Doctor's Orders: The Search for a Workable Pleading Standard in Hikma v. Amarin

"Pharmaceutical patent litigators navigate the complexities of the Hatch-Waxman Act and 35 U.S.C. § 271(b), balancing the promotion of affordable generics with the risk of inducing patent infringement."

"The Supreme Court's upcoming hearing on Hikma Pharmaceuticals v. Amarin Pharma will address the legal boundaries for generics marketing carved-out products without infringing on patent rights."

The Hatch-Waxman Act allows generics to seek FDA approval for unpatented indications through a 'skinny label.' However, Section 271(b) imposes liability for inducing patent infringement. This creates tension as generics can enter the market for unpatented uses but risk liability if they promote the drug for patented uses. The Supreme Court will hear Hikma Pharmaceuticals' case against Amarin Pharma regarding the marketing of Vascepa, which has both unpatented and patented indications, raising questions about lawful marketing practices.

Read at IPWatchdog.com | Patents & Intellectual Property Law