Greenblum & Bernstein, P.L.C.
PRACTICE GROUP NEWSLETTER
Recent News in Intellectual Property
In This Issue
· A new Orphan Drug Battle:
The District Court ordered FDA to recognize orphan drug exclusivity without requiring any proof of clinical superiority or imposing any additional conditions on its owner
Jill M. Browning
P. Branko Pejic
A new Orphan Drug Battle: The District Court ordered FDA to recognize orphan drug exclusivity without requiring any proof of clinical superiority or imposing any additional conditions on its owner
In Depomed Inc. v. United States Department of Health And Human Services, the U.S. District Court of Columbia granted Depomed’s Motion for Summary Judgment and ordered FDA to recognize orphan drug exclusivity for GRALISE Tablets “without requiring any proof of clinical superiority or imposing any additional conditions on Depomed”.
Plaintiff Depomed has developed an orphan drug, called “GRALISE”, to treat a rare condition known as post-herpetic neuralgia (“PHN”). On January 28, 2011, FDA approved this drug product under NDA No. 022544 for the designated indication. Despite having designated GRALISE as an orphan drug for the approved indication, FDA did not grant orphan drug exclusivity because the FDA’s Orphan Drug Regulations were not met.
According the FDA’s orphan drug regulations, a “sponsor of a drug that is […] the same drug as an already approved orphan drug may seek and obtain orphan-drug designation […] if it can present a plausible hypothesis that its drug may be clinically superior to the first drug”.
If the new drug is shown to be “clinically superior” to the previous orphan drug which has the exclusivity – i.e. the new drug is shown to have greater efficacy, greater safety, or providing a major contribution to patient care compared to the previously approved drug – then the drug is not considered to be the same and the FDA may approve it notwithstanding the exclusivity period.
The new drug has to be a drug that contains the same active moiety as the previously approved drug and is intended for the same use with the exception that the subsequent drug can be shown to be clinically superior to the previous drug.
Because Depomed did not prove clinical superiority, FDA denied orphan drug exclusivity. Depomed filed this action.
The court held that the plain language of the exclusivity provision of the Orphan Drug Act requires the FDA to recognize exclusivity for any drug that the FDA has designated and granted marketing approval and it is undisputed that GRALISE satisfied both of those criteria (i.e. designation and approval).
FDA can appeal the decision.
The NEWSLETTER is issued by GREENBLUM & BERNSTEIN, P.L.C., an intellectual property firm, to provide timely news in the field of intellectual property. The views and/or opinions expressed herein do not necessarily reflect those of GREENBLUM & BERNSTEIN, P.LC. For more information, contact Jill M. Browning or Branko Pejic at GREENBLUM & BERNSTEIN, P.L.C., 1950 Roland Clarke Place, Reston, VA 20191. Copyright 2013 GREENBLUM & BERNSTEIN, P.L.C.