Sichuan Gowell Pharmaceutical Co., Ltd. has secured a favorable final judgment in its appeal against the assertion that its generic version of AstraZeneca’s (AZ, NASDAQ: AZN) type 2 diabetes therapy, Forxiga (dapagliflozin), infringed upon a patent listed by AstraZeneca on the Center for Drug Evaluation (CDE)’s drug patent registration platform, known as China’s Orange Book. On June 14, 2023, the Supreme People’s Court overturned the original judgment, confirming that AstraZeneca’s patent No. 200780024135.X was not valid for use in a patent linkage case, effectively upholding Gowell’s appeal after the Center for Intellectual Property Administration (CNIPA) had initially ruled in favor of AstraZeneca.
Forxiga’s Market Position and Generic Competition in China
Forxiga (dapagliflozin), the first SGLT2 inhibitor approved in China for the management of type 2 diabetes in March 2017, expanded its indications in February 2021 to include the treatment of adult heart failure with reduced ejection fraction (HFrEF, NYHA Class II-IV) and to mitigate the risk of cardiovascular death and hospitalization for heart failure. The drug has been covered by national reimbursement since 2019. Winsunny Pharma (SHA: 601089) and Lukang Pharma (SHA: 600789) received approval for two generic versions in October 2021, with SL Pharma (SHE: 002038) and Hansoh Pharma (HKG: 3692) following suit in 2023.
Patent Linkage System and Generic Challenges in China
The drug patent linkage system in China, which officially commenced on July 5, 2021, saw dapagliflozin become the most contested drug by generic firms with Category 4 declarations. To date, 31 Category 4.1 or 4.2 declarations have been lodged against dapagliflozin. Hansoh Pharma filed a Category 4.2 patent declaration on July 23, 2021, which was deemed distinct from the originator patent. Gowell Pharma filed a Category 4.1 declaration on November 29, 2021, challenging the validity of three patents: CN2008800169027, CN201210201489X, and CN200780024135X. Specifically, regarding the CN200780024135X patent, Gowell Pharma argued that claim 9, which is essentially a crystalline patent, should not be registered on the China’s Orange Book website, https://zldj.cde.org.cn. The patent faced three invalidation requests (4W112609, 4W113508, 4W113616), all of which have been closed without affecting the validity of the registered claims.-Fineline Info & Tech
