pharm edaily

[Yoo Sung, Head of BioPlatform Center, Edaily] South Korea’s biotechnology sector is rapidly emerging as a major force on the global stage. Yet as K-Bio expands its global footprint, multinational pharmaceutical giants are ramping up efforts to block latecomers through aggressive patent strategies.

One of the most potent weapons used by Big Pharma is the patent lawsuit. Armed with decades of R&D experience and formidable legal resources, global drugmakers frequently accuse Korean firms of infringement, often as a preemptive strike against growing competition. These legal battles can delay product launches and drain resources even when the allegations are unfounded.

In this uphill battle, a recent victory by SK bioscience stands out as a rare but crucial precedent. After an five-year legal war, South Korea’s SK bioscience finally won a patent suit against Pfizer, which had accused the company of infringing on its 13-valent pneumococcal conjugate vaccine patent. The South Korean Supreme Court ruled in SK’s favor, opening the door for overseas exports of SK’s proprietary conjugate vaccine components.

Image by ChatGPT

The victory not only allows SK bioscience to push forward with exports to Southeast Asia and Latin America, but also gives momentum to its co-development of a 21-valent pneumococcal vaccine with Sanofi, and other next-generation vaccines. Adding to its recent legal wins, SK bioscience also prevailed in a patent invalidation case against Moderna over mRNA technology, further strengthening its global reputation.

Such wins remain exceptional. Korean biotech firms, with less capital and shorter R&D history, often find themselves at a disadvantage in patent disputes. Experts warn that large pharmaceutical firms often weaponize litigation not just to protect their IP but to delay or derail smaller competitors‘ entry into key markets.

In SK’s case, despite developing Korea’s first pneumococcal vaccine and obtaining regulatory approval, the patent litigation with Pfizer prevented domestic production and sales until at least 2027.

Industry insiders are calling for stronger institutional support. They urge the Korean government to strengthen the patent review system, particularly by involving more external experts in biopharmaceutical and medical device fields. Enhancing the nation’s patent capabilities is crucial for shielding innovation.

The costs of new drug development often run into hundreds of millions to billions of dollars over a decade. Yet even a successfully developed therapy can collapse under the weight of a lost patent battle. If SK bioscience had lost to Pfizer, the potential damages could have threatened its survival.

Going forward, global patent wars will likely escalate as Big Pharma aims to stifle fast-rising challengers like K-Bio. To truly establish itself as a global powerhouse, K-Bio must achieve world-class standards not just in R&D, but in intellectual property strategy as well.