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13 May 2022GenericsAlex Baldwin

BMS says Hengrui’s Abraxane infringes

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 (paclitaxel) infringes a patent.

Abraxis BioScience filed a patent infringement complaint in the US District Court of New Jersey on Wednesday, May 11, accusing Herngrui’s filing of an infringing Abbreviated New Drug Application (ANDA) for generic paclitaxel prior to the expiration of a key patent.

The patent in suit is US patent 7,820,788, titled “Compositions and methods of delivery of pharmacological agents”.

Abraxane itself is used to combat “hard-to-treat” forms of cancer, including metastatic breast cancer, forms of lung cancer, and metastatic adenocarcinoma of the pancreas.

The treatment was one of Bristol-Myers Squibb’s top ten treatments in 2021, generating approximately $1.2 billion in revenue for the pharmaceutical giant last year.

Abraxane, along with the company’s biggest revenue driver Revlimid, lost its market exclusivity in 2021.

According to the complaint, Hengrui notified Abraxis that the US Food and Drug Administration had provided Paragraph IV certification to market the drug in a notice letter in March 2022.

Abraxis has requested that the New Jersey court find that Henfrui’s planned generic infringes claims of the ‘788 patent.

It also asks the court to issue preliminary and permanent injunctions preventing Hengrui from manufacturing and marketing the treatment prior to the expiration of the patent in March 2024.

Last month, fellow Bristol-Myers Squibb subsidiary Celgene sued MSN Laboratories in order to prevent its planned generic Pomalyst (pomnalidomide) from being marketed in the US.

Pomalyst is also one of Bristol Myers’ flagship products, netting $854 million in revenue from sales in Q4 2021 according to its financial statements, making it the fourth-biggest seller for the quarter.

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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.
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4 October 2021   Bristol-Myers Squibb has sued India-based generic maker Alembic over claims that a copycat of the blockbuster leukaemia drug Sprycel, infringes a pair of patents.
Big Pharma
26 January 2023   US pharma giant says competitor’s drug Imjudo violates two patents | BMS’ blockbuster was first to use checkpoint inhibitors, says complaint.

More on this story

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.
Americas
4 October 2021   Bristol-Myers Squibb has sued India-based generic maker Alembic over claims that a copycat of the blockbuster leukaemia drug Sprycel, infringes a pair of patents.
Big Pharma
26 January 2023   US pharma giant says competitor’s drug Imjudo violates two patents | BMS’ blockbuster was first to use checkpoint inhibitors, says complaint.