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20 March 2019Big Pharma

Allergan and tribe hit back at Mylan claims in SCOTUS brief

Allergan and the Saint Regis Mohawk Tribe have again urged the US Supreme Court to hear their closely-followed litigation on tribal sovereign immunity, following a submission from generic maker Mylan in the case.

In a  filing submitted on Monday, March 19, Allergan and the Native American tribe requested the Supreme Court grant the petition for certiorari, which asks the court to answer whether tribal sovereign immunity can be asserted in an inter partes review (IPR) before the Patent Trial and Appeal Board (PTAB).

The latest brief was submitted in response to a  filing from Mylan and others, the respondents named in the suit.

Mylan claimed: “Moreover, even if the applicability of tribal sovereign immunity in IPRs were an issue worthy of this court’s review, this case would be an exceptionally poor vehicle for deciding it.”

Generic maker Mylan went on to call Allergan and the tribe’s business deal, which saw Allergan pay the tribe $13.75 million to acquire dry-eye treatment Restasis in September 2017, a “cash-for-immunity deal”.

In responding to the accusation, Allergan and the tribe claimed that the supposed “cash-for-immunity” deal is not a reason for the Supreme Court to deny review.

“The US Court of Appeals for the Federal Circuit did not reach this issue, much less adopt respondents’ characterisation of the transaction. The PTAB expressly declined to find the agreements ‘a ‘sham’’ or ‘otherwise improper under the law’,” said the brief.

In January 2018, Allergan  attempted to remove itself from IPRs brought against Restasis patents by Mylan and other generic makers, claiming that it was “no more than an exclusive field-of-use licensee”.

One month later, the PTAB  rejected the tribe’s attempt to dismiss the IPRs based on tribal immunity, in addition to finding that Allergan had retained ownership in the patents.

Then, in July the same year, the Federal Circuit  affirmed the PTAB’s decision. Allergan and the tribe requested a panel rehearing and an en banc rehearing, both of which were  denied by the Federal Circuit in later October.

Allergan and the tribe then appealed against the decision to the Supreme Court.

Mylan, in its response brief, also argued that tribal sovereign immunity cannot bar IPRs because “reconsideration of patentability is an action by an agency of a ‘superior sovereign’”, in this case, the federal government.

In response, Allergan and the tribe claimed that this argument provides another reason for granting certiorari.

“Creating a ‘public rights’ exception to sovereign immunity would eliminate immunity in a wide range of administrative adjudications. This court should grant plenary review before such a significant step is taken,” said the brief.

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16 April 2019   The US Supreme Court has declined to hear a closely-watched case on tribal immunity involving pharmaceutical company Allergan and the Saint Regis Mohawk Tribe, a Native American tribe.
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More on this story

Americas
29 October 2018   Allergan and the Saint Regis Mohawk Tribe have urged the US Court of Appeals for the Federal Circuit to stay its ruling against them pending an appeal to the US Supreme Court.
Americas
16 April 2019   The US Supreme Court has declined to hear a closely-watched case on tribal immunity involving pharmaceutical company Allergan and the Saint Regis Mohawk Tribe, a Native American tribe.
Big Pharma
7 May 2019   One of Allergan’s patents has been invalidated after it was challenged by UK-based pharmaceutical companies Accord Healthcare and Aspire Pharma.

More on this story

Americas
29 October 2018   Allergan and the Saint Regis Mohawk Tribe have urged the US Court of Appeals for the Federal Circuit to stay its ruling against them pending an appeal to the US Supreme Court.
Americas
16 April 2019   The US Supreme Court has declined to hear a closely-watched case on tribal immunity involving pharmaceutical company Allergan and the Saint Regis Mohawk Tribe, a Native American tribe.
Big Pharma
7 May 2019   One of Allergan’s patents has been invalidated after it was challenged by UK-based pharmaceutical companies Accord Healthcare and Aspire Pharma.