A decision by the U.S district court judge in Minnesota on January 28 largely rules in Biotec Pharmacon’s favour in the patent infringement suit brought by Biopolymer Engineering, Inc. d/b/a Biothera against Biotec Pharmacon ASA and its U.S. affiliate, Immunocorp. The decision eliminates from further litigation all of Biothera's claims under 12 of the 14 U.S. patents at issue in the case.
“We are very pleased that the U.S. court has agreed that Biothera, for the most part, has failed to make sufficient threshold showings in support of its infringement claims even to require a trial,” says CEO Lars Viksmoen of Biotec Pharmacon.
“Only two patents survived our motion to dismiss the infringement claims even without having to go to a trial. However, we are confident that our evidence will convince a jury that neither our skin care product nor SBG, our lead pharmaceutical product candidate, infringes either of these two patents in the United States,” continued Viksmoen.
Biothera had claimed that Biotec Pharmacon and Immunocorp infringed its U.S. patents by selling nutraceutical and skin care products (marketed in Norway under the trade name nbg®24:7™) in the U.S. Biothera also claimed that Biotec Pharmacon's pharmaceutical candidate compound SBG infringes 7 of the 14 U.S. patents at issue in this case. After the court's just announced ruling, only claims asserted against the skin care product and SBG under two patents will proceed to a trial stage.
SBG has been tested by researchers in the U.S. and is currently being used in a clinical trial at the Memorial Sloan Kettering Cancer Center to treat patients suffering from neuroblastoma.
SBG has also been used in Phase II clinical studies in other countries, where data has shown very promising results from using SBG for the treatment of diabetic foot ulcer and oral mucositis. Biotec Pharmacon is currently in phase III clinical studies with SBG for both these indications.
In addition to providing evidence that Biotec Pharmacon's products do not infringe the two remaining patents in the case, the court's ruling also permits the company to present evidence at the trial that questions the validity of the two remaining patents because of prior art that made the inventions they claim obvious, rather than truly novel discoveries entitled to patent protection. Biothera had filed a motion seeking judgment in its favour on this defense, which the court denied in the same January 28 decision.
"While it has been very expensive for our company to litigate patent claims in a U.S. court, this decision vindicates our decision to fight Biothera's overreaching claims about the coverage of its beta glucan patent portfolio," concluded Viksmoen.
