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Posts tagged Restasis
Will the Federal Circuit’s tribal immunity decision in St. Regis Mohawk Tribe v. Mylan make it to the Supreme Court?

The Federal Circuit has sided against the Tribe and Allergan.  On July 20, the Federal Circuit affirmed the decision by the Patent Trial and Appeal Board that denied the motion by the St. Regis Mohawk Tribe to terminate a series of inter partes review proceedings commenced by Mylan ($MYL) against patents listed in the Orange Book for Allergan’s ($AGN) drug Restasis®.  What are the takeaways from this decision?

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Takeaways from the Tribe’s Oral Argument at the Federal Circuit: St. Regis Mohawk Tribe v. Mylan

On June 4, 2018, the Federal Circuit heard oral argument in Allergan’s effort to assert tribal immunity at the PTAB to shut down six IPRs against its Restasis® patents.  The St. Regis Mohawk Tribe has appealed the PTAB’s prior decision that it cannot assert its immunity as a basis to terminate the IPRs.  While there was no clear indication for how the three-judge panel at the Federal Circuit would rule, there were some interesting exchanges revealing how the Court views these types of transactions, and how viable they may be in the future.

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The PTAB's Allergan / St. Regis Mohawk Decision: Explained

The PTAB has issued its much-anticipated decision on whether Allergan managed to pull off it’s scheme to avoid IPRs of its Restasis® patents by “selling” the patents to the St. Regis Mohawk Tribe.  On February 23, 2018, the PTAB denied the Tribe’s motion to terminate the IPRs on the ground based on its tribal sovereign immunity.  What were the PTAB’s reasons for denying the Tribe’s motion to terminate the IPRs?  And what are the ramifications for similar deals in the future?

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Latest developments on whether the “litigation waiver” really dooms the Tribe’s assertion of sovereign immunity against the Restasis® IPRs

Allergan’s PTAB Restasis® fight continues, and a recent email tiff before the PTAB between the St. Regis Mohawk Tribe and Mylan has added a further wrinkle to this case.  As we previously blogged, a recent decision by the PTAB (between the University of Minnesota and Ericsson) held that a State’s sovereign immunity against an IPR is waived under the Eleventh Amendment where the State affirmatively asserts the challenged patent in litigation.  That decision appeared to potentially doom Allergan’s strategy of passing off its Restasis® patents to the Tribe to defend against the IPRs.  A recent email exchange between the Tribe and Mylan (the Petitioner in the pending Restasis® IPRs) at the PTAB suggests the University of Minnesota decision may not, in fact, be the nail in the coffin that Mylan had likely hoped.  But it also shows that the Tribe may not be on as sound footing as it is claiming.

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The PTAB’s latest sovereign immunity decision leaves open as many questions as it answers.

In the latest twist in the saga pitting sovereign immunity against inter partes review, the PTAB issued a decision on December 19, 2017 that potentially jams a spoke into the wheels of future partnerships between brand pharma and Tribes.  What does this decision bode for Allergan’s Restasis® deal with the St. Regis Mohawk Tribe?  What are the consequences of this decision?

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Notable points from the Tribe's Reply Brief in Restasis® briefing before the PTAB.

The problem with these arguments is that even if they are all true (which is questionable,) they are besides the point.  The issue at stake is whether renting sovereign immunity to evade having to defend the validity of your patent is either permissible or should be permissible.  Indeed, Judge Bryson admonished Allergan for being “conspicuously silent about the broader consequences of the course it has chosen.”  (Allegan v. Teva, Dkt. 522 at 4-5).  Mr. Saunders op-ed in The Wall Street Journal is equally silent. 

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