USPTO invalidates J&J prostate cancer drug patent

The US Patent Trial and Appeal Board invalidated a Johnson & Johnson patent on its blockbuster prostate cancer drug Zytiga, a ruling that brings rivals closer to selling generic versions.

According to a Reuters report, the PTAB said a Johnson & Johnson patent describing a method of administering Zytiga should not have been granted because the process it described was obvious.

Zytiga generated nearly $2.3 billion in sales for Johnson & Johnson in 2016.

The ruling is a victory for generic drug company Argentum Pharmaceuticals LLC, which had asked the board to invalidate the patent in the hope of being able to bring its own version to the market.

Johnson & Johnson said it strongly disagreed with the decision and might ask a federal appeals court to reverse it.

The patent is due to expire in 2027.

Argentum and other generic drug firms have been blocked from launching their own versions of the drug until its expiration date.

In a statement, Argentum said: “… the U.S. Patent & Trademark Office (PTO) issued a final written decision in Argentum Pharmaceuticals LLC’s inter partes review (IPR) against the sole unexpired patent listed as covering Janssen Oncology, Inc.’s Zytiga (abiraterone acetate) drug in the Food & Drug Administration’s Orange Book.

“Janssen Oncology, Inc. is a subsidiary of Johnson & Johnson.

“Argentum challenged all claims (claims 1−20) of Janssen’s U.S. Patent No. 8,822,438, which the Orange Book states will expire in August 24, 2027.

” … the PTO concluded that Argentum ‘satisfied its burden of demonstrating, by a preponderance of the evidence, that the subject matter of claims 1–20 would have been obvious,’ and therefore ordered ‘that claims 1-20 are held unpatentable’.”

Argentum Pharmaceuticals CEO Jeffrey Gardner said: “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.

“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.”