Tiny biotech Errant sues Bluebird for patent infringement in developing gene therapy LentiGlobin

In developing LentiGlobin, now listed as the second most expensive drug in the world at $1.8 million, Bluebird infringed on its two of its recombinant vector patents, small Chicago biotech Errant claims. (Bluebird Bio)

The ongoing battle between gene therapy biotechs Bluebird Bio and Errant has nally reached the patent infringement stage. Last week, in U.S. District Court in Delaware, Errant Gene Therapeutics, a tiny Chicago company, led a lawsuit alleging that Bluebird of Massachusetts infringed its patents for a recombinant vector used in the manufacture of the treatment of two rare blood disorders.  The move comes a month after Bluebird completed its submission of a biologics license application to the FDA, asking the agency to approve its gene therapy called beti-cel as a treatment for patients with beta-thalassemia who require regular red blood cell (RBC) transfusions. The gene therapy is approved in Europe and also known as LentiGlobin. Beti-cel is designed to be a one-time treatment and is manufactured using the BB305 lentiviral vector, which adds functional copies of a modied form of the beta-globin gene to treat the underlying cause of transfusion-dependent beta-thalassemia. Errant claims that Bluebird’s BB305 lentiviral vector infringes on two of its patents. The company also claims the infringement is willful, and that damages awarded should be “enhanced for up to three times the actual damages awarded,” according to court documents. Applications for those patents date back to 2001 and 2002, and nearly a decade later, the patents were granted to the Memorial Sloan Kettering Cancer Center, which partnered with Errant. But MSKCC signed away its rights to the patents in a 2005 agreement, giving Errant commercial rights to whatever is developed using the innovations it developed.
Errant also claims that MSKCC disclosed condential information to Bluebird that allowed it to exploit the intellectual property to develop and commercialize its own gene therapy. In 2019, Bluebird established the price of LentiGlobin to $1.8 million for the one-time therapy, making it the second-most expensive treatment in the world.

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