A Medical Device Daily

Cardium Therapeutics (San Diego) reported that the U.S. Court of Appeals for the Federal Circuit, which oversees appeals in all patent-related matters in the European Union, has ruled in Cardium's favor in a case involving Arch Development and Arch's licensee, Boston Scientific (Natick, Massachusetts).

The appeal was brought by Arch and Boston Scientific after the Board of Patent Appeals and Interferences had ruled against them with respect to a series of patents and patent applications related to angiogenic treatments for coronary heart disease, including myocardial ischemia and angina.

“The completion of these important reviews of our intellectual property position, and consistent decisions in our favor, serves to underscore the value of our patent portfolio, which we believe reflects a best-in-class approach to the treatment of coronary heart disease,” said Dr. Tyler Dylan, chief business officer and general counsel of Cardium. “Having the U.S. Court of Appeals for the Federal Circuit grant a unanimous summary affirmance further confirms our belief in the strength of our position vis-a-vis third parties that have attempted to develop or acquire competing IP rights.”

Cardium is the exclusive licensee of a number of patents and patent applications of Dr. H. Kirk Hammond and colleagues at the University of California , directed to the intracoronary administration of adenovectors comprising angiogenic genes for the treatment of coronary heart disease and related conditions such as myocardial ischemia and angina.

In the U.S. and in Europe, Arch, an affiliate of the University of Chicago , and its licensee Boston Scientific pursued patent claims similar to those licensed to Cardium based on a patent application of Dr. Jeffrey Leiden et al. Following reviews by examiners and administrative patent judges, the claims being pursued by Arch and Boston Scientific were declared unpatentable in Europe and in the U.S. Arch and Boston Sci subsequently appealed from both decisions against them.

In Europe, a review was conducted by the Technical Board of Appeal of the European Patent Office at the request of Arch and Boston Sci, resulting in a decision to dismiss their appeal and to revoke their corresponding European patent grant.

In the U.S., Arch and Boston Scientific had used related patent applications by Leiden et al. that were not yet issued to “copy” claims from three U.S. patents granted to the University of California, which are exclusively licensed to Cardium. An interference proceeding to determine priority of inventorship was then initiated by the U.S. Patent and Trademark Office.

Following submissions of evidence from both sides and a review conducted by the U.S. Board of Patent Appeals and Interferences (BPAI), a panel of administrative patent judges reached a decision on preliminary motions ordering that the Leiden applicants be denied the benefit of their priority applications, that the interference be re-declared to reflect Hammond's status as the “senior” or earlier party, and that Hammond be granted a motion that the Leiden claims are unpatentable over the prior art, including the Hammond applications. The BPAI then issued an Order to Show Cause, directing the Leiden applicants to demonstrate how they could prevail on the issue of priority of invention over Hammond.

Following Leiden's response, the BPAI entered a final judgment against the Leiden applicants ordering that the interference count be awarded to Hammond, and that the Leiden applicants be held not entitled to any patent containing claims corresponding to those in the interference.

Arch and Boston Scientific subsequently appealed from the decision against them to the U.S. Court of Appeals for the Federal Circuit. Following briefing by both sides and oral arguments, the Federal Circuit has now issued a unanimous decision affirming the prior ruling in Cardium's favor that was reached by the BPAI.

Cardium's approach to the treatment of heart disease uses a standard cardiac catheter to gradually infuse an angiogenic adenovector into the coronary circulation. The intracoronary route of delivery is not only readily accessible from outside of the heart but it 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. Cardiac infusion catheters and the intracoronary delivery route are also beneficial because they are routinely used by cardiologists for performing standard diagnostic procedures such as angiography.

Cardium says that its licensed patent claims are applicable to multiple angiogenic DNAs including VEGFs, FGFs and other DNA sequences capable of promoting angiogenesis. Its therapeutic approach to the treatment of heart disease has been the focus of the most widely-conducted clinical studies for Angiogenic Gene Therapy (AGENT 1 through AGENT 4), which to date have involved 663 patients and more than one hundred U.S., European and other medical centers.