Korean pharmaceutical companies are ramping up efforts to develop generics of the global blockbuster cancer drug Jakavi (active ingredient: ruxolitinib), which is facing patent expiration in 2028. Jakavi generated sales of $4.728 billion (about 6 trillion won) worldwide last year.
According to industry sources on the 29th, Daewoong Pharmaceutical recently filed a request with the Patent Court to confirm the scope of passive rights regarding the Jakavi formulation. The respondent is Incyte Corporation, the U.S. biotech company that developed Jakavi.
The subject of the request for confirmation of the scope of passive rights filed by Daewoong Pharmaceutical is the patent for the formulation of '(R)-3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile phosphate.'
The request for confirmation of passive rights is a procedure to preemptively confirm whether it would constitute patent infringement when a generic developer applies that formulation to a generic product. Industry insiders view this request as a signal for generic development. This is because it is a process aimed at reducing the risk of patent disputes and establishing a legal basis for the release of generics.
The generic also receives priority sales rights if the developer is the first to apply for product approval. If they win the request for confirmation of rights, the product approval application could also be expedited.
Samyang Holdings also began developing a generic version of Jakavi early on. Samyang Holdings received approval for a Phase 1 clinical trial for 'SYO-2101' and 'SYO-2101R' based on Jakavi from the Ministry of Food and Drug Safety in September last year.
Unlike Daewoong Pharmaceutical, Samyang Holdings did not file a request to confirm the scope of patent rights. It seems they believe it is not too late to launch the product after the risk of patent disputes is resolved since it is an improved new drug. An improved new drug is an updated version of a drug that alters its ingredients, manufacturing method, or delivery mechanism, and it is protected by patents unlike simple generics.
Jakavi was developed by Incyte and received its first approval from the U.S. Food and Drug Administration (FDA) in 2011 as a treatment for myelofibrosis, a type of blood cancer. It has since expanded its indications in 2014, 2019, and 2021. Outside the U.S., global sales are handled by Swiss company Novartis. Domestic sales are estimated to be 23 billion won based on 2023 import performance.