|U.S. Court of Appeals for the Federal Circuit Affirms Merus’ Inequitable Conduct Claim Against Regeneron|
In today’s decision, the Federal Circuit ruled fully in favor of Merus, affirming that Regeneron’s ‘018 patent is unenforceable, having been obtained by inequitable conduct. The Federal Circuit noted Regeneron made “false” assertions, relied on a “misleading presentation,” and withheld material information from the United States Patent Office, and further, that Regeneron’s “litigation misconduct” “obfuscated its prosecution misconduct.”
“We are pleased by today’s decision, which serves as the latest vindication for Merus in this case against Regeneron,” said Ton Logtenberg, Ph.D., Chief Executive Officer of Merus. “With this decision, and based on the continued strength of our IP estate, Merus remains focused and believes it is well-positioned as an innovator in the development of full-length human bispecific antibody therapeutic candidates for serious diseases.”
Merus is a clinical-stage immuno-oncology company developing innovative full-length human bispecific antibody therapeutics, referred to as Biclonics®. Biclonics® are based on the full-length IgG format, are manufactured using industry standard processes and have been observed in preclinical studies to have several of the same features of conventional monoclonal antibodies, such as long half-life and low immunogenicity. Merus’ lead bispecific antibody candidate, MCLA-128, is expected to begin a Phase 2 clinical trial in the second half of 2017 in two metastatic breast cancer populations. MCLA-128 is also being evaluated in a Phase 1/2 clinical trial in
Forward Looking Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements.
These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our need for additional funding, which may not be available and which may require us to restrict our operations or require us to relinquish rights to our technologies or Biclonics® and bispecific antibody candidates; potential delays in regulatory approval, which would impact our ability to commercialize our product candidates and affect our ability to generate revenue; the lengthy and expensive process of clinical drug development, which has an uncertain outcome; the unpredictable nature of our early stage development efforts for marketable drugs; potential delays in enrollment of patients, which could affect the receipt of necessary regulatory approvals; our reliance on third parties to conduct our clinical trials and the potential for those third parties to not perform satisfactorily; we may not identify suitable Biclonics® or bispecific antibody candidates under our collaboration with
These and other important factors discussed under the caption “Risk Factors” in our Annual Report on Form 20-F filed with the