Within the framework of the trade agreement with the United States, the Government promotes a Patent Law that is encountering obstacles in Congress due to pressure from national pharmaceutical laboratories, which copy formulas and market “generics.”
However, many startups in the knowledge economy – especially biotechnology – are waiting for this standard to export your inventions securely.
“Especially, Biotechnology is one of the fields where Argentina has a critical scientific mass, universities, CONICET and technology-based companies. However, the patent regulatory scheme that has been in effect since 2012 ended up leaving precisely that sector out of the system,” say Pablo Palazzi and Octavio Mitelman, from the Allende & Brea studio.
“For many years, Biotechnology was trapped in a gray area: strong scientific capacity, but little patent protection“, they emphasize.
In fact, according to the Argentine Association of Private Capital, Entrepreneurs and Seeds (ARCAP), the biotechnology sector is sought after by 26.1% of venture investorsbut their influence is even greater because they can also provide solutions to the areas AgrifoodTech (45.7%) and Healthtech (28.3%).
What would change with the new Patent Law? “If Argentina becomes part of the Patent Cooperation Treaty (PCT) means that there will be what is called an international applicationthat is, the PCT functions as a “single window” for initial presentation to request protection in several countries,” explains Ornella Tesone, from the Lisicki, Litvin & Abelovich firm.
This implies that there will be greater protection and financial benefits for the export of Argentine technology.
What is changing in the patent regime in Argentina
“Argentina is taking a relevant turn in its patent policy. After 14 years of a restrictive scheme—particularly harsh on pharmaceutical and biotechnology patents—the country is moving towards a system more aligned with international standards.“, indicate Palazzi and Mitelman.
“The change includes two key decisions: the end of automatic exclusions in relation to patentable subject matter in industrial sectors such as pharmaceutical laboratories and incorporation into the international PCT system,” they point out.
“The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) is the starting point of the entire debate. Since 1995, when it came into force within the WTO, it obliges countries like Argentina to offer patent protection in all fields of technologyincluding pharmaceutical and biotechnology,” they maintain.
Furthermore, they warn that “the agreement leaves little room to exclude certain industries from the protection conferred by invention patents by administrative means.”
What the international WTO agreement says
“The famous article 27 of the ADPCI establishes a simple but forceful rule: patents should be available for any invention, in any technological fieldas long as it is new, has inventive activity and industrial application,” say Palazzi and Mitelman.
“Besides, prohibits discrimination based on the origin of the technology or the productive sector. For example, since the entry into force of the TRIPS it was prohibited for a country to decide in advance and without prior analysis to exclude pharmaceutical innovations from protection,” they point out.
According to experts, “this ‘technological non-discrimination’ clause is what put Argentina under the microscope. Although the country formally recognized pharmaceutical patents since the mid-90s, In practice, starting in 2012, it established a much more restrictive system. Through an administrative resolution, the registrability of a broad set of inventions was limited pharmaceutical and biotechnological
“That scheme was challenged judicially and criticized from multiple fronts, including intellectual property specialists and research and development industries. The questions pointed out that the public administration was replacing the technical examination with automatic and general exclusions of patentability.something difficult to reconcile with TRIPS,” they warn.
What is the PCT and how does it impact global trade?
“The PCT is the great international system for processing patents. It does not create a ‘world patent’, but allows the filing of a single international application that can then enter the national phase in more than 150 countries.“, Palazzi and Milteman highlight and list that the PCT offers:
- A single request
- An international search report
- A preliminary opinion on patentability
- More time to decide which countries to advance in
According to Palazzi and Mitelman, “each State retains the last word, but the process becomes more predictable and professional“.
“It is not that through the international application alone the patent is automatically being requested in all member countries, but rather it is the applicant who, in the request, must designate the States where protection is sought (and cases of regional patents are foreseen), the so-called ‘Designated States'”, indicates Tesone.
Palazzi and Mitelman emphasize that “for companies from the United States, Europe and other developed countries, the PCT makes it easier to include Argentina in their global strategy for the protection of technological innovations. For the Argentine INPI (National Institute of Industrial Patents), it means receiving applications with more solid technical backgrounds.”
“The expected result is more applications, greater competition, lower rate of illicit copying, but also a higher standard of exam quality“, they remark.
What consequences will the Argentine industry have?
“For the national industry the impact is not black or white. On the one hand, there are challenges: more competitive pressure and need to invest in real innovation. On the other hand, there are opportunities: greater legal security, better international insertion and the possibility that Argentine developments also use the PCT to go out into the world in a much less onerous way,” say Palazzi and Mitelman.
Tesone adds that “Argentine companies that want to patent in various markets, The PCT gives them a single initial file and international stages that do not exist today in the local procedurethus saving processing costs in each of the countries separately with everything that this implies: from administrative costs in the offices of each country to the hiring of national professionals to process them.
“There is a clear signal that can improve investment in the country and alliances, since the PCT organizes and standardizes the patent “package” from the beginningwhich makes it easier and faster for a foreign investor or partner to audit the technology and decide on a license, joint venture or investment,” he explains.
However, he warns that “it does not guarantee that INPI will grant the patent, since the decision is still national, but reduces friction in the analysis and protection strategy in several countries“.
It must also be taken into account that “the PCT, by making it easier for foreigners to ‘designate Argentina’ as the country in which they want to protect their invention and thus enter the national phase, can increase the volume of requests that impact local productive sectors“, warns Tesone.
“The reform suggests a change of approach: of the permanent exception to international standardization. The debate is no longer about whether or not to grant patents in certain sectors, but rather about how to strengthen local innovation in a system that finally becomes predictable,” conclude Palazzi and Mitelman.
