In a blow to Roche, gene therapy developer bluebird bio can continue to use “spark” in its marketing campaign for sickle cell disease—at least for a while.
A federal judge in Delaware on Tuesday denied a request by Roche’s Spark Therapeutics unit for a preliminary injunction to temporarily block bluebird’s direct-to-consumer disease awareness project, dubbed “Be the Spark.”
Although Judge William Bryson sided with the Roche unit on its likelihood to win the case and potential for irreparable harm, he found that an injunction at this point would harm bluebird even more than for Spark, and that the public interest factor also favors bluebird.
Roche’s Spark owns the first FDA-approved gene therapy, Luxturna, which is for a rare eye disease. In a lawsuit filed in May, the company argues its ongoing R&D efforts in hemophilia overlaps with bluebird’s pipeline program in sickle cell disease, as both are gene therapies for blood disorders. Bluebird’s “Be the Spark” advertising could confuse doctors and patients regarding its relationship with Spark the company and could therefore weaken Spark’s brand, the Roche unit argued.
Bluebird’s campaign includes a patient website, sparksicklecellchange.com. It also displays the word “spark,” highlighted in gold, in phrases like “Spark Change” and “Spark Action.”
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Pairing “spark” with other words doesn’t rule out the possibility of confusion, Bryson noted. But he did point out that bluebird’s use of the word is different in that it’s a common noun or a verb rather than a proper noun. Taken together, these factors point to a “slightly” likely risk of confusion, he said in an opinion.
Elaborating on confusion, the judge said, “the high price of gene therapy treatments and the fact that such treatments are relatively new to the medical field indicates that physicians will exercise an extremely high degree of care” when using such a therapy, which reduces the risk of confusion.
What’s more, Spark hasn’t presented any evidence of actual confusion. And the fact that Spark only found out about bluebird’s campaign more than a year after its launch also suggests a limited risk of confusion, the judge added.
Bluebird has invoked fair use to back its case, whereas Spark argues the defendant is using the term “spark” for a trademark purpose. After weighing various legal concerns, Bryson figured it is a question for later that won’t affect his decision on a preliminary injunction.
Despite the many arguments against Roche, the judge acknowledged there’s still a chance—no matter how small—for the company to be eventually successful, meeting one criterion for temporary injunction. For the second condition, Bryson referenced several past cases in deciding that “irreparable harm is presumed upon a finding of a merely non-negligible likelihood of success,” which Spark has established. But he did point out that Spark’s showing of irreparable harm is speculation at best at this point.
Spark’s case looked promising at this point, but things took a turn when the judge considered the other two benchmarks needed to win an early injunction: the balance of hardships and the public interest.
Spark’s failure to show actual cases of confusion and failure to offer any evidence to support its claim of serious harm has come back to bite it. In contrast to Spark’s speculations, the harm to bluebird would be “more concrete” if an injunction were put in place, the judge said. A ban would force bluebird to revise its patient website, video and brochures as well as abandon the “Be the Spark” theme. So the balance of potential harm tipped in bluebird’s favor, Bryson ruled.
In addition, the public interest is “not likely to be significantly affected” by the denial of a preliminary injunction, because neither Spark nor bluebird produces an approved therapy in the blood disorder, the judge said. But bluebird wins here again as its campaign “serves an important interest in raising awareness regarding SCD,” according to the judge.
Losing the preliminary injunction request is a setback for Roche, but it doesn’t mean the company has lost the case. A Spark spokesperson declined to comment on ongoing litigation but said, “Spark is committed to the vigorous protection and defense of its trademarks.”
In the meantime, bluebird’s LentiGlobin gene therapy program has suffered repeated setbacks. The company recently withdrew a beta thalassemia therapy branded Zynteglo from the European market after hitting reimbursement roadblocks. In the U.S., the FDA has pushed back its decision for the drug as development of its sister SCD therapy has been put under clinical hold after reports of one case of “persistent, nontransfusion-dependent anemia.” Both those therapies deliver functional copies of the beta-globin gene to a patient’s own hematopoietic stem cells.