Argentina’s national government today established new criteria for pharmaceutical patents, and criticisms and opinions are already emerging. The first to define its position was CILFA, the chamber representing Argentine drugmakers. It expressed its opposition to today’s tripartite resolution, which repeals patentability guidelines that have been in effect since 2012. The organisation says it trusts the criteria of the INPI (National Institute of Industrial Property) to grant patent status only to genuine pharmaceutical innovations.
Argentine drugmakers belonging to the chamber CILFA have issued a response to the Joint Resolution issued today by the Ministry of Health, Ministry of Economy, and National Institute of Industrial Property on pharmaceutical patents in Argentina. See Official Gazette
The chamber notes that since the implementation of patent protection for medicines in October 2000, the Argentine pharmaceutical industry has boosted competition in the market, breaking up monopolies through the launch of generic or biosimilar versions of medicines whose patents have expired or which, for technological reasons, had only one supplier.
They described one of the main problems the Argentine pharmaceutical industry faces in launching generic or biosimilar medicines as so-called evergreening patent applications. These are patents that protect minor innovations related to already known medicines without providing therapeutic effects or any other value, except to preserve monopolies and hinder the launch of competing medicines for many years.
CILFA emphasizes that there are dozens of generic and biosimilar medications of Argentine origin, including flagship drugs such as rituximab, bevacizumab, sofosbuvir, filgrastim, and adalimumab. They explain that some of these have been on the market for over 10 years and have market shares exceeding 90%, and even approaching 100%. It also highlighted the significant impact on access.
This list includes pembrolizumab, marketed under the brand name Keytruda by US-based MSD (Merck in the US and Canada). The locally produced version is 60.30% cheaper. There’s also semaglutide, marketed by Denmark’s Novo Nordisk under the brands Ozempic and Wegovy. An Argentine alternative is 63.50% more affordable.
Another comparison mentioned is that of the US multinational Biogen’s nusinersen-based Spinraza. A local version is 45% cheaper. Finally, it’s mentioned that the local version of the triple therapy Trikafta, indicated for cystic fibrosis, is 87.90% cheaper.
CILFA says the savings generated by the launch of generic and biosimilar drugs were estimated by the Latin American Economic Research Foundation (FIEL) at US$2.2 billion annually, at September 2024 prices. If the savings generated by new launches or molecules not included in the FIEL study are added to that, the total can be estimated at around US$ 3.32 billion by 2025.
This implies not only greater savings for national, provincial, and municipal governments, as well as for social security organizations and private health insurance companies, but also an expansion of coverage to more patients, thanks to the ability of insurers to treat more people with fewer resources, the group stresses.
In parallel, CILFA affirms its recognition and appreciation of the Argentine government’s decision to exclude test data protection and patent term extensions from the Reciprocal Trade and Investment Agreement recently signed between Argentina and the United States. These form part of the standard framework for US trade negotiations, but CILFA says the exclusions contribute substantially to maintaining a pro-competitive pharmaceutical ecosystem.
Thus, the repeal of Patentability Guidelines does not overturn the scientific principles or the Argentine and US case law that supported them. CILFA indicates that, as recognized by the new Joint Resolution, the INPI (National Institute of Industrial Property) must analyze patent applications on a case-by-case basis, verifying compliance with the patentability requirements established in Law 24,481 by Argentina’s Congress.
It concludes by stating that the institution trusts in the suitability and technical capacity of the INPI, currently headed by Carlos Gallo, to continue conducting patentability analyses rigorously and on a scientific basis. CILFA’s main point is that the INPI should grant patent status only to genuine pharmaceutical innovations and should reject evergreening patents.
Finally, it emphasizes that the issue transcends the private interests of the companies CILFA represents as it affects the public interest. It stresses that it’s essential to maintain a clear and robust public policy that preserves competition in the pharmaceutical market so that patients and the healthcare system can access generic and biosimilar medicines at lower prices, without artificial and undue delays lasting for years.
