Drugs

Court Upholds Patent Test Extrinsic Evidence

The Federal Circuit Court of Appeals has upheld a district court ruling that parties may rely on extrinsic evidence when establishing a claim element’s function under the doctrine of equivalents. Attorney Karalena Guerrieri (Winston & Strawn) writes in an online post that the decision came in a case brought by Intendis GMBH against Glenmark Pharmaceuticals involving an ANDA for a topical gel for treating rosacea. The courts ruled that Glenmark’s ANDA infringed the Intendis patent under the doctrine of equivalents.

The district court had held that the excipient in the alleged infringer’s product and the claimed excipients both functioned as penetration enhancers. On appeal, Glenmark argued that the district court erred in applying the function part of the so-called function-way-result test because the patent did not define the claimed excipients as penetration enhancers.

“The Federal Circuit rejected the argument that a claim element’s function must come from the intrinsic record,” Guerrieri writes. “Instead, the appropriate test, which can be proven through extrinsic evidence, is what a person of ordinary skill in the art would understand the function of the claim element to be.”

Two other arguments raised by Glenmark also were rejected by the appeals court.

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