Contrast developer Bracco Diagnostics has filed a complaint against radiopharmaceutical firm Jubilant DraxImage and two of its affiliates for alleged patent infringement regarding rubidium-based radiopharmaceuticals for cardiac PET studies.
Bracco filed papers on March 27 with the U.S. International Trade Commission (ITC), asking that the ITC issue an order to stop Jubilant from importing its Ruby-Fill rubidium-82 generators and related products and components.
Bracco is also asking for a cease-and-desist order that would prohibit the sale of Jubilant's Ruby elution system and Ruby-Fill generators that have already been imported, as well as damages and injunctive relief. Jubilant Pharma and Jubiliant Life Sciences are included in the litigation.
Bracco has also filed suit against Jubilant in the U.S. District Court for the District of New Jersey with charges similar to the ITC complaint. Bracco's patents relate to strontium-rubidium radioisotope infusion systems, according to a letter Bracco sent to customers on March 27.
"Bracco welcomes fair competition in the marketplace, but it is imperative that competitors respect the patent rights of others," wrote Bracco Vice President and General Counsel Vito DeBari.
In the letter, DeBari claims that Bracco is the "pioneer" in rubidium-82 generators and has "invested significantly" in the development and advancement of rubidium-82 infusion systems. The company said it intends to protect its investments with the complaint and lawsuit.
In a written response, Jubilant said that it has "carefully reviewed" Bracco's allegations and intends to "vigorously defend" its legal positions.
"We are very confident that ultimately Jubilant DraxImage will be successful in this litigation and do not expect the litigation to affect the continuing availability of Ruby-Fill products in the U.S. or elsewhere," the company added.
The Ruby elution system and the proprietary Ruby consumable accessories are used only with the Ruby-Fill rubidium-82 generator for PET imaging of the myocardium and manufactured only by Jubilant DraxImage, according to the company. Both devices are available throughout the U.S.
Bracco's CardioGen-82 generator produces rubidium chloride for myocardial PET imaging under rest and pharmacological stress in adult patients with suspected or existing coronary artery disease.
The Ruby-Fill generator received clearance from the U.S. Food and Drug Administration (FDA) in September 2016 and was first available in the U.S. in May 2017. The device is also available in Canada and Switzerland.
Bracco had not approached Jubilant DraxImage about its concerns regarding possible patent infringement issues, said Sarah Marquis, director of legal affairs for Jubilant DraxImage.
Bracco's complaint to the ITC also triggered an eight-day public comment period, the notice of which was published in the Federal Register on April 3. The ITC will take public comments from any parties who use the technology in healthcare or have another interest in it, she added.
The comment period is underway and ends April 11. At the conclusion, the ITC will consider Bracco's complaint based on the ITC's laws and regulations regarding products entering the U.S.
