Intellectual Property Protection in Clinical Trials

One of the most frequent comments we receive back from our clients regarding having their recently-granted Patent listed in Mexico’s Linkage Gazette is: “Why should I list it if our protected pharmaceutical product has not even reached clinical trials?”

Think of this. You have conducted enough research to get publications and a Patent out of a new and innovative technology that has shown some very promising pharmaceutical activity. But currently you have no more funding (or interest) to take your new discovery forward. Parallelly, this great competitor has come across your investigation and decides to run clinical trials on it…but without letting you know! How rude, right?

Proof on Patent non-infringement in Mexico is requested to the Applicant by the local Health Authority -the Federal Commission for the Protection against Sanitary Risks (COFEPRIS)- only when applying for a Marketing Authorization (MA), either by: showing that they own a Patent, that they have a license, or solely by declaring under oath that they comply with the non-infringement requirement. Even if it is true that our country follows indeed very strict national and international scientific, ethical, and regulatory principles to conduct clinical studies in accordance with the General Health Law (Ley General de Salud, LGS) enabled by COFEPRIS, however shocking, there is a gap in the Mexican Legislation when it comes to Intellectual Property (IP) protection, specifically Patent protection, while applying to conduct clinical trials.

Opposite to a MA Application, our local Authority does not request a proof from the Applicant to conduct a clinical trial, to evince that third-party IP rights are not being infringed. In fact, the Bolar-Exemption – which amongst other specificities, allows the importation of Patent-protected active chemical ingredients to conduct tests during the last 3 years of protection of a Patent- seems to be the only mechanism that directly links Patent protection with clinical testing. In its wider interpretation, the Bolar-Exemption does not really provide true shielding for a patented technology against unauthorized third-parties using it to apply for a clinical trial.

Based on at least the previous and based on our experience, an early listing of a granted Patent in the Linkage Gazette and specifically, in the pre-clinical trials (and pre-marketing phase) might be the only mechanism to gain an extra layer of protection in the case that unauthorized third-parties applied to conduct clinical trials on it in Mexico by providing more visibility of the granted right. Furthermore, an anticipated listing attracts additional multiple benefits for the Patent holder:

1. It allows the Applicant to comply in advance with Article 167 bis of the Regulations of Health Supplies (Reglamento de Insumos para la Salud, RIS), which is one of the requirements to request a Marketing Authorization in Mexico. That is, by the time the clinical trials are initiated/finished, the Patent will be already listed in the Gazette.
2. It may serve as an implicit proof that the invention is being worked/exploited in Mexico in the case that unauthorized third-parties applied to obtain a compulsory license (requested by a third-party for exploiting a given invention if it is not being worked by the owner after a three-year post-grant period has elapsed).
3. The listing in the Gazette does not need to be renewed and there are no fees involved in maintaining it listed during the Patent’s term.

Please feel free to drop an email to BC&B at main@bcb.com.mx if you wish to receive one-to-one specialized consulting advice related to having your Patent listed in the Linkage Gazette in Mexico.