Johnson and Johnson faces first CAR T patent battle at the UPC

Johnson and Johnson faces first CAR T patent battle at the UPC - Bristol Myers Squibb Subsidiary Files Suit Against J&J

You know, when you hear about big pharma companies going head-to-head, it often feels like a distant corporate drama, but this one really catches my attention because it’s all about the future of CAR T-cell therapy. It’s not Bristol Myers Squibb directly, which is interesting, but their subsidiary, Celgene, that’s filing against Johnson & Johnson, showing just how deep the roots of this intellectual property go. We’re talking about a core patent, believed to be tied to those crucial co-stimulatory domains—think CD28 or 4-1BB—stuff that dictates how well these engineered T-cells actually work in patients. This isn’t something they just cooked up yesterday; this patent stems from foundational academic research licensed ages ago, even before their blockbuster drugs, Abecma and Carvykti, hit the market. And honestly, the venue here, the Unified Patent Court's central division, is a huge deal because it's letting them fight both infringement and validity claims simultaneously across multiple European countries, which is super efficient compared to the old way. Just imagine, both Abecma and Carvykti are looking at over $3 billion in combined global sales annually; so yeah, the money involved here is just staggering. While the exact details are under wraps, I'm betting the dispute really boils down to super specific bits of the CAR construct itself, like the hinge or transmembrane domains, or even tiny linker sequences. These seemingly small technicalities can seriously impact how effective and safe these life-saving therapies are, you know? The outcome here isn't just about who wins this round; it could absolutely reshape how future CAR T collaborations and licensing deals, especially for foundational tech, get structured internationally. It’s kind of unusual, too, because both companies usually play nice, with tons of complex licensing agreements, so this direct suit really points to some pretty fundamental, unresolved intellectual property friction. It makes you wonder what deeper issues are really at play when they can't just settle this behind closed doors, right?

Johnson and Johnson faces first CAR T patent battle at the UPC - The Unified Patent Court's Inaugural CAR T Challenge

You know, watching this whole CAR T showdown land right at the brand new Unified Patent Court feels like watching the first real stress test on a brand new piece of machinery. It’s not just some small dispute; this is 2seventy bio—a subsidiary, mind you—coming out swinging against J&J over their bone cancer therapy, Carvykti, which really tells you how deep the ownership layers go in this industry. I’m honestly thinking the real fight isn’t just about who’s infringing, but about the technical guts of the therapy itself, probably those transmembrane domain sequences that make the T-cells actually signal correctly once they’re inside the patient. Think about it this way: we’re talking about the tiny chemical linkers connecting the recognition part of the antibody to the activation switch inside the cell; if you mess up that tiny bit, the whole therapy changes. And what’s strategically sharp here is that they didn’t just file for infringement; they immediately asked the central division to revoke the entire European Patent, which is a massive move that locks down validity arguments in one shot, avoiding the old headache of fighting in London, Paris, and Munich separately. Because this is the UPC’s first big biotech rodeo involving living material patents, whatever they decide about claim construction right now is going to become the rulebook for every complex gene therapy case coming down the pipe for the next decade or so. This isn’t just about blocking a current drug; the stakes are about market exclusivity stretching way past 2035, so yeah, this is foundational stuff we’re watching.

Johnson and Johnson faces first CAR T patent battle at the UPC - High Stakes in CAR T Patent Protection

Look, when two giants like Bristol Myers Squibb, through their subsidiary 2seventy bio, start pointing fingers at J&J over Carvykti right in the new Unified Patent Court, you know we're not talking about some minor fender-bender; this is about the very foundation of modern cancer treatment. We’re zeroing in on this specific patent, EP 3 689 383, which allegedly covers the exact mechanical blueprint—that second-generation CAR design featuring a 4-1BB co-stimulatory domain sitting right after a specific IgG4 hinge region—and that structural detail is everything for making T-cells hang around long enough to actually work. And here’s the kicker: this whole technology didn't just pop up; it traces back to academic tinkering from the late nineties, meaning these patents have been aging for decades before they became the keys to multi-billion dollar therapies, creating these tangled web of old licenses. But it’s not just the cell design they’re fighting over; I mean, the real hidden value often lies in the manufacturing side, specifically the proprietary viral vectors they use to deliver the genetic instructions, because if you can’t mass-produce safely, you’ve got nothing. Seriously, the number of patent applications globally has exploded by 350% recently, and they’re already pivoting toward next-gen 'off-the-shelf' therapies, showing how fast this field is moving past the current one-patient-at-a-time model. It's tricky too, because enforcing these patents means trying to claim rights on the engineered cell *product* while simultaneously defending the *method* of treating someone with it, which is like trying to sue someone for owning a specific hammer and also for the way they swung it. Whatever the Brussels division decides on how to interpret those claims now, it's setting the precedent for how every future gene therapy licensing deal in Europe is going to shake out, making this fight way bigger than just Abecma versus Carvykti.

Johnson and Johnson faces first CAR T patent battle at the UPC - Potential Precedents for Biopharma Patents in Europe

You know, looking back at how Europe has handled cell and gene therapy patents before the Unified Patent Court even existed, it really paints a picture of what we should expect now. Historically, the European Patent Office was usually okay with granting patents for the *process* of modifying a patient's cells outside the body, which is different from just patenting the final cell itself, so that's our baseline expectation here. We've also seen them really push for applicants to show detailed proof—not just sequences—about how stable and effective those engineered parts are when they’re actually inside a person, which means these CAR T claims can't just be theoretical wish lists. And honestly, they’ve always been more skeptical than, say, the US system when it comes to granting patents that are too wide, those "cover-all" patents on basic biological parts; they usually want claims tightly glued to a specific, non-obvious way the therapy is used therapeutically. Think about those old antibody cases, too; they established that just because two things *function* the same way doesn't mean they infringe unless their chemical structures are almost exactly the same, and that level of precision is going to be huge when interpreting the claims on these 4-1BB domains. Because of past national court battles, especially in Germany, we know the UPC judges are likely going to treat the specific type of co-stimulatory switch—like whether it’s 4-1BB or CD28—as a really weighted, essential feature when they look at infringement. It’s almost like they're forcing everyone to be super clear about what they actually invented, rather than letting them claim every possible variation down the road, which is why these technical details in the Carvykti patent are everything right now.