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J&J is to appeal Remicade patent ruling in US

As Pfizer is poised to bring biosimilar version to market

Johnson and Johnson logoPfizer has moved closer to bringing a biosimilar version of Johnson & Johnson's blockbuster Remicade to market in the US after a key patent on the brand was invalidated in a federal court.

J&J has said it intends to appeal the decision, which was handed down by US District Judge Mark Wolf in a Boston court, and ruled that the claims made in the patent (No. 6,284,471) - which expires in 2018 - had already been covered in earlier patents. 

Used to treat rheumatoid arthritis and other immune-related disease, Remicade is J&J's biggest-selling drug with sales of $6.56bn last year with the bulk of that total (around $4.4bn) coming from the US market. It accounts for just below 10% of the company's total revenues.

In Europe - where Remicade is marketed by MSD - the product has been facing direct competition since biosimilar versions were launched in 2014/2015. Last year, MSD reported that sales of the drug fell 24% to $1.8bn as competition drove down pricing.

In April, J&J's chef financial officer Dominic Caruso said the company did not expect any US competition to Remicade this year despite the approval of Celltrion's Inflectra biosimilar earlier in the same month. Pfizer's recently-acquired Hospira unit has exclusive rights to sell Inflectra in the US.

The outcome of the hearing on the 2018 patent was not unexpected as the US Patent and Trademark Office (USPTO) rejected it last year. Meanwhile, J&J is waiting for the outcome of deliberations on a second patent on Remicade (infliximab) that expires in 2027 and is also being considered by Judge Wolf in this week's hearing. 

The outcome is considered to be critical and could determine whether Pfizer risks an early launch of the product, trading off early revenues with the chances that it may have to reimburse J&J should the latter win on appeal. J&J's other patent protection for Remicade in the US expires on 3 October.

J&J's Janssen pharma unit confirmed it plans to appeal the decision and is "continuing the appeal process in the proceedings related to the '471 patent before the USPTO". The company said it is waiting for a date to be set for a hearing in the USPTO appeal.

"A commercial launch of an infliximab biosimilar prior to the outcome of the appeals would be considered an at-risk launch," it stressed.

Article by
Phil Taylor

19th August 2016

From: Marketing

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