Court Injects "Duty of Candour" Requirements for Patent Agents
In a recent decision pursuant to the NOC Regulations, the Federal Court considered s. 73(1) of the Patent Act, and held that there is a duty for patent agents to reply in good faith and make full and frank disclosure to the patent examiner. The allegation that the patent was deemed to be abandoned due to a lack of full, frank and fair disclosure under s. 73(1) was found to be justified, and the patent was deemed abandoned for the purposes of the proceeding.
Facts as Stated in Decision
The patent application contained claims to a combination product. The examiner noted that the claims were to the aggregation of two known types of compounds and objected that there was no invention in the combination unless there is a new and unexpected result. Further, there was no evidence of a synergistic effect. The examiner also made a request pursuant to s. 29 of the Patent Act for prior art cited in the United States and European Patent Offices.
In response, Lundbeck's agents noted there were no corresponding applications in the United States or Europe. However, two documents cited in the International Search Report were identified. One of these articles was the Wenk article, which has become the issue in this case.
The examiner sent a further office action indicating a concern that the invention claimed was obvious. In response, Lundbeck's agents discussed 4 articles, none of which were Wenk, and concluded that "the prior art clearly teaches away from the combination of a NMDA antagonist with an AChE inhibitor as claimed in the instant application." (para 311) Other statements made by the agents were highlighted by the Court.
Analysis by the Court
Lundbeck argued that there was no duty of candour in the prosecution of a patent application in Canada. Lundbeck also argued that since the Wenk article was before the examiner, and was not specifically cited in the office action, there was no need to discuss it further.
The Court disagreed. It held that s. 73(1) imposes a duty to reply in good faith and this is the same as a duty of candour. Relying on a decision of Justice Hughes in Searle (2007 FC 81; rev'd 2007 FCA 173), the Court agreed that there is no compulsion to seek a patent monopoly. It is sought voluntarily through an ex parte proceeding. There is ample opportunity during prosecution to make further disclosure or correct an early misstatement or shortcoming. Thus, there is an obligation on those seeking patent protection to act in good faith when dealing with the Patent Office.
The Court held that when seeking ex parte relief, a party must do more than simply present its case in the best possible light. Rather, the case must be stated fairly and any facts of law known to it which favour the other side must also be stated.
In this case, the examiner was concerned with obviousness. In response, the agents advised that there were numerous articles warning against the particular combination claimed. The Court found that these studies were not directly relevant to the issue raised by the examiner. Furthermore, the agents did not refer to the one document that was directly relevant to the issue; Wenk. Thus, the response did not fairly or accurately represent the state of the prior art at the relevant time. The fact that the Wenk article was identified in earlier correspondence does not change that the response to the patent examiner's request was not a full, fair or complete depiction of the teachings of the prior art.
The Court also rejected submissions that Wenk does not discuss the synergistic effect achieved and is not relevant for that purpose. Wenk was not found to be anticipatory, nor to render the invention obvious. However, those are different tests than the response to the examiner being considered.
Thus, ratiopharm's allegation with respect to section 73(1) was considered justified. However, technically, the Court's analysis of this issue is obiter, as the Court had already found the allegation as to inutility justified.
Other issues Raised in Decision
The application considered other allegations of invalidity of the patent described above. The allegations of anticipation and obviousness were found to be not justified. However, the Court held that the disclosure did not contain a description of the synergistic effect of the combination of the products, nor did it contain the information needed to satisfy that this effect could be soundly predicted. Thus, relying on the increased disclosure requirements that are becoming part of Canadian law, the allegation of inutility was found to be justified.
A second patent was also the subject of this proceeding. The allegation of anticipation of the other patent was found to be justified as merely explaining the mechanism which underlies a use already described cannot give rise to novelty. Thus, as the prior art if performed, would inevitably infringe the within patent, it was anticipatory and obviousness. The allegation as to inutility was also considered, but found to be not justified.
The full text of the decision can be found here.