Drugs

USPTO Should Check Keytruda Patent Requests: Lawmakers

Sens. Elizabeth Warren (D-MA) and Bernie Sanders (I-VT) and Reps. Pramila Jayapal (D-WA) and Katie Porter (D-CA) are calling on the U.S. Patent and Trademark Office (USPTO) to closely scrutinize any Merck requests for new patents for its cancer treatment Keytruda (pembrolizumab). A statement (includes a link to the letter) says Merck “has aggressively used the patent system to protect its monopoly on this drug and is now attempting to patent a new formulation of Keytruda that can be injected under the skin, raising concerns that these anti-competitive business practices will ultimately result in significant financial strain for patients.”

Keytruda was first approved in 2014, the statement says, and quickly became Merck’s biggest seller, with third quarter 2022 sales revenue of $5.4 billion. “If approved,” the lawmakers say, “Merck’s patent application for its subcutaneous formulation of Keytruda could shield the drug from competition for many years. This approach, and Merck’s use of dozens of patents to fend off Keytruda competitors, appear to be an example of the anti-competitive business practices, including double-patenting, patent thicketing, product hopping, and evergreening that [we] have long been concerned about.”

The lawmakers say the USPTO should reject any Marck patent requests that fail to meet the agency’s mission to ensure the “system as a whole does not unnecessarily delay getting generic, biosimilar, and more affordable versions of those drugs into the hands of Americans who need them.

“Abusive patent practices reduce competition and result in significant financial strain for patients,” the lawmakers say. “The non-discounted annual price of Keytruda is $165,308, and that price has increased 147% in the five years since Keytruda was launched, in large part because of limited competition.”

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