Breaking news for access to biological medicines – Brazilian court nixes biological drug eculizumab patent, says more could follow

Source: BioCentury | April 21, 2018

A Brazilian court unanimously ruled Friday to remove patent protection for Soliris eculizumab from Alexion Pharmaceuticals Inc. (NASDAQ:ALXN), opening the door for production of biosimilar versions in the country. In a statement, Brazil’s Attorney General Office said Soliris is only the first of “several other drugs” it plans to challenge in court.

Alexion markets Soliris to treat paroxysmal nocturnal hemoglobinuria in Brazil.

Brazil’s Attorney General Office argued that the patent covering Soliris has already expired because it was registered after the country signed an international IP protection agreement in January 1995 but before Brazil enacted its industrial property legislation in May 1996.

The federal prosecutors also asked the court to take into account public health, citing the drug’s high cost. According to the Attorney General’s Office, Soliris cost the country’s United Health System BRL631 million ($184.2 million) in 2016 to treat 442 PNH patients.

The case was brought before Brazil’s Superior Court of Justice and decided by the Third Panel.

In a statement, Alexion noted that Brazil accounts for a “low single digit percentage” of its worldwide Soliris sales, but declined to provide specific figures. The company said it is evaluating its options and has pending patent applications in Brazil that would extend Soliris’ protection. Alexion reported $3.1 billion in Soliris sales for 2017.

Last year, Brazilian authorities raided Alexion’s Sao Paulo office as part of an investigation into potential violations of the Foreign Corrupt Practices Act (see BioCentury Extra, May 8, 2017).

Soliris is a humanized mAb targeting complement 5 (C5).

Alexion fell $3.96 to $107.78 on Friday.

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This entry was posted in Access to Medicins, Brazil Patent Reform, Open access, Patent, Regulation. Bookmark the permalink.

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