US-Argentina patent agreement presents public health concern

An alarming unbalanced three-year agreement could result in more unmerited patents in Argentina.

As a global coalition of treatment activists working on access, Make Medicines Affordable is gravely concerned by a new agreement between the patent offices in the US and Argentina.

This agreement between the United States Patent and Trademark Office (USPTO) and the National Institute on Industrial Property of Argentina (INPI) allows patents to be fast-tracked in one country, based on the approval of a patent application in the other.

According to Othoman Mellouk, the Intellectual Property and Access to Medicines Lead at the International Treatment Preparedness Coalition (ITPC): “ The USPTO is known to be very permissive when it comes to examination accepting patentability of new formulations or minor modifications of already known substances. Argentina’s examination model has more scrutiny. If Argentina relies in the future on US examination this will unavoidably lead to abusive patents”.

The agreement came in on 3 March 2017. It is being referred to as a pilot, but with a trial period of three years, running until 2 March 2020, there is plenty of time for lucrative patent applications to be processed, too often at the expense of public health.

USTPO states that the agreement, known as the Patent Prosecution Highway, “…promotes patent application efficiency by allowing the examiner in the office of later examination to reuse the search and examination results from the office of earlier examination, thereby reducing workload and duplication of effort.”

Commenting on this, Lorena Di Giano, Executive Director of Fundacion GEP in Argentina, said: “If unmerited patent applications didn’t ‘slip through’ the current patent applications processes then perhaps this logic would be sound. However, while unmerited patents continue to be granted, at a financial and public health cost to countries and threatening the lives of patients, then this is simply a license for pharmaceuticals to profiteer more easily in both countries.”

“This agreement effectively repeals the Argentine Patent Law, negatively impacting on the price, availability and access to essential drugs. Medicines are not a commodity but a social good that guarantee the human right to health,” emphazises Di Giano.

Mellouk adds: “A policy and strategy change at the patent office level could lead to significant changes. In Argentina, for example, after the introduction of new guidelines for the examination of pharmaceutical patents in 2012, the number of patents granted was 54, while in Mexico, a similar-sized market to Argentina but which relies on the US for patentability standards, the number of patents granted in 2012 for pharmaceutical products was 2500.”

Fundacion GEP is concerned with the new approach of INPI, which sees its role as simply to “deliver [intellectual] property rights if they meet the requirements”, as reported by senior INPI staff when F-GEP met with them recently in August 2017.

“Our interpretation of this is that with this new approach, Argentina’s national patent office will prioritize commercial rights over basic human rights, such as access to health,” says Di Giano. “It is concerning that INPI may begin to grant patents without a rigorous examination of patent applications, most of which do not comply with legal requirements.”

“The argument of efficiency behind all these agreements is false. It results in the opposite for governments, with reduced inefficiency and control over their budget for public health.”