“Sham” Patent Suit
The City of Baltimore has sued Janssen Biotech, a Johnson & Johnson (J&J) unit over “sham” patent litigation that would extend its monopoly on a cancer drug by delay lower-cost generic cancer drugs, reported Ed Silverman in Pharmalot and Eric Sagonowsky in Fierce Biotech.
Johnson & Johnson’s blockbuster cancer drug, Zytiga, recently lost its shield against generic competition. According to the lawsuit, J&J used underhanded tactics to keep copycat rivals from being competitive. Angry over the high price of the prostate cancer drug, Baltimore city officials filed a lawsuit saying that the “sham” patent litigation would delay the availability of lower-cost generics, forcing the city to spend millions of extra dollars.
The lawsuit alleges that Janssen Biotech and its partner, British Technology Group, undertook a “ruse” by failing to disclose certain information to the U.S. Patent and Trademark Office, making it possible for the drug maker to deflect generic rivals longer than it might have otherwise. The delay has been costly, too, because Baltimore’s employee and retiree benefits program has overpaid for the prostate cancer medicine since 2017, the lawsuit claims.
As part of the lawsuit, Baltimore officials say that as J&J’s patent on Zytiga’s key component got close to expiration, the company applied repeatedly to patent Zytiga’s use with a steroid. The U.S. Patent & Trademark Office rejected it away five times. On the sixth attempt, J&J argued that the combination of Zytiga’s main component, abiterone acetate, with a steroid should be patentable because of its “commercial success,” and won.
The lawsuit argues that 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 claims, “As both the PTAB and the district court would later conclude, the existence of the blocking patent defeated any ‘commercial success’ argument. With no other party present to call the blocking patent to the PTO’s attention in 2013, Janssen’s ruse worked.” When Janssen persuaded the PTO to grant the patent, the company was able to sue generic drugmakers and delay competition to Zytiga, a highly profitable cancer medication.
Generics to Zytiga were launched late in 2018, according to a notice from OptumRx. The drug’s original patent expired in December 2016, so the city of Baltimore believes that J&J gained more than a year of unearned exclusivity with its litigation strategy. In the middle of May 2019, the United States Court of Appeals for the Federal Circuit affirmed a lower court’s decision invalidating the later Zytiga patent based on obviousness.
J&J executives reported that Zytiga would be subject to increasing generic erosion after the drug made $1.77 billion in the U.S. in 2018 and $1.23 billion in U.S. sales in 2017. According to a Janssen spokeswoman, the company “stands by its decision to defend the validity and infringement of the relevant patent.”
This is not the first time the City of Baltimore has been involved in a pharma antitrust suit. On another occasion the city joined other plaintiffs in a lawsuit against AbbVie over its efforts to protect Humira, considered to be the world’s bestselling medicine.
