A Medical Device Daily

A federal judge last week overturned a patent infringement lawsuit that does not seem to have set any resounding precedents for future legal scholars to scrutinize, but the decision seems to suggest that a claim of infringement had better involve devices that at least look somewhat alike in order to survive an appeal.

In an Oct. 2 decision, a majority of judges in the U.S. Court of Appeals for the Federal Circuit in Washington kicked back to a lower court a suit filed against Datascope (Montvale, New Jersey) by Johns Hopkins University (Baltimore) and Arrow International (Reading, Pennsylvania) over a device used to fragment blood clots during dialysis procedures.

Writing for the 2-1 majority, Judge Rya Zobel wrote that the jury's finding of infringement in the first trial "was not supported by substantial evidence," citing contradictory testimony offered by an expert witness hired by the plaintiff.

The lower court had awarded about $460,000 to Arrow and about $230,000 to Hopkins as a result of the jury's verdict.

According to court documents, Hopkins was the owner and Arrow the licensee of a trio of patents for a "percutaneous mechanical fragmentation catheter system" involving "a fragmentation cage or basket at the distal end of the catheter [that] expands to conform to the inner lumen of the vascular conduit." Upon deployment, the device's "fragmentation cage is rotated at a speed high enough to homogenize the thrombotic material obstructing the vascular conduit."

Datascope, which was defending its ProLumen product, argued that its device was not identical by pointing out that the ProLumen "uses a single S' shaped wire, which is rotated to break up thrombotic material." In her opinion, Zobel wrote that the plaintiff's case was based partly on the requirement of the lawsuit that the debris-removing part of the device "expand to conform" to the geometry of the blood vessel prior to rotating to debride the blockage.

An expert who testified on behalf of the plaintiffs is said to have confirmed during cross examination in the lower court case that the S-shaped wire used by Datascope's device was in contact with the blood vessel wall at "two and only two" contact points, even while rotating. However, the expert witness apparently also stated during the trial that the ProLumen fills "the lumen in all three dimensions around the circumference" while describing a video presentation on the ProLumen.

Zobel wrote that the expert's testimony that the ProLumen "remains in contact with the inner lumen in three dimensions along its length and width is incredible because it is impossible for use of this device to meet this limitation." She also mentions the expert's "contradictory testimony."

As a consequence, the court vacated the lower court's determination that Datascope's motion for judgment as a matter of law (JMOL, essentially a dismissal of the case) was invalid. Zobel wrote: "Because the jury's finding of infringement was not supported by substantial evidence, we reverse the court's denial of Datascope's motion for JMOL of non-infringement and remand to the district court for entry of a final judgment in favor of Datascope consistent with this opinion."

NIH microbiome project moves forward

The National Institutes of Health said earlier this week that it had made a number of awards for its Human Microbiome Project, a five-year project designed to explore how "complex communities of microbes interact with the human body to influence health and disease," according to the Oct. 7 statement.

NIH indicated that the program's total funding could run as high as $21 million and that the first run of work is aimed at sequencing the genomes of 600 microbial life forms. Other sources will round out the database to more than 1,000 microbial genomes.

The human microbiome is made up of all the DNA in the various microorganisms present "in or on the human body," the statement notes. Once all the DNA is sequenced, volunteers will be sampled for the presence of the microbiologicals to assess their impact on the subject's health.

The job will need at least a few new weapons, according to the statement. Alan Krensky, MD, director of the Office of Portfolio Analysis and Strategic Initiatives at NIH, said computation tools will have to be sharpened in order to get the job done. "An exceptional amount of information will be generated by this project and we need robust technologies and analytical tools that are equal to the task."

Among the grants already made is one to David Relman, MD, of Stanford University (Stanford, California) to the tune of $1.6 million in pursuit of optimization of a microfluidic device for single bacterial cell genomics. Andre Marziali, PhD, of Boreal Genomics (North Vancouver, British Columbia) snared an award of almost $800,000 to develop technology that will extract DNA to normalize species representation.

Congress offers Red Cross $100 million

Congress has decided to respond in the affirmative to a recent appeal by American Red Cross (Washington), but not to the extent that the independent charitable organization initially requested.

Wire service reports indicate that Red Cross asked Congress for $150 million in September to shore up the organization's finances after a difficult couple of years that included several hurricanes that slammed into the U.S. coast of the Gulf of Mexico, including this year's hurricanes Ike and Gustav. Congress responded with a promise of $100 million, and the praise heaped upon the organization is said to have taken Red Cross officials quite by surprise.

Gail McGovern, the organization's president, is quoted as having said she "crawled around on my hands and knees begging" Congress for help and apparently was greeted with warm thanks by the senators and representatives she visited. "I really was stunned with how pleased Congress was with how we were performing, particularly in the post-Katrina world," McGovern said.