Patent wars

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Aug 01, 2024 View in browser   By Ben Leonard and Chelsea Cirruzzo Driving The Day Lobbyists for drug and device makers are speaking out against the U.S. Patent and Trademark Office's proposal that would add requirements for patent applicants. | AP PATENT POLICIES RILE PHARMA — A wonky-but-significant proposal from the USPTO could impact drug patenting — and it’s cracking fault lines in the health care industry. Background: The U.S. Patent and Trademark Office allows patent owners and inventors to obtain more than one patent for claims with only minor differences. It blocks such claims if they’re deemed to be made to extend patent exclusivity and prevent competition. The proposal: In May, the USPTO proposed regulations it said would lower the cost of challenging each patent in a group of patents tied to “indistinct” versions of a single invention. Backers argue it would prevent “patent thickets,” or a web of patents that could stifle competition. The rule would add requirements for patent applicants stipulating that a patent’s length won’t go beyond that of an existing patent, using a practice known as a terminal disclaimer. The applicants would have to agree that the patent with the disclaimer would only be enforceable if it hasn’t been tied via terminal disclaimers to other patents deemed invalid. The USPTO move comes as Congress is divided on how to change the patent system. The backlash: Brand-name drug lobby PhRMA slammed the proposal in written comments, saying it seems to be built on a “misunderstanding” about the patent system and patent thickets. The group said new patents don’t change the terms of old ones, and no evidence cited has shown that patents using terminal disclaimers are more likely to be invalid than others. Medical device lobbying group AdvaMed said that, if finalized, the rule would reduce incentives for new technology through increasing uncertainty in patent rights. Sen. Thom Tillis (R-N.C.), who is working with Sen. Chris Coons (D-Del.) on separate legislation that would strengthen patents to keep pace with competitors like China, said the rules could turn an “inventor-friendly system on its head.” Backers: The USPTO has allies in Congress, the FTC and employer groups. Rep. Debbie Dingell (D-Mich.), who is working on legislation with Rep. Jodey Arrington (R-Texas) to address patent thickets, said the rule is “critical” to lowering drug costs and stymying future thickets. The ERISA Industry Committee, which represents large employers’ benefit interests, said the USPTO proposal strikes a balance by bolstering patent quality and allowing more generics and biosimilars to enter the market. “Too often, the only innovation that seems to emerge is another gimmick used to extend a patent,” ERIC’s senior vice president of health policy, Melissa Bartlett, said. What’s next: The agency plans to finalize the rule by December. WELCOME TO THURSDAY PULSE. Staffers working on health care in Congress — let’s grab coffee over August recess. Reach me at bleonard@politico.com. And send me or Chelsea (ccirruzzo@politico.com) your tips, news and scoops. Follow along @_BenLeonard_ and @ChelseaCirruzzo.   Live briefings, policy trackers, and procedural, industry, and people intelligence from POLITICO Pro Analysis gives you the insights you need to focus your policy strategy this election cycle.  Secure your seat.      In Congress Oregon state Rep. Maxine Dexter's track record includes getting her opioid harm-reduction package signed into law. | Maxine Dexter for Congress CAPITOL HILL’S NEW DOCTOR? As several health policy leaders — some of them doctors — are leaving Capitol Hill, Congress is poised to get a new physician: Maxine Dexter, a pulmonologist at Kaiser Permanente. Dexter, who is stepping down as an Oregon state representative later this month, beat progressive Susheela Jayapal, the sister of Rep. Pramila Jayapal (D-Wash.), chair of the Congressional Progressive Caucus, in a heavily Democratic Portland-area district in a May primary. She’s all but assured to win the seat that Rep. Earl Blumenauer (D-Ore.) is vacating after nearly three decades in Congress. As chair of the Oregon House’s Committee on Housing and Homelessness in the 2023 session, Dexter grappled with substance-use issues and the fallout of a now-overturned law decriminalizing drug possession. “There was a plan, and it was very appropriate to make it a public health issue. But there was no ability to implement it before we decriminalized it,” Dexter said earlier this week in a wide-ranging interview with Ben. “So what people saw was a lot of public use of illicit drugs and nowhere for people to go to get help.” As chair, her opioid harm-reduction package was signed into law, making overdose-reversal drug naloxone more available in public places and legalizing fentanyl test strips. She said she’ll push to get a seat on a health care-related committee and said her top priorities are mental health and reproductive rights. You can read the full Q&A with Dexter here. Cybersecurity BLOOD CENTER HIT BY RANSOMWARE — A nonprofit blood center that serves hundreds of hospitals in the southeast, OneBlood, issued an “urgent call” Wednesday for donors after it was hit by a ransomware attack. The organization said that while it can still collect and distribute blood, it’s doing so in a “significantly reduced capacity.” “We have implemented manual processes and procedures to remain operational. Manual processes take significantly longer to perform and impact inventory availability,” a spokesperson for OneBlood said in a statement. A spokesperson for the American Hospital Association said that hospitals have reported the incident is impacting patient care and that hospitals are using conservative strategies for blood. The bigger picture: The attack is just the latest in a slew of cybersecurity breaches that have threatened patient safety, data security and the bottom line of health care organizations. Also in cybersecurity: The Senate Homeland Security Committee advanced legislation Wednesday that would require CISA and HHS to collaborate on health care cybersecurity. HEALTH INSURANCE FIRST IN PULSE: MEDICARE POLLING — Medicare is the top issue for older Americans this election, according to new polling first obtained by Pulse. A bipartisan-led national poll of 1,498 likely voters ages 60 and older from polling firms Bully Pulpit International and UpOne on behalf of the Better Medicare Alliance found that 94 percent said protecting the insurance program is “very or extremely” important, higher than any issue in the survey. The poll was conducted between July 9 and 16 and has a margin of error of 2.5 percentage points. Bully Pulpit clients have included the Biden-Harris campaign. Other findings: The poll also found that 74 percent of older adults oppose cutting funding for Medicare Advantage. Insurers have argued that the Biden administration’s changes to Medicare Advantage reimbursement constitute cuts. CMS has countered that they are payment increases when accounting for beneficiaries’ health. The future of Medicare is likely to be a top health care issue this election cycle, with mounting concerns about its solvency. President Joe Biden and Donald Trump both accused each other of hurting Medicare in their June debate, and Harris is expected to take a similar position. CLAIM DENIAL CONFUSION — Nearly half of insured, working-age adults said they received a bill in the last year for care they thought should have been covered by their health insurer, according to a poll released today from the Commonwealth Fund — and many of them didn’t appeal the decisions. The survey from the think tank found that close to 1 in 5 adults said they or a family member were denied coverage for doctor-recommended care. Less than half of those denied coverage appealed. Forty-five percent of those who didn’t attempt to challenge their bills didn’t know whether they could do so, the nationally representative survey of 7,873 adults ages 19 and older between April and July 2023 found. The bigger picture: The findings come amid increased congressional scrutiny of insurers over care denials. Insurers have argued that processes like prior authorization help control health care costs and limit unneeded care. Chris Bond, a spokesperson for insurer lobbying group AHIP, said that insurers "make care more accessible and protect patients from the true drivers of rising health care costs" — pointing to hospitals and drugmakers. Artificial Intelligence CONSERVATIVE GROUP TAKES ON AI REGS — Artificial intelligence has significant potential to control health care costs, a new report from the conservative Paragon Health Institute found, but several factors could reduce its impact, the group said. To bolster AI’s potential to reduce costs, the organization argued that clinical assistance shouldn’t be required via regulations in concert with the technology when it meets certain accuracy levels and doesn’t increase health risks. “One of my concerns around getting regulation that properly balances safety and innovation is … that lobbying groups will advocate that all AI healthcare be supervised by a clinician,” Kev Coleman, a visiting research fellow at Paragon, said at a Wednesday event. The move comes as lawmakers weigh potential new AI rules and as House GOP leadership has expressed skepticism about any new AI regulation.   SUBSCRIBE TO GLOBAL PLAYBOOK: Don’t miss out on POLITICO’s Global Playbook, our newsletter taking you inside pivotal discussions at the most influential gatherings in the world. Suzanne Lynch delivers the world's elite and influential moments directly to you. Stay in the global loop. SUBSCRI     Names in the News Jesse Roach is now senior vice president of government relations at the National Kidney Foundation. He previously was chief medical officer for CVS Kidney Care. Karina Lynch is joining DLA Piper’s public policy practice as partner. She was previously at Williams & Jensen. Hannah Hurley of Sen. Kyrsten Sinema’s (I-Ariz.) office and Geoff Werth, previously of k10 Government Relations, are joining the Federation of American Hospitals as vice presidents of communications and government relations, respectively. WHAT WE'RE READING POLITICO’s Toni Odejimi reports on the Senate HELP Committee advancing legislation reauthorizing support for older Americans. The Wall Street Journal reports on blood tests that could gauge heart disease risk.   Follow us on Twitter Dan Goldberg @dancgoldberg Chelsea Cirruzzo @chelseacirruzzo Lauren Gardner @Gardner_LM Sophie Gardner @sophie_gardnerj Kelly Hooper @kelhoops Robert King @rking_19 Ben Leonard @_BenLeonard_ David Lim @davidalim Megan Messerly @meganmesserly Alice Miranda Ollstein @aliceollstein Carmen Paun @carmenpaun Daniel Payne @_daniel_payne Ruth Reader @RuthReader Erin Schumaker @erinlschumaker   Follow us

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