Key facts
- Supreme Court ruled Hikma's generic Vascepa did not infringe Amarin's patents.
- The ruling overturns a lower court's decision.
- Justice Ketanji Brown Jackson authored the unanimous 9-0 decision.
- The case involved 'skinny labels' for generic drugs.
- Hikma's generic Vascepa was approved for severe hypertriglyceridemia only.
The U.S. Supreme Court has unanimously ruled in favor of generic drugmaker Hikma Pharmaceuticals in a patent dispute concerning Amarin Pharma's cardiovascular drug Vascepa. The 9-0 decision, authored by Justice Ketanji Brown Jackson, determined that Hikma's generic version did not infringe upon Amarin's patents, overturning a previous lower court ruling. The case centered on 'skinny labels,' which restrict generic drug labels to approved uses to encourage competition. Hikma's generic Vascepa was approved solely for severe hypertriglyceridemia, omitting the use for less-severe cases still covered by Amarin's patents. Amarin had argued that Hikma's marketing encouraged doctors to prescribe the generic for the unapproved, patented use. The Supreme Court found Amarin failed to show more than a 'sheer possibility' of induced infringement, stating it is normal industry practice for generic makers to describe their products as equivalent to brand-name competitors.