Public Use
Europe
The EPO, when assessing public use considers whether the trial participants are free to dispose of the medication. The EPO will consider the trial circumstances. Where there was no requirement for the return of unused medication, the decision makers concluded that the trial organizers lost control of the medication.
The ruling was that this made the medication available to the public. The claims therefore lacked novelty.
Subsequent EPO case law clarified that not all trial protocols lead to public prior use. The European Medicines Agency's Guidelines on Good Clinical Practice require adherence to a trial protocol. The EPO has acknowledged that for trials conducted in line with the GCP guidelines participants are expected to comply with the protocol.
In a case where the protocol specified that investigators had an obligation to ensure drug accountability and return of unused medicine, trial participants were considered to have a "special relationship" with trial organizers and thus there was no public disclosure.
This "special relationship" only applies between trial investigators and participants. Where subjects were encouraged to discuss the trial with their doctors, information shared with them was deemed public.
This principle was tested where there was evidence that patients were "lost during follow-up." The EPO held that strict adherence to the protocol was the primary consideration here, superseding the subsequent loss of the patients to follow up. The patent was revoked on appeal on other grounds, but the principal of adherence to a protocol
stands.
United States
Whether a clinical trial constitutes public use may depend on the existence of confidentiality agreements and the level of detail disclosed to subjects and collaborators.
In a case where investigators, but not subjects, signed confidentiality agreements, the court held that the trial was conducted with a reasonable expectation of confidentiality. Although the subjects were not bound by confidentiality agreements, they did not know the formulations of the drug. Only the investigators knew the formulation, therefore, no public use.
In another case where samples were shipped for use in a trial with a certificate of analysis to a collaborator who did not sign a confidentiality agreement, that constituted public use.
In addition to confidentiality agreements, the level of control clinical trial investigators exercise is important. In another case, where patients failed to return unused drug product, the Court held that because the trial required patients to maintain a diary that recorded compliance with drug protocol, there was adequate control and thus, no prior use.
Printed Publications
Europe
When considering whether a clinical trial document or a press release about the trial renders a patent obvious, the EPO considers whether the document provides a reasonable expectation of or merely a hope of success.
In a case where a plan for a clinical trial was publicly available before the effective date of the patent, the EPO concluded that the plan did not provide a reasonable expectation of the direction or magnitude of the bioavailability of the active ingredient. Therefore, the invention was not obvious.
United States
The Federal Circuit has held that a subject's response to a candidate drug is an inherent result of performing a clinical trial. A published trial protocol may invalidate claims reciting aspects disclosed in the protocol, even where efficacy is a claim feature.[1] The Court upheld the use of a protocol published on ClinicalTrials.gov as prior art to invalidate claims although the protocol contained no efficacy or safety data where it was used in combination with a journal publication that included efficacy statements regarding optimal dosage.
Recommendations
In the US and Europe, innovators should assess their clinical trial protocols to ensure express terms prohibit participants from freely disposing of medication. In addition, where possible, innovators should use confidentiality agreements to prevent the public disclosure of information that may be the subject of patents to new therapeutic applications.
Innovators should file as early as possible to minimize the impact of trial disclosure on patentability. Consider filing before publication of the protocol and submitting trial data later during prosecution. In addition to adhering to good clinical practice guidelines, it is advisable to minimize and control the content of public disclosures to mitigate risk of disclosures being found to provide an expectation of success in subsequently filed applications.
About the Authors
Laura Masurovsky, Amanda Murphy, and Jeffrey Jacobstein are attorneys at Finnegan, one of the world's largest intellectual property law firms and a trusted resource for Israeli companies. The firm represents more than 300 of Israel's leading and most sophisticated companies, helping them navigate intellectual property disputes and patent infringement litigation, advising on strategic technology protection strategies to maximize value, managing patent portfolios, and developing revenue opportunities through creative patent prosecution and licensing programs. In the words of Chambers USA, "Finnegan's work is nothing short of exceptional."
[1] In re Montgomery, 677 F.3d 1375, 1382 (Fed. Cir. 2012)
contributors:
Jamie Barcombe, Jordan Gringauz, Maeve O'Flynn, Craig Slater
For more information:
Finnegan.co.il | Israelinfo@finnegan.com
in collaboration with Finnegan
