Congress enacted the Hatch-Waxman Act to strike a balance between promoting generic competition and encouraging pharmaceutical innovation. The Act requires innovators to disclose patents to the FDA for listing in the Orange Book, while generic applicants can file certifications regarding these patents. One way for generic sponsors to avoid patent disputes is by filing a “section viii statement” and using “skinny labeling” to exclude patented uses from their labeling.
In the case of GSK v. Teva, the Federal Circuit upheld a verdict that Teva’s labeling induced infringement of GSK’s method-of-use patent for carvedilol. Despite concerns raised by Professors Tu and Kesselheim, GSK did not create new law or threaten the skinny labeling pathway. The court emphasized the fact-specific nature of inducement analysis and the importance of protecting patented uses to incentivize innovation.
Subsequent court decisions have reaffirmed the viability of skinny labeling strategies for generic drug sponsors. The Federal Circuit’s ruling in Amarin highlighted the need for clarity and consistency in communication to avoid liability for induced infringement. Critics of GSK have misunderstood the legislative intent behind skinny labeling provisions, which were not meant to shield generic manufacturers from patent infringement liability.
Patents play a crucial role in incentivizing clinical research and innovation in the pharmaceutical industry. The development of new uses for approved products requires significant investment and time. Allowing generic companies to promote patented uses without liability would undermine incentives for research and development.
In conclusion, maintaining the balance between promoting generic competition and protecting patented innovations is crucial. Congress should not provide preferential treatment to generic companies using skinny labeling or undermine the incentives for developing new treatments. The current framework of the Hatch-Waxman Act preserves the delicate balance between innovation and competition, and any changes should be carefully considered to avoid unintended consequences.