Datascope Corp. has announced the filing of a motion to join Maquet Cardiovascular LLC's existing patent infringement case against Abiomed, Inc. in the federal court for the District of Massachusetts, to assert counterclaims alleging that Abiomed has engaged in false advertising by promoting its Impella® device as superior to Datascope's intra-aortic balloon pumps (IABPs). Simultaneously, Maquet is expanding its infringement case by alleging that most Impella® models infringe three patents issued to Maquet this year, thus bringing the total number of patents in the suit to six. Both Datascope and Maquet are Getinge companies.
Datascope is a leading manufacturer of IABPs, which are circulatory assist devices that use counterpulsation to help the heart pump blood in patients in need of cardiac support. Abiomed'sImpella® is a ventricular assist device used for mechanical circulatory support.
Datascope's counterclaims assert that Abiomed has engaged in a pattern of intentional and widespread false advertising regarding Impella® compared with IABP in violation of federal and state law. According to the lawsuit, Abiomed has falsely advertised that the PROTECT II trial, which was terminated for futility and was underpowered, and a related "hypothesis-generating" post hoc analysis of the PROTECT II data, demonstrate that Impella® significantly reduces major adverse events compared with IABP at 90 days. Datascope alleges that Abiomed's marketing materials are false.
Datascope's counterclaims also identify recent developments to support Datascope's position that Abiomed's superiority claims are unlawful. An example is Health Quality Ontario's February 2017 in-depth technology assessment, which concludes that "percutaneous ventricular support with Impella does not lower death rates; nor is it safer or cheaper than usual treatment with balloon pumps."1Another example is the October 2016 explorative, randomized, controlled IMPRESS trial, sponsored by Abiomed, which concludes that routine treatment with Impella CP was not associated with reduced 30-day mortality compared with IABP.2
In addition, Datascope alleges that Abiomed disseminated false representations regarding U.S. Food and Drug Administration (FDA) approval of IABP, the cost-effectiveness of Impella® compared with IABP, the standard of care, and other features of Impella®. According to the lawsuit, Abiomed advertises that IABP is not FDA-approved as safe and effective for the treatment of acute myocardial infarction, cardiogenic shock, or for use during high-risk PCI. The counterclaims state that IABP has, in fact, been designated as a Class II device and that a 2012 FDA review found that IABP offers a reasonable assurance of safety and effectiveness for these indications.
In 2016, Maquet asserted that many Impella® models infringe three Maquet patents entitled "Guidable Intravascular Blood Pump And Related Methods". Earlier this year, the U.S. Patent and Trademark Office issued three more patents to Maquet in this area; Maquet is adding the three new patents to the case. Maquet asserts that all six patents relate to significant technological developments that Abiomed improperly incorporated in many of its Impella® products, for which Maquet is entitled to just compensation. – PR Newswire