Celltrion has successfully struck a prohibition application brought by Janssen after Celltrion sought to add indications to its already approved drug.
Celltrion has an NOC to market infliximab for the treatment of indications including rheumatoid arthritis. At the time Celltrion filed its first drug submission, Janssen did not have any patents on the Patent Register. That meant that Celltrion did not have to address any patents.
However, Janssen subsequently filed an issued patent on the Patent Register for infliximab. Thus, when Celltrion submitted a SNDS for approval to also sell its infliximab product for the treatment of diseases related to various forms of inflammatory bowel disease, Celltrion needed to address this new patent.
Celltrion alleged it would not infringe the patent because none of the new intended uses relate to the patent. Rather, it was argued that the patent relates to the already-approved rheumatoid arthritis indications. Celltrion brought a motion to strike Janssen's prohibition application on this basis.
Janssen submitted that the Court needs to look at whether the drugs should be compared, not the uses of the drugs. The Court disagreed. Instead, the Court held it could construe the claims on a plain and ordinary construction, without any expert evidence. In doing so, the Court found the claims spoke specifically and directly to only rheumatoid arthritis. Thus, it was found that Celltrion's SNDS for the treatment of inflammatory bowel disease could not infringe the claims of the patent.
Janssen argued that if the Celltrion product were sold for both the rheumatoid arthritis and inflammatory bowel disease indications, then there would be direct infringement of the patent. However, the Court's view was that Celltrion's existing NOC for the rheumatoid arthritis indications does not come into play in this application.
The application was dismissed, with the order being stayed for 30 days to allow Janssen to take whatever steps they deemed appropriate.