If the applicant withholds relevant citations from the US Patent Office during Examination Proceedings with intent to deceive, this is “inequitable conduct” and will result in the Patents being unenforceable in the event of a dispute. The intent to deceive does not have to be proven directly; rather, it can be inferred from the circumstances. For example, an intention to deceive in the earlier Examination Proceedings can also be inferred from misconduct in the patent proceedings.

Regeneron sued Merus for infringement of the patent in dispute. Merus defended itself by arguing that the Patents were unenforceable due to inequitable conduct. Regeneron had withheld four relevant citations (prior art) in the Examination Proceedings of which it was aware. Regeneron, for its part, replied that the citations were only cumulative with respect to the documents already considered by the examiner. Moreover, there was no specific intention to deceive the Patent Office.

The Court of First Instance (District Court) scheduled two hearings. The first was to deal with the relevance of the citations and the second with the intent to deceive. However, only the first hearing took place. The court determined the “broadest reasonable interpretation” of the claim and concluded that a reasonable examiner would have granted the patent only because the withheld citations were not before him (“but-for materiality”). Based on the plaintiff’s procedural conduct with respect to the determination of the intent to deceive, the court concluded, to Regeneron’s detriment, that Regeneron arguably had an intent to deceive in the Examination Proceedings. The court therefore ruled that the Patents were unenforceable.

His judgment was based on the following facts:

In the run-up to the genetic engineering Patent Application, two scientific employees of Regeneron, who had also contributed to the withheld prior publications, had corresponded with an inventor of the patent in suit about the assessment of the citations and expressed concerns about the correctness of the assessment.

In the Examination Proceedings, the Examiner repeatedly rejected the claims. Although the in-house Patent Attorney had limited the claims during the proceedings to the additional feature, namely that the human gene segments are inserted at an “endogenous” mouse immunoglobulin locus, the examiner maintained the rejection. Only when the Patent Attorney submitted a presentation claiming that Regeneron had developed a commercial embodiment of the invention showing surprising results, and discussed this presentation in a personal interview with the examiner, did the examiner allow the requested claims to be granted. In the course of the patent proceedings, however, it was undisputed that Regeneron had not developed such a commercial product at that time and that the corresponding claim in the presentation was therefore false.

Shortly before the Patent Office announced the patent grant (“allowance”), a third party made a submission to the USPTO opposing a parallel Application by Regeneron, citing three prior publications (“third party submission”). A fourth citation was a Patent Application originating from certain authors of the prior publications. Regeneron also submitted these citations in the Examination Proceedings to other parallel Applications with similar claims, but not to the application for the patent in suit. The court assumed that Regeneron did not submit these citations to the examiner of the patent in suit with intent to deceive.

In the discovery process of the patent litigation, Regeneron repeatedly withheld documents that they actually had and should have produced. For example:

– In response to the court’s request to submit a characteristics analysis, Regeneron’s (experienced) litigation counsel responded that he did not understand what exactly the court meant by this and how the claim should be broken down.

– In response to the court’s request to submit an interpretation of the claim, the trial attorney stated that the claim was clear and did not require interpretation.

– An important memo from outside Patent Attorney Dr. Jones was initially included on the list of documents enjoying Attorney/Client Privilege, but it was taken off the list at trial the night before the Patent Attorney’s deposition – i.e., at the last second – and presented to the court after all.

– When the court ordered Regeneron to produce all documents related to the Dr. Jones memo, Regeneron produced only a few documents, although it later turned out that many more documents should have been produced.

– The list of documents covered by attorney/client privilege included many that did not meet the requirements for this legal confidentiality protection.

– After the discovery proceedings, a statement (affidavit) was submitted by the in-house Patent Attorney in which statements were made on various topics, whereby these topics were contained in many documents in the list of protected documents. This called into question the outcome of the discovery proceedings.

The court considered sanctions against Regeneron for this conduct of the proceedings to be indispensable. It ruled that the circumstances permitted the conclusion that Regeneron had intended to deceive in the Examination Proceedings and that the resulting consequence of unenforceability of the Patents was the only appropriate measure.

Regeneron appealed against this ruling to the Court of Appeals for the Federal Circuit (CAFC). According to settled jurisprudence, it is not permissible to infer from conduct in the patent process that there was intent to deceive in the earlier Examination Proceedings.

The CAFC rejects the appeal. The District Court did not rely solely on the conduct in the patent litigation. Rather, Regeneron had obstructed discovery in the patent litigation regarding the facts and circumstances surrounding the Examination Proceedings at that time.

Note: It is usually difficult, if not impossible, for the patent infringer to prove that the patent proprietor had an intention to deceive during the Examination Proceedings. Here, the jurisprudence that the intention to deceive can also be inferred from the circumstances helps him. The entire course of the case history can play a role here. In a blatant case such as this one, even a patent litigation process that is rich in lists cannot help.

Left: www.cafc.uscourts.gov/sites/default/files/opinions-orders/16-1346.Opinion.7-24-2017.1.PDF