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11 April 2018Americas

Bracco Diagnostics files imaging tech complaint at USITC

Imaging technology company Bracco Diagnostics has accused a radiopharmaceutical company’s image generator of patent infringement, according to a complaint at the US International Trade Commission (ITC).

The ITC published notice of the complaint on April 3.

Bracco develops technologies to assist clinicians with targeted diagnostic imaging, and is the owner of New Drug Application (NDA) number 19414 for CardioGen-82 (Rubidium-82 generator).

The system is used to produce Rubidium-82 chloride injection for intravenous injection, which can be used to obtain internal images of patients’ blood flow to the heart muscle. Through this it allows the diagnosis of heart disease.

According to its complaint, Canadian company Jubilant DraxImage is in violation of the Tariff Act of 1930. Jubilant is a nuclear medicine company developing radiopharmaceuticals used for the diagnosis and monitoring of disease.

Jubilant allegedly imports products into the US which infringe the patents of Bracco. Bracco named Jubilant’s Ruby-Fill Rubidium-82 Generators and its components as the infringing products in the complaint. The Ruby-Fill received approval from the Food and Drug Administration in 2016.

The Ruby-Full produces Rubidium-82 via chloride injection for intravenous administration and is used to obtain internal images. According to Bracco, its proprietary technology is featured in Jubilant’s Ruby-Fill.

In its complaint Bracco asked the ITC to issue a cease and desist order against the Canadian medicine company and to impose a bond on Jubilant’s products which are allegedly infringing. Such a bond would prevent Jubilant selling the product in dispute during the complaint’s review period (60 days).

Bracco also filed a patent infringement lawsuit against Jubilant at the US District Court for the District of New Jersey last month, on March 27.

The suit similarly accused Jubilant’s Ruby-Fill system of infringing US patent numbers 9,814,826, 9,750,869, 9,750,870, 9,299,467, and 9,299,468.

Bracco said Jubilant submitted an abbreviated NDA (ANDA) to market the Ruby-Fill system in 2010. According to the suit, during the course of the ANDA process Jubilant admitted that the Ruby-Fill is a “pharmaceutical equivalent” to Bracco’s own system.

The complaint and lawsuit also include Jubilant Life Sciences and Jubilant Pharma, which are Jubilant’s Indian and Singaporean affiliates.

In a statement released last week Jubilant said it would “vigorously” defend its legal rights and does not expect the litigation to affect the continued availability of Ruby-Fill products.

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