Patent ihlal davasının düşmesinde Amgen X Sandoz vakasının etkisi!….
Healthcare giant Johnson & Johnson (J&J) has dropped its lawsuit against South Korean biosimilars maker Samsung Bioepis for infringing patents on the company’s blockbuster immunology drug Remicade (infliximab).
The lawsuit related to Samsung’s biosimilar version of J&J’s blockbuster rheumatoid arthritis drug Remicade and the manufacturing process related to the drug.
South Korean electronics giant Samsung and biotechnology company Biogen Idec’s joint venture Samsung Bioepis had its biosimilar infliximab Renflexis (infliximab-abda) approved by the US Food and Drug Administration (FDA) in May 2017 . Samsung Bioepis, along with its partner Merck, launched Renflexis in July 2017, despite the ongoing patent fight.
J&J’s Janssen subsidiary had sued Samsung Bioepis to force it to participate in the so-called ‘patent dance’, a dispute resolution process set out in the Biologics Price Competition and Innovation Act of 2009.
However, a landmark decision in the Amgen vs Sandoz case by the US Supreme Court decided that biosimilars makers are able to give notice to the originator manufacturer before FDA has given final approval of the biosimilar . This decision set a precedent for other biosimilars makers, making the ‘patent dance’ optional, which could be a reason for the withdrawal in this case.
J&J has dropped the whole case ‘with prejudice’, which means that Janssen cannot bring a new case against Samsung Bioepis based on the same allegations.
Janssen still has patent litigation ongoing against Celltrion Healthcare, Hospira and HyClone Laboratories, a subsidiary of GE Healthcare, over the use of cell cultures grown for use in Celltrion’s biosimilar Remsima (infliximab), and Hospira’s biosimilar Inflectra (infliximab) .
Celltrion files infliximab patent lawsuit in US
1. GaBI Online – Generics and Biosimilars Initiative. FDA approves biosimilar infliximab Renflexis [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jan 5]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-biosimilar-infliximab-Renflexis
2. GaBI Online – Generics and Biosimilars Initiative. Notice can be given before FDA approves biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jan 5]. Available from: www.gabionline.net/Policies-Legislation/Notice-can-be-given-before-FDA-approves-biosimilar
3. GaBI Online – Generics and Biosimilars Initiative. Janssen Biotech files lawsuits for infringement of cell culture media patent [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jan 5]. Available from: www.gabionline.net/Biosimilars/News/Janssen-Biotech-files-lawsuits-for-infringement-of-cell-culture-media-patent