by Carolina Bolado
Additional reporting by Samuel Howard
Editing by Andrew Park
Ortho-McNeil-Janssen Pharmaceuticals Inc. lost a bid to toss a suit Tuesday accusing the drugmaker of marking five medical supplies with expired patents, despite the heightened pleading standards for false marking whistleblowers set by a recent ruling of the Federal Circuit.
Judge Ronald L. Buckwalter of the U.S. District Court for the Eastern District of Pennsylvania denied Ortho’s motion to dismiss the suit, ruling that retired Philadelphia doctor Bentley A. Hollander had fulfilled the particularity requirement of Rule 9(b).
Hollander alleges that Ortho falsely marked medical supplies and drugs including Risperidone, medicated anti-dandruff shampoo Nizoral, yeast infection treatment Terconazole, antibiotic Ofloxacin and dementia drug Reminyl, now called Razadyne.
After his initial complaint was dismissed by the judge for failing to sufficiently demonstrate an intention to deceive the public, Hollander filed an amended complaint detailing Ortho’s involvement in litigation over three of the patents and applications by generic drug manufacturers as proof that the drugmaker knew the patents were expired.
“Both the Federal Circuit and courts within the Third Circuit have noted that intent to deceive may be inferred from a defendant’s active involvement in litigation over a disputed patent,” Judge Buckwalter said in the opinion. “The court thus finds these allegations sufficient to support an inference of deceptive intent.”
The heightened pleading standards are required after the U.S. Court of Appeals for the Federal Circuit’s March 15 ruling in a suit against BP Lubricants USA Inc. that viable claims under the false marking statute must meet Rule 9(b)’s particularity rather than rely on general allegations.
The order invokes the gatekeeping function of Rule 9(b) and firmly asserts the need for rigorous standards to address surging numbers of false marking suits.
While Hollander’s initial complaint had alleged Ortho knew about the expired patents solely based on the company’s status as a sophisticated business entity with patent experience, the amended complaint provided dates, cases and other specific facts to allege Ortho’s intent to deceive the public.
Hollander, the former chairman of the radiology department at St. Francis Hospital in Wilmington, Del., filed his initial complaint in March 2010 claiming that Ortho had marked millions of drugs with patents that have long expired.
Risperidone is marked with U.S. Patent Number 4,804,663, which expired Dec. 29, 2007; Nizoral is marked with U.S. Patent Number 4,335,125, which expired June 15, 2000; Terconazole is marked with U.S. Patent Number D279,504, which expired July 2, 1999; Ofloxacin is marked with U.S. Patent Number 4,382,892, which expired on Sept. 2, 2003; and Razadyne is marked by U.S. Patent Number 4,663,318, which expired Dec. 14, 2008.
Hollander has taken similar action against other drug companies, including B. Braun Medical Inc., Ranbaxy Laboratories Inc., Eusa Pharma (USA) Inc. and Hospira Inc.
Representatives for the parties were not immediately available for comment on Tuesday.
Hollander is represented by Layser & Freiwald PC.
Ortho is represented by Drinker Biddle & Reath LLP and Patterson Belknap Webb & Tyler LLP.
The suit is Hollander v. Ortho-McNeil-Janssen Pharmaceuticals Inc., case number 2:10-cv-00836, in the U.S. District Court for the Eastern District of Pennsylvania.