Oral Mucosa' Cures Cold-Eeze Patent
lawnewsnetwork.com
By Shannon P. Duffy
The Legal Intelligencer
March 20, 2000
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Gel Tech Industries just can't seem to shake that Cold-Eeze patent lawsuit it was hit with last year.
A federal judge has ruled that Gel Tech's product, Zicam, may infringe on the Quigley Corp.'s patent for a zinc-based cold remedy.
Quigley's Cold-Eeze is marketed in the form of lozenges and gum, while Gel Tech's Zicam is a nasal gel administered into the nose with a nasal pump.
But U.S. District Judge Stewart Dalzell found that Quigley's patent could be read broadly enough that Zicam would be found to infringe it since it isn't limited to gum or lozenges, but instead describes a "method" for applying an "effective dose" of zinc to the "oral mucosa."
The ruling in Quigley Corp. v. Gum Tech International is a victory for attorney Frederick A. Tecce of Philadelphia's McShea & Tecce, who filed the patent suit on behalf of Quigley accusing Gel Tech Industries, Gel Tech LLC and Gum Tech International of infringing the 1990 patent.
Gel Tech's lawyers, Michael A. Schwartz of Philadelphia-based Dechert Price & Rhoads and Sid Leach of Snell & Wilmer in Phoenix, Ariz., argued that the case should be dismissed on the basis of arguments made by the inventor, George A. Eby III, to the Patent Office during the prosecution of the patent.
But Dalzell found that the defense wasn't entitled to a quick win because Zicam could be found to infringe Quigley's patent, either literally or under the doctrine of equivalents.
While one of the claims in the patent specifically states that the remedy be in the form of a lozenge, Dalzell found that two other claims did not specify any method of delivery.
On those claims, the lawyers disputed whether Zicam could be found to infringe a patent that calls for a zinc compound to be applied to the "oral mucosa."
Gel Tech argues that because its product is a "nasal gel" that is "applied intranasally," it simply cannot be said to apply a dose of zinc gluconate to the oral mucosa, and that its nasal gel does not remain in contact with the oral mucosa long enough to saturate the oral mucosa, as required by the second element of the patent claim.
Gel Tech also argued claims that statements Eby made in the process of prosecuting the patent foreclose the application of that patent to "any method or product where zinc compounds are applied to the nasal mucosa."
But Tecce argued that Zicam nasal gel does indeed reach the oral mucosa. Zicam's instructions, he noted, direct the user to blow the nose before pumping in the gel, which, Tecce said, results in the gel's application to the oral mucosa.
Tecce offered an affidavit by Dr. Andrew Goldberg who opined that Zicam "delivers its spray gel to the user in such a way as to result in the application of zinc gluconium to the oral mucosa as that term is defined in [Quigley's] patent."
He also argued that Zicam is designed to remain in contact with the oral mucosa long enough to saturate that mucosa -- the second element of the claims -- as evidenced by Zicam's packaging, which refers to a "constant release and long-lasting suspension of its active ingredient."
Finally, Tecce argued that Zicam's instructions for use -- directing repeated application of ZICAM, including the use of ZICAM for a 48-hour period after symptoms subside -- fall under the last element of the patent claims, which discloses the application of additional doses "until the cold has been treated."
Dalzell found that an obvious initial question for the court was the meaning of the term "oral" as used in the claim.
The "ordinary and customary" meaning of the word, he said, "would appear in this context to be 'of or pertaining to the mouth, as a part of the body.'"
But Dalzell found that in the context of Quigley's patent, the more important term to define was "oral mucosa," which is defined as the "lining of the mouth, tongue and throat."
Dalzell next rejected Gel Tech's argument that Quigley's suit was barred due to statements made by Eby to the Patent Office that seemed to rule out a nasal delivery of the zinc.
In one such statement, Eby said, "The inventor has on various occasions tested a zinc gluconate spray intranasaly [sic], and it was not found to be effective in cold treatment."
But Dalzell found that "at this stage in claim interpretation, the question before us with respect to these statements is whether they serve to reveal the true meaning of the language used in the claims themselves, with the proviso that ... we cannot use the prosecution history to 'enlarge, diminish, or vary the limitations in the claims.'"
Dalzell said Gel Tech was asking the court to take the prosecution history to hold that the phrase "a method for treating," as used in the patent claims, should be limited to mean only methods other than nasal sprays.
"We find that the prosecution history cannot so limit our interpretation of the claim," Dalzell wrote.
"Mr. Eby's communication with the PTO certainly makes clear that he is focused solely on application to the oral mucosa, and that application to other mucosa, in particular the nasal mucosa, is not a part of his claimed invention."
Even though Eby specifically claimed to the PTO that he had found a nasal spray to be ineffective, Dalzell said the courts "cannot take these statements to change the meaning of the claim into a form palatable to [the defense]."
To do so, Dalzell said, would violate one of the key teachings on the court's role in claim construction announced in Markman v. Westview Instruments, Inc.
"Were we to employ the prosecution history to exclude various methods from this locution, we would unquestionably be 'diminishing' the limitation of the claim, which is exactly what we cannot do at this stage," Dalzell wrote. |
