Johnson & Johnson announced that a US federal court determined that a patent covering Remicade (infliximab) is invalid, ruling in favour of Celltrion and Pfizer's Hospira unit. Johnson & Johnson said that it is "disappointed" with the decision and plans to appeal to the Court of Appeals for the Federal Circuit.
In April, the FDA approved Celltrion's Inflectra (infliximab-dyyb), a biosimilar version of Remicade, which will be marketed in the US by Pfizer. In response to court ruling, Pfizer said it was "committed to bringing biosimilars to patients in the US as quickly as possible, and are continuing with the preparation of our launch plans for Inflectra for 2016." Remicade, which is indicated for the treatment of several autoimmune disorders, including Crohn's disease, ulcerative colitis and rheumatoid arthritis, generated sales of $6.6 billion last year, with $4.5 billion in the US.
Commenting on the court's decision, Cowen & Co. analyst Joshua Jennings said it "is clearly a negative with the implication being that Pfizer will potentially move forward" with a launch in the fourth quarter. However, Barclays analyst Geoff Meacham noted that even if Pfizer starts selling Inflectra, insurers may hesitate to pay for the biosimilar "until the legal landscape is settled."
In the ruling, District of Massachusetts Judge Mark Wolf said the antibodies covered by patent number 6,284,471, which expires in 2018, were already disclosed in an earlier patent. In addition, Wolf is considering the validity of a second patent on Remicade, which expires in 2027. Johnson & Johnson indicated that it is also continuing the appeal process in the proceedings related to patent number 6,284,471 before the US Patent & Trademark Office, and is awaiting a date to be set for an oral hearing.
Johnson & Johnson noted that a commercial launch of an infliximab biosimilar prior to the outcome of the appeals would be considered an at-risk launch. The company reaffirmed its 2016 guidance for operational sales to grow in the range of 3 percent to 4 percent, despite the possibility of a biosimilar launch on or after October 3. Meanwhile, J.P. Morgan analysts suggested that "assuming biosimilar competition, we think Remicade revenues will decline by just over $1 billion in 2017, costing [Johnson & Johnson] close to $0.20 in [earnings per share]."
For related analysis, see Spotlight On: Biosimilars – what lessons for the US market can we learn from Europe?
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