Federal Circuit rejects the pharmaceutical company's attempt to dodge the revision of its patents



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The Federal Circuit prevented a private company from using the rights of a Native American tribe to prevent the patent office from revising its patents. The case concerns a pharmaceutical company, Allergan, who paid the Saint Regis Mohawk tribe for "owning" its patents, and then invoked sovereign immunity to avoid review inter partes ( IPR). The Congress has created IPR procedures to improve the quality of patents by giving third parties the opportunity to challenge patents at the Patent Office. Stressing the public interest in the nature of IPRs as an administrative body – the Patent Office -, the court of appeal found that tribal immunity could not be invoked to terminate this proceeding

. companies, including Mylan, for violating its patents related to Restasis, a treatment for the symptoms of chronic drought. Mylan responded by filing IPRs challenging the patents. Allergan responded by "selling" these patents to the Saint Regis Mohawk Tribe (which received millions of dollars from Allergan as part of the transfer). After the patents were transferred, the tribe claimed sovereign immunity and asked the Patent Office to terminate the IPRs.

As a rule of thumb, sovereign immunity refers to the concept that a sovereign entity (here, the Mohawk tribe of Saint Regis) can not be subject to the jurisdiction of another sovereign (here, the states United States, in the form of the Patent Office) unless the first entity is in agreement. The agreement with Allergan required the tribe to badert sovereign immunity for the purpose of terminating the Patent Office's proceedings before the Restasis patents were revoked. Allergan paid to use tribal sovereignty to block efforts to invalidate his patents.

After the Administrative Judges of the Patent Office rejected the IPR application for termination, the Mohawk Tribe of Saint Regis appealed to the Federal Circuit. The appeal has aroused much public interest and many amicus briefs have been filed on both sides, including a memoir [PDF] from the R-Street Institute and FEP. We explained that if Allergan's tactics were allowed, it would undermine the IPR process and would lead many other companies to use the same system to avoid examination of their patents.

The Federal Circuit has now ruled [PDF] that sovereign tribal immunity can not be used to protect patents against IPR procedures. In a unanimous decision, the Court held that tribal sovereign immunity does not apply in IPR proceedings as they are more closely related to executing executive branch actions – where tribal sovereignty does not apply – to federal courts between private parties

. on a number of factors. For example, the panel noted that the director of the Patent Office has the discretion to institute or not a reconsideration, and thus "if the intellectual property rights belong to a tribe, it is because & # 39; 39, a politically responsible federal official authorized the institution of patents. "The court also noted that the petitioners do not exercise full control over the course of IPR proceedings because, once initiated, "The Commission may choose to continue the examination even if the petitioner chooses not to participate." IPR is an act by the agency in reconsidering its own granting of a public franchise. "

Judge Dyk joined the majority opinion in its entirety, but also filed a concordant opinion that underscores the important purpose of the IPR procedures: to allow the Patent Office to eliminate patents that are not applicable. it emits by mistake. The Patent Office receives over 600,000 applications per year, giving examiners about 22 hours to review each application. Some type of reconsideration is necessary because "[r] supply constraints in the initial review period inevitably lead to erroneously issued patents". This has been recognized for a long time. Prior to the existence of IPRs, there was a different reconsideration process in which patents could be subject to post-grant review, and no one had quarreled – before or during St. Regis Sovereign Immunity prevented the Patent Office from proceeding with such a review

Tribal sovereignty is an important issue that has important implications for the government. self-determination and the justice of the Amerindians. But we were concerned to see private companies attempting to praise sovereign immunity in order to avoid the administrative processes created to protect the public interest. In this case, the tactic was part of an attempt to use bad patents to support drug prices for everyone. We are happy that the federal circuit has rejected the tactics.

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