The induced infringement statute, 35 U.S.C. §271(b), does not apply to generic drug manufacturers who comply with FDA labeling requirements, because such compliance constitutes a lawful use of the patented invention under the Patent Clause's grant of exclusive rights, and any extension to cover such conduct would exceed Congress's power under Article I, Section 8, Clause 8.

The question is whether Amarin's complaint states a claim for induced infringement against Hikma. The relevant constitutional text is Article I, Section 8, Clause 8 (the Patent Clause), which grants Congress power to secure exclusive rights for limited times, and the Tenth Amendment, which reserves to the states powers not delegated. The statute at issue is 35 U.S.C. §271(b): 'Whoever actively induces infringement of a patent shall be liable as an infringer.' At the ratification era, the Patent Clause was understood to grant inventors exclusive rights only to make, use, and sell their inventions, but not to extend to activities compelled by law or incidental to lawful distribution. The First Congress's Patent Act of 1793 made only direct infringers liable. The common law of torts at the founding held that one who aids and abets a tort is liable only if the aid is intentional and substantial; mere compliance with regulatory requirements does not constitute aiding and abetting. Here, Hikma's statements were required or permitted by FDA regulations and standard industry practice. The skinny label, patient leaflet, website, and press releases all complied with federal law. Such compliance cannot constitute 'active inducement' within the original meaning of the statute. To hold otherwise would extend patent rights beyond the statutory grant and intrude on state substitution laws, raising serious Tenth Amendment concerns. Therefore, Amarin's complaint fails to state a claim. The holding is that generic manufacturers who comply with FDA labeling requirements are not liable for induced infringement based on the label itself or related communications that are required or customary. Downstream, patentees must rely on direct infringement claims against physicians or patients, or seek relief through the FDA's patent listing process.