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www.fdanews.com/articles/213152-klobuchar-seeks-answers-from-drugmakers-on-improperly-listed-patents

Klobuchar Seeks Answers From Drugmakers on Improperly Listed Patents

January 23, 2024

Senator Amy Klobuchar (D-Minn.) is tackling the FTC’s recent warning letters to drug manufacturers who had improperly listed patents in the FDA’s Orange Book by sending letters to the six pharmaceutical companies that have not yet removed the offending patents.

Pointing out the harm of this practice, the letter states, “improperly listing a patent in the Orange Book can harm consumers, raise prices, and stifle competition by preventing cheaper generic drugs from entering the market for up to 30 months, and drives up the cost of entry by generic drug manufacturers by pushing them into expensive litigation before entering the market.”

Specifying the high cost of pharmaceuticals in the U.S., Klobuchar’s letter says that “the reasons for this are many, but one reason is the continued abuse of patent rights to extend monopoly control over a drug.”

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