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

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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 finally reached the patent infringement stage.

Last week, in U.S. District Court in Delaware, Errant Gene Therapeutics, a tiny Chicago company, filed 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) transfusionsThe 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 modified 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.

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Errant also claims that MSKCC disclosed confidential 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.

While Bluebird filed its BLA last month, Errant maintains that the company is actively commercializing the product “in a manner that conditions the market for one-time gene therapies and Bluebird’s first U.S. product launch,” according to the complaint.

Errant claims that Bluebird is conducting programs to build awareness of LentiGlobin, providing information on potential reimbursements and developing relationships with “opinion leaders, hospital administrators and other relevant external stakeholders,” who could help facilitate sales of the treatment, it said in the complaint.

The Chicago biotech also claims that Bluebird is engaged in “stockpiling, ramp up manufacturing, commercial manufacturing, marketing and other commercialization activities for the BB305 vector that are not reasonably related to obtaining FDA approval.”  

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Errant was established by Patrick Girondi, whose son was two years old when he was diagnosed with beta thalassemia. Girondi began funding research by MSKCC scientist Michel Sadelain, but by the time the patents were granted, Errant had rights to them.