On June 25, 2010—nearly one full year after submitting a provisional application to the US Patent and Trademark Office (USPTO)—the company Galapagos submitted a US patent application for their compound filgotinib via the national route. On the same day, they submitted an identical patent application via the international PCT route.
In their patent applications, Galapagos claimed the use of filgotinib for the prevention and treatment of a wide range of diseases, including rheumatoid arthritis, autoimmune diseases in general, transplant rejection, and proliferative disorders.
Four months later, the patent examiner at the USPTO issued a so-called “Non-final Rejection”, rejecting most of the claims in Galapagos’ patent application. In response, Galapagos submitted an amended patent application in which the claims were reduced to only the use of filgotinib for the treatment of rheumatoid arthritis.
Two and a half years after submitting the provisional patent application, the amended US patent was granted, thereby protecting filgotinib for the treatment of rheumatoid arthritis in the US. Several years later, the patent application that was submitted via the international PCT route at the European Patent Office (EPO) was granted in more than 30 European countries.
From 2011 through 2017, Galapagos filed several divisional patent applications in the US for the use of filgotinib in the treatment of individual diseases and conditions, including organ rejection, inflammatory bowel disease, and psoriatic arthritis, thereby creating a broad patent portfolio for filgotinib.
In the US, the drug application is still pending before the FDA (updated : November 2020). In contrast, on September 25, 2020, the European Commission granted EU marketing authorization for filgotinib under the trade name Jyseleca® for the treatment of adults with moderate-to-severe active rheumatoid arthritis; on the same day, the Japanese Ministry of Health, Labor and Welfare also granted regulatory approval for filgotinib.
Would you like to learn more about how the IP rights for a specific compound can be obtained via the national and/or international PCT routes, using the story of filgotinib as a case study? If so, consider taking our brand-new online IP course in which we discuss several teaching cases based on real-world R&D projects, highlighting the importance of protecting the IP rights for biomedical inventions.