AbbVie Ordered to Quickly Produce Docs in Humira Infringement Suit
The Feb. 8 ruling, from U.S. Magistrate Judge Richard A. Lloret, came in response to Boehringer's second set of production requests pertaining to its "unclean hands" defense in Abbvie's infringement suit, which accuses the German drugmaker of trying to illegally capitalize on Humira's clinical success.
February 11, 2019 at 05:33 PM
4 minute read
A federal magistrate judge has ordered AbbVie Inc. to promptly comply with an earlier command that it turn over documents related to an alleged campaign aimed at stymieing biosimilar competition to its $20 billion immunosuppressant Humira, warning against further efforts to throw “wrenches into the gears” of its high-stakes patent case against Boehringer Ingelheim International GmbH.
The Feb. 8 ruling, from U.S. Magistrate Judge Richard A. Lloret, came in response to Boehringer's second set of production requests pertaining to its ”unclean hands” defense in Abbvie's infringement suit, which accuses the German drugmaker of trying to illegally capitalize on Humira's clinical success.
Lloret said that the corporate records Boehringer was seeking fell well within the scope of his previous order, and he mandated AbbVie's “rapid and punctilious compliance” by March 11.
“The time for wrangling over the contours of the requests, or of the deficiency categories noted by Boehringer, is past,” Lloret, who is visiting from the Eastern District of Pennsylvania, wrote in a 10-page memorandum. “AbbVie chose to fight the 'unclean hands' discovery to the last ditch. I am declaring the fight over. AbbVie will produce the documents.”
Among its affirmative defenses in the case, Boehringer has alleged that AbbVie engaged in a “global effort” of pursuing overlapping and non-inventive patents in order to create a “patent thicket” that would delay competition for its blockbuster drug.
In June, Lloret said it remained to be seen whether Boehringer's theory would be viable as a patent defense. But Lloret said that question was best left until after discovery, and he ordered AbbVie to respond to Boehringer's request.
Boehringer, however, has grown frustrated with what it said was AbbVie's refusal to turn over the full range of materials covering its patenting program, including alleged attempts by AbbVie to increase its patent coverage for Humira and to suppress biosimilar competition. Abbvie countered that Boehringer had tried to broaden the scope of its original requests to documents unrelated to its unclean-hands defense, saying that further production would require additional and time-consuming searches.
Lloret said Feb. 8 that all of the documents Boehringer sought were relevant to its defense, which could be “potentially dispositive” to the case, and he rejected AbbVie's claims that discovery would take up too much time.
“AbbVie has already elected to spend its time resisting discovery. It litigated and lost, twice,” he said. “Months will not be absorbed with compliance.”
Bruce M. Wexler, an attorney for Boehringer, said Monday that he was “pleased with the careful attention given by the court to this issue of great importance.”
An attorney for AbbVie did not respond to a call seeking comment on the order.
AbbVie filed its suit in 2017 under the Biologics Price Competition and Innovation Act, a federal law that provides for expedited regulatory approval of drugs that are exceptionally similar to innovative products already being sold in the United States.
The Chicago-based drugmaker targeted just eight patents, but said it could assert dozens more if Boehringer tries to take its biosimilar to market. Boehringer has obtained approval from the U.S. Food and Drug Administration for its copycat but has yet to launch the drug.
AbbVie, meanwhile, has been moving to protect its blockbuster product, which accounted for 65 percent of the company's total net revenues in 2017. According to filings with the U.S. Securities and Exchange Commission, the drug generated more than $18 billion in global sales in 2017, up 14.6 percent from the year before.
AbbVie has signaled that it hopes to increase worldwide sales of Humira to $21 billion by 2020. The company's updated financials for 2018 are expected to be released later this month.
The case, filed in the U.S. District Court for the District of Delaware, is captioned AbbVie v. Boehringer Ingelheim Pharmaceuticals.
AbbVie is represented by William F. Lee, William G. McElwain and Amy K. Wigmore of Wilmer Cutler Pickering Hale and Michael P. Kelly and Daniel M. Silver of McCarter & English.
Boehringer is represented by Bruce M. Wexler, Eric W. Dittmann, Isaac S. Ashkenazi, Chad Peterman, Young Park and Carl Minniti of Paul Hastings and James D. Taylor Jr., Selena E. Molina, Christopher R. Hall and Andrea P. Brockway of Saul Ewing.
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