Cyclosporine - USA

Product: RESTASIS® (Cyclosporine Ophthalmic Emulsion) 0.05%

Innovator: Allergan

Generic Filer: Mylan

Patents: US8629111, US8633162, US8642556, US8648048, US8685930 and US9248191 

Court: The Patent Trial and Appeal Board (The PTAB)

Patent & Exclusivity Information: Each of the patents is listed in FDA’s Orange Book are set to expire on August 27, 2024. (Click here to view Patent & Exclusivity)

Points to Ponder:

• Transfer of Patent Rights & Dismissal of IPRs.

• Doctrine of sovereign Immunity.

Background:

• 08^th December, 2016: The PTAB instituted Inter Partes Review (IPRs) proceedings filed by Mylan Pharmaceuticals, Inc. (“Mylan”)

• 31^st March, 2017: The PTAB granted motions to join Teva Pharmaceuticals USA, Inc. (“Teva”) and Akorn Inc. (“Akorn”) (collectively with Mylan, “Petitioners”)

• 08^th September, 2017: The Saint Regis Mohawk Tribe contacted the Board to inform that the Tribe acquired the challenged patents and to seek permission to file a motion to dismiss these proceedings based on the Tribe’s sovereign immunity.

• 15^th September, 2017: A consolidated oral hearing for these proceedings was scheduled.

• 22^nd September, 2017: The Tribe filed Patent Owner’s Motion to Dismiss for Lack of Jurisdiction Based on Tribal Sovereign Immunity.

• 13^th October, 2017: Petitioners' (Mylan) filed an opposition to the Tribe’s motion to terminate.

• 20^th October, 2017: The Tribe filed a reply to Petitioners’ (Mylan) opposition.

• Allergan granted exclusive license to the treatment to the Saint Regis Mohawk Tribe      to acquire Restasis with $ 13.75 million payment.

• The tribe acquired rights to Restasis in September 2017.

• Generic filer Mylan had requested six Inter Parties Reviews (IPRs) of the patents, claimed it was a “desperate” and “transparent” delay tactic, in a filing at the US District Court. (The Eastern District of Texas, Marshall Division)

• On September 8, 2017, less than a week before the scheduled hearing, counsel for the Saint Regis Mohawk Tribe contacted the PTAB and said that the Tribe acquired the challenged patents and to seek permission to file a motion to dismiss these proceedings based on the Tribe’s sovereign immunity. (Earlier US universities have successfully employed this strategy for a heart valve patent owned by the University of Maryland, Baltimore was immune to IPR)

• Due to the interest of public, The PTAB invited parties to file briefs as amicus curiae to dismiss the Native American tribe’s case. The PTAB received amicus briefs from the following parties: The Oglala Sioux Tribe; Public Knowledge and the Electronic Frontier Foundation; Legal Scholars; Askeladden LLC; DEVA Holding A.S; The High Tech Inventors Alliance; The Seneca Nation; Native American Intellectual Property Enterprise Council, Inc.; Software & Information Industry Association; U.S. Inventor, LLC; The National Congress of American Indians, National Indian Gaming Association, and the United South and Eastern Tribes; Luis Ortiz and Kermit Lopez; The Association for Accessible Medicines; BSA The Software Alliance; and James R. Major, D.Phil.

• Allergan attempted to remove itself from the IPRs, claiming that it was “no more than an exclusive field-of-use licensee” in January, 2018.

Key events of 23rd February 2018:

• The PTAB find that the tribe doesn’t have sovereign immunity in this case. The PTAB said “In view of the recognized differences between the state sovereign immunity and tribal immunity doctrines, and the lack of statutory authority or controlling precedent for the specific issue before us, we decline the tribe’s invitation to hold for the first time that the doctrine of tribal immunity should be applied in IPR proceedings”

• The PTAB determined that the proceedings could continue without the tribe’s participation in view of “Allergan’s retained ownership interests in the challenged patents”. Based on the terms of the license between Allergan and the tribe, the licensee transferred “all substantial rights” in the challenged patents back to Allergan, so the proceedings can continue with Allergan as the patent owner. According to the PTAB, based on the record before it, the tribe has not retained anything more than an “illusory or superficial right” to sue for infringement of the challenged patents.

• The Patent Trial and Appeal Board PTAB determined that the Saint Regis Mohawk Tribe failed to establish the doctrine of tribal sovereign immunity.

Summary: 

On 23^rd February 2018, The Patent Trial and Appeal Board (PTAB) has rejected the Saint Regis Mohawk Tribe’s attempt to dismiss Inter Parties Reviews (IPRs) related to Cyclosporine (Restasis) having ground of tribal Sovereign Immunity. 

List of filed IPR:

1.     IPR2016-01127 related to US'930 patent

2.     IPR2016-01128 related to US'111 patent

3.     IPR2016-01129 related to US'556 patent

4.     IPR2016-01130 related to US'162 patent

5.     IPR2016-01131 related to US'048 patent

6.     IPR2016-01132 related to US'191 patent