11th Circuit Rules that the Scope of Orphan Drug Exclusivity is Determined by the Rare Disease or Condition Designation, Not the Approved Indication

Exclusivity, Orphan drug

Recently, the Eleventh Circuit sided with Florida-based Catalyst Pharmaceuticals Inc., holding that the U.S. Food and Drug Administration’s interpretation of the Orphan Drug Act is contrary to the plain language of the statute. Catalyst Pharm., Inc. v. Becerra. The court found that the FDA unlawfully infringed on an exclusivity period it awarded to Catalyst for…

FDA Rejects Vanda Pharmaceuticals Efforts to Force ANDA-Filers to Include Labeling Statements Related to its Three-Year Exclusivity

Exclusivity, FDA

Last week, the FDA rejected Vanda Pharmaceutical’s Citizen Petition requesting that FDA withhold approval of ANDAs for its schizophrenia drug, Fanapt®, for three years.  (Letter from Janet Woodcock, M.D., Director Center for Drug Evaluation and Research, to Richard L. Gulino, Senior Vice President, General Counsel and Secretary, Vanda Pharmaceuticals Inc., dated Nov. 28, 2016.)  Specifically,…

Generic’s Counterclaims for Non-Infringement are Proper Despite Covenant Not to Sue From Brand

CNS, Counterclaims, Covenant, Exclusivity, Forfeiture, Jurisdiction, Non-infringement, Trigger

On April 9, 2014, in Purdue Pharmaceutical Products, L.P. v. TWi Pharmaceuticals, Inc., Civ. No. 12-5311 (D.N.J.), Judge Jose L. Linares of the United States District Court for the District of New Jersey ruled that a generic drug company who is not a first-filer has standing to assert a counterclaim for non-infringement despite the issuance…