The US District Court for the District of Massachusetts on Thursday officially ruled Janssen’s main formulation patent on its blockbuster rheumatoid arthritis drug Remicade invalid, making way for the entry of biosimilars to the US market.

The ruling brightens the prospect for South Korean biosimilars developer Celltrion and its regional sales partner Pfizer’s plans to debut Remsima, a biosimilar drug referencing Remicade in the US market in as early as October. 


The district court’s ruling also reaffirms a previous decision by the US Patent & Trade Office which invalidated Janssen’s 471 Patent.

The trial over Janssen‘s US-based 471 Patent came after Janssen, a subsidiary of Johnson & Johnson, filed a lawsuit against Celltrion and Pfizer on claims that their biosimilar drug infringes its patent which expires in 2018.

The trial was held on an expedited schedule after the court accepted Celltrion’s request to speed up the legal process on the patent dispute it claims is being exploited by Janssen, a subsidiary of Johnson & Johnson, to delay the entry of biosimilar drugs to the US market.

Biosimilars refer to cheaper, near-replicas of biologic drugs that have lost patent protection. Celltrion’s Remsima, also known as Inflectra, is a biosimilar drug referencing Remicade, J&J’s blockbuster drug which racked up some $6.6 billion in worldwide sales last year.

A separate hearing to discern the validity of Janssen’s other remaining patent — the 083 Patent involving Remicade’s cell culture composition, which Janssen says expires in 2027 — is pending.

The Korean drug maker welcomed the court’s decision on Thursday. “Celltrion has once again proven its potential by winning a formulation patent suit against a multinational pharmaceutical company,” the company said in a statement.

“This ruling removes key hurdles to the launch of Remsima’s launch in the US, the largest biologics drug market in the world,” it said.

By Sohn Ji-young (jys@heraldcorp.com)