AbbVie scores a key win in Alzheimer's drug patent suit

2022-08-26

A California federal appeals court on Thursday let AbbVie off the hook from a whistleblower lawsuit alleging the company held fraudulent patents on two Alzheimer’s drugs, therefore overcharging Medicare. The case traces back to a complaint filed by patent lawyer Zachary Silbersher back in 2018, accusing Allergan of withholding information from the Patent Trademark Office that may have led the agency to reject patents for Namenda XR and Namzaric, extended release drugs to treat Alzheimer’s-associated dementia. AbbVie swallowed Allergan for $63 billion in 2020. “Having wrongfully excluded generic competition, Defendants were able to and did charge monopoly prices for these drugs,” the complaint states. Plaintiffs argued that “each and every claim for payment or reimbursement for Namenda XR and Namzaric that would have been substituted for a less expensive generic equivalent . . . constituted a False Claim” that violated the False Claims Act. Silbersher filed a qui tam suit, which allows whistleblowers to bring lawsuits on behalf of the US under the FCA and share up to 30% of any government profits. However, the recent ruling in AbbVie’s favor ultimately came down to the FCA’s public disclosure bar, which prevents a whistleblower from “repackaging publicly disclosed information for personal profit.” AbbVie filed a motion to dismiss the suit in 2019, accusing plaintiffs of “copy and pasting” public information to form their argument. “Mr. Silbersher is not a corporate insider, and his complaints do not alert the government to unknown financial fraud. Instead, they regurgitate allegations that have long been in the public domain, without providing any information that is ‘independent of and materially adds to’ prior public disclosures,” the motion to dismiss states. “Parasitic lawsuits like these are tailor-made for dismissal under the FCA’s Public Disclosure Bar.” A US district court denied the motion to dismiss in 2020, deciding that the public disclosure bar did not apply. However, a panel of three appeals judges overturned that decision on Thursday, writing in their opinion that “the key factual information underlying Silbersher’s complaint was all publicly disclosed and much could be found in websites maintained by the PTO and other government agencies.” However, the judges did note that Silbersher may still bring his action forward if he is deemed an original source of the information in his complaint. “The panel expressed no view on whether relator still could bring his qui tam action because he was an ‘original source’ of the information in his complaint. The panel remanded to the district court for further proceedings,” court documents state.

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