Business Concentrates INTELLECTUAL PROPERTY
Allergan seeks tribe’s help in patent case Dry-eye drug is at the center of a novel maneuver to squash generic competition In a novel arrangement, the pharmaceutical maker Allergan has enlisted the Saint Regis Mohawk Tribe to help protect the dry-eye drug Restasis against patent challenges by would-be competitors. The New York tribe, which could be immune from federal patent challenges, has taken ownership of six patents covering the cyclosporine emulsion eye treatment. Allergan retains exclusive licenses to the patents until they end in 2024. Allergan will make a one-time payment of $14 million plus $15 million in annual royalty payments to the American Indian tribe. If it succeeds, Allergan’s gamble will protect a $1.5 billion revenue
stream representing about 10% of the firm’s annual sales. The deal could also be a harbinger of similar agreements by other branded pharmaceutical makers who had previously relied on “pay for delay” drug deals. Those deals pay competitors to delay the introduction of generic versions of drugs with disputed patents. Because the tribe is considered an autonomous state under U.S. law, Allergan believes it is immune from U.S. Patent & Trademark Office actions that could invalidate the Restasis patents. Competitor Mylan asked for USPTO hearings last year, claiming Allergan’s discoveries
Launched in 2003, Restasis had $1.5 billion in sales last year.
were anticipated by previous patents. USPTO has previously exempted stateowned universities from patent challenges under the legal concept of sovereign immunity, explains Richard Chinn, a partner in the intellectual property law firm Oblon, McClelland, Maier & Neustadt. “Under the U.S. Constitution, states are immune against suits in federal courts,” he says. The question, Chinn says, is will USPTO accept the sovereign status of the St. Regis tribe? Mylan doesn’t think it should and calls the deal “a transparent, last-minute attempt to shield the [patents] from inevitable cancellation.” Mylan’s protest comes from a notice it filed on Sept. 11 in a concurrent Texas federal court lawsuit brought by Allergan to stop Restasis generics from Mylan and other firms. Mylan adds that the change in patent ownership would not only give Allergan an undeserved victory with USPTO but also affect Mylan’s defense in the court case.—MARC REISCH
LITIGATION
First responders sue Arkema Seven emergency personnel claim Texas chemical fire resulted in injury from toxic fumes
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C&EN | CEN.ACS.ORG | SEPTEMBER 18, 2017
cal personnel who responded to the scene, the suit says, were also overwhelmed and began to vomit and gasp for air. Around the same time that the first responders reported the effects of the fumes, the first of nine nonfunctioning refrigerated trailers containing organic peroxides caught fire. But Spurlock says it is not yet clear whether the alleged toxic fumes were emitted before or after the trailer ignited. Two additional trailers ignited on Sept. 1, and officials later purposely ignited the rest. Spurlock says the first responders were not given personal protective equipment such as respirators. The suit faults Arkema for “failing to provide accurate information” about hazards. The plaintiffs remain under doctors’ care, she adds. In a statement, Arkema says it will “vigorously defend a lawsuit that we believe is gravely mistaken,” adding that “we totally cooperated with all first responders and the
Dark streaks at Arkema’s Crosby, Texas, site indicate where organic peroxides ignited after flooding caused power failures. numerous regulatory agencies working with us to keep the public safe.” The U.S. Environmental Protection Agency reports it flew aircraft to test smoke from the Arkema fires and that it did not detect chemicals in amounts exceeding short-term air quality values. The incident is under investigation by EPA, the Texas Commission on Environmental Quality, and the U.S. Chemical Safety & Hazard Investigation Board.—MELODY BOMGARDNER
C R E D I T: A LL ERGA N ( V I A L ) ; A R KE MA ( P LA N T )
One week after the first of nine trailers containing organic peroxides caught fire at an Arkema facility in Crosby, Texas, seven first responders have filed a lawsuit against the chemical company. The Sept. 7 suit alleges that Arkema was negligent in failing to properly prepare for a power outage. Lack of refrigeration at the site, which was inundated with nearly 2 meters of water from Tropical Storm Harvey, caused the organic peroxides to degrade and explode. The suit alleges the first responders were exposed to unspecified “toxic fumes” early on Aug. 31. The first responders were guarding a 2.4-km perimeter around the Crosby site when they became overwhelmed by fumes, according to Kimberley M. Spurlock, an attorney representing the seven. According to the suit, “One by one, the police officers and first responders began to fall ill in the middle of the road.” Medi-
