Direct Purchasers Sue Janssen and BTG International Over Sham Zytiga Patent

A proposed class action was recently filed in New Jersey federal court on behalf of direct purchasers against Johnson & Johnson unit Janssen Biotech and BTG International, alleging the companies filed “sham” patent litigation to block generic competition for the blockbuster prostate cancer drug Zytiga.  

The lawsuit states that Janssen obtained a patent on the compound in Zytiga in 1997, launched the drug in 2011, and that the initial patent expired in 2016.  The suit alleges that in order to maintain the drug’s sales of over $1 billion a year, Janssen sought and obtained a second patent in 2014.  Despite initially rejecting Janssen’s second patent application, finding that the formulation was too obvious to patent, the United States Patent and Trademark Office eventually agreed with Janssen’s argument that Zytiga’s “commercial success” showed that combining abiraterone with a steroid was not obvious.  But Janssen allegedly concealed the true reason for Zytiga’s success: BTG’s earlier, separate patent on abiraterone itself (which Janssen had a license on) blocked other companies from making or selling a competing abiraterone product.  Plaintiffs allege that Janssen and BTG asserted that second patent in meritless infringement litigation against would-be makers of generic Zytiga.  Plaintiffs allege that this conduct delayed generic competition, and that absent Janssen’s sham suits, generic versions of Zytiga would have been available in 2016.

The case is KPH Healthcare Servs. Inc. v. Janssen Biotech Inc., No. 20-cv-5901 (D.N.J.).  A similar lawsuit was filed about a year ago on behalf of a proposed class of end-payors that purchased Zytiga indirectly from defendants.