From Founders' Desk by Mr. Harsh Gupta, Founder, Lawsymptoms!
Abstract
The dispute between Moderna, Pfizer and BioNTech is important to decode as it involves the million-dollar stakes of the parties involved in the patent infringement case. Moderna is the plaintiff who sued Pfizer and BioNTech for using mRNA technology for the production of Covid vaccine under which three of its components are claimed to be infringed by the defendants. Furthermore, it is also a disputed fact that who owns mRNA technology is unclear. Various suits have been filed against Maridona for using patented technology for which no licence was sought.
The dispute is complex in the factual sense itself wherein a compulsory licence was granted by the US Government to produce vaccines as soon as possible. Furthermore, Mardona voluntarily issued a pledge under which it was proclaimed that patent rights will not be enforced during the pandemic. Defendant alleged that such issuance of the pledge itself amounts to an implied patent. Furthermore, the intention of the Plaintiff is to seek monetary compensation from the parties not to stop them from using the mRNA technology. While some argue that broad claims made by Moderna are false due to previous art. The dispute is still ongoing and its faith can have an impact on the future progress of medicines by using mRNA technology.
Keywords
mRNA Technology, Pfizer, Moderna, BioNTeach, patent, infringement
Introduction
A flexible vaccine technology with the potential to treat a number of diseases is the mRNA vaccine platform. Many nations and businesses throughout the world are interested in it since it has been hailed as the dawn of a new era in medicine. Who owns the mRNA and the lipids that coat the mRNA to permit transport, which is its two key components, is unclear. Over this new technology, several disputes on intellectual property rights are currently being waged. Moderna and BioNTech/Pfizer are involved in one of the major conflicts.
mRNA Vaccine platform
Vaccines are protectors against grey invaders in the human body. They do not cure the disease but their nature of work is precautionary as it prevents a body from various forms of outside attack. Attack in medical terminology can be the spread of deadly infection inside the body or harm caused by bacteria, viruses or other harmful chemicals. Sometimes these attacks are also termed bio-weapons. A normal response of a vaccine is to produce likewise bacteria or viruses inside the body and fight against them and subsequently trigger the immune response system. However, vaccines may cause various side effects from mild fever, and drowsiness to various allergic reactions. Usually, in common practice, a vaccine contains weakened or dead bacteria or viruses but with the evolution of technology and the advent of technical instruments scientists have been able to produce vaccines under which a molecule is used instead of part of an actual bacteria or virus known as Messenger RNA wherein RNA stands for Ribonucleic Acid. The speciality of mRNA is that it does not enter into the nucleus so there is no chance of alteration of DNA. It is a kind of RNA which is responsible for protein production, it quickly breaks down once the process of making protein by cells ends.
Legal Dispute between the parties
The legal dispute revolves around who owns the intellectual property rights over the most lucrative technology i.e. mRNA technology and more precisely its components. Moderna in August 2022, instituted a suit against two giants Pfizer and BioNTech for infringing three out of eight patents which are protected in the US Patents Office as eight different articles under the name of mRNA-1273 COVID-19 VACCINE called Spikevax.
Moderna’s Standpoint
Historically, Moderna was founded as a small research-based startup and mRNA technology was its subject matter in 2010. It claims to be the first research institute that used mRNA technology to build medicines long before COVID-19 emerged and there was no other research carried out by any other company. There were certain technical challenges it faced during its effort to conduct successful research and make good medicines out of it but eventually, it succeeded. Furthermore, the covid vaccine which was developed by Moderna named Spikevax has eight patents registered in its name and it is alleged that out of eight patents, three patents have been infringed by Pfizer and BioNTech. The objective of Moderna in filing the suit was pretty clear, it was not to stop them from functioning or using its patents but seeking compensation from them. Moderna further alleges that no licence has been sought to use the alleged patents and that is why it amounts to infringement. As far as the nature of the three patents is concerned, it covers how modifying the chemical structure of mRNA has stabilised it through novel ways and furthermore, how the mRNA platform was optimised through identified ways which eventually lead to the development of new techniques on a larger scale.
Patents were granted on two novel grounds are, first, in order to minimize immune response against mRNA itself, technology and efforts were made to replace uridine with 1-methyl pseudouridine to fight against mRNA itself and another ground was finding out the efficacy by producing neutralising antibodies through encoding a full-length coronavirus spike protein in a lipid nanoparticle formulation.
Despite that Moderna was able to produce the vaccine at a very fast pace, the factor which was responsible for such a pace was the grant of compulsory licence by the USA as per the reports published in The Intercept so that as soon as the genomic sequence of SAR-COV-2 was published, Moderna already conducted its clinical trials on six patients for various infectious diseases even before covid arrived. Compulsory licensing is a way of authorisation by which in case of emergency government has the power to grant such a licence under which the party does not need prior permission or authorisation or licence from the patent holder to use its patent and it serves the public health objective when the national health infrastructure is at stake. In the present situation, the objective was to produce the COVID vaccine by using the already existing technology so that time can be saved and utilised in further research.
As of now, the situation is normal the notion should be to apply for the licence rather than keep infringing the patent rights of other patent holders. Recently, Arbutus Biopharma Corp. and Alnylam Pharmaceuticals Inc. filed an infringement suit against Moderna against the use of lipid nanoparticle technology. However, the response of Moderna to the above-mentioned plaintiffs was that it sold its vaccine to the US government on the basis of an executed contract between the Government and Moderna as part of its contractual obligations. Technically, the suit should be filed against the government itself, not Moderna.
Pfizer and BioNTech Standpoint
Moderna in its suit in paragraph no. 83 claimed that the ‘574 patent has been infringed and also the nature of infringement is either literal or as per the doctrine of equivalents it includes making, using, selling, offering for sale, and/or importing of its vaccine which further violates 35 U.S.C. § 271(c). The joint response of Pfizer and BioNTech was that it is an attack on the hard work put forth by the various Scientists also mRNA technology is not new and it is evolving ever since the 1970s. Long back in the mid-2000s, the University of Pennsylvania found that in order to restrain the immune response by the body against foreign invaders mRNA itself, chemical modification and high-performance liquid chromatography can be used and eventually they got patented this discovery and a patent was issued as Patent no. 966. Further, it is alleged that Moderna claims exclusive rights over the same modification but in reality, the discovery was made much before the patent was granted to Moderna.
Even Moderna itself got the licence from Cellscript LLC-University of Pennsylvania for their mRNA technology and as a result, in this process, they also learnt the purification techniques.
Furthermore, Moderna in its suit in paragraph no. 105 and paragraph no. 125 alleged that the 600’ Patent and the 127’ Patent have also been infringed. Again, this contention of the plaintiff has been refuted jointly by Pfizer and BioNTech. Lipid nanoparticles are responsible for the delivery of mRNA structures into cells and Moderna establishes its arguments on the false claim as it is evident from the fact that international patent application no. 2010/144740 and in the 966 patent, it is already disclosed the same components and ratios of the LNP technology as claimed by Moderna. Modern is at top of the iceberg claiming infringement of that patent for which they are themselves being used.
Furthermore, as far as the encoding of full-length protein spike is concerned for which Moderna is claiming to have exclusive rights over it, again it’s not something new considering prior knowledge among the scientists about the efficacy of the same before Moderna got a patent over it.
Implications on the world & the way forward
There have been various concerns over the ownership of mRNA Technology. Many are of the opinion that nobody owns it but it is a gift to the whole world. Some are of the opinion that Moderna will fail in its attempt to claim compensation for its patent infringement claim because of the prior art. As far as the way forward is concerned, in common parlance, a licence should be obtained from its patent holder but it is not possible considering dispute regarding ownership still persists and when multi-billion dollars are at stake for all the parties, such suits get dragged for years. Furthermore, even if the parties take risk of taking licensing from one claiming to be the owner of patented technology, that licence may have no validity considering the factor of ownership itself in dispute. This dispute should get settled as soon as possible in the general interest and also in the parties' interest. One way forward is that the US Patent Office itself should decide the case instead of the courts through simplified intes partes review.
Furthermore, as far as implications on the world are concerned, it is not just about patent infringement on covid-vaccines but the components involved in mRNA technology itself as it has great potential to treat several other deadly diseases such as Cancer. The qualitative analysis of the mRNA technology depicts that its efficient use leads to low-cost manufacturing and has the capacity for pacy development in the field of research which can impact the health infrastructure manifoldly around the world.
Due to its effectiveness, the potential for low-cost manufacturing, capacity for speedy development and safe administration, mRNA vaccines have been prophesied to be a promising alternative to conventional vaccine approaches. The facility to make mRNA can also be used for vaccines for different diseases making manufacturing flexible.
Conclusion
When COVID-19 emerged, Madrona voluntarily took a pledge under which it specifically emphasised the fact that it will not enforce its patent rights. In one way, it was an implied way of granting licences to all the pharma companies involved in the making of COVID-19-based vaccines. Subsequently, in March 2022, it revoked its pledge and soon after the suit was instituted against Pfizer and BioNTech. It was further alleged that the pandemic was still not over, and the pledge was made for the duration of the pandemic, therefore, it will amount to the grant of an implied licence.
The author is of the opinion that none of the parties affirmed their stand. At one point, there is the denial of any such infringement of patent rights of Moderna by Pfizer and BioNTech and on the other hand, they claimed that an implied licence was issued in the form of the pledge by Moderna.
The author finds out a few issues which the readers must ponder upon. First, whether any issuance of the pledge in general interest will amount to an implied licence and if yes, then what will the repercussions be once the pledge is revoked without giving any prior warning or notice? Second, whether in the case of a dispute concerning ownership over certain technology, herein, mRNA platform components, what methods should be used where the doctrine of equivalence is of less use technically or should the patent office itself hold ownership and grant licence and whether doing the same will not violate the fundamental principles of patent laws.
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