The Drug Price Competition and Patent Term Restoration Act (known as the Hatch-Waxman Act), was enacted in 1984 and serves as the foundational framework for generic pharmaceutical approvals and patent litigation. Hatch-Waxman established a regulatory framework that led to expanded access to affordable medicines. Importantly, the Hatch-Waxman framework found the appropriate balance between rewarding innovation through patent protection and enabling competition through a streamlined process for generic market entry. In 2010, Congress enacted the Biologics Price Competition and Innovation Act (BPCIA), which established a similar regulatory and patent pathway for biosimilar drugs. Viatris supports these important pieces of legislation and advocates for the preservation of these pillars to ensure patient access to generics and biosimilars.
In 2011, Congress established another important regulatory mechanism, known as Inter Partes Review (IPR), which allows a third party to challenge the validity of a patent in a cost-effective and efficient manner. IPR and patent litigation are two separate means of reviewing patent validity, and Congress intended to make both systems available to ensure only high-quality patents are granted. In recent years, some stakeholders have attempted to undermine and weaken the IPR process by making it more difficult to challenge weak or inappropriate patents or by forcing third parties to choose between patent litigation or the IPR process. Viatris supports both the IPR and Hatch-Waxman framework for patent litigation and recognizes these as important mechanisms necessary to prevent patent abuse and ensure fair competition in the pharmaceutical markets.