You are a Business and Intellectual Property (IP) Director of a young biotech company headquartered in Cambridge, Massachusetts, U.S.A. Your company aims to develop vaccines to eradicate multiple diseases caused by viruses such as the SARS-COV-2 virus. Your company relies on a new technology, called synthetic messenger RNA (mRNA), to discover new, efficient vaccines to prevent diseases caused by viruses.

Both DNAs and RNAs are molecules comprised by strands. DNAs are double-stranded molecules containing a set of genetic instructions for the production of all varieties of proteins for the body. DNAs produce RNAs - single-stranded molecules, among which mRNAs, which carry a given set of genetic information from the DNA to ribosomes. The latter act as protein factories, producing the desired types of proteins according to the genetic information received (see image below).

Specific needs for proteins lead to different sets of genetic information being carried by mRNAs, which lead to the production of proteins for specific - and different - functions. The goal of the above process is to produce proteins, the very basis of life - they perform functions essential to the cells and are responsible for building, repairing and maintaining the various parts of the body.

Albeit the importance of stabilizing a coronavirus spike protein prior to its fusion with a human cell - so as to prevent structural rearrangement of the virus and enable the necessary production of viable antigens to induce strong immune response in a vaccine - the coronavirus spike is inherently unstable when isolated. The U.S. National Institutes of Health (NIH), an agency of the U.S. Department of Health and Human Services focused on medical research, was able to engineer a technology to "freeze" and stabilize the coronavirus spike protein before it is fused with human cells. It had done so prior to the advent of the current pandemic, filing and obtaining the registration of a patent for the application of this invention to be used for the MERS-CoV. At the beginning of the pandemic, NIH scientists filed a new patent application for the application of the same technology to the new SARS- CoV-2 virus (summarized here).

Your company identified and isolated a set of four human DNA gene sequences and corresponding mRNAs that lead to the production of different proteins relevant for the production of antigens for a vaccine, promoting a stronger immune response by the body. When the four different mRAs sequences isolated are synthesized in the laboratory, leading to a specific coding sequence designed by your scientists, the resulting synthetized/modified mRNA coding thread delivers to ribosomes an optimized protein code to be replicated by the latter, triggering a superior immune response from the body.

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You have to debate with a group of experts in your company what patents it will be applying for, and what measures it has to take in relation to overall IP protection.

You also have to reach a decision in relation to the best strategy to pursue for the development and commercialization of a new vaccine on a global scale.

In this regard, considering the limited size of your company, a start-up with 150 employees, you are aware of the fact that Article 31 and 31bis of the 1994 TRIPS Agreement(https://www.wto.org/english/docs_e/legal_e/31bis_trips_04c_e.htm) allows for the issuance of a compulsory licensing for patents, under certain conditions, by countries that are members of the World Trade Organization (WTO). Compulsory licensing allows governments to directly produce or authorize third parties to produce a generic version of a patented product or process, without the prior authorization of the patent owner. This governmental authorization can be provided without prior negotiation with the patent owner, in cases of national emergency, extreme urgency or public non-commercial use. This right is reaffirmed in the 2001 Doha Ministerial Declaration on TRIPS and Public Health. This Declaration confirms the right of countries to make use of compulsory licensing includes medicines, their right to freely justify the need for compulsory licensing and define what constitutes a national emergency. The Declaration includes public health crises (mentioning as examples HIV/AIDS, malaria and epidemics, among others) under the definition of compulsory licensing. Article 31bis of the TRIPS allows compulsory licensing to be granted also by governments that export drugs, when production capacity is lacking in the importing country. "Adequate remuneration" should still be provided by the government to the patent owner under compulsory licensing, albeit the term is not defined by the TRIPS. A government may resort to compulsory licensing if the patent owner makes available to the public a process or method in insufficient quantity, quality or high prices.

Your company already made it clear that it wants to prevent compulsory licensing in relation to your proprietary technology to be declared by any governments, as it could trigger a cascade effect of claims across countries and thereby weaken your patent rights.

You will have 30 minutes to read and debate in groups of 5 your answers to the questions below:

Questions (justify your choices):

1. What are the different experts within your company you should involve throughout the decision-making process before deciding what action you will advise the C-level management to adopt?

2. Can you file patent application(s) for the human DNA and/or mRNA isolated in your company's laboratory? Is there a difference between the U.S. and Europe in this regard? How will you choose to proceed with the filing(s), at the national level or via the Patent Cooperation Treaty (PCT)?

3. Can you file patent application(s) for the modified mRNA developed by your laboratory in Europe? And in the U.S.? How will you choose to proceed with the filing(s), at the national level or via PCT?

4. In relation to the technology used for the production of your vaccine, would you have to obtain any IP licenses? Please specify.

5. As a start-up, how could you ensure that development, production and distribution of the vaccine responds to a global demand? List a couple of alternatives available to accelerate and bring those processes into economies of scale.

6. How would you seek to charge for the vaccine based on your ownership of the relevant patents? As a patent owner, what alternative strategies could you consider and implement, so as to try to avoid the issuance of compulsory licensing by any governments?

Supporting readings (and video) to be provided to students for the case study:

https://www.modernatx.com/mrna-technology/science-and-fundamentals-mrna-technology

https://www.epo.org/law-practice/legal-texts/html/epc/2016/e/r27.html

https://www.epo.org/law-practice/legal-texts/html/guidelines/e/g_ii_3_1.htm

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3982540/

Compulsory licensing under the TRIPS https://www.wto.org/english/tratop_e/trips_e/public_health_faq_e.htm;

TRIPS Articles 31 and 31bis https://www.wto.org/english/docs_e/legal_e/31bis_trips_04c_e.htm;

and 2001 Doha Declaration on the TRIPS Agreement and Public Health https://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.htm

https://www.tesla.com/blog/all-our-patent-are-belong-you