This post was written after a suggestion by Pablo Paz , an Argentinian colleague in the patent world who has been working on the issue for quite a while, as well thanks to the information provided by another patent professional, in this case from Mexico, Lorena Rojas Vega , whose thesis in the master on Intelletual Property and Innovation at the San Andres University ( Buenos Aires) dealt with the public domain and patents.

The first thing a company should do before rolling out a new product is to find out whether it is going to infringe any industrial property right (trademarks, designs or patents). If that step is ignored, the launch of a new product can turn into a nightmare when the company is sued for allegedly infringing a patent, utility model, trademark or design, though I will focus on patents. Unfortunately, many companies proceed to launch new products without carrying out that previous research.

In order to prevent that nightmare from happening, the key is to carry out a “FTO” or “Freedom to operate” search. These searches are not straightforward at all. Without entering into details, one must check that:

The product does not infringe the technical features defined in the claims of patents granted in those markets where it will be commercially exploited. It is worth noting that there are two types of infringement: “literal infringement”, where the product includes all the claimed technical features and infringement under the theory of the equivalents. In the latter case, the features might not be equal to those claimed but fall into the scope of protection defined by the theory of the equivalents.

The fact that the patent was granted is not enough; it is also necessary to check that the patent is still in force, that it has not expired due to non-payment of renewal fees or that the patent has not been revoked in an opposition procedure or declared invalid by a court.

If the FTO search has been thorough, and the product is not in any of those situations, the company can be assured that it will not be sued for infringement of a patent once the product is rolled out. On the other hand, if the product has been found to infringe a patent in force, it might be worth exploring the possibility of getting a license. Another option would be to obtain cross-licenses if the product is also patented. In the latter case, both companies could commercially exploit the patents without fear of being sued for alleged infringement. If there was a large number of patents involved, it would be best to participate in a patent pool, if available. Further information is available in this article (WIPO magazine).

In the pharmaceutical field, there are databases, such as Medspal, developed by “medicines patents pool” , which provides information on the legal status of patents on essential drugs for the treatment of diseases such as TB, HIV and cancer in developing and least developed countries. Such databases greatly facilitate the elaboration of FTO searches.

Recently, however, there has been some confusion, at least in a number of Latinamerican countries due to the publication of lists of “patents in the public domain”: INDECOPI-Peru (listado de patentes farmacéuticas que se encuentran en dominio público), INAPI-Chile (Buscador de dominio público) o IMPI-Mexico (Gaceta de solicitudes de patente de uso libre e invenciones del dominio público).   

Although the drafting of these lists is a comendable task, one must be cautious. These lists are said to provide patents that are already in the public domain, but what they are really saying is that those patents are no longer in force. Nevertheless, a commercial exploitation of those patented inventions, allegedly in the public domain could entail the infringement of previous patents, still in force.

Nowadays, it is common to find inventions, especially in pharma, blockbuster drugs, where all aspects are protected by a large number of patents, in what is known as “patent thicket”. I am going to refer to a specific case that I know from having written about it some time ago; the drug adalimumab, marketed under the trademark Humira. In 2018, it was the world’s best-selling drug and, in this article it is called the $15 billion drug. The “patent thicket” that protects all aspects of this drug is reckoned to be made up of more than 100 patents. At least two of those patents granted by the European Patent Office relate to the dosage of the drug. Those European Patents validated in UK were abandoned once invalidity actions were started by generic companies.

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Method for the generation of monoclonal antibodies (Source: Wikipedia)

As a result, those two Europen patents are no longer in force in UK. Here you have the independent claim of one of the dosage patents, EP294004B1:

La imagen tiene un atributo ALT vacío; su nombre de archivo es image-8.png

This claim is not any longer in force in UK, but if the dosage defined in the claim (40 mg every 14 days) is to be applied for this antiTNFa monoclonal antibody, and this is protected by an earlier patent still in force, there will be a patent infringement. Nevertheless, this patent would appear in one of those “patents in the public domain”. The conclusion would be that one must be very cautious with those lists published by some national IP Offices on “public domain” patents.

Leopoldo Belda Soriano

En español


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