Over the last two years global pharmaceutical companies Moderna and Pfizer have featured regularly in the headlines due to their breakthrough developments in the creation of COVID-19 vaccines. Both companies are once again in the spotlight. Moderna has raised an action against Pfizer and other rival drug company, BioNtech, claiming that they used certain key elements of technology which Moderna developed when creating its own COVID-19 vaccine.
Background
In 2010 and 2016 Moderna filed patents for its messenger RNA (or mRNA) technology. All three companies have used this technology to create their individual COVID-19 vaccines. In years gone by, vaccines were generally created by using parts of a virus to stimulate an immune response by the body. In contrast, in the case of mRNA technology the vaccine uses messenger RNA, which is manmade in a lab, to send genetic instructions that teach cells to make a protein or part of a protein that catalyses an immune response.
In March 2020, Moderna pledged not to enforce its COVID-19 related patents while the pandemic was ongoing. This was part of a wider worldwide undertaking by many pharmaceutical companies to refrain from enforcing their intellectual property rights in order to enable manufacturers from third world countries to produce the vaccines at reduced costs.
In March this year, the company announced that it would continue to abstain from enforcing its patents in low to middle income countries but that it expected rival pharmaceutical companies to respect its IP rights.
Moderna has confirmed that it is not looking to have Pfizer or BioNtech's vaccines removed from the market as it is arguable that doing so would hinder the progress of the world's vaccination efforts. However, they are seeking damages for alleged patent infringement.
Moderna is also itself being sued for patent infringement by two rival biotech companies, Arbutus Biopharma and Alnylam Pharmaceuticals. Both companies are asserting that Moderna used technology which they claim to have first developed to make lipid nanoparticles that are key to delivering the mRNA into cells. Moderna's position is that in this instance infringement was in fact permitted by the US government in a legal agreement which contained a clause allowing the government to waive patent rights for companies that develop goods during public emergencies.
Waiving IP rights in time of crisis
The decision by pharmaceutical companies, such as Moderna, to waive its IP rights are rare. Many argued during the pandemic that the scale of the problem warranted companies taking unprecedented measures (such as waiving their IP rights) to reduce any barriers to mass production of medicines, PPE and vaccines.
Patents confer an exclusive right of ownership and use over a patent holder's invention for a prescribed period. There was, therefore, concern that any companies who had patented technology which was crucial to the vaccine-making process would consequently obtain a monopoly on vaccine production as no other manufacturer could use their patented technology without their permission.
For this reason, many perceived IP rights as a barrier that would prevent smaller companies or manufacturers in poorer nations from being able to develop and deliver the vaccine. In an unprecedented move, many vaccine developers, such as Moderna, opted not to enforce their IP rights at the height of the pandemic to help accelerate the vaccine rollout globally.
In turn, the pandemic has highlighted that when global tech brands and pharmaceutical companies come together with a common goal, they can develop crucial technology more quickly than was previously thought possible, the COVID-19 vaccines being a prime example.
Following on from the pandemic and the holding of COP26 last year, there is an argument that a similar waive of IP rights should be exercised to catalyse the development of green technologies to solve the climate crisis.
However, large pharmaceutical and tech companies invest significant sums and years of research into developing new technology and manufacturing processes. Without the prospect of patent protection being available to help companies exercise exclusivity and maximise profit from their innovations, many brands may be disincentivised to develop new ideas or technologies. In turn, this may hinder competition, reducing the pool of talent and variety of company resources available to develop solutions to new problems faced by society.
Enforcement of IP rights
If you consider that your patent is being infringed, and you haven't agreed not to enforce your IP rights, then interdict can be obtained in the Scottish courts to prevent a competitor or any third party from performing, or continuing to perform, an activity which infringes your patent. It can can also be sought on an interim basis which would prevent any infringing activity from taking place until the dispute is resolved either through settlement or litigation. Compensation can also be sought, by way of damages, if your business suffers financial loss as a result of the infringement.
Moderna's dispute with Pfizer and BioNtech illustrates that, while the decision to waive IP rights may be taken in certain circumstances, it is still important for businesses to be cognizant of their IP rights and their ability to enforce them if circumstances change.
It is crucial for businesses to have a robust brand protection strategy and to enforce their IP rights when necessary. If you would like to speak to one of our experts about patent infringement, or IP protection in general, please get in touch with a member of the IP, Technology & Data team or your usual contact at Brodies.
