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News article18 November 2021European Innovation Council and SMEs Executive Agency

Dispute over Moderna’s patent and Pfizer licensing agreement

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OWNERSHIP DISPUTES OVER MODERNA’S VACCINE

The pharmaceutical company Moderna Inc., well-known for its Covid-19 vaccine, reportedly filed the related patent application at the United States Patent and Trademark Office, without mentioning the names of three United States government scientists, working for the National Institutes of Health (NIH) and who took part in developing the above-mentioned vaccine. 

The scope of patent protection is to grant an exclusive right over an invention, in this particular case a vaccine, for a limited period of time, in order to exploit it and obtain economic benefits. In this way, the owner of the patent can prevent others from using its vaccine without permission – keeping in mind that the patent is usually owned by the inventor, or in many cases by the inventor’s employer. This dispute over the inventorship of the vaccine could therefore imply that the intellectual property rights over the vaccine may have to be shared between Moderna and the US government. In such a case, if the three NIH scientists were finally recognised as co-inventors of the vaccine, the NIH would be considered as co-owner and as such could grant licensing agreements without requiring Moderna’s authorisation. This could in turn have important repercussions on the vaccine’s availability worldwide, especially in least developed regions.

The three scientists collaborated with Moderna’s researchers in developing the principal patent application, the messenger RNA (mRNA), consisting in the concrete genetic sequence that allows the vaccine to generate an immune response in our body. 

On the one hand, Moderna has recognised the collaboration and contributions of the three NIH scientists for developing the formula, but does not consider them as co-inventors, since it claims that the sequence for the mRNA was achieved by its own scientists.

On the other hand, the NIH representative argues that the three US scientists played a substantial role in developing the crucial elements of the genetic sequence. 

The dispute has just started and, for the moment, the patent application has been filed but the patent has not been issued. If the current dispute results in a situation of co-ownership of the vaccine between Moderna and the NIH, additional licensing agreements could be signed, affecting the availability and price of the vaccine. 

This case is a vivid illustration of the fact that inventorship and IP ownership issues may have global repercussions – here, in terms of access to the vaccine at a global scale.

 

PFIZER LICENSING AGREEMENT FOR COVID-19 ORAL PILL

Early this month, the pharmaceutical company Pfizer announced the creation of an oral medication pill for the treatment of Covid-19. While the clinical trials are still going on and the company is waiting for the regulatory approval, they already announced the adoption of a licensing agreement, to expand access in less developed countries. 

As mentioned above, Pfizer has signed an agreement in order to sub-license the manufacture of the antiviral treatment Paxlovid. The licence has been granted to the Medicines Patent Pool (MPP), a United Nations-backed international organisation created by Unitaid, whose mission is to enhance developing countries’ access to these medicines, as well as to push their manufacture. It is a way for pharma companies to license their life-saving treatments and to facilitate additional production and distribution of the generic compound, facilitating a worldwide access. 

The MPP will therefore provide sub-licences to the sub-licensees that expressed their interest to manufacture and sell the product. Further information on how to get a licence at the MPP can be found here.

This licensing agreement grants royalty-free access in all countries covered by the agreement, concretely 95 countries, meaning that Pfizer will not receive royalties on the pill’s sales, as long as the Public Health Emergency of International Concern persists. 

The main advantage of this treatment is that it reduces the reaction time, meaning that it can be prescribed to patients from the first symptoms, or first awareness of an exposure. As a consequence, a significant reduction of 89% in the hospitalisations and death rates due to Covid-19 has been demonstrated.  

Moreover, it can be stored at room temperature, meaning that it does not need any specific refrigeration conditions during its transportation and distribution, making it accessible to a bigger volume of the world’s population.

Pfizer is not the first pharmaceutical company to take steps towards the licensing of its products in the fight against Covid-19. Actually, its competitor Merck & Co signed a deal last month with the MPP, in order to allow manufacturers in developing countries to have access to its own covid pill molnupiravir. 

The license of Paxlovid, when approved, could make the difference in the fight against Covid-19, allowing low- and middle-income countries, with low vaccination rates, to benefit from this generic medicine, and consequently, saving lives. 

 

 

 

Details

Publication date
18 November 2021
Author
European Innovation Council and SMEs Executive Agency