Pharma prefers the old EU patent rules

The ideas and innovators shaping health care

Jun 06, 2023 View in browser   By Erin Schumaker, Carmen Paun and Ben Leonard POLICY PUZZLE The EU is trying to streamline its patent system but pharma's not on board. | Leon Neal/Getty Images Pharmaceutical companies are opting out of a new unified patent system that European Union countries launched last week. The new system is supposed to be inventor-friendly, providing a single patent that protects inventions in the 17 EU countries that have signed on while establishing a single Unified Patent Court where those patents can be challenged. But companies can opt to stick with the old system, and POLITICO’s Helen Collis reports that early data shows that many of the firms choosing to do so are drugmakers. In the old system, inventors are awarded patents by either national courts or the European Patent Office. A European patent covers as many as 39 countries, including all EU members, but in practice it’s a bundle of patents — one for each country — enforced nationally. Any judgment on a unitary patent by the Unified Patent Court would be effective in all 17 countries. The complexity of the old system suits the industry because it forces competitors to challenge patents in multiple jurisdictions. If a generics company won its challenge to a unified patent, it would automatically gain access to all markets under the system. Sticking to the national system “allows you strategically to better defend your patents,” said Sergio Napolitano, general counsel at Medicines for Europe, the generics lobby. “This fragmentation is especially to the detriment of generic companies because they have to litigate country by country.”   DON’T MISS POLITICO’S HEALTH CARE SUMMIT: The Covid-19 pandemic helped spur innovation in health care, from the wide adoption of telemedicine, health apps and online pharmacies to mRNA vaccines. But what will the next health care innovations look like? Join POLITICO on Wednesday June 7 for our Health Care Summit to explore how tech and innovation are transforming care and the challenges ahead for access and delivery in the United States. REGISTER NOW.     WELCOME TO FUTURE PULSE Citi Field, N.Y. | Ben Leonard This is where we explore the ideas and innovators shaping health care. The Lazarex Cancer Foundation is in Washington today for an event on increasing access to cutting edge cancer care. Among the panels is one featuring a chat with three House members: Republicans Buddy Carter of Georgia and Pete Sessions of Texas and Democrat Robin Kelly of Illinois. Share any thoughts, news, tips and feedback with Ben Leonard at bleonard@politico.com, Ruth Reader at rreader@politico.com, Carmen Paun at cpaun@politico.com or Erin Schumaker at eschumaker@politico.com. Send tips securely through SecureDrop, Signal, Telegram or WhatsApp. Today on our Pulse Check podcast, your host Ben talks with Robert King about his interview with Medicare Director Meena Seshamani and her approach to charting a path in drug price negotiations. Listen to today’s Pulse Check podcast FOLLOW THE MONEY Ketamine is a promising treatment for depression, but getting it affordably is another matter. | AFP via Getty Images “We have something which works well and is cheap — nobody’s giving it. While the other one, which is much more expensive, because it’s FDA-approved, is being given.” — Amit Anand, psychiatry professor at Harvard Medical School and physician at Mass General Brigham Intravenous ketamine shows promise as a therapy for hard-to-treat depression, but there’s a caveat, according to an author of a new study that compared it to electroconvulsive therapy. Since IV ketamine is a generic medication more typically used as an anesthetic, “no organization or drug company is going to spend millions of dollars to get FDA approval for it,” said Amit Anand, lead study author and psychiatry professor at Harvard Medical School and physician at Mass General Brigham. “There’s no money in generic medication.” Some clinics offer Spravato, a nasal-delivery version of a ketamine-like drug that some insurers cover. Off-label IV ketamine, also prescribed at clinics, isn't covered. Cost considerations: Seeing patients get “fleeced” at ketamine clinics was partly why Anand wrote the grant to study generic IV ketamine for treatment-resistant depression, he told Erin. “If you have a large study done, maybe third-party payers will start paying for intravenous ketamine and patients won’t have to pay out of pocket.” Patients are considered to have treatment-resistant depression if they have tried at least two depression treatments without their symptoms improving. In the head-to-head study, published in the New England Journal of Medicine, Anand and his colleagues gave IV ketamine to 195 patients with treatment-resistant depression. Their symptoms improved as much as those who received electroconvulsive therapy, a more traditional treatment, in which doctors send electric currents through a patient's brain while they're under anesthesia. Six months later, both groups reported similar improvements in quality-of-life scores. The percentage of patients who had muscle pain or weakness after treatment was higher in the ECT group, while patients in the ketamine group were more likely to have dissociative symptoms. What’s next? A next step for the research, Anand said, is a larger study of more than 1,000 patients over the next six years of ketamine vs. ECT for acutely suicidal patients. Nearly 40 percent of participants in the NEJM study had previously attempted suicide. “Antidepressants take four to six weeks,” Anand said. “ECT works very fast. So for an urgent situation, like if somebody is acutely suicidal or acutely psychotic or acutely not eating or drinking, you have to get them better.” Given what he’s seen so far, Anand believes ketamine might work as fast as ECT in critical situations, or perhaps even faster.   GET READY FOR GLOBAL TECH DAY: Join POLITICO Live as we launch our first Global Tech Day alongside London Tech Week on Thursday, June 15. Register now for continuing updates and to be a part of this momentous and program-packed day! From the blockchain, to AI, and autonomous vehicles, technology is changing how power is exercised around the world, so who will write the rules? REGISTER HERE.     WASHINGTON WATCH Lopez Obrador says the U.S. needs to deal with its demand for fentanyl. | Marco Ugarte/AP Photo To reduce fentanyl overdoses, policymakers have to address the societal problems undergirding demand for the drug. That was the consensus of top health officials from the U.S., Canada and Mexico meeting at the White House Tuesday. It was also a nod to Mexican President Andres Manuel Lopez Obrador, who’s made that case repeatedly in the face of pressure from the U.S. to crack down on the drug cartels in his country. “When I visited President Lopez Obrador in March, he told me how important it is to embrace a broader public health approach, including addressing the social determinants of health,” said Rahul Gupta, the director of the White House Office of National Drug Control Policy, in his opening speech at the North American Drug Dialogue Public Health Summit. POLITICO's Alice Miranda Ollstein will ask Gupta about the fentanyl crisis at tomorrow's POLITICO Health Care Summit at 11 a.m. Next steps: The health officials agreed that a broader approach involves considering people’s needs for employment, housing, food security, child care and education. Mexico’s Health Secretary Jorge Alcocer Varela cited “social, economic and emotional factors and even cultural factors” driving drug use, adding that all sectors of society should be involved in the response. Canadian Minister of Mental Health and Addictions Carolyn Bennett said substance abuse is linked to trauma. “If you think that the people have needed to numb out either their physical pain or their psychic pain, then we can find the compassion that it's going to take to move this through,” she said.   Follow us on Twitter Ben Leonard @_BenLeonard_ Ruth Reader @RuthReader Carmen Paun @carmenpaun Erin Schumaker @erinlschumaker   Follow us

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