The Basel, Switzerland-based company instigated the action after it had previously succeeded in a case protecting Gilenya (fingolimod)’s patents on the dosage regimen through the US Patent Trial and Appeal Board (PTAB).
Involved in the latest round of lawsuits are close to 30 generic manufacturers, amongst these number are Mylan, Teva, Dr. Reddy’s and Biocon.
A spokesperson commented, on request, that “Novartis is pleased with the decision by the PTAB upholding the validity of the dosage regimen patent for Gilenya. Novartis continues to believe strongly in the Intellectual Property (IP) covering our medicines and will continue to vigorously defend our IP rights, including those provided by Orange Book-listed patents covering Gilenya”.
The spokesperson continued, “Since the PTAB decision has upheld the validity of the dosage regimen patent, Novartis has commenced dosage regimen patent infringement litigation against ANDA [abbreviated new drug application] filers”.
In addition, the spokesperson clarified that the dosage regimen patent protection runs until December 25, 2027.
Should the generic manufacturers launch Gilenya rivals regardless, the companies involved would risk being found guilty of patent infringement and would, therefore, have to pay damages to Novartis.
If Novartis succeeds in retaining exclusivity after this latest round of cases, it will be able to continue reaping the lucrative sales that the product has achieved – over the course of the 2017 financial year, the product brought in $3.18bn (€2.71bn) in sales.
The treatment is used to manage relapsing forms of multiple sclerosis and, only a few months ago, achieved US Food and Drug Administration (FDA) approval for the use of the treatment in children aged 10 to 17.
Alongside consolidating its grip on its branded products, Novartis has also recently announced the decision to focus on its core business areas by cutting away its antibiotics research. This followed on from the decision earlier in the year to shed its stake in the consumer health joint venture it held with GSK for $13bn.