Autoimmune disorders are on the rise across the globe. No one is sure why, but the usual suspects of diet, stress, and the general unfriendliness of modern life to our delicate immune systems are all subject to blame. Regardless of the cause, there is no doubt that for those afflicted an autoimmune condition can be debilitating, or at a minimum life disrupting. Because many such conditions are systemic and hard to diagnose, treatments that are effective are often of very high value — both in terms of costs to patients, as well as with respect to the return to normalcy they can sometimes deliver alongside their high price tags.
One of the autoimmune conditions on the rise worldwide is alopecia areata, sometimes referred to as “spot baldness.” With estimates that 700,000 Americans — with rates higher in minority communities — are currently afflicted, the causes of the condition are recognized as being complex and often arising for the first time during childhood. For reasons not yet fully understood, the immune system in patients with alopecia areata attacks the hair follicles, resulting in unwanted hair loss. While there may be a correlation with COVID-19, or even vaccines, the recent uptake in cases globally has of course raised interest in treatments. With no cure yet discovered, finding an effective treatment for the condition has required “trial and error,” at least until three new treatments were approved by the FDA, in 2022, 2023, and 2024 respectively. All of these new treatments are cytokine modulators referred to as JAK inhibitors. As we would expect, there are a number of patents around JAK inhibitors, including one (US Patent No. 9,662,335) owned by Incyte Corp. That patent was asserted by Incyte against Sun Pharma, the company that most recently got FDA approval for its alopecia areata treatment.
Indeed, July 2024 saw Sun get FDA approval for Leqselvi, a twice-daily oral medication for alopecia areata. In clinical trials, the drug helped a third of those suffering from severe cases (over 50% scalp hair loss) achieve an 80% improvement in hair regrowth — compared to less than 1% seeing similar results with a placebo. In other words, for the lucky ones that benefit from Leqselvi — the benefit is real. Unfortunately for those patients, the scheduled October 2024 launch of the new treatment was postponed indefinitely when Incyte sued Sun for infringement of the ‘335 patent. In addition to the lawsuit filing, Incyte moved for a preliminary injunction, which was granted by the district court judge. A federal xircuit appeal of that injunction decision followed.
On appeal, the Federal Circuit reversed the grant of the injunction, in a May 7, 2025, decision authored by Chief Judge Moore. (That same day, Moore also authored a decision in an appeal brought by Incyte from a post-grant review petition it filed against one of Sun’s patents.) In the appeal, Sun challenged the grant of the injunction on two grounds. First, that Incyte failed to show that it was likely to suffer irreparable harm, and second, that Incyte had not demonstrated a likelihood of success on the merits of its ‘335 patent infringement claim against Leqselvi. As it turns out, all it took was the irreparable harm argument to have the injunction set aside.
To start, the panel acknowledged that irreparable harm could occur where a patentee would otherwise be forced to give an infringer a “head start” or loses the “first mover advantage.” This would be true even in the prescription drug space, “when patients are unlikely to switch treatments.” That is especially true in the context of Leqselvi, where “it is undisputed that patients are unlikely to switch treatments” — especially that lucky subset of patients for whom the drug is effective at all. Still, the panel noted that Incyte’s arguments about an improper “head start” if Leqselvi were to launch had only been presented in a cursory fashion. Upon consideration of the undisputed facts, however, the panel concluded that the district court erred in determining that, but for Leqselvi, Incyte would be in pole position to bring a similar treatment to market.
For one, the panel recognized that while Sun was ready to launch Leqselvi, the ‘355 patent itself had a limited lifespan left. Meanwhile, Incyte was years from launching its competing drug, which made the reality that Sun would have a “head start” something that was “inevitable” and not tethered to the presence of injunctive relief. Because the district court erred in finding “that, absent an injection, Incyte would be first to market,” the finding of irreparable harm was “clearly erroneous” and the injunction was reversed.
Ultimately, this decision presents an interesting scenario where the limited lifespan of a patent renders it less effective as a means of keeping out a competitive product from the market. At the same time, should Sun launch Leqselvi and the ‘355 patent be found both infringed and valid, then Incyte could be entitled to a reasonable royalty based on Leqselvi sales. Not a bad backup option for Incyte, even as they now face the harsh market reality that Sun will capture market share while Incyte gets its drug through the arduous approval process. At least suffering patients that can benefit from Leqselvi will have a chance to find some relief in the meantime. And we have some further clarity from the Federal Circuit on the proper role of preliminary injunctions in pharma cases to work with.
Please feel free to send comments or questions to me at gkroub@kskiplaw.com 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, and Markman Advisors LLC, a leading consultancy on patent issues for the investment community. Gaston’s practice focuses on intellectual property litigation and related counseling, with a strong focus on patent matters. You can reach him at gkroub@kskiplaw.com or follow him on Twitter: @gkroub.
The post Into The Sun: Federal Circuit Provides Clarity On The Role Of Injunctions In Pharma Cases appeared first on Above the Law.
Autoimmune disorders are on the rise across the globe. No one is sure why, but the usual suspects of diet, stress, and the general unfriendliness of modern life to our delicate immune systems are all subject to blame. Regardless of the cause, there is no doubt that for those afflicted an autoimmune condition can be debilitating, or at a minimum life disrupting. Because many such conditions are systemic and hard to diagnose, treatments that are effective are often of very high value — both in terms of costs to patients, as well as with respect to the return to normalcy they can sometimes deliver alongside their high price tags.
One of the autoimmune conditions on the rise worldwide is alopecia areata, sometimes referred to as “spot baldness.” With estimates that 700,000 Americans — with rates higher in minority communities — are currently afflicted, the causes of the condition are recognized as being complex and often arising for the first time during childhood. For reasons not yet fully understood, the immune system in patients with alopecia areata attacks the hair follicles, resulting in unwanted hair loss. While there may be a correlation with COVID-19, or even vaccines, the recent uptake in cases globally has of course raised interest in treatments. With no cure yet discovered, finding an effective treatment for the condition has required “trial and error,” at least until three new treatments were approved by the FDA, in 2022, 2023, and 2024 respectively. All of these new treatments are cytokine modulators referred to as JAK inhibitors. As we would expect, there are a number of patents around JAK inhibitors, including one (US Patent No. 9,662,335) owned by Incyte Corp. That patent was asserted by Incyte against Sun Pharma, the company that most recently got FDA approval for its alopecia areata treatment.
Indeed, July 2024 saw Sun get FDA approval for Leqselvi, a twice-daily oral medication for alopecia areata. In clinical trials, the drug helped a third of those suffering from severe cases (over 50% scalp hair loss) achieve an 80% improvement in hair regrowth — compared to less than 1% seeing similar results with a placebo. In other words, for the lucky ones that benefit from Leqselvi — the benefit is real. Unfortunately for those patients, the scheduled October 2024 launch of the new treatment was postponed indefinitely when Incyte sued Sun for infringement of the ‘335 patent. In addition to the lawsuit filing, Incyte moved for a preliminary injunction, which was granted by the district court judge. A federal xircuit appeal of that injunction decision followed.
On appeal, the Federal Circuit reversed the grant of the injunction, in a May 7, 2025, decision authored by Chief Judge Moore. (That same day, Moore also authored a decision in an appeal brought by Incyte from a post-grant review petition it filed against one of Sun’s patents.) In the appeal, Sun challenged the grant of the injunction on two grounds. First, that Incyte failed to show that it was likely to suffer irreparable harm, and second, that Incyte had not demonstrated a likelihood of success on the merits of its ‘335 patent infringement claim against Leqselvi. As it turns out, all it took was the irreparable harm argument to have the injunction set aside.
To start, the panel acknowledged that irreparable harm could occur where a patentee would otherwise be forced to give an infringer a “head start” or loses the “first mover advantage.” This would be true even in the prescription drug space, “when patients are unlikely to switch treatments.” That is especially true in the context of Leqselvi, where “it is undisputed that patients are unlikely to switch treatments” — especially that lucky subset of patients for whom the drug is effective at all. Still, the panel noted that Incyte’s arguments about an improper “head start” if Leqselvi were to launch had only been presented in a cursory fashion. Upon consideration of the undisputed facts, however, the panel concluded that the district court erred in determining that, but for Leqselvi, Incyte would be in pole position to bring a similar treatment to market.
For one, the panel recognized that while Sun was ready to launch Leqselvi, the ‘355 patent itself had a limited lifespan left. Meanwhile, Incyte was years from launching its competing drug, which made the reality that Sun would have a “head start” something that was “inevitable” and not tethered to the presence of injunctive relief. Because the district court erred in finding “that, absent an injection, Incyte would be first to market,” the finding of irreparable harm was “clearly erroneous” and the injunction was reversed.
Ultimately,this decision presents an interesting scenario where the limited lifespan of a patent renders it less effective as a means of keeping out a competitive product from the market. At the same time, should Sun launch Leqselvi and the ‘355 patent be found both infringed and valid, then Incyte could be entitled to a reasonable royalty based on Leqselvi sales. Not a bad backup option for Incyte, even as they now face the harsh market reality that Sun will capture market share while Incyte gets its drug through the arduous approval process. At least suffering patients that can benefit from Leqselvi will have a chance to find some relief in the meantime. And we have some further clarity from the Federal Circuit on the proper role of preliminary injunctions in pharma cases to work with.
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, and Markman Advisors LLC, a leading consultancy on patent issues for the investment community. Gaston’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.
