Tag: patent position

Company News: After U.S. court ruling, Merus reaffirms freedom to operate for its MeMo® transgenic mouse for therapeutic human antibodies

– Regeneron’s ‘018 patent’ is considered invalid and Merus not infringing –

Merus B.V., a leader in developing best-in-class antibody therapeutics to treat cancer patients, today announced a series of pivotal events in its litigation with Regeneron Pharmaceuticals Inc. Previously, Regeneron sued Merus accusing it of infringing U.S. Patent No. 8,502,018 (‘018 patent’) directed to a particular method of making a genetically modified mouse, which Regeneron asserted was useful to produce therapeutic antibodies.

Merus argued that Regeneron had interpreted its patent in an overbroad manner, and that the patent claims were indefinite and invalid. On November 21, 2014, in a fifty-nine page decision, the United States District Court for the Southern District of New York agreed with Merus on virtually every issue, stating:  “[t]his Court generally agrees with the constructions Merus proposes, limiting the Patent to a far narrower scope than asserted by Regeneron.”  The court also ruled that Merus has demonstrated “clear and convincing evidence that [a key claim term] lacks reasonable certainty and is therefore indefinite.” On December 19, 2014, Regeneron filed papers with the court conceding that under these rulings, Merus does not infringe any asserted claim of the ‘018 patent, and that these claims are invalid. With this ruling and Regeneron’ s concessions, there are no outstanding claims against Merus. The only remaining issues include Merus’ claim against Regeneron that it unlawfully procured its patent from the U.S. Patent Office and Merus’ request that Regeneron pay the legal fees incurred by Merus.

Company News: Patent Position of Merus’ MeMo® Mouse Strengthened by Ruling of European Patent Office

– Freedom to operate confirmed

– Successful opposition against Regeneron’s patent EP 1 360 287 B1 for transgenic mice producing therapeutic human antibodies

Merus B.V., a biopharmaceutical company focusing on innovative human antibody therapeutics, announced today that it has successfully retained full freedom to operate for its proprietary transgenic MeMo® mouse. In opposition proceedings at the European Patent Office, the opposition division ruled on September 17 that European patent EP 1 360 287 B1, owned by Regeneron Pharmaceuticals Inc., was revoked in its entirety.

In 2012, Regeneron was granted a European patent entitled “Methods of Modifying Eukaryotic Cells”. The patent is part of Regeneron’s IP portfolio around its VelocImmune® mouse for therapeutic human antibodies. Merus filed an opposition against this patent in June 2013, thereby requesting revocation of the patent.

Company News: InDex Pharmaceuticals Strengthens IP Position for Kappaproct

– Novel patent for Phase III lead drug candidate filed in the EU, US –

InDex Pharmaceuticals today announced the filing of  a new patent with the United States Patent and Trademark Office and with the European Patent Office. The company thereby continues to strengthen the company’s intellectual property portfolio around its lead drug candidate Kappaproct. The newly filed patent with the title “Methods for prevention of colectomy” covers methods for preventing or reducing the need of colectomy using an oligonucleotide with a specific core sequence and has the potential to extend patent protection on Kappaproct to 2032.  Kappaproct is a DNA-based synthetic oligonucleotide, which functions as an immunomodulatory agent by targeting TLR9. Kappaproct is currently in a phase III study in Europe for the treatment of chronic, active, treatment-refractory ulcerative colitis. InDex Pharmaceuticals already holds broad patent protection for Kappaproct for the treatment of steroid-resistant inflammatory diseases in both Europe and the US through at least 2027, with the possibility of a 3 to 5-year term extension after market approval.

In June 2012, InDex Pharmaceuticals reported positive data from the Company’s compassionate use program with its lead compound Kappaproct. The findings published in the peer-reviewed journal  Inflammatory Bowel Diseases showed that more than two years post treatment, all but one of the treated patients had avoided the need for colectomy, with the longest patient being in symptom-free remission for over 27 months.