While some experts believe the decision could lead to greater generic access, others point out that many device patents exist alongside patents for the active ingredient, meaning that the overall effect on competition may be limited. Furthermore, branded companies may find ways to minimize the impact of the ruling by reissuing patents to include the active ingredient or by asserting device patents in separate lawsuits.
In conclusion, while the Federal Circuit’s ruling offers a potential path for challenging improper Orange Book listings, its practical effect on the pharmaceutical market will depend on future legal developments and how the industry responds.
