10/13/2017
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`Waxman hits out at Allergan patent deal with Mohawk tribe
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`Allergan Inc
`Waxman hits out at Allergan patent deal with Mohawk tribe
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`emocrat accuses US drugmaker of blocking competition from generic rivals
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`Former congressman Henry Waxman accused Allergan of 'blocking competition that would create price competition and provide patients with a choice'
`© Getty
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`OCTOBER 8, 2017 by David Crow in New York
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`The architect of landmark legislation that established the system for generic medicines in the US has hit
`out at Allergan, accusing the drugmaker of blocking competition by transferring its patents to a Native
`American tribe.
`
`The intervention by Henry Waxman, the former Democrat congressman, comes amid mounting
`criticism of Allergan in Washington, after it transferred patents protecting a $1.5bn eyecare drug to a
`tribe in an unusual attempt to see off a challenge from generic rivals.(cid:638)
`
`After taking ownership of the patents last month, the Saint Regis Mohawk Tribe applied to have a
`challenge against the intellectual property thrown out on the grounds that its status as a sovereign nation
`gave it immunity. The tribe received an upfront payment of $13.75m from Allergan and a potential $15m
`a year in royalties.(cid:638)
`
`Mr Waxman, who was in congress between 1975 and 2015, described Allergan’s manoeuvring as
`“troubling” and said the drugmaker had transferred the “patent to a sovereign nation with the intention
`of extending the drug’s monopoly”.(cid:638)
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`He said the move would have the effect of “blocking competition that would create price competition and
`provide patients with a choice”.(cid:638)
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`Last week, Senator Claire McCaskill, a Democrat, introduced a bill designed to thwart the Allergan
`arrangement, which would prohibit tribes from claiming sovereign immunity in patent disputes. Several
`other prominent politicians, including Republicans, have either requested a probe into the deal or
`criticised it.(cid:638)
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`Mr Waxman’s criticism is damaging because the bipartisan legislation he passed in 1984 with Senator
`Orrin Hatch, a Republican, is held up by the pharma industry as a grand compromise that sped up the
`introduction of generic medicines while protecting intellectual property rights.
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`https://www.ft.com/content/81bd8930-abb8-11e7-aab9-abaa44b1e130?mhq5j=e7
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`MYLAN - EXHIBIT 1150
`Mylan Pharmaceuticals Inc. et al. v. Allergan, Inc.
`IPR2016-01127, -01128, -01129, -01130, -01131, -01132
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`10/13/2017
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`Waxman hits out at Allergan patent deal with Mohawk tribe
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`“When drafting the Hatch-Waxman Act, Senator Hatch and I worked hard to find a balance that would
`promote price competition while providing at the same time incentives for manufacturers, such as
`extending their patent life,” Mr Waxman told the Financial Times.(cid:638)
`
`He added: “Now we are seeing efforts that are throwing off the balance we achieved.”
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`Allergan has said it only intends to use the arrangement with the tribe to protect it from a quasi-judicial
`patent appeals process known as inter-parties review (IPR), which is loathed by the pharmaceutical
`industry. Legal challenges brought under the Hatch-Waxman process will continue as normal, the
`company says.(cid:638)
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`However, intellectual property lawyers have told the FT that there is no legal impediment to prevent
`pharmaceutical companies from using the same ploy to frustrate copycat rivals challenging their patents
`in the courts under Hatch-Waxman.
`
`Mr Hatch’s office did not return a request for comment, although the senator has been critical of the IPR
`process in the past.(cid:638)
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`In a statement, Allergan said: “Respectfully, Mr Waxman is not appreciating the facts of our agreement
`with the St Regis Mohawk Tribe.”
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`Allergan said the arrangement was “aimed squarely” at removing the “double jeopardy” of having to fight
`challenges in the courts as well as those brought under the “fatally flawed IPR process”. The group said
`the IPR system had led to a “new generation of stock manipulators and ‘reverse trolls’ who do nothing to
`advance patient welfare”.(cid:638)
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`Allergan’s patent switch has caused a political furore at a time when the pharmaceutical industry is
`already under pressure over the cost of its medicines and struggling to repair its reputation after the
`Martin Shkreli price-gouging scandal.(cid:638)
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`Chip Davis, president of the Association for Accessible Medicines, the trade group for generic
`drugmakers, said the “level of scrutiny bordering on outrage in Washington is only starting on this”.(cid:638)
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`However, Mr Davis predicted that Allergan would not bow to the political pressure, describing the
`company’s chief executive, Brent Saunders, as someone “highly engaged in DC” who “understands
`politics well”.(cid:638)
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`“He didn’t enter into this lightly and would not have done so unless he thought they would prevail and
`withstand the legal and political scrutiny,” Mr Davis said.
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`https://www.ft.com/content/81bd8930-abb8-11e7-aab9-abaa44b1e130?mhq5j=e7
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