27 Oct
2021

Life sciences patent eligibility in Latin America: a guide

Patents are critical to the life sciences industry and often spark intense and heated debate. To be successful, one key strategy that should be pursued by life sciences companies is building and maintaining a patent portfolio capable of distinguishing itself from competitors, as well as representing a well-reasoned business strategy. Companies should secure their patent assets by maximising patent coverage of the core technology and its potential improvements. One reason is that patents can demonstrate the commercial potential of a company’s technology, they are also the driving force for major events in the lifecycle of a life sciences company, among them:

  • ensuring that the innovator company can protect the return on investment necessary to fund future research efforts;
  • finding and establishing strategic collaborations;
  • garnering venture capital investment to create joint ventures, undergo mergers and acquisitions, and public offerings; and
  • litigation.

As companies are increasingly looking to grow and expand their businesses in geographical areas outside the United States, Europe and Japan, Latin American countries have been representing attractive markets for the fast-growing life sciences industry. Opportunities include the huge market potential, for example, in agriculture, human and animal healthcare, food processing, environmental applications, industrial biotechnology and next-generation medicines. The growing economy also makes the region attractive for foreign investment.

Life sciences companies that are seeking to do business in Latin America should be aware of the significant differences in the interpretation and application of the local patent laws, in order to seek the best protection of their patent portfolio in different Latin American countries.

Given the differences in what is considered patent-eligible subject matter among Latin American countries, life sciences companies should consider the relevant differences to ensure that the most commercially relevant scope of protection for their life sciences inventions is ultimately obtained in these jurisdictions.

Insights

Historically, Latin America has had less developed IP regulations compared to the United States and European countries. Nevertheless, the region has taken steps to improve its position on intellectual property.

The WIPO study World Intellectual Property Indications 2020 (www.wipo.int/edocs/pubdocs/en/wipo_pub_941_2020.pdf) reveals 55,700 patents were filed before 32 offices in Latin America and the Caribbean region in 2019, meaning an average growth within a 10-year timeframe (2009-2019) of 0.7%. In addition, the number of patent grants in 2019 was 26,800, an average growth of 4.1% in comparison to 2009.

The 2021 ninth edition of the US Chamber International Intellectual Property Index (www.theglobalipcenter.com/wp-content/uploads/2021/03/GIPC_IPIndex2021_FullReport_v3.pdf), which ranked 53 countries in relation to their IP laws, regulations and enforcement, reports that four Latin American countries (Costa Rica, Dominican Republic, Colombia and Mexico) ranked in Category 1 (which measures the strength of an economy’s environment for patents, related rights and limitation) with a score above 50%.

The Latin America regional evaluation ranked the following countries, from the first to the last positions:

  • Mexico;
  • Costa Rica;
  • Dominican Republic;
  • Colombia;
  • Chile;
  • Peru;
  • Brazil;
  • Argentina;
  • Ecuador; and
  • Venezuela.

The results for the 2021 ninth edition compared to the 2020 eighth edition show a positive change in the IP environment in Mexico, Colombia, Peru, Chile and Costa Rica. The first four countries form part of the Pacific Alliance, which launched the patent prosecution highway agreements in 2015. Patents reviewed and approved in a member country are eligible for expedited review within the Pacific Alliance. This helps companies expand quickly between member countries, ensuring that their inventions are protected.

Moreover, Mexico saw an improvement in its score of 3.87% as a result of several actions taken to benefit the IP environment, such as:

  • the new Federal Law for the Protection of Industrial Property (which entered into force on 5 November 2020);
  • the implementation of some commitments in the United States-Mexico-Canada Agreement;
  • the implementation of patent prosecution highway pilot programmes to recognise examinations made by the USPTO, the Japan Patent Office, the Spanish Intellectual Property Office and the China National Intellectual Property Administration; and
  • a parallel patent grant initiative signed between the USPTO and the Mexican Patent Office that allows for patents to be granted in Mexico based on published US patents.

When considering the economies of Brazil, Russia, India, China and South Africa, Brazil has seen improvements in the IP environment between 2012 and 2021 of 4%. Although this number is modest, the government has also been making efforts to improve the local IP environment.

The revocation of Section 229-C of the Brazilian IP Act (Law 9,279/96), which took place on 26 August 2021, along with the backlog fighting programmes launched in 2019, the patent prosecution highway agreements signed with several countries (eg, the United States, Europe, Japan and South Korea, among others) and the recent developments of the National Intellectual Property Strategy (ENPI), are likely to have a positive impact on the Brazilian IP environment.

The now revoked Section 229-C of the Brazilian IP Act once established the need for approval by the National Agency of Sanitary Supervision (ANVISA) for the grant of pharmaceutical patents (including biotechnological inventions) prior to the Brazilian Patent Office’s (BRPTO) substantive examination. This section imposed serious obstacles to the issuance of pharmaceutical patents whenever the Brazilian public health system considered the object of the application as being of public health interest. The previous double examination by both ANVISA and the BRPTO frequently resulted in controversial opinions on patentability, which contributed to delays in prosecution and provoked litigation. Therefore, with the revocation of Section 229-C, both domestic and international pharma companies are finally free of ANVISA’s intervention in the prosecution of pharmaceutical patents. This legal change is also expected to contribute to the efforts towards the attack of the patent examination backlog, as all applications that were awaiting ANVISA’s prior consent have returned to the BRPTO and will enter the backlog fighting programme. 

On 9 June 2021, Brazil approved the first action plan for the implementation and monitoring of the ENPI, which is expected to last for 10 years. The purpose of the ENPI is to establish governance and coordination for initiatives, projects and programmes related to intellectual property. It aims to foster creativity, investments in innovation and access to knowledge, promote competition and Brazilian social and economic development. The ENPI has a seven-point structure:

  • intellectual property for competition and development;
  • dissemination, training and capacity building in intellectual property;
  • governance and institutional strengthening;
  • modernisation of legal and infra-legal frameworks;
  • compliance and legal security;
  • intelligence and vision for the future; and
  • the insertion of Brazil into the global IP system.

Life sciences inventions and patentability challenges

In a dynamic and growing global commercialisation landscape, a strong patent portfolio is key for any life sciences company’s growth and survival. One or a series of patent applications should be filed providing the broadest possible patent protection covering the core technology. Further, filing patent applications in several jurisdictions strengthens a patent portfolio by expanding a company’s presence in the global marketplace. A company should consider filing in:

  • specific countries with a large target market for the product;
  • countries where competitor’s manufacturing facilities are located; and
  • countries that export products to other countries through channels of distribution.

Although there is no clear definition of the term ‘life sciences’, it is commonly used as generally comprising the science behind biotechnology, pharmacy, medicine, agriculture, food, cosmetics, diagnostic tools and devices, among others.

Patenting inventions in the life sciences field poses challenges, due to the scientific and technological complexities and the substantial differences between individual jurisdictions on how life sciences inventions are handled. Life sciences inventions may sometimes be located at the borders of science, ethics and law, giving rise to intense and heated debate regarding patent eligibility.

Therefore, when drafting a patent application, it is vital that life sciences companies and patent attorneys be aware of the differences across the jurisdictions of interest. The requirements for obtaining patents on an invention in the life sciences field are the same as those for any patent in other fields of knowledge, that is, the invention must:

  • be novel;
  • involve an inventive step (ie, must be non-obvious);
  • have an industrial application; and
  • be repeatable and comprehensible.

Stringent description and enablement requirements when examining life sciences inventions may sometimes limit claims to the embodiments that were actually achieved by the inventors. In this sense, certain life sciences inventions can face the need for a heightened level of disclosure that may require the inclusion of a greater number of concrete embodiments of the invention or the deposit of the biological material at an international depositary authority to provide support and enablement to the claimed invention. In addition, elaborating on unexpected results is advisable to provide support for overcoming obviousness rejections during examination.

With regard to patent eligibility, there are striking differences among Latin American countries. Tables 1.1 and 1.2 details the patent eligibility of a non-exhaustive list of subject matters in the life sciences field under the current IP laws from Brazil, Mexico, Chile, Colombia, Peru, Uruguay and Argentina. The subject matters have been generally classified as non-patentable or patentable, but specific questions should always be addressed on a case-by-case basis.

Table 1.1: Patent eligibility across Latin American countries (P: patentable; NP: non-patentable)

Subject matterBrazilMexicoChile
Animals, plants and parts thereof:
- isolated from natural sources
- genetically modified
NPPNP
Only the specific construct and polynucleotide can be protected, not the organism.

Microorganism:
 - isolated from natural sources
- genetically modified

NP
P
PP
Process for producing genetically modified microorganisms, animals or plantsPPP
Animals and plants cannot be patented, only the specific construct and polynucleotide.
Breeding methods using traditional techniquesNPNPNP
Breeding methods using molecular techniquesPPNP
Polypeptides and polynucleotides:
- isolated from natural sources
- modified
NP
P
PP
Natural biological processesNPNPNP
ExtractsNPNPP
Compositions comprising a natural productP
Provided that the composition is not composed solely of the natural product.
PP
Monoclonal/chimeric/humanised antibodies
Fully human
P
NP
PP
Polyclonal antibodyNPPP
HybridomaPPP
Process for obtaining polyclonal antibodiesNPPP
Stem cells (embryonic or non-embryonic)NPPP
Process for obtaining embryonic or non-embryonic stem cellsPP
Isolated and obtained through a technical process, not a therapeutic method.
P
Stem cell applicationsPPP
With the proviso that the invention does not refer to methods of surgical or therapeutic treatment of the human or animal body, as well as the diagnostic methods.
Diagnostic methodP
When conducted ex vivo.
NPNP
Therapeutic methodNPNPNP
Surgical methodsNPNPNP
Second-use claimsPPP
KitsPPP
Computer-implemented inventionP
Software is a non-patentable subject matter. However, computer-implemented inventions having technical character and making a technical contribution do not fall within this statutory exclusion
P
Software is a non-patentable subject matter. However, computer-implemented inventions having technical character and making a technical contribution do not fall within this statutory exclusion.
P
With the proviso that the invention must describe physical characteristics that contribute to solve the technical problem. Software cannot be patented in Chile.
AI implemented inventionsPPP
Personalised medicineNPNPNP
Aptamers biosensorsPPP
With the proviso that the invention is directed to the device.
CAR-T cellsNPPP
With the proviso that the invention does not refer to methods of surgical or therapeutic treatment of the human or animal body, as well as the diagnostic methods.
OrganoidsNPP
In general, yes. However, some organoids may be prohibited if the authority considers that they fall within a patentability restriction (eg, if they are contrary to public order).
P
With the proviso that the invention does not refer to methods of surgical or therapeutic treatment of the human or animal body, as well as the diagnostic methods.
CRISPR-based platformPPP
Only if claimed as an ‘in vitro method’, the specific construct and polynucleotide may be also claimed.
Microbiome-based innovationsPPP
4D bioprinting and tissue engineeringPPP
With the proviso that the invention does not refer to methods of surgical or therapeutic treatment of the human or animal body, as well as the diagnostic methods.
4D printed tissue or organNPPP
With the proviso that the invention does not refer to methods of surgical or therapeutic treatment of the human or animal body, as well as the diagnostic methods.

Table 1.2: Patent eligibility across Latin American countries (P: patentable; NP: non-patentable)

Subject matterColombiaPeruUruguayArgentina
Animals, plants and parts thereof:
- isolated from natural sources
- genetically modified
NP
P
NPNPNP
Microorganism:
- isolated from natural sources
- genetically modified
NP
P
PPP
Process for producing genetically modified microorganisms, animals or plantsPPPNP
Breeding methods using traditional techniquesPPNPNP
Breeding methods using molecular techniquesPPPNP
Polypeptides and polynucleotides:
- isolated from natural sources
- modified
NP
P
NPNPP
Natural biological processesNPNPNPNP
ExtractsPNPNPP
Compositions comprising a natural productPP
Access contract is mandatory, Decision 391.
PP
Monoclonal/chimeric/humanised antibodies
Fully human
P
NP
NPNPP
Polyclonal antibodyPNPNPP
HybridomaPNPNPP
Process for obtaining polyclonal antibodiesPPPP
Stem cells (embryonic or non-embryonic)NPNPNPNP
Process for obtaining embryonic or non-embryonic stem cellsPPPNP
Stem cell applicationsNPNPPNP
Diagnostic methodNPNPNPNP
Therapeutic methodNPNPNPNP
Surgical methodsNPNPNPNP
Second-use claimsNPNPNPNP
KitsPPPP
Computer-implemented inventionPP
Products and methods with industrial application with the assistance of a human.
Software copyright.P
AI implemented inventionsN/AP
Products and methods with industrial application with assistance of a human.
Software copyright.P
Personalised medicineNPNPNPP
Aptamers biosensorsNPNPNPP
CAR-T cellsPNPCase-by-case analysis.NP
OrganoidsPNPCase-by-case analysis.NP
CRISPR-based platformPPCase-by-case analysis.P
Microbiome-based innovationsNPPCase-by-case analysis.P
4D bioprinting and tissue engineeringPPCase-by-case analysis.P
4D printed tissue or organPNPCase-by-case analysis.P

Comment

Life sciences is one of the most complex fields of intellectual property, as the science behind the inventions is constantly and quickly evolving, creating challenges to IP legislation around the world.

In order to be successful in today’s competitive and rapidly changing patent landscape, life sciences companies must develop and sustain high-value patent portfolios. These patent portfolios face unchartered waters due to the differences in patent eligibility across different jurisdictions.

IP regulations are not harmonised throughout Latin America, and every country requires a unique approach. It is therefore imperative that life sciences companies seek expert advice early, with the aim of understanding the relevant patent laws and evaluating what aspects of the research may be patentable, the scope of protection that could be achieved in different jurisdictions and what type of data may be required to support a patent application. This will ensure that the most commercially relevant scope of protection for life sciences inventions is ultimately obtained in the jurisdictions of interest.

We would like to thank our colleagues for their valuable contribution to this chapter: Maria Pia Carvalho Guerra (I’B the IP Hub, Kasznar Leonardos Latin Desk, Brazil);

María Belén Ievoli and José Maria Vicetto (Estudio Izquierdo & Vicetto, Argentina);

Arturo Covarrubias and Matías Valenzuela (Covarrubias Strategic IP, Chile); Giovanni Agudelo (Cuesta Lawyers, Colombia); Jose Juan Mendez (Méndez + Cortés SC Attorneys & Engineers, Mexico); Medalith Albarracin (BARLAW – Barrera & Asociados S Civil de RL, Peru); and Gonzalo Fernández Secco and Isabel Fernández Requena (Fernandez Secco & Asociados, Uruguay).