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As U.S. lawmakers consider ways to lower drug prices, they are turning to strategies such as: Medicare Negotiations and Self-payment amountA new uproar is brewing over pharmaceutical patents.
Sen. Dick Durbin (D-Ill.) said in a May 21 floor speech that patents that protect brand-name drugs from competition allow drug companies to manipulate prices beyond what is permitted by the language of current patent law. Hearing Member of the U.S. Senate Judiciary Committee.
“Anyone who’s taken an introductory course on this business knows what’s going on,” Durbin said. “The patent system is being manipulated and used by lawyers to extend the life of patents in order to avoid competition, to avoid generics, and to keep costs down.”
Blockbuster drugs like Eli Lilly & Co.’s Humalog and AbbVie Inc.’s Humira have benefited from such patent extensions, which allow companies to raise prices without fear of a competitive market, he said.
The bipartisan Patent Abuse Act, proposed by Senators John Cornyn (R-TX) and Richard Blumenthal (D-CT), was passed. Approval by the Judiciary Committee in 2021 Returning in 2023 However, the bill is still awaiting floor debate. Five bipartisan initiatives Something that is not yet widespread.
But patent reform would create more problems than it solves and would do little to lower drug prices, said David Kappos, a former administrator of the U.S. Patent and Trade Office.
“There is a lot of misunderstanding among lawmakers in general about the role of patents in determining drug prices,” Kappos said. “The claim that drug patents drive up drug prices through practices such as so-called ‘evergreening’ and ‘patent thickets’ is widely misunderstood.”
Evergreen trees and bushes
Evergreening refers to the practice of adding secondary patents, such as new delivery systems like inhalers or syringes, to extend a drug’s protected expiration date. Opponents call this evergreening, but industry supporters call it “Lifecycle Management. “
The patent conundrum is clear in the allegations against AbbVie. Handling the blockbuster drug HumiraThe company holds more than 100 patents, and opponents allege that it is using legal tactics to intentionally stifle competition.
But Kappos argues that what seem like minor improvements are actually the result of incremental innovation. Former PTO DirectorAndrei Iancu is co-chair of the Innovation Promotion Council.
“Pharmaceutical companies spend hundreds of millions, even billions, of dollars on further innovation, creating vastly improved versions of their products,” Kappos says, “and then they bring those products to market, and lo and behold, patients and doctors love them.”
Kappos said companies that make generic drugs are legally allowed to replicate the original product once the patent expires, but the popularity of the new innovation justifies the cost.
“It gives better results, fewer side effects, better outcomes. We want more of that,” Cappos said.
And generic drugs have certainly penetrated the market, Kappos said, adding that generic drugs are 90% of prescriptions.
But a 2023 study found that, on average, pharmaceutical companies can extend exclusivity protection for branded drugs by about three years through secondary patents. study A study from the UCLA Anderson School of Management found that the extended protections have increased costs to consumers by more than $52 billion, but only for some drugs.
Industry-friendly legislation
Wouldn’t the patent system be improved if we didn’t ban these practices? The Cornyn-Blumenthal bill “strengthens the patent system by approving new products, stimulating innovation, protecting and bringing generic drugs to market, and lowering drug prices,” Blumenthal said. release.
Kappos believes the patent system should be strengthened by rewarding inventors.
Kappos supports two bipartisan bills introduced by Sens. Chris Coons (D-Delaware) and Thom Tillis (R-N.C.): PREVAIL would limit patent challenges, and PERA would make it easier to obtain patents. Delaware and North Carolina are two major centers of pharmaceutical manufacturing.
Critics compete These changes will not address the cost of medicines and will reinforce existing patent practices.
The industry supports these bills because they would provide additional defenses to the current patent system and “they are not a waste of resources attacking the good faith efforts of biopharmaceutical companies,” Kappos said.
Kappos worries that lawmakers are getting wrapped up in their own ideas about solutions and are muddying the waters with flawed thinking.
“There were some statements made at the[May 21 hearing]that should be of some concern to anybody who cares about the United States leading in medical innovation,” Kappos said. “They’re trying to make the patent system a scapegoat for the prices of drugs that we all want to make affordable.”
