The St. Regis Mohawk Tribe and Restasis patent

St. Regis Mohawk Tribe Territroy

The St. Regis Mohawk Tribe and Restasis Patent is a notable case in the realm of intellectual property law, patent law, and indigenous rights. This case involves the St. Regis Mohawk Tribe, a federally recognized tribe in the United States, and the pharmaceutical company Allergan, which developed the eye medication Restasis. The case highlights the innovative yet controversial strategy of transferring patents to a Native American tribe to leverage sovereign immunity as a defense against patent challenges.

Background

Restasis is a prescription medication used to increase tear production in patients who have a condition known as chronic dry eye. Developed by Allergan, Restasis has been protected by multiple patents, generating significant revenue for the company. As the patents approached their expiration dates, Allergan faced potential generic competition, which could significantly impact its sales.

The Deal

In 2017, in an unprecedented move, Allergan transferred the patents for Restasis to the St. Regis Mohawk Tribe. In return, the tribe received an upfront payment and was promised annual royalties as long as the patents remained valid. The rationale behind this transfer was the doctrine of sovereign immunity, which protects federal and state governments from certain legal challenges, including some patent disputes. The St. Regis Mohawk Tribe, as a sovereign entity, sought to use this immunity to shield the Restasis patents from challenges at the United States Patent and Trademark Office (USPTO), specifically through the inter partes review (IPR) process.

Legal and Ethical Implications

The arrangement between Allergan and the St. Regis Mohawk Tribe sparked a significant debate within the legal, business, and indigenous communities. Proponents argued that it was a legitimate strategy to protect intellectual property and that it provided a new revenue stream for the tribe. Critics, however, saw it as an abuse of patent law and sovereign immunity, potentially setting a dangerous precedent for other companies to avoid patent challenges.

Court Rulings

The case eventually reached the courts, where the validity of using sovereign immunity in this context was tested. In February 2018, the United States Court of Appeals for the Federal Circuit ruled that tribal sovereign immunity does not apply to inter partes review proceedings at the USPTO. This decision meant that the patents could be challenged despite the transfer to the St. Regis Mohawk Tribe.

Impact and Legacy

The St. Regis Mohawk Tribe and Restasis patent case has had a lasting impact on patent law, sovereign immunity, and the strategies employed by pharmaceutical companies to protect their patents. It has prompted discussions and legislative proposals aimed at preventing similar arrangements in the future. Moreover, it has raised questions about the role of indigenous tribes in the patent system and the broader implications for their sovereignty and economic development.