Quigley Likely To Prove Gum Tech's Zicam Infringes Its Patent, Judge Finds

Quigley Corp. is likely - but not certain - to succeed in its claim of patent infringement against Gum Tech, Philadelphia federal court Judge Stewart Dalzell finds in his April 19 memorandum and order.

The Cold-Eeze zinc gluconate lozenges maker showed a likelihood its patent would be found to be valid and that Gum Tech's Zicam Cold Remedy homeopathic zinc nasal spray infringes that patent, the memorandum explains. Gum Tech is extending Zicam with an Allergy Relief spray (¹ (Also see "Gel Tech Extending Zicam With Allergy Relief Homeopathic Nasal Gel" - Pink Sheet, 24 Apr, 2000.)).

However, Judge Dalzell denies Quigley's motion for preliminary injunction against Gum Tech, noting Quigley did not show the requisite irreparable harm it would suffer. "We have found that the hardships here would fall disproportionately on Gum Tech were we to impose such an injunction," the judge concludes.

The patent at issue, '465, involves the application of zinc gluconate to virus-infected tissues to reduce the duration of the common cold.

Quigley charges Zicam is covered by two claims of its '465 patent involving "a method for treating the common cold" and "a method for treating symptoms commonly associated with the common cold...to reduce the duration or severity thereof," and comprising application of zinc gluconate to the oral mucosa. On March 9, the court decided the patent claims "are restricted to applications of zinc gluconate to the lining of the mouth, tongue and throat."

To decide whether to issue a preliminary injunction, the judge considers four factors: the likelihood of success on the merits; the irreparability of harm without injunction; the balance of hardships between the parties; and the demands of the public interest.

The criteria for likelihood of success on the merits refers both to patent validity and infringement. Regarding patent validity, the court concludes it is "unlikely that Quigley will fail to succeed in showing the '465 patent valid on this basis," noting the patents referred to by Gum Tech as prior art do not specify zinc gluconate and are not methods for treating the common cold. Also, the court decides the '465 patent "is unlikely to be found invalid...as obvious."

Gum Tech additionally had argued the patent is invalid because it was issued on a false premise. George Eby, the patent holder, had made repeated representations to the Patent & Trademark Office that nasal sprays were not effective; Gum Tech says because Zicam is effective, Eby's statements were inaccurate and tainted the patent. "We do not find Gum Tech's argument persuasive," the court responds.

Regarding the criteria of proving infringement to show likely success, the court concludes, "although it is a close case," Quigley has shown evidence of infringement. The court based its decision on testimony from Gum Tech's medical expert who noted in an informal experiment Zicam was observed to reach the user's throat 12 minutes after application in the nose.

"It would seem clear from [the expert's] testimony that when Zicam is used as directed, at least some of the product reaches the throat....Thus, on the basis of our interpretation of the '465 claims, it would appear almost certain that Quigley will prove that Zicam is applied to the oral mucosa," the judge asserts.

However, "there are two other claim elements that are not as clearly in Quigley's favor: it must show that Zicam 'saturates' the mucosa, and also that Zicam applies an 'effective dose' of zinc gluconate."

Even though Quigley showed a likelihood of success on the merits, it did not meet the other three criteria for injunction: showing likelihood of harm, balance of hardships and the public interest.

The most persuasive evidence against issuance of a preliminary injunction was Quigley testimony of the "explosive" results produced by national publicity, the judge notes. After segments on CNN, Headline News and ABC's 20/20 mentioned Cold-Eeze, Quigley's sales boomed, but almost immediately about 40 other zinc products appeared on the market.

"The truth of the matter, at least to date, is that Quigley is the victim of its own explosive success, and not the victim of Gum Tech's conduct," the judge asserts.

The court noted because two-thirds of Gum Tech's 1999 sales were from Zicam, to enjoin its sale would "likely constitute a corporate death sentence." By contrast, "Quigley and its stockholders will not have their interests snuffed out if we at this juncture allow Gum Tech to remain in existence," the judge adds.

Eby, the holder of the '465 patent licensed by Quigley, refuses to participate in the suit.