Federal Appeals Court Rules in Cardium's Favor
Over Boston Scientific and Arch Development
on Patents for the Treatment of Heart Disease
SAN DIEGO, CA – May 11, 2006 – Cardium Therapeutics, Inc. (OTCBB: CDTP) announced that the U.S. Court of Appeals for the Federal Circuit, which oversees appeals in all patent-related matters in the United States, has ruled in Cardium’s favor in a case involving Arch Development Corporation and Arch's licensee, Boston Scientific Corporation. 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 M. Dylan, Chief Business Officer and General Counsel of Cardium Therapeutics. “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-à-vis third parties that have attempted to develop or acquire competing IP rights.”
About the Patents and Patent Proceedings
Cardium Therapeutics is the exclusive licensee of a number of patents and patent
applications of Dr. H. Kirk Hammond and colleagues at the University of California
(UC), which are generally 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. Angina, which is frequently
experienced as chest pain, can severely limit patients' daily activities and
is a disorder that affects millions of adults worldwide.
In the United States and in Europe, Arch Development Corporation (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 also unpatentable in the United States. Arch and
Boston Scientific subsequently appealed from the decisions against them, in both
the U.S. and Europe.
In Europe, as reported on March 29, 2006, a review was conducted by the Technical
Board of Appeal of the European Patent Office at the request of Arch and Boston
Scientific. That review resulted in a decision to dismiss their appeal and to
revoke their corresponding patent grant in Europe.
In the United States, Arch Development 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 (representing the claims in dispute) be awarded to Hammond,
and that Leiden et al. 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 (Federal Circuit), which
is generally responsible for all appeals in patent-related matters. Following
oral arguments, which were held on May 4, 2006, the Federal Circuit has now issued
a unanimous decision affirming the prior ruling in Cardium’s favor that was reached
by the BPAI.
The Federal Circuit Court of Appeals also elected to issue its affirmance without
further written opinion pursuant to Federal Circuit Rule 36, which as described
in the Court’s accompanying notes is generally used only when the losing party “has
utterly failed to raise any issues in the appeal that require an opinion to be
written in support of the court’s judgment of affirmance.” In connection with
the judgment, the Court’s costs are to be borne by the losing party appellant.
As further reflected in the Court’s accompanying notes, petitions for rehearing
are rarely granted by the Federal Circuit, and are normally not considered appropriate
following a Rule 36 summary affirmance by the Court. In addition, while the losing
party remains free to petition to the U.S. Supreme Court for a writ of certiorari,
the Federal Circuit points out that there is no automatic right to such an appeal
from the judgments of the Federal Circuit.
Additional information and case files regarding the U.S. interference proceedings
are currently available from the U.S. Patent and Trademark Office with reference
to patent files 5,792,453, 6,100,242 or 6,174,871, which are assigned to the
Regents of the University of California and exclusively licensed to Cardium Therapeutics;
and from the U.S. Court of Appeals for the Federal Circuit in connection with
the case of Leiden v. Hammond (2006-1023). Additional information and case files
regarding the European Opposition Proceedings are currently available from the
Boards of Appeal of the European Patent Office with reference to Arch Development
Corporation patent file 0 668 913.
About Cardium’s Clinical Development Program
Cardium's approach to the treatment of heart disease (which is claimed in the
above-referenced UC patents and patent applications) 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.
Adenovectors are the most widely-studied DNA delivery vehicles in human clinical
trials; and, in the context of heart disease, angiogenic adenovectors are believed
to be particularly useful as biologics in that they do not integrate into the
human genome but can bind to and remain in the heart for a sufficient period
of time to promote the development of new blood vessels. Adenovectors are also
considered to be significantly more efficient than naked plasmid DNA for gene
transfer; and naturally-occurring biological receptors for adenovectors are believed
to facilitate its binding to a broad area of heart muscle supplied by the infused
coronary circulation. Employing this readily-accessible coronary delivery route
to the myocardium avoids the need for any mechanical devices or approaches that
require entry into the heart chambers or piercing of the surrounding heart muscle,
or that result in delivery and gene expression concentrated along needle tracks
in the injected myocardium.
Cardium's licensed patent claims are applicable to multiple angiogenic DNAs including
VEGFs, FGFs and other DNA sequences capable of promoting angiogenesis. Of these,
the FGF-4 angiogenic DNA employed in Cardium's Generx™ product candidate (which
is separately licensed to Cardium by New York University), was selected as being
advantageous for promoting blood vessel growth in the heart. In particular, FGFs
are believed to activate a number of downstream angiogenic factors, including
VEGFs and related proteins that can contribute to the process of forming stable
blood vessel growth in ischemic areas of need such as oxygen-deprived tissue
downstream of narrow or blocked coronary arteries and/or smaller blood vessels
located within the heart muscle.
While angioplasty and stenting as well as coronary artery bypass graft (CABG)
surgeries can be performed for mechanically opening or surgically bypassing blockages
of the large epicardial blood vessels that surround the myocardium, neither angioplasty
nor CABG are believed to be capable of also addressing blockages or limitations
affecting the mid-sized to smaller blood vessels which are located deeper within
the heart muscle. These deeper blood vessels, which form the underlying coronary “microcirculation,” are
directly responsible for conveying oxygenated blood into close proximity with
the adjacent heart tissue. In addition, microcirculatory impedance or resistance
to flow at the downstream level is believed to contribute substantially to reducing
overall blood flow through the myocardium – which may be a contributory cause
of ischemia in patients with heart disease. In that regard, many patients continue
to experience angina even after surgical and other interventions have been performed
to mechanically open or bypass accessible portions of the large upstream blood
vessels that initially conduct blood flow into the heart.
Cardium's 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. Results from meta-analyses
of the AGENT 3 and AGENT 4 studies, as well as results from the AGENT 2 mechanism-of-action
study (demonstrating positive enhancement of myocardial perfusion (blood flow
to the heart muscle in patients with ischemia), as measured by single-photon
emission computed tomography (SPECT) imaging), are expected to be discussed with
the FDA in preparation for the planned initiation of an AGENT 5 clinical study
of Generx and to be reviewed at one or more upcoming scientific symposia.
About Cardium
Cardium Therapeutics, Inc., founded in 2003 and headquartered in
San Diego, is a medical technology company primarily focused on the development,
manufacture and sale of innovative therapeutic products for the interventional
cardiology market. In October 2005, Cardium acquired a portfolio of cardiovascular
growth factor therapeutics from the Schering AG Group, Germany, including the
later-stage product candidate, Generx™, and completed a $30 million financing.
Generx (alferminogene tadenovec) is a DNA-based growth factor therapeutic being
developed for potential use by interventional cardiologists as a one-time treatment
to promote and stimulate the growth of collateral circulation in the heart of
patients with angina pectoris. As announced in March 2006, Cardium has also acquired
InnerCool Therapies, Inc., a San Diego-based medical technology company in the
emerging field of therapeutic hypothermia, which is designed to rapidly and controllably
cool the body in order to reduce cell death and damage following acute ischemic
events such as cardiac arrest or stroke, and to potentially lessen or prevent
associated injuries such as adverse neurologic outcomes. For more information
about Cardium's InnerCool subsidiary and therapeutic hypothermia, including its
Celsius Control System™, which has now received regulatory clearance in the U.S.,
Europe and Australia, please visit www.innercool.com. For more information about
Cardium and its businesses, products and therapeutic candidates, please visit
www.cardiumthx.com.
Forward-Looking Statements
Except for statements of historical fact, the matters discussed in this press
release are forward looking and reflect numerous assumptions and involve a variety
of risks and uncertainties, many of which are beyond our control and may cause
actual results to differ materially from stated expectations. For example, there
can be no assurance that intellectual property proceedings will be ruled in our
favor, that any rulings in our favor will not be successfully appealed or remanded
for further consideration, that any corresponding patent claims issued will be
enforceable, that third parties will not apply or acquire competing claims that
could potentially dominate one or more aspects of our product candidates or therapeutic
approaches, that clinical trials and other efforts to accelerate the development
of our Generx™ product candidate will be successful, that necessary regulatory
approvals will be obtained, that our actual or proposed products and treatments
will prove to be safe or effective, that third parties on whom we depend will
perform as anticipated, that our products or product candidates will lead to
value enhancing or partnering opportunities, or that we will succeed in enhancing
long-term shareholder value. Actual results may also differ substantially from
those described in or contemplated by this press release due to risks and uncertainties
that exist in our operations and business environment, including, without limitation,
our limited experience in the development of DNA-based cardiovascular therapeutics
and therapeutic hypothermia devices, our dependence upon proprietary technology,
our history of operating losses and accumulated deficits, our reliance on collaborative
relationships and critical personnel, and current and future competition, as
well as other risks described from time to time in filings we make with the Securities
and Exchange Commission. We undertake no obligation to release publicly the results
of any revisions to these forward-looking statements to reflect events or circumstances
arising after the date hereof.
Copyright 2006 Cardium Therapeutics, Inc.
All rights reserved. For Terms of Use, please visit www.cardiumthx.com.
Cardium Therapeutics™ and Generx™ are trademarks of Cardium Therapeutics, Inc.
InnerCool Therapies®, Innercool®, and Celsius Control System™ are trademarks
of InnerCool Therapies, Inc.
Source: Cardium Therapeutics, Inc. |
