Samsung Bioepis Faces Seven Pharma Lawsuits
Samsung Bioepis, as it continues to expand its footprint in the global biosimilar market, has found itself caught up in seven separate legal disputes with so-called “Big Pharma” companies including Janssen, Pfizer, and Novartis. The pattern suggests that major global pharmaceutical firms are intensi
Samsung Bioepis, a key player in the global biosimilar market, is currently embroiled in seven separate lawsuits filed by major pharmaceutical companies such as Janssen, Pfizer, and Novartis. These legal battles primarily revolve around secondary rights like manufacturing processes and trademarks, despite the expiration of substance patents for the original drugs.
According to Samsung Bioepis' annual report, the company has recorded these lawsuits as contingent liabilities, acknowledging the uncertainty surrounding potential resource outflows.
The most significant dispute involves Janssen Biotech, a subsidiary of Johnson & Johnson, concerning a manufacturing exemption related to Supplementary Protection Certificates (SPCs). Samsung Bioepis applied for this exemption while producing 'Pyzchiva,' its biosimilar of Stelara, in Denmark. Janssen has since filed suit, alleging non-compliance with the required conditions, with a preliminary injunction and claims for damages currently under consideration.
A crucial aspect of the ruling will be whether storage of products for export purposes and production before obtaining marketing authorization are permissible.
Disputes with Pfizer and Novartis are also ongoing. Pfizer filed a suit in Australia against Samsung Bioepis's etanercept biosimilar, 'Benepali (Brenzys),' disputing patent infringement related to the manufacturing process. Meanwhile, a trademark dispute with Novartis in Canada over their treatment for macular degeneration, 'Byooviz,' has resulted in a lost appeal but a granted application for a stay of enforcement, with the trademark remaining in use.
The situation is further complicated by a class action lawsuit in Canada, alleging violations of the Competition Act and a separate lawsuit over a breach of a settlement agreement with Janssen. These legal entanglements highlight the challenges faced by biosimilar companies. Analysis of biopharmaceutical patent litigation in the United States between 2010 and 2023 suggests that only 4% of lawsuits involved substance patents, with the remaining 96% revolving around follow-on patents covering manufacturing processes, formulations, and methods of administration.
Samsung Bioepis has stated that it is currently unable to provide an official position on the litigation, emphasizing its commitment to addressing the matter through the legal process. The outcome of the European Union's Court of Justice ruling is anticipated to serve as a significant milestone, shaping the global production and inventory strategies of biosimilar companies.
Written by urgent.news from BusinessKorea's reporting — not their text. Machine-written — may contain errors; check the original before relying on it.
