Brazilian consumers will have to wait more than 20 years to have access to generic versions of more than 40 medicines, according to a survey by the Brazilian Association of Generic Medicine Manufacturers (PróGenéricos).
Although 20 years is the maximum term established by Law 9,279/96, which defines intellectual property rules in Brazil, the sole paragraph of Article 40 stipulates that the term of a patent may not be less than 10 years from the date of grant by the National Institute of Industrial Property.
What happens currently is that the period during which the INPI keeps the process under review can take more than a decade.
One of the examples listed by PróGenéricos is the drug Champix, a Pfizer product used to treat smoking addiction. The patent was filed with the INPI in November 1998, but was only reviewed in June 2010, almost 12 years later.
Due to Article 40, consumers who could have counted on generic versions of the product in November 2018 will have to wait another 19 months. They will only have access to the generic version in June 2020.
For Telma Salles, executive president of PróGenéricos, this protection mechanism violates the right to competition, does not stimulate the country's industrial development, and harms consumers. "It is an unnecessary mechanism, unprecedented in international law," she says.
The executive also states that, as INPI analyses are slower than ideal, the patent application and the period during which the patent awaits analysis already count toward the protection period. "Anything exceeding 20 years is abuse and violates patent law itself," she points out.
Article 40 does not only pose problems for the national pharmaceutical sector. Several other sectors of the economy, such as chemicals and agribusiness, among others, also feel the effects of legislation that prevents the launch of products similar to the inventions of international companies in the country.
Due to this scenario, the Brazilian Association of Fine Chemicals, Biotechnology, and Specialties Industries (Abifina), with support from PróGenéricos and the FarmaBrasil Group, filed a Direct Action of Unconstitutionality (Adin) questioning the compatibility of the sole paragraph of Article 40 of the Intellectual Property Law with the constitutional order.
“The losses to society are enormous. In the case of medicines, this scenario not only represents a significant barrier to access to medicines, but also interferes with the expansion of generic drug manufacturers, who are forced to delay their launches,” argues Salles.
Medicines
PróGenéricos has compiled five emblematic examples of drugs that, if the rule in the sole paragraph of Article 40 of the Intellectual Property Law is maintained, will only reach the market as generics after the maximum period stipulated by law, which is 20 years. The market data below are from IMS Health.
Januvia
The MSD product, which has Sitagliptin Phosphate as its active ingredient, has a patent valid until 2022. Filed in July 2002, its analysis was only completed in April 2014 and it is expected to lose patent protection in April 2024, with a minimum extension period of 21 months.
Used in the treatment of diabetes, the product can cost up to R$ 185.78. If there were a generic version, however, it would cost at least R$ 120.75, not counting market discounts that can reduce prices by an average of 60%, further benefiting consumers.The product sold 688,100 units in 2013, generating sales of R$75.7 million.
Victoza
Another product for diabetes, from Novo Nordisk, is also an example of patent extension under Article 40. The product, whose patent was filed in August 1997, was due to expire in August 2017. However, it can only be made generic in January 2023, which means that its patent was only analyzed in January last year. "We are aware of the INPI's lack of infrastructure to meet the demand for filings, but that is not what is being discussed. The fact is that since August 1997, Brazil has respected this patent," says Salles.
Victoza, which can cost consumers up to R$392.46, could cost at least R$255.09, without taking into account discounts offered by the industry and retailers, which can reach 60% in practice. The product generated R$149.3 million in 2013, with 31,100 units sold.
Nexavar
This Bayer product, used in the treatment of liver cancer, also serves as an example of the difficulties that this mechanism established by the sole paragraph of Article 40 of the LPI can pose for patients. Although it could have reached the market in generic form from January 2020 under the legal deadline, it will only be able to reach the market from February 2023, i.e., with a delay of 39 months.
The product, which costs R$7,019.05, would cost at least R$4,562.35 in its generic version. In 2013, Bayer generated R$5.1 million in Brazil from the sale of 998 units of the product, whose active ingredient is sorafenib.
Tykerb
Used in the treatment of breast cancer, GSK's product had its patent filed in January 1999 and was due to expire in January 2019. However, as the patent was only reviewed in May 2011, patients will have to wait until May 2021 to have access to the generic version of the drug.
The product, which costs up to R$4,192.18, could cost at least R$2,724.91 in its generic version. GSK sold 430 units of the product in Brazil, recording sales of R$1.7 million.
Champix
A product intended for smoking cessation treatment, which would have had its patent expire in November 2018, will only have its first generic version available in November 2020, i.e., 19 months later. With a potential cost of up to R$ 1,115.62, users of the product could purchase it for a minimum of R$ 725.15, without applying the discounts offered by the industry and retailers, which can reach 60%.
Developed and produced by Pfizer, the product recorded sales of R$16.1 million in 2013, with 31,100 units sold.
About ProGenerics
Founded in January 2001, the Brazilian Association of Generic Drug Manufacturers (Pró Genéricos) is an entity that brings together the main laboratories involved in the production and marketing of generic drugs in the country.
A non-profit organization, its main mission is to contribute to improving access to medicines in Brazil by consolidating and expanding the generic drug market.
Together, PróGenéricos members account for approximately 90% of generic drug sales in Brazil. Working with various sectors of society and public and private institutions, Pró Genéricos channels the actions of its members, adding weight to the public debate on issues relevant to the health sector and the development of the pharmaceutical industry in Brazil. Visit the website: www.progenericos.org.br