Klaria Pharma

The ISA opinion on the claims made in the patent application for the Sumatritan Oral Film was that all claims fulfilled the requirements for novelty and inventive step.  Since patent authorities like the EPO rely on the ISA to highlight any problems in patent claims before the patent is granted, the ISA opinion is the first critical step in gaining patent protection for any invention.

Under normal circumstances, once the patent is granted the patent life is 20 years.  This is the case for the original Sumatritpan Oral Film patents, which currently give the product exclusivity until 2038.  Once the new patent is granted, the patent protection and thus the market exclusivity will be extended to 2045 - 20 years after the filing date of 2025.

A seven-year extension of the patent life is a very significant change in the overall calculated value of any drug product, particularly in the migraine market which is projected to continue a yearly 8-12% growth rate in the future.  For a product like the Sumatritpan Oral Film, which is expected make a significant impact on the current approximately 5 billion dollar per year global sumatriptan market, at least seven additional years of market exclusivity adds significant value to the overall product.