Opening Another Front in the Brand/Generic Battle? | Axinn, Veltrop & Harkrider LLP
Although it’s not often that I read a decision by the U.S. Court of Federal Claims, it appears that Vanda may be opening a new front in the brand/generic battle by surviving a motion to dismiss in a case it brought under the Fifth Amendment takings clause relating to FDA sharing certain information with generic applicants regarding dissolution rate and other specifications for two of Vanda’s products, Hetlioz (tasimelteon) and Fanapt (iloperidone). If Vanda is successful, FDA may be prohibited in the future from assisting generic applicants with setting product specifications, which may make it more difficult for generics to obtain approval and to design products that more closely match their branded counterparts.
What’s really interesting about this suit is that the crux of Vanda’s complaint is that FDA shared with generic applicants a dissolution specification that FDA had proposed to Vanda during the NDA approval process for Vanda’s products. But, once Vanda adopted those specifications, it asserts that such information became protectable trade secrets that FDA was barred from sharing with generic applicants. In denying the motion to dismiss the takings clause causes of action, the court noted that determining whether Vanda has a proprietary interest in the specifications is a “more vexing issue” that will need to be evaluated as the case proceeds.
Of course, Vanda is no stranger to suing FDA. In fact, as previously posted here, Vanda has been very active in pursuing relief in court against FDA, so much so that its CEO and co-founder has stated that he believes that FDA is retaliating against the company for its litigious behavior.
But success by Vanda in this lawsuit may have a significant impact on FDA’s review and approval of generic products. FDA traditionally works with applicants to adopt similar product specifications to ensure that generic products will perform the same as the reference brand product. If FDA is going to be more limited in the direction that it can provide to generic applicants on the development of their specifications, review and approval of generic products will certainly be delayed, likely causing a ripple effect on drug prices generally. And, in light of this decision, it will be interesting to see if more brand companies turn to the Court of Federal Claims to pursue takings clause actions against FDA.
“Such a ruling may adversely impact (or preclude altogether) the FDA’s ability to provide other brand name and generic manufacturers with comparable assistance. As raised by the Court during oral argument, without comparing the data and information of an approved NDA to the proposed data and information included in a generic’s ANDA under review, the FDA may authorize inconsistent results.
www.govinfo.gov/…
