Drugs

Courts Differ on Drug Patent Litigation Stays

Recent cases have produced differing results when courts have considered requests to stay litigation of drug patent disputes during inter partes review (IPR) proceedings authorized under the 2012 America Invents Act. WilmerHale attorneys Andrea Jeffries and Nancy Schroeder say that the litigation stay requests raise questions about the 30-month stay provided by the Waxman-Hatch Act, and whether it should be extended.

They say that in four court cases, two decisions extended the regulatory stay along with a litigation stay, and two did not extend the regulatory 30-month stay because the courts did not believe they had authority to do so.

Jeffries and Schroeder write that the number of requested litigation stays may increase with the expansion of IPR practice against pharmaceutical patents, raising concerns about maintaining the benefits of the 30-month regulatory stay. They note that in cases involving Lilly and Alcon, the federal courts constructed their authority to extend the 30-month stay narrowly, requiring a showing of specific instances of failure to reasonably cooperate in expediting the action beyond the stay request itself.

“Other courts,” they conclude, “may be more willing to consider arguments to extend the regulatory stay based on the court’s inherent authority to prevent prejudice resulting from the effective shortening of the 30-month stay, a broader reading of [the law on Paragraph 4 certification] or both,” as in cases described involving Novartis and Abbott.

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