1/11/2018 Allergan’s Restasis Patents Are Valid, Fed. Circ. Told – Law360
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Allergan’s Restasis Patents Are Valid, Fed. Circ. Told
By Dorothy Atkins
Law360, San Francisco (January 10, 2018, 8:55 PM EST) — The Saint Regis Mohawk Tribe, which
acquired Allergan Inc.’s patents on the dry-eye drug Restasis, urged the Federal Circuit on Tuesday to
reverse a ruling that invalidated four of its Restasis patents as obvious, arguing that the lower court’s
decision to ax the patents is “fraught with legal error.”
In their opening brief, the tribe and drugmaker argued that the lower court’s decision to invalidate
the patents is not supported by the law, and it “substitutes statistical analysis for common sense.”
They said the ruling raises a nearly impossible barrier for pharmaceutical companies by requiring
them to show that their claimed invention is statistically better than the closest prior art formulation.
But that’s not a requirement found in the law, they said.
“These errors, which matter not only to this case, but more broadly to any case analyzing the
obviousness of patents in the pharmaceutical arts, require reversal,” the tribe and drugmaker said.
The appeal is the latest happening in a lawsuit that Allergan launched against Mylan Inc., Teva
Pharmaceuticals USA Inc. and Akorn Inc., alleging their generic drugs infringe four patents for
After a bench trial in Texas’ Eastern District, Senior U.S. Circuit Judge William Bryson, who was
sitting by designation, found in October that the generic-drug makers infringed the patents.
However, the judge ruled that all four patents are invalid as obvious in light of prior art. The judge
found that the efficacy results in Allergan’s clinical trials on Restasis were not “unexpected” and
Allergan’s arguments that they were is “more advocacy than science.”
Judge Bryson also said two of the four patents blocked other drugmakers from entering the market
and he criticized Allergan’s decision to transfer the patents to the Saint Regis Mohawk Tribe. Allergan
moved the patents to the tribe in September, in an effort to use the tribe’s sovereign immunity to
protect them from inter partes review at the Patent Trial and Appeal Board. Allergan has since
licensed the patents back.
But in their opening brief Tuesday, Allergan and the tribe said that Judge Bryson’s “unexpected”
analysis wasn’t legal. The judge didn’t focus on the key measures that demonstrate efficacy in
treating the underlying dry eye condition, as required by all the asserted claims constructions, and
Judge Bryson overlooked the results of the third clinical trial, they said.
Ultimately, Restasis proved statistically to be significantly better than other eye-drop formulas,
Allergan and the tribe argued. Also, the district court erred in ignoring the evidence that Restasis has
been a commercial success, garnering up to $1.5 billion in sales per year, and filling a need for a
therapeutic dry eye treatment.
“The district court’s consideration of that issue was legal error that skewed the overall obviousness
analysis by removing a critical safeguard against hindsight bias,” they said.
Restasis is the only dry eye drug approved by the Food and Drug Administration to increase the
production of a patient’s natural tears, and before it hit the market in 2003, no other treatment
existed, they said. Also, there is no evidence that Allergan’s two patents blocked others from
competing and providing another treatment for dry eye disease, particularly since one expired in
2009, they said.
“Here, skilled artisans had plenty of time and room to experiment, including a safe harbor … but
none developed a successful dry-eye treatment,” the said.
Counsel for the parties didn’t immediately respond late Wednesday to requests for comment.
The patents at issue are U.S. Patent Numbers 8,629,111; 8,648,048; 8,685,930; and 9,248,191.
Allergan is represented by Jonathan E. Singer, Juanita R. Brooks, Susan E. Morrison and Robert M.
Oakes, Deanna J. Reichel and Joseph A. Herriges of Fish & Richardson PC. The Saint Regis Mohawk
Tribe is represented by Christopher L. Evans and Michael W. Shore of Shore Chan DePumpo LLP.
Teva is represented by J.C. Rozendaal, Michael E. Joffre, R. Wilson Powers III, Pauline M. Pelletier and
William H. Milliken of Sterne Kessler Goldstein & Fox, Mylan is represented by Douglas H. Carsten,
Wendy Devine and Anna G. Phillips of Wilson Sonsini Goodrich & Rosati. Akorn is represented by
Michael R. Dzwonczyk, Azy Kokabi and Mark Boland of Sughrue Mion PLLC.
The case is Allergan Inc. v. Teva Pharmaceuticals USA Inc. et al., case number 18-1130, in the U.S.
Court of Appeals for the Federal Circuit.
–Additional reporting by Matthew Bultman. Editing by Kelly Duncan.
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