The recent decision by the Federal Circuit regarding induced infringement claims has brought to light an important aspect of the Hatch-Waxman Act. This case involving Amarin and Hikma sheds light on the use of “skinny labels” by generic drug manufacturers to avoid infringement issues in standard cases.
Amarin’s drug, Vascepa®, has two FDA-approved indications, and Hikma sought to market a generic version by omitting one of the indications in its labeling. Initially, Amarin’s patents were found to be infringed but later ruled as obvious. However, in a subsequent lawsuit for induced infringement, the Federal Circuit reversed the District of Delaware’s decision, citing Hikma’s labeling and marketing materials as evidence of induced infringement.
Looking ahead, innovators should be cautious of generic manufacturers’ public statements when marketing their products, even under “skinny labels.” This case underscores the importance of monitoring how generics promote their products to avoid potential claims of induced infringement.
The Federal Circuit’s decision considered various aspects, including Hikma’s labeling, website promotions, press releases, and sales figures. These elements collectively led the court to believe that there was a plausible claim for induced infringement based on how Hikma’s statements could influence prescribing decisions by healthcare providers.
In conclusion, this case serves as a reminder that post-marketing actions and public statements by generic manufacturers can play a crucial role in determining induced infringement claims, even when using “skinny labels.” It is essential for both innovators and generics to be mindful of how they present their products to avoid potential legal implications down the line.