© Reuters FILE PHOTO: An Amgen sign is seen at the company’s office in South San Francisco, California October 21, 2013. REUTERS/Robert Galbraith/Files/File Photo
By Brendan Pearson and Blake Britten
(Reuters) – A division of Johnson & Johnson has sued Amgen Inc (NASDAQ: ) filed a public lawsuit Wednesday alleging it infringes two patents over J&J’s (NYSE: ) plan to market a drug for other diseases similar to its best-selling Stelara.
Stelara accounted for $9.1 billion of global drug sales last year, compared to J&J’s $52 billion. The sales volume for the first nine months of this year was 7.3 billion dollars, which is an increase of 7.9% compared to the same period last year.
The drug is approved to treat Crohn’s disease, the skin condition psoriasis and related arthritis. It is a biological drug, that is, it is made in living cells.
In the year A 2009 law allows companies to make biosimilars of biological drugs. But J&J Amgen said it did not follow the legal process that requires the companies to litigate any patent disputes.
If Amgen launched the drug, J&J said it would be infringing on J&J’s patents on the drug’s active ingredient and its use to treat ulcerative colitis.
J&J told the court that Amgen’s filing indicated that the US Food and Drug Administration could approve the biosimilar in the second or third quarter of 2023, and that Amgen intended to begin selling it next May.
An Amgen spokeswoman said the company had no comment on the lawsuit. J&J said in a statement that Janssen “is confident in its intellectual property and has filed a lawsuit to protect its rights.”