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4 October 2021AmericasMuireann Bolger

BMS sues over generic of blockbuster leukaemia treatment

Bristol-Myers Squibb (BMS) has sued India-based generic maker Alembic over claims that a copycat of the blockbuster leukaemia drug Sprycel (dasatinib), infringes a pair of patents.

The Delaware-based pharmaceutical company filed the complaint at the District Court at the US District of New Jersey, demanding a court order to prevent generics of the drug until the expiration of the patents, US numbers 7,491,725 and 8,680,103.

Alternatively, it has requested compensation if generic versions are rolled out before then.

According to the complaint, the US Patent and Trademark Office issued the ’725 patent entitled “Process for preparing 2-aminothiazole-5-aromatic carboxamides as kinase inhibitors” to inventors Jean Lajeunesse, John D. DiMarco, Michael Galella, and Ramakrishnan Chidambaram in 2009.

Five years later, the office went on to grant the ’103 patent entitled “Process for preparing 2-aminothiazole-5-aromatic carboxamides as kinase inhibitors” to the same inventors.

In August 2021, BMS said that it had received a letter from Alembic stating that claims of the ’725 and ’103 patents are either invalid or will not be infringed by its proposed commercial manufacture, use, and sale of  a generic version of the drug.

In the letter, Alembic also insisted that it  would engage in this commercial activity before the expiration of the ’725 and ’103 patents

This latest dispute over Sprycel comes after BMS settled suits with other Indian pharma companies Dr. Reddy’s and Lupin over patents covering the drug in July.

According to BMS’ financial results, Sprycel generated $1 billion in worldwide sales during the first six month of 2021.

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More on this story

Americas
18 January 2022   The US Court of Appeals for the Federal Circuit has turned down a Bristol Myers Squibb subsidiary’s appeal to overturn a controversial $1.2 billion patent verdict loss against Kite Pharma.
Generics
7 April 2022   Bristol Myers Squibb has sued MSN Laboratories over its planned generic of Pomalyst, which it claims infringes six patents owned by BMS’ subsidiary Celgene.
Generics
13 May 2022   A subsidiary of Bristol-Myers Squibb has sued Chinese pharma company Jiangsu Hengrui Pharmaceuticals, alleging that the company’s planned generic of cancer medication Abraxane infringes a patent.