Overview
Cohen Milstein represents the City of Baltimore in this antitrust class action against Janssen Biotech, Inc., Janssen Oncology, Inc., Janssen Research & Development LLC (collectively, “Janssen”) and BTG International Limited (“BTG”), a global healthcare company. Plaintiffs allege that the defendants engaged in anticompetitive conduct preventing generic manufacturers from entering the market with competing abiraterone acetate products for more than year, delayed the entry of additional generic competitors, and has cost purchasers hundreds of millions of dollars in overcharge damages.
On August 5, 2019, Cohen Milstein and co-counsel filed a consolidated class action complaint on behalf of plaintiffs.
Case Background
In 1997, the U.S. Patent & Trademark Office (“USPTO”) issued U.S. Patent No. 5,604,213 (“’213 patent”) to Janssen for its compound abiraterone. Like all patents, it would expire in 20 years – in December 2016.
On April 28, 2011, Janssen got approval from the FDA for Zytiga, abiraterone acetate tablets, for the treatment of prostate cancer in combination with prednisone. For the next five and a half years, because of the ’213 patent, Janssen had a legitimate monopoly on sales of Zytiga. The company made billions of dollars. Plaintiffs allege that U.S. sales of Zytiga went from $191 million in 2011 to $463 million in 2012, its first full year on the market. In 2015, U.S. Zytiga sales exceeded $1 billion.
Plaintiffs allege that beginning in 2007 through 2014, Janssen (with assistance of BTG) sought a second patent on a method of using abiraterone acetate in combination with prednisone to treat prostate cancer, given the fact that ’213 patent would be terminated in 2016 and generic manufacturers would be able to enter the market.
Unfortunately for Janssen, USPTO repeatedly rejected this second patent application, finding that, among other things, the method was “obvious.” Years later the Patent Trial and Appeal Board (PTAB) and district court, under broad and narrow claim constructions respectively, would both reach the same conclusion.
Janssen pivoted and pursued a “commercial success” argument with the USPTO, arguing that combining abiraterone acetate and prednisone could not possibly have been obvious because of the tremendous commercial success that Zytiga enjoyed.
Plaintiffs further allege that in making this argument, Janssen failed to tell the USPTO that the ’213 patent, covering the only active drug compound in Zytiga, prevented anyone other than Janssen from making or selling any drug product containing that compound. (This is what is commonly referred to as a “blocking patent.”) As a result, Zytiga enjoyed commercial success not because it demonstrated the supposed non-obviousness of the combination of abiraterone and acetate, but because no one else could make or sell an abiraterone acetate product.
Plaintiffs claim that Janssen’s “unexpected commercial success” ruse worked, and in 2013 on that basis – and that basis alone – the USPTO issued Patent No. 8,822,438 (the ’438 patent).
Plaintiffs further claim that in order to protect Janssen’s monopoly, Janssen and BTG then asserted the ’438 patent in infringement litigation that they both knew they could never ultimately win in the courts. Their goal was not to win a litigation victory, though; it was simply to delay generic competition.
Plaintiffs argue Janssen and BTG did win their patent infringement litigation charade. Together, they were able to delay generic competition by more than one year. During that year, Zytiga was among the most profitable drugs sold by Johnson & Johnson, worldwide. In the United States, sales of Zytiga for the twelve months ending December 31, 2017 were $1.228 billion. In 2018, United States sales of Zytiga climbed to $1.771 billon.
Plaintiffs allege that absent the defendants’ unlawful conduct, generic competition for Zytiga would have entered as early as December 2016. Instead, the defendants’ unlawful conduct prevented generic manufacturers from entering the market with competing abiraterone acetate products for more than a year, delayed the entry of additional generic competitors, and has cost purchasers hundreds of millions of dollars in overcharge damages.