Second medical use and innovation : A perspective from Europe and India
Jokinen, Jami (2018-06-12)
Second medical use and innovation : A perspective from Europe and India
Jokinen, Jami
(12.06.2018)
Tätä artikkelia/julkaisua ei ole tallennettu UTUPubiin. Julkaisun tiedoissa voi kuitenkin olla linkki toisaalle tallennettuun artikkeliin / julkaisuun.
Turun yliopisto
Tiivistelmä
The topic of this research is second medical use patents and the regulation concerning them in Europe and India. The main focus of the research is the scope of protection afforded for the patents and the relevance of this scope in relation to innovation in the pharmaceutical industry. The patent law in Europe, where the required level in order to receive patent protection is quite low, is compared with India, where the level is much higher.
The requirements to receive a second medical use patent in Europe have been set quite low, which has led to multiple types of pharmaceutical products based on second medical use claims being patented. In India, an additional criterion for patenting a second medical use has been incorporated, which requires that a pharmaceutical product must have better therapeutic efficacy than the previously known pharmaceutical that utilized the same active substance in order to receive patent protection.
However, in order to determine the scope of protection afforded for patents, the analysis of the qualifying criteria is not enough as also the scope of protection that the patents offer must be analyzed. Through the analysis of case law, it was determined that the scope of protection that is afforded for second medical use patents is determined through the patents claims. Additionally in Europe, generic manufacturers can enter the market with products that are equivalent to the patented products but that have omitted the patented use from their packaging and patient information pamphlet. These are so called skinny label products.
Due to the scope of protection that is afforded to the patents, the special qualification that was designed in India seems to not have a purpose as the free market is also capable of controlling the usefulness of the pharmaceuticals. Additionally, it was noted that the criterion has a negative effect, as it may potentially limit the research regarding pharmaceuticals.
The requirements to receive a second medical use patent in Europe have been set quite low, which has led to multiple types of pharmaceutical products based on second medical use claims being patented. In India, an additional criterion for patenting a second medical use has been incorporated, which requires that a pharmaceutical product must have better therapeutic efficacy than the previously known pharmaceutical that utilized the same active substance in order to receive patent protection.
However, in order to determine the scope of protection afforded for patents, the analysis of the qualifying criteria is not enough as also the scope of protection that the patents offer must be analyzed. Through the analysis of case law, it was determined that the scope of protection that is afforded for second medical use patents is determined through the patents claims. Additionally in Europe, generic manufacturers can enter the market with products that are equivalent to the patented products but that have omitted the patented use from their packaging and patient information pamphlet. These are so called skinny label products.
Due to the scope of protection that is afforded to the patents, the special qualification that was designed in India seems to not have a purpose as the free market is also capable of controlling the usefulness of the pharmaceuticals. Additionally, it was noted that the criterion has a negative effect, as it may potentially limit the research regarding pharmaceuticals.