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The Conversation: How patent law and medicine regulations could affect New Zealand’s access to a Covid-19 vaccine

Prime Minister Jacinda Ardern speaks to a lab technician during a visit to the Malaghan Institute of Medical Research at Victoria University on August 27. Photo / Getty Images

By Jessica C Lai of The Conversation

New Zealand has allocated an undisclosed sum, in the order of hundreds of millions of dollars, to access Covid-19 vaccines when they become available.

The funding is on top of a $37 million vaccine strategy, but the government has not released specifics because of commercial sensitivities that “could prevent the best possible deal for New Zealanders”.

Apart from the intricacies of global efforts to develop, test and distribute a vaccine, there are also domestic legal issues the government might need to consider, particularly in patent law and the regulatory review of medicines.

Legislative changes to future-proof the law could avoid delays and lower access costs.

Patent law and access

Some fear pharmaceutical companies could patent a Covid-19 vaccine and hold the world hostage, demanding monopoly prices.

But to get a patent the invention has to be novel and non-obvious. There is possibly enough public information about vaccines currently under investigation or in trials to make it difficult for a company to prove novelty or non-obviousness.

Even if a vaccine were in some way patent-protected in New Zealand, the government is already negotiating for access.

If the negotiations fail or the prices demanded are too high, New Zealand law allows for compulsory licensing and Crown use of patented inventions. Both are also allowed under international trade law.

At the moment, an application for a compulsory licence is only possible after negotiations with a patent owner have failed and if three years have lapsed since the patent was granted (or four years since the patent application was filed). But international trade law states that any requirement to negotiate with the patent owner may be waived in the case of a national emergency or other circumstances of extreme urgency.

A model of a coronavirus is displayed next to boxes for Covid-19 vaccines at an exhibit by Chinese pharmaceutical firm Sinopharm in Beijing. Photo / AP
A model of a coronavirus is displayed next to boxes for Covid-19 vaccines at an exhibit by Chinese pharmaceutical firm Sinopharm in Beijing. Photo / AP

Parliament should consider amending New Zealand patent law to be clear that, in a national emergency, anyone can apply for a compulsory licence at any point, without the requirement to negotiate with the patent owner first.

Both international and New Zealand law allow pharmaceutical products manufactured under a compulsory licence to be exported to address a serious public health problem in another country. This might prove important for Pacific nations.

Government emergency access

Government departments can use patented inventions for the services of the Crown. This can be delegated, for example, to a local pharmaceutical manufacturing company.

In an emergency, there is no requirement for the Crown to negotiate a licence with the patent owner first. Nor does the Crown need to wait for a certain period of time to lapse.

This currently covers protecting New Zealand’s security or defence, or managing a state of emergency. A global pandemic can

How patent law and medicine regulations could affect New Zealand’s access to a COVID-19 vaccine

New Zealand has allocated an undisclosed sum, in the order of hundreds of millions of dollars, to access COVID-19 vaccines when they become available.

The funding is on top of a NZ$37 million vaccine strategy, but the government has not released specifics because of commercial sensitivities that “could prevent the best possible deal for New Zealanders”.

Apart from the intricacies of global efforts to develop, test and distribute a vaccine, there are also domestic legal issues the government might need to consider, particularly in patent law and the regulatory review of medicines.

Legislative changes to future-proof the law could avoid delays and lower access costs.

Patent law and access

Some fear pharmaceutical companies could patent a COVID-19 vaccine and hold the world hostage, demanding monopoly prices.

But to get a patent the invention has to be novel and non-obvious. There is possibly enough public information about vaccines currently under investigation or in trials to make it difficult for a company to prove novelty or non-obviousness.




Read more:
Whoever invents a coronavirus vaccine will control the patent – and, importantly, who gets to use it


Even if a vaccine were in some way patent-protected in New Zealand, the government is already negotiating for access.

If the negotiations fail or the prices demanded are too high, New Zealand law allows for compulsory licensing and Crown use of patented inventions. Both are also allowed under international trade law.

At the moment, an application for a compulsory licence is only possible after negotiations with a patent owner have failed and if three years have lapsed since the patent was granted (or four years since the patent application was filed). But international trade law states that any requirement to negotiate with the patent owner may be waived in the case of a national emergency or other circumstances of extreme urgency.

Parliament should consider amending New Zealand patent law to be clear that, in a national emergency, anyone can apply for a compulsory licence at any point, without the requirement to negotiate with the patent owner first.

Both international and New Zealand law allow pharmaceutical products manufactured under a compulsory licence to be exported to address a serious public health problem in another country. This might prove important for Pacific nations.




Read more:
Why ‘vaccine nationalism’ could doom plan for global access to a COVID-19 vaccine


Government emergency access

Government departments can use patented inventions for the services of the Crown. This can be delegated, for example, to a local pharmaceutical manufacturing company.

In an emergency, there is no requirement for the Crown to negotiate a licence with the patent owner first. Nor does the Crown need to wait for a certain period of time to lapse.

This currently covers protecting New Zealand’s security or defence, or managing a state of emergency. A global pandemic can trigger a state of emergency, as happened in New Zealand in March 2020. But to future-proof the law, parliament should consider amending the definition of “emergency” to specifically include health

Pfizer, BioNTech, Regeneron Hit With Patent Lawsuits Over COVID-19 Drugs And Vaccines

Three top names in the fight against the coronavirus and the COVID-19 disease that can result from it have been sued for patent infringement. The trio includes Regeneron Pharmaceuticals (NASDAQ:REGN), Pfizer (NYSE:PFE), and BioNTech (NASDAQ:BNTX). The plaintiff is privately held Allele Biotechnology and Pharmaceuticals.

Allele alleges that the three all used its mNeonGreen fluorescent protein to develop their COVID-19 products without paying royalties for the substance. Medical researchers inject fluorescent proteins into cells to track reactions within those bodies. This tracking is used to help determine the effect of medicines and vaccines on the body.

Regeneron is currently developing REGN-COV2, an experimental cocktail of two antibodies to treat COVID-19. The company became a hot topic last week when it was revealed President Donald Trump was administered REGN-COV2 as part of his treatment for COVID-19.

Pfizer and BioNTech have teamed up to develop a coronavirus vaccine; their candidate, BNT162b2, is considered one of the front-runners in the race to bring a vaccine to market.

mNeonGreen was allegedly used in both programs. Allele said in its complaint, filed in a California federal court, that “only through the use of mNeonGreen” were the companies able to develop their products with relative speed.

This, in turn, allowed them to be awarded “an immediate $400 million in grants and over $4 billion in sales of the vaccine to date,” although BNT162b2 has, like other candidates, not yet been approved for use by any major pharmaceutical regulator. Allele is seeking to recover the royalties for its product, although it wasn’t immediately clear how much it is requesting.

Regeneron said it disagreed with Allele’s complaint and would “vigorously defend” its position in court. Neither Pfizer nor BioNTech has formally reacted to the lawsuit.

This article originally appeared in the Motley Fool.

Eric Volkman has no position in any of the stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.

The Pfizer company logo is seen in front of Pfizer's headquarters in New York The Pfizer company logo is seen in front of Pfizer’s headquarters in New York Photo: AFP / Don EMMERT

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