The rapid growth of biologic therapeutics—a class of medicines produced in living cells and then purified—has led to a significant rise in multi-jurisdictional patent disputes. With billions of dollars in sales at stake, innovators and biosimilar manufacturers are protecting their products through diverse global patent portfolios spanning various subject matters, from structure and formulation to methods of use and manufacture.
The complexity of biologics’ global manufacturing and supply chains often complicates the task for patentees to determine if, when, and where competitors might be infringing their patents. Production methods, often kept as closely guarded secrets and taking place outside the US, are particularly challenging to assess. Even when competitor product samples are available, the detailed manufacturing information often remains obscure, making litigation discovery the primary method for uncovering these methods.
Addressing this issue, the US possesses a unique discovery statute, 28 U.S.C. §1782, designed to assist litigants in unearthing crucial information from adversaries for use in foreign proceedings. This statute covers anticipated litigation and other disputes, including patent office proceedings, arbitrations, and potential government investigations (source).
Section 1782 applications have become increasingly common in biologics-related disputes. These ex parte applications must meet three threshold statutory factors: the target must reside or be found in the judicial district where the application is made, the evidence must be intended for use in a foreign proceeding, and the request must be made by a foreign or international tribunal or by any interested person. If these factors are met, the application is reviewed by the court, which decides whether to grant it based on four discretionary factors. Courts often handle these applications with accompanying declarations that establish the need for discovery, satisfaction of the statutory factors, and proposed subpoenas for documents and testimony.
In cases where the court authorizes service of subpoenas, the target can lodge objections or move to quash. Furthermore, the statute covers discovery for use before various bodies, including foreign courts, the Unified Patent Court, and arbitral bodies, but excludes private adjudicatory bodies as per the US Supreme Court’s ruling (link).
Counsel specializing in cross-border issues should carefully manage protective orders to avoid pitfalls, especially given differing international confidentiality rules like the UK’s confidentiality clubs. If used judiciously, §1782 can be a powerful tool for biologics manufacturers engaged in global patent disputes, allowing them to level the playing field where other jurisdictions lack robust discovery mechanisms.
For an in-depth analysis, consult the original article on Bloomberg Law (link).