Intellectual Property

Intellectual property rights, such as patents and trademarks, are critically important incentives that drive future innovation and enable medical breakthroughs that improve patients’ lives. Strong IP systems establish clear and enforceable rights and protections for patent holders while ensuring that non-innovative and obvious products do not receive patent protection or exclusivity. The ability for parties to challenge the validity of a patent is critically important to ensuring equitable IP rights and preventing efforts to extend exclusivity and delay competition based on weak or meritless patents. Essential to achieving a balanced IP regime is ensuring that patents eventually expire, thereby promoting generic competition and enabling patient access to affordable medicines.


5,228 patents held by Viatris

Preserving Hatch-Waxman

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.

Pro-Competitive Patent Settlements

Patent settlements, or legal agreements between brand and generic drug manufacturers to end litigation over patent disputes in exchange for guaranteed market entry of generic medicines by a certain date is an essential business practice within the pharmaceutical industry.

Patent settlements are an important tool to ensure timely market entry of lower-cost generic and biosimilar medicines and remove a key hurdle for generic manufacturers – unpredictable and costly litigation. Patent settlements are often incorrectly described narrowly as “pay-for-delay” agreements, or brand drug companies paying generic manufacturers to keep medicines off the market. Viatris is opposed to pay-for-delay agreements that delay patient access to medicines beyond the time a brand name drug loses patent protection or market exclusivity. Viatris supports pro-competitive patent settlements that result in generic market entry prior to patent expiration and increase patient access to lower-cost medicines. A recent study estimates that patent settlements between brand and generic drug manufacturers have resulted in savings of more than $11 billion to patients and the U.S. government.

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