10/13/2017
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`Allergan Partners With Indian Tribe to Protect Drug Patents -- 3rd Update | Fox Business
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`Allergan Partners With Indian Tribe to Protect
`Drug Patents -- 3rd Update
`
`By Jonathan D. Rocko(cid:119) Published September 08, 2017 Features Dow Jones Newswires
`
`Allergan PLC has taken a novel step to protect top-selling drug Restasis from generic competition: the company has sold the
`drug's patents to an Indian tribe in upstate New York to block rivals from challenging the patents at the U.S. Patent and
`Trademark O(cid:119)ice.
`
`The St. Regis Mohawk Tribe, which operates a casino on its reservation near the Canadian border, asked the patent o(cid:119)ice on
`Friday to drop patent challenges filed by Akorn Inc., Mylan NV and Teva Pharmaceutical Industries Ltd. due to the tribe's special
`legal status as a sovereign government, which the tribe says gives it immunity from patent-o(cid:119)ice review.
`
`If its moves succeed, Allergan will be able to avoid a pending hearing before a patent-o(cid:119)ice panel on the patents for its Restasis
`dry-eye drug, a key product for the company. A separate review of the Restasis patents, by a federal court in Texas, will continue.
`
`"We are completely open to having these patents adjudicated in the federal courts. But we don't think, going through that, we
`should be subject to a second review" at the patent o(cid:119)ice, Allergan CEO Brent Saunders said in an interview.
`
`Teva said it would keep pursuing its patent challenges, while criticizing Allergan's tactic as "new and unusual way for a company
`to try to delay access to high quality and a(cid:119)ordable generic alternatives."
`
`Akorn and Mylan didn't respond immediately to requests for comment.
`
`The agreement entitles the tribe to a $13.75 million initial payment and $15 million in annual royalties, starting next year, until
`the Restasis patents expire or are no longer valid. Allergan retains the rest of the revenue from Restasis, Allergan's second-
`biggest seller a(cid:120)er Botox with $1.4 billion in sales last year.
`
`Dale White, general counsel for the 13,000-member tribe, said it would use the proceeds to diversify revenue beyond its casino
`and address "unmet needs" in areas such as housing, health care and education.
`
`"Even though the casino has been good for us, we can't rely on it long term. We have to diversify," he said.
`
`The legal maneuvering is a new twist on drug companies' longtime fight to protect their lucrative products from lower-priced
`generics, whose introduction usually cuts into and then largely eliminates sales of the brand-name drug within months.
`
`Allergan has been trying to shield the drug from competition on many fronts, including from a new dry-eye drug, called Xiidra,
`from rival Shire PLC. Allergan also is fending o(cid:119) lower-price generics, suing potential manufacturers in the federal court in Texas
`for patent infringement.
`
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`http://www.foxbusiness.com/features/2017/09/08/allergan-partners-with-indian-tribe-to-protect-drug-patents-3rd-update.html
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`MYLAN - EXHIBIT 1148
`Mylan Pharmaceuticals Inc. et al. v. Allergan, Inc.
`IPR2016-01127, -01128, -01129, -01130, -01131, -01132
`
`

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`10/13/2017
`
`Allergan Partners With Indian Tribe to Protect Drug Patents -- 3rd Update | Fox Business
`
`The federal court in Texas held a trial on the claims last week, and Allergan expects a decision within the next few months,
`according to Bob Bailey, the company's chief legal o(cid:119)icer.
`
`Allergan took out the Restasis patents in 2013 as the company began facing generic threats. The company says the Restasis
`patents don't expire until 2024, while generic rivals argue the patents shouldn't have been granted in the first place and should
`be ruled invalid.
`
`To invalidate the patents, Akorn, Mylan and Teva asked the U.S. Patent and Trademark O(cid:119)ice under a process known as inter
`partes review.
`
`The IPR process was established six years ago as a quicker, cheaper path to determine the validity of patents, compared with the
`process in federal courts. But critics, including drug companies, say it has been exploited by so-called patent trolls, hedge funds
`and others.
`
`The Supreme Court is weighing the constitutionality of the patent-o(cid:119)ice challenge process.
`
`Allergan still faces a potential loss in the case it initiated in federal court. It is unclear if tribal sovereign immunity could protect
`drug patents in federal court.
`
`But patent-law experts say Allergan seems to have found a way -- under a web of court and patent-o(cid:119)ice decisions -- to at least
`avoid the risk of setback at the patent o(cid:119)ice.
`
`"Barring some radical change in the law, it looks like Allergan just checkmated everybody," said Jacob Sherkow, an associate
`professor at New York Law School's Innovation Center for Law and Technology.
`
`Michael Carrier, an intellectual-property specialist at Rutgers University Law School, said such an outcome would remove a
`valuable tool for keeping down drug costs. "This is an ominous development because there will be a lot of cases, unlike this
`case, that will only be challenged through IPR" because the cumbersome federal court process may deter generic-drug makers
`from challenging the patents for some expensive drugs, Mr. Carrier said.
`
`There is precedent for sovereign immunity in patent-o(cid:119)ice cases. In January, the Patent Trial and Appeal Board, the patent-
`o(cid:119)ice panel that hears intellectual-property challenges, dropped a case against the University of Florida citing its sovereign
`immunity as a state institution.
`
`A(cid:120)er that ruling, Michael Shore, a lawyer at Shore Chan DePumpo LLP in Dallas that represented the university, said the firm
`began looking for an Indian tribe that was interested in taking advantage of the "arbitrage opportunity."
`
`A(cid:120)er signing on the St. Regis Mohawk Tribe as a client, Mr. Shore said, they pored over patent-o(cid:119)ice cases and identified
`Allergan "as a company that looked like their needs were acute." The tribe proposed the deal in early August and is trying to
`reach more, he said.
`
`Write to Jonathan D. Rocko(cid:119) at Jonathan.Rocko(cid:119)@wsj.com
`
`(END) Dow Jones Newswires
`
`September 08, 2017 16:44 ET (20:44 GMT)
`
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`10/13/2017
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`Allergan Partners With Indian Tribe to Protect Drug Patents -- 3rd Update | Fox Business
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`10/13/2017
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`Allergan Partners With Indian Tribe to Protect Drug Patents -- 3rd Update | Fox Business
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