A Medical Device Daily

Cardium Therapeutics (San Diego) reported that it has won a patent decision vs. Arch Development and Arch's licensee, Boston Scientific (Natick, Massachusetts), in proceedings in the U.S. and Europe.

Arch Development (an affiliate of the University of Chicago ) and Boston Scientific had pursued patent claims similar to those licensed to Cardium, based on a patent application of Dr. Jeffrey Leiden and others. Following reviews by examiners and administrative patent judges, the claims being pursued by Arch and Boston Scientific have been declared unpatentable in both regions, Cardium said.

It added that the ruling served to distinguish its approach to the treatment of coronary heart disease from competitive techniques such as those being utilized by Corautus Genetics (Atlanta), which has a collaboration agreement with Boston Scientific.

Cardium is the licensee of patents and patent applications of Dr. H. Kirk Hammond and colleagues at the University of California (Berkeley), generally focused on the intracoronary administration of adenovectors comprising angiogenic genes for the treatment of coronary heart disease and related conditions such as myocardial ischemia and angina.

Dr. Tyler Dylan, chief business officer and general counsel of Cardium, said, “We believe that our approach to treating angina by infusing angiogenic adenovectors to trigger the growth of new blood vessels in the heart represents a best-in-class technique.“

Cardium's approach to the treatment of heart disease (claimed in the patents in dispute) uses a standard cardiac catheter to gradually infuse an angiogenic adenovector into the coronary circulation. “The intracoronary route of delivery is readily accessible from outside of the heart and directly supplies the underlying heart muscle as well as the coronary endothelium, to which adenovectors can bind and from which blood vessels grow in the process of angiogenesis,“ Cardium said.

It said that Corautus, Boston Scientific's collaborator for angiogenic gene therapy, has been following an alternate approach for delivering genes to the heart using a “naked“ plasmid DNA vector in which the plasmid is mechanically injected from inside the heart chamber, or chambers, outward into the surrounding muscle using multiple injections. The approach relies upon a needle-deploying device, the Stiletto system, supplied by Boston Scientific, and an angiogenic gene (VEGF-2), which was licensed to Corautus by Human Genome Sciences (Rockville, Maryland).

The company also noted that earlier this month Corautus suspended a trial using its technique, as a result of several serious adverse events of pericardial effusion, though these were not related to its use of VEGF-2 (Medical Device Daily, March 15, 2006).

In other legalities:

• DexCom (San Diego), the recent winner of FDA approval for a continuous glucose monitoring system, reported that the U.S. Patent and Trademark Office has granted its requests for reexamination of four patents owned by Abbott Diabetes Care (Almeda, California).

The patents in question were acquired by Abbott in its 2004 acquisition of TheraSense (Almeda) and currently serve as the basis of a patent infringement claim filed by Abbott vs. DexCom in the U.S. District Court for the District of Delaware.

DexCom filed a request to reexamine U.S. patent No. 6,565,509 on Jan. 25, and it filed requests to reexamine U.S. patent nos. 6,175,752; 6,329,161 and 6,284,478 on Feb. 1.

DexCom said its reexamination requests are based on prior art patents and publications – “many of which, it said, were not considered during the U.S. patent office's initial review of the applications that resulted in the four patents – that may render the claims of Abbott's patents invalid under U.S. patent laws.“

In granting the reexamination, the USPTO determined that the prior art cited by DexCom raised “substantial new questions of patentability“ as to all four asserted patents.

• Another in a series of class action lawsuits has been filed vs. PainCare Holdings (Orlando, Florida) and certain of its officers in the U.S. District Court for the Middle District of Florida, for the class period Aug. 27, 2002, through March 15.

The suit alleges material overstatements of the organization's financial results, a resultant investigation by the Securities and Exchange Commission and its restatement of financial results for FY2000 and FY05. Reports of these events resulted in a 13% decline in the company's stock price on March 15.

The suit was filed by the firm of Klafter & Olsen (Washington).

• Medtronic (Minneapolis) in a statement acknowledged the recent decision by the Delaware District Court judge who ruled on post-trial motions by both Medtronic and Cordis (Miami Lakes, Florida), a subsidiary of Johnson & Johnson (New Brunswick, New Jersey), in a patent infringement case known as Palmaz I that involves stent products no longer manufactured by Medtronic.

The judge denied Cordis' motion to reinstate a prior damages verdict made in 2000 and ruled that the issue of damages will be deferred until all liability issues are determined through appeal. The court also denied Medtronic's post-trial motion for a new trial, a ruling that Medtronic intends to appeal.

Medtronic said that the decision “has no bearing on the arbitration decision in Medtronic's favor announced last week, in a case involving Medtronic and Cordis known as Palmaz II. It also does not affect the actions that Medtronic announced . . . regarding a patent infringement lawsuit filed against Guidant in Ireland.“

The Palmaz I case involves the Medtronic Microstent II, GFX and GFX II stents. These products were found to infringe two Cordis patents commonly known as the '762 and '984 patents. The Cordis '984 patent is currently under re-examination by the U.S. Patent and Trademark Office due to “substantial new questions of patentability“ that have arisen concerning this patent.