Drugs

Court Says it Can Hear Paragraph IV Conversion Case

The Delaware federal court has denied a defendant’s motion to dismiss a generic drug patent case, rejecting the argument that conversion of a Paragraph IV certification to a Paragraph III certification deprives the court of subject matter jurisdiction. Attorneys Charles Chevalier and Christine Gaddis (Gibbons) write in their firm’s online IP Law Alert that the court reasoned that in a Waxman-Hatch action, subject matter jurisdiction exists when a patent owner alleges that the filing of an ANDA infringes its patent and conversion of the type of certification does not remove that jurisdiction.

The court also reasoned, the attorneys write, that a Paragraph IV to Paragraph III conversion would not moot a case unless the defendant met the “formidable burden” to show that its wrongful conduct would not occur, and the defendants in this case had not met that burden because they expressly refused to stipulate that they would not reconvert back to a Paragraph IV certification.

The attorneys say that while the court denied the motion to dismiss the suit for lack of subject matter jurisdiction, it granted the defendants’ motion for partial judgment on the pleadings. The court held that the plaintiff could no longer obtain relief on their claim because the defendants had converted to Paragraph III certifications and FDA would not approve the defendants’ ANDA product until after the expiration of the plaintiffs’ patents.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome