Simmering feud between bluebird and a rival continues with allegations of patent fraud
Bluebird bio was hit with a patent infringement lawsuit last week from a Chicago-based biotech it has had an ongoing beef with calling for $2 billion to help cure the “irreparable harm” caused by alleged willful infringement.
Bluebird bio is facing a lawsuit from Errant Gene Therapeutics for violating patent law in two instances, the company says.
The suit alleges that bluebird infringed the rights of EGT’s recombinant vectors used in the gene therapy treatment of rare diseases such as sickle cell disease and beta thalassemia for its drugs Zynteglo and LentiGlobin. EGT has an exclusive license from the Memorial Sloan Kettering Cancer Center to patents titled “vector encoding human global gene and use thereof in treatment of Hemoglobinopathies.”
In 2016, Errant said that bluebird and Third Rock, a venture capital firm co-founded by bluebird CEO Nick Leschly, blocked their gene therapy from reaching the market. In 2010, Errant was set to start clinical trials with MSK and NIH, and Third Rock met with MSK and “admitted” that the Errant vector was better than bluebird’s.
That, Errant alleges, led to a secret agreement to stall the development of Errant’s vector. MSK demanded that Errant find a commercial partner as a condition before starting clinical trials — but despite Errant fulfilling that condition, MSK rejected the contract and instead initiated arbitration against Errant, the drug developer claimed in the lawsuit.
EGT, which changed its name to San Rocco Therapeutics in May, was established in 1993 by CEO Patrick Girondi after his son Rocco was diagnosed with beta thalassemia, an inherited blood disorder. Errant developed the viral vector alongside MSK in 2000. Errant contacted MSK scientist Michel Sadelain, who published a paper showing the potential of the gene therapy in mice, and started to fund his research. Five years later, Errant bought exclusive rights of the tech for blood disorders, and the company patented the vector in 2009.
MSK granted Errant an exclusive commercial license in 2005, the lawsuit states.
The latest suit alleges that bluebird willfully infringed on two of Errant’s patents. In September, bluebird was granted breakthrough designation for its gene therapy for beta thalassemia.
“Bluebird has engaged and continues to engage in non-regulatory conduct and post-FDA submission activities related to the commercialization of the BB305 vector, which infringes on the ‘179 and ‘061 patents,” the lawsuit states.
This current lawsuit highlights bluebird’s ramp-up of commercial manufacturing in the US for the BB305 vector, as well as stockpiling and other commercialization activities for the vector that Errant says “are not reasonably related to obtaining FDA approval.”
According to the lawsuit, EGT claims it has suffered irreparable harm, and asks for $2 billion. It says that its own gene therapy is slated to cost more than $1 million less than bluebird’s, which is projected to cost $2 million per patient. Leschly caused jaws to drop in 2019 when he announced that it would have a price tag of $1.8 million per patient, just behind Novartis’ spinal muscular atrophy therapy treatment Zolgensma for the crown of most expensive treatment.
The lawsuit has been a long time coming. In August 2019, the New York Supreme Court sanctioned bluebird for $25,000, and rejected its efforts to prevent EGT from proceeding with a lawsuit by holding the company in contempt.