A Medical Device Daily

I-Flow (Lake Forest, California) said it will continue to pursue its patent and trade secret rights against Apex Medical Technologies (San Diego), its president, Mark McLaughlin, in the U.S. District Court for the Southern District of California; and also against distributors of Apex's Solace Pump, including Zone Medical (San Diego).

I-Flow said that "in view of early successes achieved in the lawsuit in the Southern District of California," it will ask the court to rule that Apex, McLaughlin and Zone have infringed its '481 patent. The company said it also is "vigorously moving forward" in the case to protect its trade secrets.

Zone reported last week that the U.S. Patent and Trademark Office had rejected all claims in I-Flow's Patent No. 5,284,481, titled "Compact collapsible infusion apparatus." Zone said the USPTO reexamined I-Flow's patent for infusion devices and that all claims were rejected as "anticipated or obvious in view of prior art."

Mark McGlothlin, founder and president of Zone, said, "Our Solace product is an affordable, latex-free infusion pump designed to compete against latex-containing pumps, which currently dominate the market." He added: "We believe I-Flow's lawsuit is designed to force us to use our resources to defend costly litigation instead of competing in the market based on the merits of our respective products.

"This is a David vs. Goliath situation [that] I-Flow has chosen to use litigation to distract attention from the fact that their product is based on 20-year-old technology and contains natural rubber latex that may contact patients and caregivers."

Zone said the Solace Pain Management System, launched in July 2007, "has been well-received by surgeons and patients worldwide in both inpatient and outpatient environments."

I-Flow said the defendants of its lawsuit asked the USPTO to reexamine its patent in response to the filed litigation and that the USPTO took the action without input from I-Flow.

The company said it will now have an opportunity to present its position to the USPTO in support of the patentability of the '481 patent. I-Flow said that it believes that the USPTO will reconfirm the patent, as it did in 1994 when it issued the patent.

"Indeed, the primary prior art relied on by Apex, McLaughlin and Zone in the reexamination process that I-Flow has not yet participated in, and relied upon by the USPTO in rejecting the claims, is in fact technology owned by I-Flow," the company said.

Donald Earhart, president/CEO and chairman of I-Flow, said the company success includes both its patent and "a total package that includes a high quality disposable pump, a patented silver-coated soaker catheter, more than 60 clinical studies, our FDA-cleared indications that ON-Q significantly reduces the need for narcotics and provides better pain relief than narcotics alone following surgery and ... our unsurpassed surgical sales force that spans the U.S. No other company in the market today even comes close to matching the breadth of our quality product line and the strength of our distribution. This is why we are the leader in this space."

I-Flow says it continues to believe that Apex, McLaughlin and distributors of the Solace Pump infringe the '481 patent and the company said it would continue to protect its patent and trade secrets in the courts.

I-Flow makes drug delivery systems and surgical products for post-surgical pain relief and surgical site care.