Johnson & Johnson's blockbuster cancer med Zytiga only recently lost its shield against generic competition, and according to a new lawsuit, that’s because J&J used underhanded tactics to keep copycat rivals at bay.
The City of Baltimore sued the company's Janssen unit, arguing it pursued a "ruse" to delay Zytiga generics. That delay has been costly, too, the lawsuit claims: Thanks to J&J's tactics, Baltimore's employee and retiree benefits program has overpaid for the prostate cancer med since 2017, the lawsuit says.
Baltimore officials argued that as J&J’s patent on Zytiga’s key component neared expiration, the company applied repeatedly to patent Zytiga's use alongside a steroid. The U.S. Patent & Trademark Office turned it away five times—but on the sixth try, J&J won. That time, the company argued the combination of Zytiga’s main component—abiterone acetate—with a steroid should be patentable because of its “commercial success,” Baltimore’s suit says.
But J&J’s original Zytiga patent and associated monopoly protection was the reason for that commercial success, not any innovation tied to the combination, the city's lawsuit argues.
"As both the PTAB and the district court would later conclude, the existence of the blocking patent defeated any 'commercial success' argument," the lawsuit says.
Still, "with no other party present to call the blocking patent to the PTO’s attention in 2013, Janssen’s ruse worked," the city argues. After it finally persuaded the PTO to grant that patent, the company used it to sue generic drugmakers and effectively delay Zytiga competition.
Generics to the profitable cancer med only launched late last year, according to a notice from OptumRx. The drug’s original patent expired in December 2016, so Baltimore argues J&J scored more than a year of unearned exclusivity with its litigation strategy.
Just last week, the United States Court of Appeals for the Federal Circuit affirmed a lower court's decision invalidating the later Zytiga patent based on obviousness.
A Janssen spokeswoman said the company “stands by its decision to defend the validity and infringement of the relevant patent."
It isn’t the first time Baltimore has gotten involved in a pharma antitrust suit. The city previously joined other plaintiffs in suing AbbVie over its efforts to protect Humira, the world’s bestselling medicine.