Hanmi Pharmaceutical has filed with the Korean Intellectual Property Office a patent extension request for its incrementally modified drug Fenocid (ingredient: fenofibric acid) to prevent competitors, including Korea United Pharm, from launching a generic copy.
Fenocid, a treatment for hypercholesterolemia, was launched in 2013. Patients with hypercholesterolemia, one of the dyslipidemias, cannot control the level of triglyceride even after ingesting statins, which raises the risk of cardiovascular diseases. Unlike Fenofibrate-based predecessors which had to be taken after a meal, patients can take Fenocid conveniently regardless of meals, making it popular.
Fenocid posted 6.29 billion won ($5.65 million) in accumulated prescription sales in the first three quarters of this year, up 6.3 percent from 5.83 billion won a year earlier.
To make a generic copy available, Korea United Pharma and its affiliate Korea Biochem Pharm requested the KIPO’s judge over whether their generic drug infringed on Hanmi’s patent in Fenocid’s compounds.
Hanmi holds its patent in the oral pharmaceutical composition that includes fenofibric acid and alkaline agents until 2030. However, if Korea United avoids the patent with a KIPO’s ruling that Korea United’s generic composition does not infringe on Hanmi’s, Korea United can launch a generic early.
To counterattack, Hanmi has drawn up the so-called evergreening strategy. Evergreening refers to a patent developer’s plan to extend the period of the patent to retain royalties, by launching a follow-up drug with a new mixture of isomer, capacity, dose, shape, base, and combination with other medications. To fight against evergreening, a generic copy maker should file another patent suit to nullify the extension of the patent.
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