"Blockbuster's Evergreening Delays Entry of Biosimilars"

Companies holding blockbuster-level bio new drugs are analyzed to be delaying the entry of biosimilars (biopharmaceutical generics) by utilizing the 'patent evergreening' strategy.

Kim Taekwon, Senior Researcher of the IP Cooperation Team at the Korea Institute of Patent Technology Promotion, is giving a lecture on the topic of "Patent Strategy Analysis for Biopharmaceutical Evergreening" at "Bio Korea 2023" held at COEX, Gangnam-gu, Seoul on the afternoon of the 12th.
[Photo by Lee Myunghwan]

On the afternoon of the 12th, Kim Taekwon, a senior researcher of the IP Cooperation Team at the Korea Institute of Patent and Technology Promotion, explained this during a lecture titled 'Analysis of Evergreening Patent Strategies for Biopharmaceuticals' at 'Bio Korea 2023' held at COEX in Gangnam-gu, Seoul.

Evergreening is a strategy used by multinational pharmaceutical companies to avoid the expiration of patents on blockbuster drugs. Typically, patents in major pharmaceutical markets such as the United States are guaranteed for 20 years, and the extension system can increase the patent duration by up to 5 years. After that, other companies can enter the market with biosimilars, leading to price reductions due to competition. This method strengthens the monopoly position in the market by extending the patent duration.

For the evergreening strategy, pharmaceutical companies first set a broad patent scope when initially registering a biopharmaceutical patent. Subsequently, they file additional patents by adding or modifying detailed uses, structures, formulations, or manufacturing methods of the biopharmaceutical. Through this, they defend patent rights and extend the period of monopoly in the market.

An example of the evergreening strategy is AbbVie's autoimmune disease treatment drug 'Humira' (generic name: adalimumab). Humira is a blockbuster drug with U.S. sales alone reaching $18.62 billion (approximately KRW 24.75 trillion) last year and was considered the highest-selling drug worldwide before the COVID-19 pandemic. When Humira's patent expired in January, the U.S. pharmaceutical company Amgen was the first to release the biosimilar 'Amjevita.' Among domestic companies, Samsung Bioepis and Celltrion are also preparing to launch Humira biosimilars.

The developer AbbVie began developing Humira in 1993 and filed a substance patent with the U.S. Patent Office in 1996. In 2002, it received the first approval from the U.S. Food and Drug Administration (FDA) for rheumatoid arthritis, an autoimmune disease, and later obtained approvals for additional indications. The Korea Institute of Patent and Technology Promotion analyzed a total of 746 patents related to Humira. The types of patents were diverse, including not only medical uses but also formulations, manufacturing methods, diagnostics, and automatic delivery devices.

In particular, due to the complexity of biopharmaceutical structures, many patents were filed for manufacturing methods. Patents related to Humira's manufacturing methods accounted for the largest number of patents along with use patents. Researcher Kim explained, "Compared to synthetic drugs, biopharmaceuticals have complex structures and it is difficult to establish conditions such as cell culture or separation and purification, allowing for securing various patents. From the original developer's perspective, there is room to claim patent infringement at various stages."

Researcher Kim added, "(Humira) employed an evergreening patent strategy that continued exclusivity through various patents even after the substance patent expired," and "Through this, a patent barrier was formed, allowing for a protection period of at least 42 years after patent application and 25 years after FDA approval."

This content was produced with the assistance of AI translation services.