Drugs

SCOTUS Backs Teva in Aloxi Patent Dispute

The Supreme Court unanimously refused to reinstate Helsinn Healthcare’s patent for its anti-nausea drug Aloxi, thereby supporting Teva, which launched a generic version of the drug last year. Reuters reports that Aloxi is indicated to prevent nausea and vomiting in patients receiving chemotherapy.

According to the report, the dispute centered on a licensing and purchase agreement that Helsinn struck with another drug company in 2001 to distribute the drug in the U.S. and defray its costs. Teva said the patent was invalid because the deal was reached nearly two years before Helsinn first applied for a patent, and thus was a public sale.

Teva’s position had been supported by the Court of Appeals for the Federal Circuit, which invalidated the patent, finding that a commercial offer or contract to sell a product makes it available to the public. Helsinn had said the decision hindered small companies that often need partners to develop and bring drugs to the market and would stop them from developing new medicines.

The high court said that the America Invents Act did not change the meaning of the on-sale doctrine under which patent protection cannot be granted for an invention that was on sale before the effective filing date of the application.

Reuters says the ruling “could make it easier to cancel key patents, especially among smaller drugmakers, widening the patent law provision prohibiting the patenting of an invention if it has been on sale or offered to the public more than a year before the patent application was filed.”

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