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16 May 2019Big Pharma

Federal Circuit rules against J&J in Zytiga dispute

The US Court of Appeals for the Federal Circuit delivered a  blow to Johnson & Johnson (J&J) on Tuesday, May 14, by confirming the invalidation of a patent covering blockbuster prostate cancer drug Zytiga (abiraterone acetate).

The dispute over Zytiga dates back to 2015 when Janssen, a subsidiary of J&J, and partner BTG, a global healthcare company, first filed a patent infringement case against a number of generic drugs companies at the US District Court for the District of New Jersey.

J&J accused the companies of infringing US patent number 8,822,438, called “Methods and compositions for treating cancer”. The ‘438 patent lists forms of anti-cancer agents, including anti-inflammatory medication prednisone.

J&J claimed that the companies had infringed the patent by filing Abbreviated New Drug Applications (ANDAs) for generic abiraterone tablets.

In response, some of the generic companies, including Amerigen Pharmaceuticals, Mylan Pharmaceuticals, and Wockhardt, filed three inter partes reviews (IPR) alleging that claims of the ‘438 patent were invalid due to obviousness.

Articles in multiple journals published before the ‘438 patent was filed referred to prednisone in relation to cancer treatment, and the petitioners argued that this prior art rendered the ‘438 patent obvious.

The US Patent and Trial Appeal Board (PTAB) agreed with the petitioners and found the claims asserted in the patent to be obvious. The PTAB said that a person with ordinary skill in the relevant art would have known that prednisone could be used as a cancer treatment.

The District Court for the District of New Jersey also held the ‘438 patent to be obvious over prior art.

J&J appealed against the PTAB’s decisions as well as the court’s ruling, and the Federal Circuit consolidated the appeals.

J&J claimed that the PTAB improperly construed the term “treatment” by not requiring prednisone to have an anti-cancer effect, and that the PTAB had relied on an incorrect construction of the ‘438 patent in finding that its claims would have been obvious.

However, on Tuesday, the Federal Circuit rejected these arguments.

The Federal Circuit noted that the PTAB construed “treatment” as “including the eradication, removal, modification, management or control of a tumour or primary, regional, or metastatic cancer cells or tissue and the minimisation or delay of the spread of cancer”.

This definition was correctly construed “in light of intrinsic evidence and under the broadest reasonable interpretation standard”, the court said, and so J&J’s argument on this point is “unavailing”.

Overall, “substantial evidence” supports the PTAB’s conclusion of obviousness, the court added.

As J&J’s arguments were “unpersuasive”, the Federal Circuit dismissed the appeals and upheld the decisions of the PTAB and the District Court for the District of New Jersey.

Speaking to LSIPR, a spokesperson for Janssen said the company has no comment on Tuesday's ruling. The spokesperson did confirm that 250mg generic versions of Zytiga entered the US market in the final quarter of 2018.

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29 October 2018   Johnson & Johnson has revealed its intention to appeal against a district court’s invalidation of a patent covering its prostate cancer drug Zytiga (abiraterone acetate).
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Big Pharma
10 October 2019   Johnson & Johnson has committed $500 million to research and development programmes over the next four years in a bid to eliminate HIV and tuberculosis across the world by 2030.

More on this story

Americas
29 October 2018   Johnson & Johnson has revealed its intention to appeal against a district court’s invalidation of a patent covering its prostate cancer drug Zytiga (abiraterone acetate).
Americas
18 January 2018   The Patent Trial and Appeal Board has invalidated a Johnson & Johnson patent covering its prostate cancer drug Zytiga (abiraterone acetate).
Big Pharma
10 October 2019   Johnson & Johnson has committed $500 million to research and development programmes over the next four years in a bid to eliminate HIV and tuberculosis across the world by 2030.