[Click eStock] "Hanmi Pharm, Low Likelihood of Injunction Approval in Rollontis Patent Infringement Lawsuit"

[Asia Economy Reporter Ji Yeon-jin] Daishin Securities announced on the 7th that it judged "the possibility of injunction approval is low" regarding the patent infringement lawsuit filed by Bioverativ Therapeutix, a subsidiary of French pharmaceutical company Sanofi, against Spectrum, the license partner of Hanmi Pharm's neutropenia biopharmaceutical 'Rolontis', and maintained a buy investment opinion and a target price of 400,000 KRW for Hanmi Pharm.

Researcher Lim Yoon-jin of Daishin Securities explained, "For the injunction of Rolontis to be approved, it must be proven that the damage caused by patent infringement is significant. Considering that the main products of Bioverativ and the indications of Rolontis are different, it is judged that the possibility of proving Bioverativ's damage and injunction approval is low."

Bioverativ filed a lawsuit in the Delaware court in the United States claiming infringement of three patents related to Rolontis, and filed a claim for damages and an injunction application.

Spectrum holds global development and sales rights for regions excluding Korea, China, and Japan under the license agreement with Hanmi Pharm for Rolontis signed in 2012. The contract includes a clause stating that "Spectrum is exempt from liability in patent infringement lawsuits filed by third parties."

Main patents for pharmaceuticals include substance patents, use patents, composition patents, and formulation patents, but the details of the three patents Bioverativ claims Rolontis infringes have not been disclosed. Bioverativ is a bio company specializing in hemophilia treatments and blood products, acquired by Sanofi in January 2018 for $11.6 billion. Its main products include 'Eloctate', a long-acting hemophilia A treatment that extends half-life by binding coagulation factors VIII and IX to the Fc region of immunoglobulin G1 (IgG1), and 'Alprolix', a hemophilia B treatment. Last year, the global sales of Eloctate and Alprolix were $1.25 billion (1.4 trillion KRW) and $730 million (812 billion KRW), respectively.

Rolontis is a biopharmaceutical developed independently by Hanmi Pharm using the sustained-release platform technology 'Lapscovery', a sustained neutropenia treatment that binds G-CSF (granulocyte colony-stimulating factor) to the Fc region of immunoglobulin G4 (IgG4). The patent infringement lawsuit filed by Bioverativ is presumed to concern the sustained-release technology.

Researcher Lim said, "Typically, patent lawsuits are held about two years after filing, so the possibility of delay in Rolontis' FDA approval process due to this patent lawsuit is low. Given the difficulty in proving patent infringement, concerns about Hanmi Pharm's 'Lapscovery' technology and other biopharmaceuticals based on this technology are considered excessive." He added, "The U.S. FDA is currently conducting an on-site inspection of Hanmi Pharm's Pyeongtaek biofactory where Rolontis' raw material is produced, and it is expected that the FDA approval decision could be confirmed as early as July after the inspection is completed."