The global pharmaceutical and biotech market is heating up in a "patent war without gunfire." Korean biotech corporations that were once helpless against big pharma's patent offensives are now breaking through the "patent citadel" with head-on wins. Going beyond simple generics production, they are leveraging proprietary technologies to overcome big pharma's checks and secure practical gains.
According to the pharmaceutical and biotech industry on the 5th, Samsung Bioepis (Samsung Epis Holdings) recently ended its patent dispute with U.S. company Regeneron. The two sides had waged an intense legal battle over the biosimilar (generic) of the macular degeneration treatment Eylea, but on the 3rd, just nine days before the Intellectual Property High Court ruling, they struck a surprise settlement and withdrew the lawsuit.
◇ broke into the 14 trillion won market… Samsung Epis Holdings' "securing practical gains"
The settlement is a clear example of K-bio's negotiating power in the global market. Eylea is a mega-blockbuster drug with annual global sales of 14 trillion won. Regeneron filed a patent infringement suit against Samsung Bioepis in Jan. last year to block market entry but lost at the first instance. Regeneron's choice to settle right before the appellate ruling is seen as a stopgap to reduce the risk of losing.
With the settlement, Samsung Bioepis removed uncertainty. Under the agreement reached on the 30th of last month, it can launch Eylea biosimilars (brand names Afiliu and Opuviz) in regions outside the United States and Canada. Starting in Apr., it will roll out products sequentially in major European countries, and from May in countries other than Korea, to secure early market share.
◇ SK bioscience scores "back-to-back wins" against Pfizer and Moderna
SK bioscience has seized the upper hand in court against leading global vaccine makers. In May last year, SK bioscience won a final victory in a lawsuit with U.S. company Pfizer over bulk material for a pneumococcal vaccine.
Back in 2017, during the first lawsuit, it stepped back by settling and delaying product launch until 2027, but it did not back down in the second suit that Pfizer filed in 2020, claiming that "exporting research-use bulk material also violates the settlement." Overcoming a first-instance loss, it won consecutively in the second and third instances, securing independent business opportunities.
In Apr. last year, it also won in a patent invalidation trial against Moderna, "a powerhouse in messenger ribonucleic acid (mRNA)." It neutralized an mRNA manufacturing technology patent that Moderna had registered in Korea. An SK bioscience official said, "We laid the groundwork to break down patent barriers and secure our own technology."
◇ "Patent suits are a fate"… intensifying "money game"
Experts predict that patent disputes will become more frequent and fiercer as K-bio's growth accelerates. Big pharma holding original drugs are raising entry barriers by not only changing formulations and adding indications at patent expiry, but also filing various lawsuits as a strategy to defend patents.
In fact, slugfests among big pharma are common in the global market. AbbVie (Humira) and Amgen (Amjevita), and Amgen (Prolia) and Sandoz, for example, have fought tit-for-tat legal battles before settling with conditions such as market partitioning or royalty payments.
Lee Seung-kyu, vice chair of the Korea Biotechnology Industry Organization, said, "The fact that overseas pharmaceutical companies bring lawsuits paradoxically proves that the technology of Korean corporations is that threatening," adding, "Because delays in biosimilar launches ultimately lead to higher medical costs for patients, it has become an essential survival condition for corporations to build sophisticated patent strategies and legal response capabilities."