10/13/2017
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`Partnership Between Drug Giant And Native American Tribe May Affect Patent Challenges : NPR
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`September 19, 2017 · 4:59 PM ET
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`ARI SHAPIRO, HOST:
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`Now a story of strange bedfellows. One is drug giant Allergan, maker of Botox and
`other hugely popular medicines. The other is a small Native American tribe in upstate
`New York. As David Sommerstein of North Country Public Radio and our Planet
`Money team reports, the partnership could make it harder to challenge drug patents.
`
`DAVID SOMMERSTEIN, BYLINE: Allergan's drug for dry eyes, Restasis is a
`blockbuster - 1 and a half billion dollars in sales last year. So the company wants to
`protect its patent for the drug as long as it can, until it expires in 2024. Now, it used to
`be a lot easier to protect patents. A generic drug maker would say, hey, Allergan, your
`Restasis drug isn't new and novel enough to deserve patent protection; we should be
`able to make it, too, and sell it cheaper. But Allergan could tie up the whole thing in
`expensive lawsuits for years. It often worked out in the patent holder's favor. But in
`2011, Congress wanted a change. Bob Stoll was a commissioner for the U.S. Patent and
`Trademark Office who helped streamline the process.
`
`BOB STOLL: An effective and less-costly manner than spending millions of dollars
`going to court.
`
`SOMMERSTEIN: Now instead of a lawsuit, there was a simpler process - a review
`board. And you know what? It worked. The board had its own problems - patent trolls,
`multiple challenges. But the pendulum swung from the patent holder to the patent
`challenger.
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`MICHAEL SHORE: It's pretty well known as the patent death squad. It's a kangaroo
`court in my opinion.
`
`SOMMERSTEIN: Michael Shore is a patent lawyer in Dallas. He represents big
`companies like Allergan and also public universities. This new review board made his
`job harder. But in January he found a workaround. He was representing the
`University of Florida, and he successfully argued his client's patent couldn't be
`challenged at the review board because it's a state university, part of the government
`of Florida, a sovereign entity. So Michael Shore, sitting at his desk, savoring his
`victory, had a thought. How can I do this for all my clients? He needed more sovereign
`entities.
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`SHORE: Actually I think I did a Google search on sovereigns, and Indian tribes came
`up.
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`MYLAN - EXHIBIT 1144
`Mylan Pharmaceuticals Inc. et al. v. Allergan, Inc.
`IPR2016-01127, -01128, -01129, -01130, -01131, -01132
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`Partnership Between Drug Giant And Native American Tribe May Affect Patent Challenges : NPR
`10/13/2017
`SOMMERSTEIN: So Shore started calling Indian tribes, and eventually he ended up
`on the phone with Dale White, general counsel for the 13,000-member Saint Regis
`Mohawk Tribe. And they came up with a plan. The Mohawks called Allergan and said,
`hey, give us your Restasis patent, $14 million and some royalties. We'll lease the
`patent back to you so you can make the drug, and we'll protect the patent at the review
`board.
`
`I mean this must be really crazy to just have this plop out of the sky in your lap really.
`
`SHORE: (Laughter) Yeah, it's - we're all kind of shaking our heads a little bit.
`
`SOMMERSTEIN: The Mohawks have a modest casino. But like most Native tribes,
`there's a lot of poverty on the reservation.
`
`SHORE: So having the ability or opportunity that might come along with this business
`venture is life-changing for the tribe.
`
`SOMMERSTEIN: When the deal was announced, there was a lot of blowback. Critics
`called it sleazy, a hornet's nest. David Mitchell is founder of a new not-for-profit called
`Patients For Affordable Drugs. He says he has nothing against the Mohawks. But he
`says the deal keeps generics out of the market, and that means higher prices for people
`who need medicines.
`
`DAVID MITCHELL: Allergan is gaming that system, thwarting the will of Congress,
`finding a way to abrogate the law and thereby hurting patients. And it's flat out wrong.
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`SOMMERSTEIN: If this sovereignty protection stands up, Indian tribes could end up
`with lots of patents and a substantial revenue stream, and the pendulum would swing
`back in favor of the patent holder. For NPR News, I'm David Sommerstein.
`
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