Argentina took a step backwards last month when it revoked key guidelines that defined what could – and could not – be patented in its pharmaceutical sector. 

For more than a decade, Argentina’s patentability guidelines have helped prevent pharmaceutical monopolies, enabling timely competition to enter the market, lowering prices of medical tools, and improving people’s access to treatment. 

These guidelines were fully in line with the World Trade Organization’s (WTO) TRIPS Agreement, which allows countries to define patentability standards as based on public health needs. However, Argentina’s recent shift risks undermining access to medical tools by opening the door to broader, unwarranted monopolies. 

For Médecins Sans Frontières (MSF), patent rules are not an abstract, legal matter. They determine who can produce medical tools, under what conditions, and whether people receive treatment in time or are left waiting. 

Across our projects, we see the same pattern. When monopolies persist, the supply of medical tools is constrained and costs are high, resulting in delayed or denied treatment. 

Generic competition

Alternatively, when competition from other pharmaceutical companies is enabled, access expands. For instance, access to hepatitis C treatment expanded dramatically in places where affordable generic treatments were introduced. With the entry of generic competition, the price for a 12-week treatment course for two new, oral medicines, sofosbuvir and daclatasvir, dropped from $147,000 to $120 per person.   

In global health, access to medical tools is often framed as a question of price. But long before exorbitant prices are set by pharmaceutical corporations, other fundamental factors have already been decided. 

These include who is allowed to produce, where production can take place, and where those products can be sold. These factors are shaped by patent rules and, crucially, by how strictly those rules are applied.

Patents are time-limited exclusive rights granted by governments with a duration of 20 years from the filing date and are granted only if certain criteria are met. 

Under the WTO TRIPS Agreement, patents are granted for new inventions that involve an inventive step and are capable of industrial application. 

But countries retain policy space to determine how these criteria are applied in practice. When patentability standards are applied loosely – for example, granting new patents for minor modifications on the same medicine – monopolies extend beyond what the system is meant to protect. 

Competition is delayed, and high prices persist. Minor improvements, such as a reduced pill burden or easier administration, can benefit people, but they do not justify a new 20-year monopoly. 

Rigorous standards

Applying patentability standards rigorously – by granting patents only where the criteria are truly met – allows competition to emerge earlier, lowering prices and expanding access.

For years, Argentina offered one of the clearest examples of how rigorously applying patentability standards works in practice.

Its patentability guidelines limited the granting of weak patent claims – for example, patents on new forms, dosages, or uses of existing medical tools – and restricted overly broad claims, such as attempts to cover entire classes of compounds without demonstrating a real technical contribution. 

These patentability guidelines created a more disciplined system that enabled timely generic competition. Critically, rather than concentrating supply options in the hands of patent holders or their selected licensees, the guidelines allowed independent producers to enter the market which, in turn, supported the importation and domestic production of generic medical tools.

The guidelines also improved how Argentina’s patent system in the pharmaceutical sector functioned by discouraging the filing of weak claims early on, reducing unnecessary filings, easing the administrative burden, and making full use of the policy space under the WTO TRIPS Agreement to ensure that patent rules served innovation as well as public interest. 

The impact was measurable. Only about 18% of follow-on pharmaceutical patent applications identified globally were filed in Argentina, while many other countries continued examining large volumes of weak claims. 

Under Argentina’s guidelines, patent grant rates dropped from around 9% to below 1%, and the overall likelihood of a patent being granted fell from roughly 70% to about 16% overall. That meant fewer unwarranted monopolies, more room for generic producers to enter the market, and less litigation risk, with disputes arising in less than 1% of cases, according to research.

In other words, the system rewarded genuinely new inventions in a way that was not anti-innovation. It was, instead, a way of applying the rules that aligned patent protection with its intended purpose while also preserving space for competition and access and, ultimately, prioritising public health needs.

Experiences from other countries show how different approaches to the application of patent rules can lead to very different outcomes.

Access at risk

In India, strict patentability standards have supported a strong generic industry that supplies medical tools globally. For example, India rejected a follow-on patent on the cancer drug, imatinib mesylate, making it clear that minor modifications do not justify new monopolies and preserving space for generic production. 

In contrast, similar follow-on patents on this drug were granted in South Africa, extending patent exclusivity by 10 years beyond the original patent term and, as a result, delaying competition and keeping the prices of this important drug high.

When monopolies persist and the prices of medical tools are kept high, public health systems may have to ration care; families often face unaffordable treatment costs; and countries’ dependence on a single supplier risks shortages or complete stockouts of medical tools, all of which can delay treatment scale-up. 

Argentina’s decision to roll back its guidelines risks moving in this direction, where people’s access to affordable healthcare may be delayed or denied.

At a time when there is a growing global concern over the need to strengthen production capacity and make health supply systems more resilient after the COVID-19 pandemic, Argentina’s patentability guidelines are a rare and functioning example of how to use an existing legal space to balance innovation, access, public health, and development.

That example is at risk.

Argentina’s policymakers now have an urgent responsibility: to restore and safeguard the country’s patentability standards before the damages become entrenched, and access to medical tools is pushed further out of reach.

In the end, access is not only about the invention of medical tools. It is also – and ultimately – about who gets treated and who is left waiting.

Dr Monica Rull is the interim executive director of Médecins Sans Frontières Access.

Dr Rachel Soeiro is head of the Americas Hub of Médecins Sans Frontières Access.

Image Credits: AMR Industry Alliance, Flickr/Takacsi75.