Companies Anticipate Another Precedential Ruling from the Federal Circuit Three Judge Panel Based on One Over-Arching Argument
LOS ANGELES, CA / ACCESSWIRE / December 19, 2018 / Decision Diagnostics Corp. (otc pink:DECN) Decision Diagnostics Corp. is a 16 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 a growing brand of glucose test strips and meters as highly accurate alternatives for legacy diabetic, proprietary, and pet testing glucose test strips. The company’s current portfolio of test strips includes its GenUltimate!, GenChoice!, GenSure!, and GenUltimate! TBG test strips, its Avantage! and Precise! Glucometers, and its PetSure! and GenUltimate! 4Pets testing products for dogs, cats and horses.
Decision Diagnostics through its subsidiary corporations PharmaTech Solutions, Inc. and Decision IT Corp. announces today that the companies have appealed the court decision in its case against Johnson & Johnson (JNJ) and two Lifescan divisions, Nevada U.S. District Court case 2:2016cv00564, to the U.S. Court of Appeals for the Federal Circuit in Washington, DC. The Federal Circuit Court hears all appeals involving U.S. Patents.
In the companies’ case the trial judge ruled incorrectly that the doctrine of prosecution history estoppel preclude us from arguing that LifeScan’s OneTouch Ultra infringes the patents-in-suit by the doctrine of equivalence. According to the trial judge, during the prosecution of the patents, the original patent applicants amended their claims and made arguments to the examiner indicating that they were surrendering any way of comparing measurements taken by an analyte monitoring system other than the comparison of analyte measurements taken at different times with each other. Specifically, the trial judge wrongly concluded that to infringe, a device had to first convert a current measurement to an analyte measurement before any comparison would be made. The trial judge relied on erroneous claims made by Johnson & Johnson in their pleadings and oral arguments.
Robert Jagunich, Chairman of the companies comments, ”The companies had several paths we could have followed during the drafting of this appeal. We could have listed all of the paragraphs in the trial judge’s ruling where he erred, or we could have focused on the one over-arching issue that we chose to argue, the one issue that the Circuit Court judge panel will likely hone in on. Having been in front of this court twice previously we have learned that once the three judge panel sustains an appeal on one issue, all of the other claims are superfluous and considered mute. Therefore, we took the straight path. We strongly believe that our appeal will end with a positive conclusion, and another Precedential (new law) ruling from the Federal Circuit court.
The companies argue in their appeal that the trial judge did not dig deep enough into the patent file and thus erred because ”the conversion element” had been disclosed in the prior art (other similar patents granted along the way). Instead, as the companies illustrate in their appeal, this element was highlighted in the prosecution history of the companies’ patents to show how currents measured at different times could be meaningfully compared, and all of this discussion happened twenty years ago, not in the trial judge’s courtroom in 2017 and 2018 as Johnson & Johnson misleadingly lead the trial judge to believe.
Keith Berman. CEO of Decision Diagnostics, the companies CEO commented, ”Our application of the patent laws is spot on. In this case we strongly believe that we have a winner. And with a new Precedential ruling, there is potential for DECN to be a big winner. Johnson & Johnson sold infringing product, its popular OneTouch Ultra family of products, from 2010 through the expiration of our patents in February 2017. The courts have held that cases such as ours can ”look back” six years in infringement matters, and while J&J’s OneTouch family is not as popular in the market as it once was, there was not a year from 2010 through February 2017 (the ”look-back” years) where J&J’s Lifescan divisions did not earn less than an estimated $1.2 billion in annual revenues, or an estimated $300 million in annual profits.”
The company’s central argument is that the trial judge cannot arbitrarily apply prosecution history estoppel when the prior art already disclosed the claim language added. This is a novel, even brilliant argument, and is not one that has been made to the Federal Circuit previously. However, the existing precedent suggests that the reasoning of our appeal brief is more than solid.
Mr. Berman concluded, ”Cases such as ours, where the technology rights held our companies are directly related to the method J&J took and used to determine glucose, the single purpose of this offending product, often create ill-gained profit damage awards that have been at the low end of 5% and the high end of 20% of profit. And in some similar cases, awards have resulted in a royalty penalty (revenue damage model) of up to 10% of revenues in the 6-year look-back period.”
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.
Forward-Looking Statements
This release contains the company’s forward-looking statements which are based on management’s current expectations and assumptions as of December 18, 2018, 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.
