A guide to patent waive off for Covid vaccines

Know everything about patent/IPR waive off for Covid vaccines!

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Bayslope MAY 2021

IPR Waive Off – Covid-19

INTRODUCTION WHAT IS IN THIS REPORT? Through this report, we are providing answers to most of queries that are coming up around the patent waive-off talks on COVID19 related patent assets. Bayslope team has done a detailed secondary research to identify what patent waive off is all about, what are the benefits, and its significance and the same is presented in the report.

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IPR Waive Off – Covid-19

What is COVID-19 patent waive off?

It is a proposal submitted by India along with South Africa at WTO (World Trade organization) to give access to covid19 vaccine formulations so that other countries can produce more vaccines to immune their population.

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IPR Waive Off – Covid-19

When was the request submitted?

The request was submitted first in Oct 2020

What is the status?

Currently, 120 members are in favor of relaxing patent/IPR limitation and remaining are yet to comment. Germany has outrightly rejected the waive-off proposal.

Where is the request submitted?

The waive-off proposal is submitted at WTO (World Trade organization) which is 164 members’ body.

What is WTO? It is an organization that administers complex trade rules among nations.

Who is in Favor so far?

US, Australia, France, Russia, and other EU members.

Who is Opposing?

Vaccine manufacturers are against the waive off.

Germany too is opposing the waive-off.

What is required for the waive-off?

It requires consensus of all 164 WTO members to approve the submitted proposal.

Is IPR a real barrier?

IPR is not the only barrier but yes IPR is one of the barriers that can significantly impact the availability and production of medical tools such as diagnostic kits, vaccines, and other medial accessories.

Top US companies

Vaccine

Pfizer, Moderna, Johnson Johnson, and AstraZeneca.

&

What's Moderna stand?

Moderna says that it will NOT file any infringement suits even if someone copies their patented formula for vaccines production during the pandemic.

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IPR Waive Off – Covid-19

How does Moderna stand help?

Their stand opens the door for other vaccine developers who might want to copy its vaccine and make it available to their population.

What is Pfizer’s stand?

Pfizer says it is “not at all” in favor of the waiver.

Do all WTO members have to agree?

Yes, all needs to agree, and a single NO would reject the proposal. In other words, the decision to waive the vaccine-related patents must be unanimous.

What will happen if it is waived off?

If waivers are approved, vaccine developers will have to share their know-how/knowledge base for the very complex manufacturing of covid vaccines.

What are alternatives to IPR waiver?

One approach could be to issue a compulsory license that essentially allows third-party manufacturers to make and sell other companies’ patented products such as drugs, vaccines etc.

The compulsory license can be applied in 2 ways: 1. Any WTO members can apply for the license, where a government the permits local manufacturers to produce a product (in this case vaccine, drugs, diagnostic kits etc.) without the consent of the patent owner for domestic consumption.

2. A government could apply for the license to export to a country that lacks the manufacturing facilities to provide for its domestic market.

How can patent waive off help India or pharma companies in India?

India or pharma companies can start manufacturing exact or copycat versions of some of the world’s leading Covid-19 vaccines, without the fear of any legal action such as infringement by manufacturers such as Pfizer and AstraZeneca.

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IPR Waive Off – Covid-19

Any companies building RNA/mRNA based covid vaccines in India?

Yes, Pune-based Gennova Biopharmaceuticals is developing messenger RNA (mRNA) COVID19 vaccine and there is a possibility that the company may benefit by patent waivers.

Who owns vaccines?

mRNA

BioNTech and the US company Pfizer jointly owns a patent on a vaccine.

How much time it can take?

Waiving the patent protections could take months or even years.

What are big pharma companies saying?

They say that waive off will not help much because making vaccines is much more complex

than simply following a recipe. It requires factories with specialized equipment, highly trained workers, and stringent quality control.

Can waive off help?

Waiving patent rights will not immediately help populations in need around the world get the vaccine any faster but it can certainly help access to all medical accessories that can help produce more vaccines based on the need of the country.

What is COVAX? It is a program built by WHO for vaccine supply to ensure poorer countries get fair vaccine supply to end the pandemic.

What is the practical solution?

As per many pharma companies, the immediate solution is to use existing manufacturing capacity and produce as many vaccines as possible in the short term.

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IPR Waive Off – Covid-19

Important statement from former FDA officials “There are currently no generic vaccines primarily because there are hundreds of process steps involved in the manufacturing of vaccines, and thousands of check points for testing to assure the quality and consistency of

One may transfer the IP, but the transfer of skills is not that simple,” said Norman manufacturing.

Baylor, who formerly headed the Food and Drug Administration’s Office of Vaccines Research and Review, and who is now president of Biologics Consulting.

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IPR Waive Off – Covid-19

One may transfer the IP, but the transfer of skills is not that simple

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IPR Waive Off – Covid-19

Two decades ago, WTO had passed a temporary waiver allowing poor countries to import cheap generic drugs for HIV, tuberculosis, and malaria amid health crises.

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IPR Waive Off – Covid-19

What’s India current Specific steps taken by India situation? to combat the pandemic situation!

While India being of the world’s largest pharma hub, specifically, Along with submission of IPR waive off vaccine manufacturers, but we proposal following steps are taken by Indian are falling short of vaccines due government: to multiple reasons: • Ban on vaccines exports • Huge and dense population • Importing vaccines from other countries.

• Only 2 pharma companies One example is the drug controller general are producing vaccines gave permission to Dr Reddy's Lab to • Export to other countries import Russian vaccine for emergency use • Vaccine demand is multiin India and the first consignment of fold greater than vaccine Russia’s single-dose vaccine, Sputnik has production. arrived.

• The government is proceeding with fasttracked emergency approvals for COVID19 vaccines from world leading companies including Pfizer-BioNTech, Johnson & Johnson, Novavax, and Moderna.

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IPR Waive Off – Covid-19

What are Indian experts saying?

What are Indian experts saying?

As per Dr KV Balasubramanian, a vaccine industry veteran and life science industry consultant, "India has a reasonable knowledge base on vaccine platforms such as whole virion vaccines (inactivated or live virus), viral vectors and recombinant proteins". Here the patent waiver may not be of much help. The

technology that is used for producing mRNA vaccines is new for Indian developers and hence patent waive off might be useful for such technology.

Former Managing Director of India’s leading vaccine manufacturer - Indian Immunologicals Ltd (IIL)

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IPR Waive Off – Covid-19

What are benefits of patent waive off?

1. Companies will be able to manufacture more vaccines locally. For example, it can allow India and other countries to use vaccine formulation used in the US to produce more vaccines locally 2. One of the ways to produce cheaper vaccines 3. Easy accessibility to vaccines 4. Can help speed the end of pandemic

Current Challenges in producing more vaccines apart from IPR?

MANUFACTURING

RAW MATERIAL

KNOWLEDGE

Limited specialized manufacturing facilities

Shortage of raw materials, vials, stoppers and other components

Restricting technical knowledge required in manufacturing mRNA vaccines

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IPR Waive Off – Covid-19

PATH AHEAD While there are a lot of barriers for India to immune its huge & dense population and IPR is certainly one of the biggest challenges. While it is true that the WTO approval may take from days to months to years, but one can hope for fast approval on the proposal.

Till the time we have more tools and resources to immune our population, we should follow guidelines and precautions by respective authorities and government advisories.

Wear Masks

Sanitize Hands

Social Distancing

Stay Home

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IPR Waive Off – Covid-19

Have any Query?

We hope you find the information provided in the report relevant and useful. If you have any queries, Get in touch with our experts surbhi@bayslope.com.

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