Entyvio lawsuit?

See the DrugPatentWatch profile for Entyvio

What is the Entyvio lawsuit about?

Entyvio, also known as vedolizumab, is a medication used to treat inflammatory bowel disease (IBD) and ulcerative colitis. It was developed by Takeda Pharmaceuticals and Celgene (which merged with Bristol Myers Squibb in 2019).

The Entyvio lawsuit refers to a series of patent infringement lawsuits filed by Takeda Pharmaceuticals against several biosimilar manufacturers, including Momenta Pharmaceuticals, Sandoz (a division of Novartis), and Accord Healthcare. The lawsuits aim to prevent these companies from launching their own versions of Entyvio in the United States until Takeda's patents expire.

Why are biosimilar manufacturers challenging Takeda's patent?

Biosimilar manufacturers argue that Takeda's patents are overly broad and not valid. They claim that the patents cover obvious or routine aspects of the Entyvio manufacturing process, which should not be eligible for patent protection.

According to a source from [1], the American Medical Association (AMA) and several other healthcare organizations have expressed support for biosimilar products, arguing that they increase competition and reduce healthcare costs.

Which patents are being challenged?

Takeda has filed multiple lawsuits targeting different patents for Entyvio. The most recent lawsuit, filed in 2022, challenges patents covering the manufacturing process for Entyvio [2].

What are the implications of the lawsuit on patients?

The lawsuit may delay the entry of biosimilar versions of Entyvio, which could limit patients' access to affordable treatment options. According to a report by the Kaiser Family Foundation, biosimilars have the potential to save the U.S. healthcare system $254 billion from 2020 to 2025 [3].

When does exclusivity expire?

The United States patent and trademark office (USPTO) database lists the U.S. patent for Entyvio as expiring in 2033 [4].

Sources:

[1] American Medical Association, "Biosimilars: A New Option for Patients with Complex Diseases" (2018)
[2] Court records, "Takeda Pharmaceuticals v. Momenta Pharmaceuticals et al." (2022)
[3] Kaiser Family Foundation, "Biosimilars in the United States: An Overview" (2020)
[4] United States Patent and Trademark Office, "Patent and Application Information" (2023)