Catheter Connections, a start-up company co-founded by nurses seeking to reduce deadly hospital-acquired bloodstream infections, announced today the issuance of U.S. Patent Number 8,343,112. This is the sixth patent issued to the Company in a portfolio that broadly covers its DualCap® technology for disinfecting IV connectors ─ technology which helps protect hospital patients from deadly infections.
The Company has the only granted U.S. patents for protecting and disinfecting "male luer" connectors, which are the connectors used to connect IV tubing lines to IV catheters. In its mission to save patient lives, Catheter Connections conceived, developed, manufactures and markets the DualCap System™, which includes DualCap® ─ the first 510(k) cleared medical device that disinfects male luer connectors, killing the microorganisms known to cause bloodstream infections and protecting the connectors from contamination.
The Company has pending lawsuits against Ivera Medical Corporation ("Ivera") in the U.S. District Court of Utah, Central Division, where it accuses Ivera of infringing some of its patents, unfair competition, deceptive practices and false advertising related to the marketing of Ivera's male luer disinfectant cap.
Ivera has a history of filing suits against its competitors ─ Excelsior Medical Corporation, Hospira, Inc., and Catheter Connections ─ and has patent infringement suits pending against each in the U.S. District Court for the Southern District of California. While the California Court recently denied a request to stay these suits without prejudice to filing the request again, the stay has no impact upon the pending inter partes reexaminations in which the United States Patent and Trademark Office ("USPTO") has rejected each of Ivera's patent claims for which reexamination was requested. The Court has not examined the merits of Ivera's suits and by denying the stay it did not make any comment about whether the USPTO will invalidate the contested patent claims.
The USPTO sometimes makes mistakes and issues a patent that should not have been granted in the first place. Because these mistakes happen an "inter partes reexamination" procedure was created, which allows a third party to challenge the validity of an issued patent. Reexamination of Ivera's patents was granted by the USPTO on the basis that there was a reasonable likelihood the challenger would prevail with respect to at least one claim challenged in the request for reexamination. Subsequently, the USPTO has issued office actions rejecting all of the contested claims.
"We are confident that the USPTO will not reverse itself on the rejection of Ivera's claims, as statistics published by the USPTO show that once it has granted an inter partes reexamination and rejected claims, 89% of the time the patent ends up with rejected or changed claims. Moreover, in the response Ivera filed with the USPTO, it did not amend any of the rejected claims. Thus we expect the rejections will be confirmed," said Vicki Farrar, Esq., CEO of Catheter Connections. "Hospitals are rapidly gaining an understanding of the importance of increasing patient safety by protecting the male luer from contamination. Being the only company that has issued patents protecting devices which disinfect male luer connectors, we are in a strong position to provide hospitals with the complete solution they are seeking to help reduce IV catheter-related bloodstream infections. We are vigorously defending our intellectual property and will not stand by and let others exploit our efforts of bringing this life-saving technology to the public."