Appeals Court Set to Hear and Then Decide DECN’s Seminal Legal Question at Issue in Long Simmering Patent Battle with Johnson & Johnson and its Successor
LOS ANGELES, CA / ACCESSWIRE / May 7, 2019 / Decision Diagnostics Corp. (OTC PINK: DECN) is a 17 year old, diabetes-focused bio-technology R&D firm, manufacturer, quality plan administrator, FDA registered medical device customer support organization, and exclusive worldwide sales and regulatory process agent for the GenUltimate! (“Sunshine”) diabetes test strip, the internationally launched GenSure! (“Feather”) diabetes test strip, and its GenChoice! (“Ladybug”) test strip now under review for FDA 510K clearance. The company also markets the PetSure! test strip for the diabetic testing of dogs and cats, a diagnostic specifically designed to run on the market leading Zoetis Alpha Trak meter system, and the GenUltimate! Test 4Pets test strip and Avantage! meter launched earlier in 2019, and the panacea GenUltimate! TBG (“Dragonfly”) highly precise diabetes testing system, ready for clinical trials.
In October 2018, DECN found itself on the wrong side of an inaccurate and unfair ruling by the Nevada Federal District Court in its long running patent battle with industry giant Johnson & Johnson (J&J). Specifically, the Court modified the questions at issue long after the conclusion of the briefings and oral arguments. Rather than directing his ruling to the “equivalent” (which in DECN’s case is the J&J/LifeScan system), the Court instead directed its ruling to the system claimed in DECN’s patents. More specifically, the Court misrepresented DECN’s principal arguments with its ruling by mistakenly comparing DECN’s patented system to itself and ignoring J&J’s infringing system and the basis for DECN’s lawsuit.
DECN immediately appealed this lower court ruling to the United States Court of Appeals for the Federal Circuit (the patent court). Briefings were completed and some 10 days ago the Federal Circuit court asked both sides to provide ”black-out” dates so that the court could set the date for the court ordered Mediation and the oral arguments. Dates from the Federal Circuit court are expected shortly and are tracking presently for events to occur in mid-June 2019.
Keith Berman, CEO of DECN, commented, ”While we were obviously disappointed by the lower court’s ruling, where upon analysis it appears that the trial judge ignored the entirety of DECN’s principal arguments and handed J&J a victory. We concluded that the judge was wrong, and J&J’s foot dragging indicates to us that they probably think so too.
Mr. Berman continued, ”Although egregious in itself, this Court also short circuited DECN’s right to bring a false advertising claim in our original action. J&J’s Chairman, who had extensively discussed the workings of J&J’s system in public forums and in the media, represented that J&J’s system operated in a manner that if he were taken at his word, infringed on DECN’s patented system; a clear confession of guilt to patent infringement. However, in their lawsuit defense, J&J argued that their Chairman ”misspoke.” If this is true, then J&J’s Chairman misspoke numerous times over an extended period, and was never corrected by his staff. J&J cannot have it both ways. Either their OneTouch Ultra system, subsequently sold to private equity firm Platinum Equity, is the equivalent to ours, which we strongly believe to be true, or the J&J Chairman’s public statements constitute false advertising of a product that J&J sold over 30 million boxes of annually for the 6-year look back period of time.”
In the upcoming arguments in front of a 3-judge Appeal panel, DECN will argue the highly erroneous nature of the Court’s unacceptably misstated “tangential exception” question. That being said, the act of comparing DECN’s system to itself was not the worst part of the trial judge’s ruling. When the trial judge ordered the court clerk to dismiss the lawsuit with prejudice, that act also foreclosed DECN’s ability to bring a false advertising claim against J&J in this case. The record in this lawsuit strongly suggests that J&J engaged in false advertising on the part of J&J’s Chairman who made numerous public statements to audiences that had the effect of describing in detail DECN’s patented system.
Mr. Berman concluded, ”We firmly believe that the Federal Circuit will easily follow our arguments, which were made in pleadings and then will be made again in the upcoming oral arguments. The company plans an additional updates as soon as the court sets the date for the oral arguments. Once dates are set, we can more clearly handicap the path and schedule to an Appeals Court ruling in this matter. While it may appear that little has happened in this matter, the opposite is true. The company does not expect this case to go to trial. J&J has sold their Lifescan, Inc. division and must, at this point view this patent matter as something hanging out there that requires resolution. ”
ABOUT DECISION DIAGNOSTICS CORP
Decision Diagnostics Corp. is the leading manufacturer and worldwide distributor of diabetic test strips engineered to operate on legacy glucose meters. DECN’s products are designed to operate efficiently and less expensively on certain glucose meters already in use by almost 7.5 million diabetics worldwide. With new inspired technology diabetic test strips already in the final stages of development, DECN products compete on a worldwide scale with legacy manufacturers currently selling to 71+ percent of a $12 billion at-home testing market.
This release contains the company’s forward-looking statements which are based on management’s current expectations and assumptions as of May 6, 2019, regarding the company’s business and performance, its prospects, current factors, the economy, and other future conditions and forecasts of future events, circumstances, and results.
SOURCE: Decision Diagnostics Corp.