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15 December 2020Big PharmaSarah Morgan

Judge rejects Allergan challenge to FCA suit

A California judge has allowed a patent attorney to proceed with his claims against Allergan which allege the pharmaceutical company fraudulently obtained patents to monopolise pricing.

In a 76-page opinion, Judge Joseph Spero of the US District Court for the Northern District of California rejected Allergan’s bid to dismiss the False Claims Act (FCA) lawsuit.

Patent lawyer Zachary Silbersher had filed the suit in 2018, alleging that Allergan had misled the US Patent and Trademark Office (USPTO) into issuing invalid patents protecting the Namenda XR (memantine hydrochloride) and Namzaric (memantine hydrochloride and donepezil hydrochloride), drugs which are used to treat dementia-related to Alzheimer’s disease.

According to Silbersher, the patents allowed Allergan to perpetuate its monopoly power and overcharge the federal government and the states for these drugs under various programmes, including Medicare and Medicaid.

Spero, in his opinion, held that the allegations were sufficient to raise the FCA claims.

Allergan had argued that Silbersher’s claims failed under the public disclosure bar because they are based on information that is drawn from the public patent prosecution files.

In response, Silbersher argued that the bar doesn’t apply because the 2010 amendments to the FCA narrowed the public disclosure bar, limiting the types of hearings and proceedings that trigger the public disclosure bar.

Siding with Silbersher, the court concluded that the patent prosecution history, which was published on the USPTO’s Patent Application Information Retrieval system, didn’t constitute a “Federal . . . hearing” under the bar.

“More broadly, the court finds that the disclosures in the patent prosecution history discussed above were not made through one of the channels specified in the current version of the public disclosure bar,” added Spero.

Allergan also claimed Silbersher’s FCA claims were insufficiently alleged and must be dismissed. Again, the court dimissed the argument.

The court refused to dimiss the case and has set a case management conference for January 15, 2021.

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More on this story

Big Pharma
11 November 2020   The US Court of Appeals for the Federal Circuit concluded that a New York judge had rushed to grant summary judgment in an inventorship dispute between Ferring and Allergan.
Big Pharma
7 September 2020   The US Federal Trade Commission has approved a final order regarding charges that biopharmaceutical company AbbVie’s $63 billion acquisition of Allergan would violate US federal antitrust law.
Americas
18 January 2021   Allergan should not be permitted to immediately appeal against a recent ruling which requires it to face allegations that it monopolised the pricing of dementia drugs, according to a New York-based patent attorney.