Pharmaceutical drug patent extension in Brazil suspended
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Brazilian pharmaceutical drug patent extension suspended

By GlobalData Healthcare 30 Jul 2021 (Last Updated July 29th, 2021 18:03)

Pharmaceutical drug patent extension is temporarily suspended in Brazil to enable new generic drugs to be produced due to the Covid-19 pandemic.

In April 2021, a Brazilian Supreme Court Judge, Justice Dias Toffoli, announced the temporary suspension of pharmaceutical drug patents to address the ‘public health emergency’ caused by the Covid-19 pandemic. Augusto Aras, the Brazilian Prosecutor General, requested this suspension to enable new generic drugs to be produced where currently patents from larger biopharma companies are preventing this from happening. However, this could potentially impact large biopharma marketing their drugs in Brazil and managing their return on investments in terms of drug development.

Brazilian patent law provides protection for drugs for 20 years from the filing date of the application or a minimum of ten years from when it was issued by the Brazilian Health Regulatory Agency, Agência Nacional de Vigilância Sanitária (ANVISA). This, therefore, means that biopharma companies could be entitled to up to 20 years of patent protection where Aras stressed this is preventing urgent generic drugs from being developed to treat Covid-19 and variants. According to GlobalData’s Pharma Intelligence Center Drugs database, there are over 200 drugs that were approved from 2001 to 2006 in Brazil that due to this suspension may lose their patent protection over the next five years. Figure 1 shows the top five companies that have drugs marketed in Brazil that may lose patent protection in this case. GlaxoSmithKline has the highest proportion with 26%, Novartis 14%, Sanofi 11% and both Pfizer and Bayer with 8%.

The chart also shows that the marketing companies with the largest proportion of drugs possibly losing patent protection over the next five years are large biopharma with headquarters located in the US and Europe. This could mean that these companies may be unable to manage their return on investments made for drugs without patent extension where there are delays in receiving marketing approval from the regulatory authorities. The drug makers will need to rely on patent extensions or exclusivity rights to protect against commercial exploitation and generic drug competition.

Suspension of patent extension could support Brazil with access to lower drug prices and cheaper generic drugs, particularly for Covid-19. However, could this deter large biopharma in the future from marketing innovative drugs in Brazil where they are less likely to reap the benefits?

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