U.S. Court of Appeals for the Federal Circuit Affirms Merus' Inequitable Conduct Claim Against Regeneron
UTRECHT, The Netherlands, July 28, 2017 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq:MRUS), a clinical-stage immuno-oncology company developing innovative bispecific antibody therapeutics (Biclonics®), today announced that the U.S. Court of Appeals for the Federal Circuit affirmed the trial court's conclusion that Regeneron Pharmaceuticals, Inc. engaged in inequitable conduct before the United States Patent and Trademark Office while prosecuting U.S. Patent No. 8,502,018 ('018 patent), entitled "Methods of Modifying Eukaryotic Cells."
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."
About Merus N.V.
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 Europe in gastric, ovarian, endometrial and non-small cell lung cancers. Merus' second bispecific antibody candidate, MCLA-117, is being developed in a Phase 1 clinical trial in patients with acute myeloid leukemia. The Company also has a pipeline of proprietary bispecific antibody candidates in preclinical development, including MCLA-158, which is designed to bind to cancer stem cells and is being developed as a potential treatment for colorectal cancer and other solid tumors, as well as MCLA-145 designed to bind to PD-L1 and a non-disclosed second immunomodulatory target, which is being developed in collaboration with Incyte Corporation.
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 Incyte or Incyte may fail to perform adequately under our collaboration; our reliance on third parties to manufacture our product candidates, which may delay, prevent or impair our development and commercialization efforts; our ability to protect our proprietary technology; our patents may be found invalid, unenforceable, circumvented by competitors and our patent applications may be found not to comply with the rules and regulations of patentability; we may fail to prevail in existing and potential lawsuits for infringement of third-party intellectual property; and our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to be infringing on other marks.
These and other important factors discussed under the caption "Risk Factors" in our Annual Report on Form 20-F filed with the Securities and Exchange Commission, or SEC, on April 28, 2017, and our other reports filed with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change, except as required under applicable law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
+1 973 361 1546
+1 646 368 8014
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Merus N.V. via Globenewswire
About GlobeNewswire by notified
One Liberty Plaza - 165 Broadway
NY 10006 New York
GlobeNewswire by notified is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.
Subscribe to releases from GlobeNewswire by notified
Subscribe to all the latest releases from GlobeNewswire by notified by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from GlobeNewswire by notified
Global Health and Gavi Veteran Anuradha Gupta to Lead Global Immunization at Sabin3.10.2022 16:00:00 CEST | Press release
WASHINGTON, Oct. 03, 2022 (GLOBE NEWSWIRE) -- Veteran public health leader Anuradha Gupta, who has spearheaded a host of successful global initiatives to improve the health of women and children and boost vaccine access and uptake, has joined Sabin Vaccine Institute as President of Global Immunization. Gupta’s record of crafting and implementing creative solutions to seemingly intractable health challenges is particularly significant now with life-saving childhood immunizations sustaining their largest backslide in decades, fueled largely by the pandemic. Gupta comes to Sabin after eight years with Gavi, the Vaccine Alliance, where she served as Deputy CEO and led efforts to center policies, programs and partnerships around vaccine equity, gender and communities. She also pioneered the concept of zero-dose children – those who have not received a single dose of the most basic vaccines – and drove efforts to create a new model of country-level partnerships. “Anuradha Gupta is a stellar
Once-weekly insulin icodec demonstrates superior reduction in HbA1c in combination with a dosing guide app versus once-daily basal insulin in people with type 2 diabetes in ONWARDS 5 phase 3a trial3.10.2022 14:02:33 CEST | Press release
Bagsværd, Denmark, 3October 2022 – Novo Nordisk today announced headline results from the ONWARDS 5 phase 3a trial with once-weekly insulin icodec in people with type 2 diabetes. The ONWARDS 5 trial was a 52-week, open-label efficacy and safety treat-to-target trial investigating once-weekly insulin versus once-daily basal insulin (insulin degludec or insulin glargine U100/U300) in 1,085 insulin-naïve people with type 2 diabetes in a clinical practice setting including fewer trial visits compared to the other ONWARDS phase 3a trials. Once-weekly insulin icodec was used in combination with a dosing guide app to guide titration. The trial achieved its primary endpoint of demonstrating non-inferiority in reducing HbA1c at week 52 with insulin icodec compared with once-daily basal insulin analogues. From an overall baseline HbA1c of 8.9%, once-weekly insulin icodec achieved a superior reduction in estimated HbA1c of –1.68%-points compared with –1.31%-points for the once-daily basal insulin
Cellebrite Appoints Adv. Ayala Berler Shapira as General Counsel3.10.2022 13:00:00 CEST | Press release
PETAH TIKVA, Israel and TYSONS CORNER, Va., Oct. 03, 2022 (GLOBE NEWSWIRE) -- Cellebrite DI Ltd. (Nasdaq: CLBT), a global leader in Digital Intelligence (DI) solutions for the public and private sectors, today announced that Ayala Berler Shapira has been named General Counsel (GC) of the company. As part of the company’s further growth Ayala Berler Shapira will strategically manage all legal aspects and will assume complete responsibility and lead the legal and compliance organization of Cellebrite. She will be a member of Cellebrite’s executive management team. Ayala brings 27 years of experience in both global technology companies and in some of the leading law firms in Israel. Prior to joining Cellebrite, Ayala served as Deputy GC of Amdocs, where she led the global business and corporate legal domains, supported the company’s M&A activity, and served as Head of Compliance. Before that, she was the GC of Jungo, an Israeli software company operating in the telecommunication market. A
Correction: Notice on Convocation of Extraordinary General Meeting of Shareholders of AB Klaipėdos nafta3.10.2022 12:56:56 CEST | Press release
Correction of Annex No 1 (Draft decision) and Annex No 2 (Ballot paper) was made. Notice is hereby given that on the initiative and by the resolution of the Board of AB Klaipėdos nafta, legal entity code 110648893, with the registered office at Burių str. 19, Klaipeda (hereinafter - the Company), Exraordinary General Meeting of Shareholders of the Company will be held on 20 October 2022 at 1:00 p.m. The meeting will be held in the Company’s office at Buriu str. 19, Klaipeda, in the administrative office of the Company (in the hall of the meeting on the 2nd floor). Agenda of the meeting: Regarding the approval of amendment of Remuneration Policy of AB Klaipėdos nafta. The shareholders will be registered from 12:00 a.m. to 12:55 p.m. The persons intending to participate in the meeting shall have a personal ID document (an authorized representative shall have an authorization approved under the established procedure. The natural person’s authorization shall be notarized. An authorization
eGain named a Representative Vendor in the 2022 Gartner® Market Guide for Customer Service Knowledge Management Systems3.10.2022 12:30:00 CEST | Press release
SUNNYVALE, Calif., Oct. 03, 2022 (GLOBE NEWSWIRE) -- eGain Corporation (NASDAQ: EGAN), the leading knowledge management platform provider for customer engagement automation, today announced that it has been named in the 2022 Gartner Market Guide for Customer Service Knowledge Management Systems. “In 2022, 74% of Customer Service and Support (CSS) leaders cited improving knowledge and content delivery to customers and employees as a priority. In the absence of direct peer interactions when working from home, reps will need in-the-moment, personalized, contextually aware information within the flow of work in order to assist customers and resolve their requests,” wrote authors Pri Rathnayake and Drew Kraus in the Guide. The report provides an overview of the market, outlines trends and challenges, and offers a framework to evaluate vendor capabilities to help enterprise leaders select the right platform and partner for their knowledge initiatives. Vendors were evaluated across three cate