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1 August 2017Americas

BMS takes AstraZeneca to court over cancer treatment

Bristol-Myers Squibb (BMS) has taken AstraZeneca to court over the alleged infringement of a patent for cancer treatment.

BMS and AstraZeneca are competitors in the field of immunotherapy, a breakthrough treatment for cancer.

“The treatment of cancer using immunotherapy represents a scientific breakthrough that is revolutionising cancer treatment by manipulating a patient’s immune system to eliminate cancer cells,” said the suit.

Filed at the US District Court for the District of Delaware on Wednesday, July 26, the suit alleged that AstraZeneca has exploited BMS’s inventions with its “later-developed antibody product Imfinzi (durvalumab)”.

T cells are one class of specialised cells in the human body—they destroy pathogens or malignant cells—and to do that, the T cells distinguish healthy cells from pathogens through the activation or deactivation of various receptors on the cell’s surface.

One of these receptors is a protein called programmed death-1 receptor (PD-1), which “functions as a checkpoint on the immune system that can downregulate T cell activity to prevent an overactive immune response”.

To activate this function, the protein must bind to one of its ligands—programmed death-ligand 1 (PD-L1) being one of them.

Imfinzi is an anti-PD-L1 antibody used in methods for treating cancer and enhancing an immune response.

According to BMS, a number of cancers express PD-L1 on their cell surface, meaning they can “exploit PD-1’s ability to downregulate the immune response”.

BMS said that it developed an anti-PD-1 antibody called Opdivo (nivolumab), the first anti-PD-1 antibody approved anywhere in the world for cancer treatment.

It owns US patent number 9,402,899, called “Immunopotentiative composition”, which was issued from a divisional application.

The patent is directed to methods of treating cancer by administering an anti-PD-L1 monoclonal antibody that inhibits the interaction between PD-1 and PD-L1.

“As shown by prescribing information for Imfinzi, AstraZeneca received approval from the US Food and Drug Administration on May 1, 2017 to market and sell Imfinzi as a treatment,” said BMS.

AstraZeneca’s antibody is described in US patent number 8,779,108, assigned to MedImmune and called “Targeted binding agents against B7-H1”, according to the suit.

It said that in an information disclosure statement filed on August 7, 2012, during the pendency of the application that led to the ‘108 patent, AstraZeneca cited EP1537878.

BMS added that the ‘878 patent is a European counterpart to the ‘899 patent and so AstraZeneca had knowledge of the patent family by August 2012.

The plaintiff is seeking damages, compensation, a finding of wilful infringement, attorneys’ fees and other relief the court deems just and proper.

A spokesperson for BMS said that the purpose of the suit is to “seek compensation for the infringement" of BMS's IP rights and to protect its immuno-oncology business.

They added that the claim does not “seek to interfere with patient access to these products”.

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