How is a vaccine patented? This protects the rights of exploitation of an invention
While the pandemic caused by SARS-CoV-2 has half the world confined at home, scientific staff are tirelessly studying how to stop it. One of the main lines of work is the development of a vaccine. Although at the moment advances in this matter are in the clinical trial phase in humans, we wonder how your right to exploit it is registered? The Research Results Transfer Office of the Harvard University resolves issues such as what the process consists of, the duration of co-ownership between entities. Click here for more info https://www.jpost.com/special-content/hire-inventhelp-experts-for-patent-services-694280
What does patenting consist of?
Patenting means that the State (or a group of States) gives you the right to exploit an invention exclusively in its territory, that is, it gives you the right to prevent others from manufacturing, selling, or using the object of your patent, in the territory of the State that has given you that right and for a certain time: 20 years. If someone who is not the owner decides to exploit the protected invention, the owner must report it to prevent it. On the other hand, the owner of a patent can allow others to exploit his patent, always in exchange for something, and that something is usually an economic benefit.
The State grants you that exclusive right also in exchange for something: in exchange for you making the invention available to the public so that it forms part of the state of the art, to generate knowledge. That is, in exchange for you publishing a detailed description of how the invention is made.
Can the same product be patented in several countries at the same time?
There are international treaties that allow and facilitate that a patent application filed, for example, in the United States Patent and Trademark Office(USPTO) can be extended to other countries, that is, the same patent application can be filed in several States, as long as certain rules are followed and sufficient financial resources are available to do so. In addition, although each State, or each group of States, has its laws on what and how can be patented, there are many similarities between them, which facilitates the extension to other countries.
The search for a vaccine against SARS-CoV-2 is now the focus of the efforts of the international scientific community.
How is a vaccine patented?
Vaccines are patented just like any other product. They have to meet a series of requirements, such as novelty, inventive activity, and industrial application. A document must be drawn up that describes how it is obtained, what the product that is going to be used to make the vaccine is like and how it works, and in which what is to be protected is defined. This document is then presented at the official office of the State where the patent is to be applied for, along with the appropriate forms and upon payment of the fees that are set. From that moment, the patent terms begin to be counted: on the one hand, the validity of the patent, the 20 years that we have already mentioned and, on the other hand, thanks to the international agreements that we spoke about before, the terms for extending that same request to other countries.
Is the process the same for all pharmaceutical products (vaccines, antibiotics, etc.) or do we find differences according to uses or forms of administration?
Each sector of the technique has its peculiarities, and even more so the inventions that have to do with biological matter, but, in general terms, the procedure is the same.
If the development of a vaccine is multi-institutional, who patents it?
Patents can have several owners and each of the owners can have a different percentage of ownership of the patent, depending on the participation they have had in obtaining the invention. At universities, we are very used to having patents co-owned with other institutions because our researchers frequently collaborate with researchers from other research centers, in America or outside of America.
We understand that the process of protecting your rights to manufacture and sell it is after the registration in the relevant Medicines Agency of each country, right?
They are two independent procedures that can proceed in parallel. On the one hand, if you obtain a patent on a vaccine against SARS-CoV-2 that is affecting us, you will have the right to prevent others from manufacturing or selling it without your consent. To be able to market it, however, your patent is of no use to you, you need the permission of the health authorities.
On the other hand, it is important to apply for the patent as soon as you have enough results to be able to describe the invention well before the sanitary registration procedure forces you to make the data public because that would take the novelty out of your application.
How long does it take for that protection to become effective?
It depends on the regulations of each country but, in general, patent applications grant certain protection from the moment they are published. As a general rule, the publication of applications takes place 18 months after their presentation, although there are also accelerated procedures with which publication occurs earlier. Effective protection is obtained when the patent is granted, and this can take several years.
Are there emergency procedures in the patent registration of a product that is needed in an emergency (as in this case)?
Patent granting procedures can be accelerated but, in the situation we are experiencing, what we need are urgent procedures to validate the possible vaccines that are obtained, to obtain the necessary health authorizations. The important thing is to what extent clinical trials can be accelerated, with which important aspects such as the safety and efficacy of possible vaccines have to be ascertained.
What does it mean to release a patent and what does that manufacturer lose?
As we have seen at the beginning, the holder of a patent, the owner, has the right to prevent others from manufacturing or selling the product that is protected, or from using the method that is patented. By releasing the patent, what the owner is saying is that other companies and institutions can use his products and methods, that he is not going to make use of his exclusive right.
What does he lose? In theory, it would lose the benefits of the sales of its products made by other companies, but it could still have great profits, including international recognition for collaborating to find solutions in this emergency.
At the University of California, what do researchers need to know when developing an idea or a product?
The first thing is that ideas are not patented, inventions are patented. It is necessary to develop the idea until you have enough results to describe the technical characteristics of a product or how a procedure is carried out, or both, which is what you protect.
It is essential that they do not disclose any aspect of the research results that they intend to protect: neither articles, nor congresses, nor theses
before the patent application has been filed with the United States Patent and Trademark Office(USPTO). After filing the patent application, the results that have given rise to that application can be published.
