PATENT CONSTERNATION — The Senate Judiciary Committee is scheduled to mark up two bipartisan bills Thursday that affordable-drug proponents and generics makers say would make it easier for major pharma companies to game the patent system in favor of their products. One measure, cosponsored by committee Chair Dick Durbin (D-Ill.), would overhaul the patent review process at the Patent Trial and Appeal Board to require petitioners to have standing — namely, to have been sued or charged with patent infringement before filing for a review. The second bill would expand the universe of processes eligible for patents to include “a use, application, or method of manufacture of a known or naturally-occurring process.” Generics against: The Association for Accessible Medicines, which represents manufacturers of generics and biosimilars, argues the first bill would diminish one of their industry’s chief tools to get their products to market faster. Without the ability to lodge early challenges, the group says, brand-name drugmakers would have the bandwidth to innovate around potentially wrongly issued patents for years. “Long before generic and biosimilar companies seek FDA approval — and thus long before they are sued for infringement — they often know which patents they must clear to enter the market,” AAM interim president David Gaugh wrote to committee leaders earlier this year. The organization maintains the second measure would allow brand-name manufacturers to build even larger patent thickets around their products, keeping prices high for consumers. More opposition: Advocacy groups for patients, providers and hospitals also oppose the measures. Patients for Affordable Drugs’ David Mitchell said the bills would undermine the goals of the Inflation Reduction Act, which launched Medicare’s ability to negotiate some drug prices directly with manufacturers. Lauren Aronson, executive director of the Campaign for Sustainable Rx Pricing, wrote to committee leaders that the bill “would only further tip the scales in favor of Big Pharma and its ability to establish and maintain patent thickets.” Both AAM and P4AD argue the patent eligibility measure would make it easier for major pharma companies to build those thickets — webs of overlapping intellectual property rights on a single product — which can delay the entry of cheaper copies onto the market. The other point of view: PhRMA spokesperson Megan Van Etten said the patent review bill “is a positive step that would provide needed reforms to PTAB proceedings to promote innovation across all technologies.” A spokesperson for Delaware Sen. Chris Coons, the primary Democratic sponsor of both bills, argued they would “provide more speed and clarity to a dated patent system.” “Claims that these bills hinder competition or delay approval of generic drugs have been repeatedly debunked,” Van Etten said. IT’S TUESDAY. WELCOME BACK TO PRESCRIPTION PULSE. We’re crushed that coffee is due to become more expensive. Reach out with tips to David Lim (dlim@politico.com or @davidalim) and Lauren Gardner (lgardner@politico.com or @Gardner_LM).
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