Prostate Cancer Drug Patent Lawsuit Dismissed

Court invalidates patent for abiraterone acetate (Zytiga).

A United States administrative court recently invalidated a patent for Johnson & Johnson’s prostate cancer drug abiraterone acetate (Zytiga), according to Reuters. This court ruling may clear the path to bring generic versions of the drug to the market.

Notably, the Patent Trial and Appeal Board ruled that the original patent in question, which described the administration of the drug, should not have been in place because administration was obvious, according to the article.

Argentum Pharmaceuticals LLC filed the suit challenging the patent in September 2016 to bring its own generic version of abiraterone acetate to the market.

Johnson & Johnson told Reuters that it disagreed with the ruling and may ask for a reversal.

"We are disappointed in and strongly disagree with the US Patent and Trademark Office's (USPTO) decisions relating to Zytiga as part of the Inter Partes Reviews,” Johnson & Johnson said in a statement. “We are evaluating our options with respect to a request for rehearing and/or appeal to the Court of Appeals for the Federal Circuit. We believe the '438 patent is valid and will continue to vigorously defend it."

The patent in question is set to expire in 2027 and generic manufacturers have been prohibited from launching their versions of the drug until it expires, according to the article.

Reuters said that abiraterone acetate generated $2.3 billion for the manufacturer in 2016.

Abiraterone acetate is an oral oncolytic drug used in combination with prednisone for the treatment of metastatic castration-resistant prostate cancer, which is resistant to hormonal or surgical treatments, according to Johnson & Johnson.

"We are pleased that the PTO has ruled in Argentum's favor by holding all claims of the last remaining Orange Book patent for Zytiga to be obvious. The inter partes review process is an important tool by which generic and biosimilar companies can create prescription drug savings by ensuring that non-innovative patents do not block competition. Argentum's core mission is to lower the cost of prescription drugs by challenging patents that are not innovative and which artificially support high drug prices,” Argentum said in a statement. “We believe that the PTO's decision will be upheld if appealed by Janssen, and will save the US healthcare system billions of dollars over the next decade. Those savings will inure to the benefit of American patients by improving their access to the high quality, safe, and effective FDA-approved generic alternatives that they deserve."