In a recent article published by IAM Magazine, titled “Why Pharma Companies Should File Patents Later In The R&D Process,” Alexander R. Trimble, PhD, a prominent patent attorney, explores the optimal timing for pharmaceutical companies to file patents related to clinical trials. Trimble challenges the conventional practice of filing patent applications before Phase I clinical trials and suggests that a more strategic approach can enhance patent exclusivity and value.
The conventional strategy of filing patents before Phase I clinical trials stems from concerns about potential invalidation based on public use. However, Trimble argues that for most clinical trial-related inventions, this conservative approach is unnecessary and counterproductive. Instead, he proposes a more favorable default timeframe—after the start of Phase II clinical trials—which would not increase the risk of invalidation but would maximize exclusivity and patent value.
Key to understanding this strategy is distinguishing between Phase I and Phase II trials. Phase I trials primarily focus on evaluating treatment safety, identifying safe dosage ranges, and spotting potential side effects. Since they do not generate the efficacy data needed to support a finding of public use, delaying patent filing until after Phase I trials are completed and Phase II trials have begun is a prudent move.
On the other hand, Phase II trials can provide data sufficient to support a finding of public use. As such, Trimble recommends considering the start of Phase II trials as the reference point for filing the patent application. Further delaying the filing until after the Phase II trials are completed may still be viable, as courts have recognized that the review of clinical trial data is part of the experimentation process.
In specific cases where the invention changes between Phase II and Phase III trials, it may be advisable to delay filing until after the Phase III trial starts. The court’s decision in In re Omeprazole Patent Litigation illustrates this point, as a formulation change between Phase II and Phase III necessitated further experimentation and did not constitute public use.
However, Trimble advises that potential risks must be considered. Delaying patent filing may expose pharmaceutical companies to the risk of clinical trial-related publications qualifying as printed publications, which can impact patent validity. While inventions such as drug formulations with specific subcoatings may not be sufficiently detailed in clinical trial-related publications, new uses for known drugs or novel administration protocols might be, and thus require earlier filing.
To safeguard against potential issues, Trimble suggests implementing best practices. These include enforcing strict confidentiality agreements for clinical trial investigators to limit invention disclosure and ensuring that clinical trial participants are only informed about the administered drug and dosage, not the invention itself.
