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23 May 2019Big Pharma

City of Baltimore accuses Janssen of delaying generics

Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, is being sued for “unlawfully” delaying generic competition to Zytiga, its branded cancer medication.

In a complaint filed on May 16 at the US District Court for the Eastern District of Virginia, the City of Baltimore said the company had created a “ruse” before the US Patent and Trademark Office to prevent generic versions of the drug from entering the market.

In 1997, Janssen was granted a patent for the compound abiraterone acetate (Zytiga). That patent—U.S. Patent No. 5,604,213 (the ’213 patent)—expired in December 2016.

In April 2011, Janssen received approval from the Food and Drug Administration for Zytiga, for the treatment of prostate cancer in combination with prednisone (a steroid). “For the next five and a half years, because of the ’213 patent, Janssen had a legitimate monopoly on sales of Zytiga,” the complaint said.

Baltimore claimed that as the expiry date on the ‘213 patent drew near, Janssen repeatedly attempted to patent the use of Zytiga in combination with a steroid. But, this was rejected by the US Patent and Trademark Office (USPTO) on the basis that it was obvious to combine Zytiga with a steroid.

But, Janssen tried again, this time arguing that the combination of Zytiga and the steroid could “not possibly have been obvious because of the tremendous commercial success that Zytiga enjoyed”. The USPTO agreed and issued the patent as US number 8,822,438.

“In making this argument, though, Janssen never called the USPTO’s attention to the at-the-time-unexpired ‘213 patent. It never pointed out 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,” alleged Baltimore’s claim.

According to the City of Baltimore, Zytiga didn’t enjoy commercial success because it had demonstrated that the combination was non-obvious, but because no one else could make or sell an abiraterone acetate product at the time the ‘438 was issued.

The claim added: As both the Patent Trial and Appeal Board and the district court would later conclude, the existence of the blocking patent defeated any ‘commercial success’ argument.”

This isn’t the first time Janssen has been sued over Zytiga. In April, a US health insurance provider sued Janssen for filing “sham” patent litigation in a bid to stop generic forms Zytiga from entering the market.

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More on this story

Generics
25 April 2019   A US health insurance provider is suing a subsidiary of Johnson & Johnson for filing “sham” patent litigation in a bid to stop generic forms of a prostate cancer treatment from entering the market.

More on this story

Generics
25 April 2019   A US health insurance provider is suing a subsidiary of Johnson & Johnson for filing “sham” patent litigation in a bid to stop generic forms of a prostate cancer treatment from entering the market.