The ruling’s impact could be felt most strongly through further litigation. Generics makers may file counterclaims in infringement suits, arguing that patents are improperly listed. Additionally, private plaintiffs or the FTC may take legal action under antitrust laws, which could lead to penalties for companies that continue to list device-only patents.
Teva’s appeal could also affect the trajectory of this case, as the full Federal Circuit or even the U.S. Supreme Court may decide to review the decision. However, even if the ruling stands, attorneys predict that it will take some time before there is any noticeable change in the market.
Impact on Drug Pricing and Generic Access
One of the most significant concerns surrounding the ruling is its potential effect on drug prices. The FTC has long argued that patents on drug devices without the active ingredient hinder competition and inflate prices by triggering the 30-month stay that delays the approval of generic versions. However, the impact of this ruling on drug pricing is still unclear, as removing device patents from the Orange Book may not significantly affect the availability of generics in the short term.
