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Thursday, July 11, 2024 | Back issues
Courthouse News Service Courthouse News Service

FTC Wins Access to Big Pharma Records

PHILADELPHIA (CN) - Two pharmaceutical companies must hand redacted documents over to the Federal Trade Commission in connection with a case accusing them of initiating sham litigation against competitors, a federal judge ruled.

In litigation dates back to Sept, 2014, and is currently the government's most significant case targeting "reverse settlements," which the agency describes as a scheme to maintain or extend a monopoly through the use of sham patent infringement litigation.

In his ruling on Monday, U.S. District Judge Harvey Bartle III said that the documents produced by AbbVie and Besins, as well as by companies acquired by the two, were not protected under attorney-client privilege or the word product doctrine, which shields communications created in the run-up to litigation.

The documents, which are mostly emails, contain mostly non-confidential facts regarding the companies' commercial strategies for AndroGel, a synthetic form of testosterone.

Their version of AndroGel contained a "penetration enhancer" that increased the absorption of the drug. Teva Pharmaceuticals and Perrigo Company, in their application to the Food and Drug Administration to make their own generic version of the drug, included a different penetration enhancer.

The FTC claims AbbVie and Besins sued the generic manufacturers to induce them to stay out of the market for AndroGel, despite the fact the patent on the drug itself -- but not the penetration enhancer -- was expired.

The companies ultimately entered into a "reverse settlement," in which the plaintiffs -- AbbVie and Besins -- got the defendants to agree to stay out of the market.

Bartle dismissed the agency's claims against Teva in May, saying that the generic manufacturer had not violated antitrust law, the first ruling of its kind since the Supreme Court ruled in 2013 that such arrangements could be illegal.

But the judge did not dismiss the FTC's claims against AbbVie and Besins. In his ruling ordering the makers to provide the documents, some of which involved lawyers and "of counsel" employees, Bartle wrote that "the involvement of an attorney in the communication does not mean that the privilege must apply."

In one document, for example, contained a redacted portion quoting a patent examiner stating a fact on status of AndroGel and included commentary by an AbbVie's outside counsel. Judge Bartle wrote that the attorney's "I believe" or "My opinion is" were protected by attorney-client privilege.

Another included discussions of the bioequivalence -- or how much of two different drugs is absorbed by the body -- of AndroGel and its generic version, which Bartle wrote "reflect business concerns."

The judge concluded, "These documents were created by a business employee for the purpose of planning business strategy ... The court finds that the attorney-client privilege does not apply to the redacted statements drafted by business employees.

"Finally, the work product doctrine does not apply. AbbVie has not explained how these business planning documents relate to anticipated litigation. These documents were created in the ordinary course of business and would have been created irrespective of whether any litigation was pending in order to assess Solvay's business strategy for AndroGel. ... The redacted portions of these pages concerning AndroGel must be produced," Bartle wrote.

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