30 November 2022

A COVID-19 patent update

In our Autumn/Winter 2021 edition of Inside IP, we looked at whether or not a patent waiver for COVID-19 vaccines might be effective and we explored both sides of the debate.

In the article, we concluded that in view of significant manufacturing challenges, and the need for any new party to conduct clinical trials, it would seem that a patent waiver/crown use/compulsory licensing would be unlikely to significantly speed up manufacture and vaccine inequality. At the time of writing the previous article, little progress had been made in reaching any World Trade Organisation (WTO) patent waiver terms.

However, in June 2022, the WTO announced a compromise text, striking a deal on a partial patent waiver for COVID-19 vaccines. The decision gained consensus among its members, including the United Kingdom and the European Union.

The agreement is narrower than the initial proposal made by South Africa and India in October 2020 and does not currently cover diagnostics and therapeutics. Thus, treatments such as antibodies and antivirals are exempt, as are COVID-19 testing kits. The waiver allows developing countries to authorise the use of patented compositions and processes for the manufacture of COVID-19 vaccines without the consent of the rights holder in order to produce vaccines for domestic markets and eligible countries. This will take place via a compulsory licence that will be obtained through an accelerated procedure. Patent holders will be compensated as compulsory licences guarantee royalties to their holders. The idea is to facilitate the obtaining of compulsory licences for certain patents, although this does require that member countries already have such a mechanism in their national laws.

The waiver covers a five-year period and states that the WTO will consider its extension to diagnostics and therapeutics within six months. The WTO Director General, Ngozi Okonjo-Iweala, argues that the compromise text will “contribute to ongoing efforts to deconcentrate and diversify vaccine manufacturing capacity.”

However, parties on both sides of the debate are unhappy with the present agreement. Some charities, such as Oxfam and Médecins Sans Frontières, and countries such as India, South Africa, Pakistan, Indonesia, Egypt, and Tanzania have argued that it does not go far enough and have called for it to be extended to diagnostics and therapeutics later this year. It is however noted that many COVID-19 treatments for example, are used to address other diseases. Meanwhile, The International Federation of Pharmaceutical Manufacturers & Associations has argued that it undermines innovation and rather than IP being a barrier, gaps in infrastructure and trade barriers are more significant reasons why vaccines have not been administered equitably worldwide.

While South Africa is pleased with the move, the government has also admitted that the manufacture of vaccines is a daunting task. “To scale up the production on the continent, further partnerships will be needed including access to know-how and technologies,” the South African government said in a statement.

We have seen wealthy nations discarding expired vaccines and developing countries turning down donations due to a lack of demand, so how effective the waiver will be remains to be seen. Its success may well rest on the willingness of rights holders to transfer their relevant know-how, particularly related to vaccine manufacture.
Waiver or no waiver, it seems that the COVID-19 vaccine litigation space is about to get very interesting. Platform mRNA technologies were patented many years before the pandemic and battles are breaking out.

In October 2020, Moderna announced that it would not enforce its patent rights pertaining to COVID-19 vaccines globally in order to allow the creation and distribution of vaccines during the pandemic. However, now that the crisis has diminished, Moderna has reversed this policy in developed countries. From March 2022, all IP rights were declared fully enforceable except in 92 low- and middle- income countries (known as Advance Market Commitment, or AMC, countries).

At the end of August 2022, Moderna filed a patent lawsuit against Pfizer and partner BioNTech related to their COVID-19 vaccine. The lawsuits, deposited in the United States District Court for the District of Massachusetts and the Regional Court of Düsseldorf in Germany, allege that mRNA technology Moderna developed before the pandemic, patents filed between 2010 and 2016, was copied . The lawsuits are seeking unspecified financial damages.

Moderna Chief Legal Officer, Shannon Thyme Klinger, is quoted as saying: “Outside of AMC 92 countries, where vaccine supply is no longer a barrier to access, Moderna expects Pfizer and BioNTech to compensate Moderna for Comirnaty’s ongoing use of Moderna’s patented technologies.” (Comirnaty® being the Pfizer/BioNTech vaccine that we have become so familiar with in recent times.)

“We are filing these lawsuits to protect the innovative mRNA technology platform that we pioneered, invested billions of dollars in creating, and patented during the decade preceding the Covid-19 pandemic,” Moderna chief executive Stephane Bancel says.

In Germany, Moderna has asserted EP 35 90 949 and EP 37 18 565.

Moderna’s press release states: “First, Pfizer and BioNTech took four different vaccine candidates into clinical testing, which included options that would have steered clear of Moderna’s innovative path. Pfizer and BioNTech, however, ultimately decided to proceed with a vaccine that has the same exact mRNA chemical modification to its vaccine as Spikevax®. Moderna scientists began developing this chemical modification in 2010 and were the first to validate it in human trials in 2015.”

It goes on: “Second, and again despite having many different options, Pfizer and BioNTech copied Moderna’s approach to encode for the full-length spike protein in a lipid nanoparticle formulation for a coronavirus. Moderna scientists developed this approach when they created a vaccine for the coronavirus that causes Middle East Respiratory Syndrome (MERS) years before COVID-19 first emerged.”

Moderna is only seeking damages, not an injunction, in order to maintain vaccine supply. The unspecified damages sought from Pfizer and BioNTech are to be calculated only from March of this year. Nevertheless, these figures would still be substantial, considering Pfizer projected its 2022 revenue to be approximately US$32 billion from Comirnaty® alone. Furthermore, no damages are being sought in relation to sales to AMC 92 countries.

Pfizer and BioNTech are expected to defend their position with BioNTech noting that “BioNTech’s work is original, and we will vigorously defend against all allegations of patent infringement. BioNTech also values and respects valid and enforceable intellectual property rights of others and remains confident in its intellectual property.”

Both Pfizer/BioNTech and Moderna are already facing other lawsuits relating to their respective mRNA platforms. Moderna is in an ongoing dispute with the US National Institutes of Health over the credit for key patents relating to mRNA technology and in July, German biotech company, CureVac, filed a lawsuit against BioNTech claiming it violated patents linked to the engineering of certain mRNA molecules. Pfizer and BioNTech quickly responded with a complaint in a US district court, seeking a judgment that they did not infringe US patents held by CureVac and, at the start of September, Pfizer and BioNTech filed proceedings at the High Court of England and Wales, seeking a judgment that their mRNA COVID-19 vaccine does not infringe CureVac’s European patents.

The litigation will be interesting to watch develop as such an order of magnitude and prevalence in the public domain are rarely seen.