One of the most promising treatments for blood cancers like leukemia and lymphoma is CAR-T therapy. While some of the science behind this new wave of treatments is complex, the basic premise behind them is simple. The sick patient is infused with genetically modified T-cells, natural cancer killers, prompting an immune response that sometimes results in the body killing off the cancer on its own.
While CAR-T therapy doesn’t work yet for all patients and all cancers, when it does work, the effect is nothing short of miraculous, with patients who were marked for certain death achieving stable remission and cures. At this point, CAR-T therapy is still an experimental treatment, and numerous biotech companies are in a race to receive FDA approval for their particular CAR-T variants. The financial stakes are high, considering the enormous cost of developing these treatments to begin with, as well as the potential profits available to those companies successful in commercializing their technology.
As with any major medical advance, patents have a role to play in picking out the eventual winners and losers with respect to CAR-T therapies. Interestingly, even though no company is yet FDA-approved, two of the leading CAR-T companies, Juno Therapeutics and Kite Pharma, have been embroiled in patent litigation for years — across a number of litigation fronts. Their ongoing adversarial escapades offer a contemporary glimpse into how modern big-ticket patent litigation plays out in the biotech industry, and illustrates the risks both patent owners and alleged infringers face as a result of the uncertainties of litigation. Considering the commercial importance of this class of cancer treatments, it is no surprise that both companies have spent freely in procuring top legal counsel, and are pressing their claims against the other aggressively.
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We can start with Juno, a well-pedigreed pioneer in the CAR-T field. In fact, Juno appears to own a critical patent on CAR-T, an asset it has no choice but to protect and on occasion exploit. The value of Juno’s patent rights is enhanced by the commercial challenges the company has faced, including clinical trial deaths that have compromised Juno’s efforts to obtain FDA approval for its CAR-T treatment. In short, Juno’s patent is an important backstop in case those commercialization woes fester.
Precisely because it is such an unmistakably important patent, however, Juno’s asset has already come under attack from a leading competitor. That competitor, Kite, preemptively filed a validity challenge in the USPTO — the notorious inter partes review or IPR — taking advantage of the recent changes in patent law to put Juno’s key asset at risk. While IPR proceedings are most typically used by patent infringement defendants as a more cost-effective (and legally effective) way of killing patents asserted against them, there is nothing stopping a company like Kite from trying to kill a competitor’s patent even before that patent is asserted against the IPR filer.
Fortunately for Juno, it won the IPR filed by Kite. Undaunted, Kite has filed for Federal Circuit appellate review of the IPR decision, and the parties are currently briefing the issues on appeal — with Kite arguing that the Supreme Court’s upcoming adjudication of the constitutionality of IPR proceedings potentially rendering its failed attempt to IPR Juno’s patent moot. Accordingly, there is still a chance that Kite could succeed in removing the Juno patent before it is ever used as a way to extract royalties from, or potentially even enjoin, any eventually-approved Kite CAR-T treatment. Considering the stakes, this is one Federal Circuit appeal to watch, and will be of interest to both practitioners and shareholders in both companies. While Juno has succeeded thus far in defending its patent, this story illustrates the challenging environment for patent owners in the age of the IPR, even as the Supreme Court considers the constitutionality of the IPR proceeding altogether.
Perhaps as a form of retaliation against — but more likely as a way to gain leverage over — Kite, Juno chose an aggressive approach and filed its own action in District Court, asserting patent infringement against Kite’s CAR-T therapy. In response, Kite moved to dismiss the case as premature, relying on the safe harbor against patent infringement claims granted to clinical trial activity, and arguing that Juno lacked standing to sue Kite until its product was FDA-approved and on sale. For its part, Juno argued that Kite’s filings seeking FDA-approval were enough to support its infringement case, especially when coupled with Kite’s extensive preparations for commercializing its CAR-T treatments, such as its physical facility for making the patient therapies.
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In a recent decision, the District Court sided with Kite, and dismissed the case as premature. While a temporary setback for Juno, it is no doubt hopeful that it will prevail in the Federal Circuit and have the IPR decision in its favor affirmed, while waiting for the right moment — likely right after Kite launches a commercial FDA-approved product at the latest — to reinitiate its infringement case.
While the litigation path forward for both parties remains a bit murky, it is clear that neither side intends to allow the other to bully them. Both Juno and Kite have already demonstrated a willingness to take the fight to the other, informed by their mutual understanding that Juno’s patent is a valuable pawn in the broader commercialization chess match for CAR-T therapies. What this situation demonstrates is that in modern patent litigation, there are numerous opportunities for parties on both sides of a case to press the initiative and assume an offensive stance. When the underlying technology is so potentially valuable, it is difficult to imagine that a passive approach is the best one for either side.
At bottom, however, it is clear that Juno’s patent will eventually reach its day of reckoning on the merits. Whether it survives that reckoning will clearly have important ramifications for both Kite and Juno, as well as the broader CAR-T market. In the meantime, patent lawyers and investors will be watching these battles with interest. More importantly, however, we can all hope that CAR-T therapies prove themselves effective weapons in the war against cancer — irrespective of whether the patents on those therapies can survive in today’s challenging patent litigation environment.
Please feel free to send comments or questions to me at [email protected] or via Twitter: @gkroub. Any topic suggestions or thoughts are most welcome.
Gaston Kroub lives in Brooklyn and is a founding partner of Kroub, Silbersher & Kolmykov PLLC, an intellectual property litigation boutique. The firm’s practice focuses on intellectual property litigation and related counseling, with a strong focus on patent matters. You can reach him at [email protected] or follow him on Twitter: @gkroub.