When Your Strongest Asset Is What You Leave Off the Label
The most valuable thing a competitor can do to your patent is comply with the law around it. That is the quiet lesson for IP-intensive businesses in the US Supreme Court’s unanimous June 2026 ruling in Hikma v. Amarin (read it here).
Amarin held a method-of-use patent on the cardiovascular indication for its drug Vascepa. Hikma launched a generic under a skinny label that carved out that patented use and kept only the off-patent one. Amarin’s induced infringement claim leaned on the totality of Hikma’s conduct: its label, its leaflet, its website, its investor press releases. The Court was unmoved. Inducement requires affirmative steps to encourage infringement, it held — not statements a physician could read as encouragement, and certainly not routine regulatory compliance, standard equivalence language, or what the drug didn’t say. Omissions, vagueness and “obvious alternative explanations” don’t cross the line.
For brand- side IP Managers, a second medical use patent is a real asset, if you can, figure out and claim all commercially viable indications – because the generic and biosimilar companies will. For generics and biosimilar teams, it confirms that a disciplined carve-out plus genuinely neutral commercial conduct is a defensible launch strategy, though note that Australian courts (Apotex v Sanofi, the pregabalin litigation) look hard at real-world market behaviour and won’t always reach the same result.
The takeaway for any IP-intensive organisation: your competitive position is decided long before litigation, in the choices about what you patent and how you behave commercially around it. Treat IP strategy as a business decision, not a filing exercise — and design your evidence trail, on both sides of the fence, before you need it.

