Contrave Weight Loss Drug Patents Infringed by Generic Maker, Court Rules
A Delaware federal judge ruled on Oct. 13 that Actavis Laboratories FL Inc. infringed three patents with a planned generic version of the weight-loss drug Contrave, rejecting the company's defense as a "classic case" of hindsight bias.
October 16, 2017 at 10:26 PM
15 minute read
A Delaware federal judge ruled on Oct. 13 that Actavis Laboratories FL Inc. infringed three patents with a planned generic version of the weight-loss drug Contrave, rejecting the company's defense as a “classic case” of hindsight bias.
In a 35-page opinion, U.S. District Judge Richard G. Andrews of the District of Delaware said that Actavis had failed to invalidate Orexigen Therapeutics Inc.'s patents during a three-day trial in June.
He found that while Contrave's two active ingredients had been known to counteract weight gain, Orexigen's novel combination of naltrexone hydrochloride and bupropion hydrochloride to fight obesity in adults protected the patents and doomed the generic drugmaker's defenses of obviousness and written description. The ruling allowed Orexigen to maintain its period of exclusivity on its only drug through 2030.
“Defendant's argument, it seems to me, is a classic case of hindsight bias,” Andrews wrote. “Defendant begins with the combination plaintiff ultimately patented and then seeks to justify that combination by combining prior art references that simply would not guide a person of ordinary skill to choose this combination.”
An attorney for Actavis declined to comment Monday on the ruling, and the company did not respond to an inquiry forwarded by counsel.
Orexigen had sued Actavis in June 2015, alleging that the company's abbreviated new drug application for its generic had infringed on seven patents. However, Orexigen later withdrew four patents from its complaint, leaving intact claims surrounding its so-called '626, '111 and '195 patents.
Actavis, which is based in Florida and operates as a subsidiary of Allergan plc, had attacked the patents, arguing that prior art would have alerted professionals in the pharmaceutical field to the potential for naltrexone and bupropion to treat “weight-related comorbidity,” such as Type 2 diabetes or hypertension.
Actavis pointed specifically to a 2002 peer-reviewed paper disclosing the sustained release of bupropion for reducing weight and depressive symptoms in obese patients, as well as three patents, issued in 2003, which it said outlined the combined use of naltrexone and bupropion for combating obesity.
Andrews, however, found important differences between the prior art and Contrave.
The study—identified in the opinion by the name Jain—had shown that the weight loss effects of bupropion were “relatively modest at best,” and had reported an associated risk of seizures, making the medication an unlikely starting point for further examination,” Andrews said.
Meanwhile, Andrews said the so-called “O'Malley” patents identified just a single example of naltrexone and bupropion being used to minimize weight gain during smoking cessation therapy. There had been no indication that naltrexone would enhance bupropion's effect on weight loss, the judge said.
“Defendant argues that a person of ordinary skill would have been motivated to combine the teachings of Jain and O'Malley to arrive at the combination of bupropion and naltrexone for weight loss,” Andrews wrote. “Defendant's rationale is based on a person of ordinary skill reaching the conclusion that naltrexone was effective for weight loss and that the combination had been previously used in connection with weight loss.”
An attorney for Orexigen did not respond Monday to a call seeking comment on the decision.
Orexigen is represented by Mary B. Graham, Rodger D. Smith II and Stephen J. Kraftschik of Morris, Nichols, Arsht & Tunnell and Chad J. Peterman, Bruce M. Wexler and Michael F. Werno of Paul Hastings.
Actavis is represented by Melanie K. Sharp, James L. Higgins and Robert M. Vrana of Young Conaway Stargatt & Taylor and Scott J. Bornstein, Richard C. Pettus, Jonathan D. Ball and Justin A. MacLean of Greenberg Traurig.
The case is captioned Orexigen v. Actavis.
Tom McParland can be contacted at 215-557-2485 or at tmcparland@alm.com. Follow him on Twitter @TMcParlandTLI.
A Delaware federal judge ruled on Oct. 13 that Actavis Laboratories FL Inc. infringed three patents with a planned generic version of the weight-loss drug Contrave, rejecting the company's defense as a “classic case” of hindsight bias.
In a 35-page opinion, U.S. District Judge Richard G. Andrews of the District of Delaware said that Actavis had failed to invalidate Orexigen Therapeutics Inc.'s patents during a three-day trial in June.
He found that while Contrave's two active ingredients had been known to counteract weight gain, Orexigen's novel combination of naltrexone hydrochloride and bupropion hydrochloride to fight obesity in adults protected the patents and doomed the generic drugmaker's defenses of obviousness and written description. The ruling allowed Orexigen to maintain its period of exclusivity on its only drug through 2030.
“Defendant's argument, it seems to me, is a classic case of hindsight bias,” Andrews wrote. “Defendant begins with the combination plaintiff ultimately patented and then seeks to justify that combination by combining prior art references that simply would not guide a person of ordinary skill to choose this combination.”
An attorney for Actavis declined to comment Monday on the ruling, and the company did not respond to an inquiry forwarded by counsel.
Orexigen had sued Actavis in June 2015, alleging that the company's abbreviated new drug application for its generic had infringed on seven patents. However, Orexigen later withdrew four patents from its complaint, leaving intact claims surrounding its so-called '626, '111 and '195 patents.
Actavis, which is based in Florida and operates as a subsidiary of
Actavis pointed specifically to a 2002 peer-reviewed paper disclosing the sustained release of bupropion for reducing weight and depressive symptoms in obese patients, as well as three patents, issued in 2003, which it said outlined the combined use of naltrexone and bupropion for combating obesity.
Andrews, however, found important differences between the prior art and Contrave.
The study—identified in the opinion by the name Jain—had shown that the weight loss effects of bupropion were “relatively modest at best,” and had reported an associated risk of seizures, making the medication an unlikely starting point for further examination,” Andrews said.
Meanwhile, Andrews said the so-called “O'Malley” patents identified just a single example of naltrexone and bupropion being used to minimize weight gain during smoking cessation therapy. There had been no indication that naltrexone would enhance bupropion's effect on weight loss, the judge said.
“Defendant argues that a person of ordinary skill would have been motivated to combine the teachings of Jain and O'Malley to arrive at the combination of bupropion and naltrexone for weight loss,” Andrews wrote. “Defendant's rationale is based on a person of ordinary skill reaching the conclusion that naltrexone was effective for weight loss and that the combination had been previously used in connection with weight loss.”
An attorney for Orexigen did not respond Monday to a call seeking comment on the decision.
Orexigen is represented by Mary B. Graham, Rodger D. Smith II and Stephen J. Kraftschik of
Actavis is represented by Melanie K. Sharp, James L. Higgins and Robert M. Vrana of
The case is captioned Orexigen v. Actavis.
Tom McParland can be contacted at 215-557-2485 or at tmcparland@alm.com. Follow him on Twitter @TMcParlandTLI.
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