know-how and raw materials.

(The writer is a policy analyst. The expressed views are personal.)