- Jazz Pharma 24-2274.pdf

• Whether enjoining the act of applying for FDA approval of a new indication is supportable under eBay where the court’s findings concern only harm from market entry.: To enjoin noncommercial conduct such as seeking regulatory approval, the patentee must show a causal nexus and that enjoining the application is necessary to prevent infringement; findings about harm from future market entry are too speculative and attenuated to justify barring an FDA application without further analysis.

- Regeneron 24-1965.pdf

• Causal nexus for irreparable harm in preliminary injunction involving an FDA-approved biosimilar whose BLA scope could encompass noninfringing variants.: Causal nexus is not defeated merely because the FDA-approved application could allow noninfringing variants where the record shows the accused infringer intends to market only the infringing product and a noninfringing alternative is not shown to be actually planned or readily achievable; when the accused product essentially embodies the claimed invention (not a complex multi-feature product), the causal-nexus inquiry may have little additional work to do beyond tying the harms to the infringing product.

- Smartrend 24-1616.pdf

• Effect of reversing/vacating liability determinations on a permanent injunction.: When the underlying infringement judgments are reversed or vacated and a new trial is required, the permanent injunction predicated on those liability findings must be vacated.

- Wonderland Switzerland 23-2043.pdf

• Whether a permanent injunction may issue for a patent when the patentee did not request injunctive relief, and what showing is required for irreparable harm under eBay.: Granting a permanent injunction is an abuse of discretion when the prevailing party expressly declined to seek that remedy, and irreparable harm cannot be based on speculative or conclusory assertions; the district court must tie irreparable injury and inadequacy of legal remedies to concrete record evidence.