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Janssen, BTG Invalid Patent to Prevent Competition for Zytiga Class Action

Box and Bottle for Zytiga

This class action presents a familiar story: a group of pharmaceutical companies—Janssen Biotech, Inc., Janssen Oncology, Inc., Janssen Research & Development, LLC, and BTG International Limited—unfairly prevented generics of a profitable drug  (Zytiga) from entering the market, thus costing consumers and health insurers more than they should have paid. However, at issue here are not payoffs and illicit agreements but patents and their validity.

Patents are granted for novel inventions, designs, or discoveries. They are generally not granted to inventions or discoveries that are obvious in light of existing technology.

An obvious invention may be patentable, however, if the inventor can present “secondary considerations” that overcome obviousness—for example, if a product using the obvious invention became commercially successful because of the obvious invention.

In 1997, Janssen was granted a patent for its compound abiraterone acetate. In 2011, Janssen got FDA approval of its abiraterone acetate drug Zytiga to treat prostate cancer in combination with prednisone. The company made billions on the drug.

Janssen and its partner BTG wanted to extend the monopoly when the patent expired in 2016, the complaint claims, so they filed a patent application for a method of prostate cancer treatment using abiraterone acetate in combination with prednisone.

Unfortunately, the complaint says, this invention was obvious for several reasons. Both drugs were already known as ways to treat prostate cancer. Also, abiraterone must be given with a glucocorticoid; prednisone was a commonly-used glucocorticoid and it had already been used to treat prostate cancer with another drug similar to abiraterone. The patent application was rejected.

Janssen then tried the commercial-success argument. If the combination had been obvious, the argument went, Zytiga would not have been so instantly successful; someone would have already been doing it. The complaint says this was a false argument, because the drug’s patent was still in force. In other words, no one else had the right to offer such a treatment.

The patent was granted.According to the complaint, Janssen then used the patent to stifle competition even though it knew it would ultimately lose that fight. However, the arguments would buy it time. 

In 2018, sales of Zytiga rose to $1.77 billion.

Without this false patent, the complaint says, generic competition for Zytiga would have begun no later than October 2017. Instead, the complaint said, Janssen and BTG delayed other drugs’ entry, thereby forcing consumers and insurers to pay more for treatment than they should have. The complaint says that the false arguments were anticompetitive and prevented valid competition, in violation of federal and state antitrust and state consumer protection laws, among other things.

The class for this action is all persons and entities in the Indirect Purchaser States and territories named in the complaint who indirectly bought, paid for, or provided reimbursement for some or all of the price of Zytiga or abiraterone acetate, other than for resale, between December 13, 2016 and until the anticompetitive effects of this conduct stops.

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