Shockwave Announces Decisions From the U.S. Patent and Trademark Office on Inter Partes Review Proceeding
July 08 2020 - 4:33PM
Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the
development of Intravascular Lithotripsy (IVL) to treat complex
calcified cardiovascular disease, announced today that the company
received the initial rulings related to two of the inter partes
review (IPR) cases that were initiated by Cardiovascular Systems,
Inc. (CSI).
In December 2018, CSI filed petitions for IPR with the Patent
Trial and Appeal Board (PTAB) of the U.S. Patent Office (USPTO) to
challenge the validity of three of Shockwave’s issued patents. CSI
asked the PTAB to reconsider the original decision of the USPTO to
issue those patents and asked that all claims of each patent be
invalidated.
The PTAB ruled today that a key claim in U.S. Patent No
8,956,371 (the ‘371 patent) is valid. This claim is generally
directed to a device that creates shockwaves inside of a balloon
catheter that is delivered over a guidewire.
Further, the PTAB ruled today that some claims of the U.S.
Patent No 8,956,371 are invalid and that all claims of U.S. Patent
No 8,728,091 (the ‘091 patent) are invalid. Shockwave does
not agree with the ruling that these claims are invalid. The
IPR decisions are appealable to the U.S. Court of Appeals for the
Federal Circuit, and Shockwave remains committed to prosecuting and
protecting its patent portfolio to the fullest extent possible.
All claims of the ‘371 and the ‘091 patents remain valid and
enforceable until appeals have been exhausted and Shockwave is not
prohibited from selling or continuing to develop its IVL
technologies.
“We are very pleased that the court validated claim 5 of our
‘371 patent, which protects the broad embodiment of our IVL
technologies. Specifically, claim 5 describes a device that
is delivered over a guidewire and generates shockwaves with
electrodes inside of a balloon catheter. We believe that any
viable, much less commercially viable, IVL device must contain
these elements,” stated Doug Godshall, President and Chief
Executive Officer of Shockwave Medical. “While we disagree with the
other invalidity findings of the PTAB, we believe we have strong
arguments supporting the validity of all claims of both our ‘371
and our ‘091 patents and we intend to appeal this decision with the
expectation that we will prevail in our appeal. We believe that our
robust portfolio of 40 issued U.S. patents and 50 issued foreign
patents captures and protects the truly unique and sophisticated
IVL technology that has already helped over 30,000 patients with
severely calcified arteries. Our business and pipeline remain
compelling, our customer support is strong, and we remain highly
committed to the continued advancement of IVL as a treatment for
calcified cardiovascular disease.”
Documents related to the IPR can be accessed on the USPTO’s
website at the following link:
https://developer.uspto.gov/ptab-web/#/search/documents
About Shockwave Medical, Inc.
Shockwave Medical is focused on developing and commercializing
products intended to transform the way calcified cardiovascular
disease is treated. We aim to establish a new standard of care for
the interventional treatment of atherosclerotic cardiovascular
disease through our differentiated and proprietary local delivery
of sonic pressure waves for the treatment of calcified plaque,
which we refer to as Intravascular Lithotripsy (IVL). IVL is a
minimally invasive, easy-to-use and safe way to significantly
improve patient outcomes. To view an animation of the IVL procedure
and for more information, visit www.shockwavemedical.com.
Forward-Looking Statements.
This press release contains statements relating to Shockwave’s
expectations, projections, beliefs, and prospects (including
statements regarding Shockwave’s product development outlook),
which are “forward-looking statements” within the meaning of the
federal securities laws and by their nature are uncertain. Words
such as “believe,” “may,” “will,” “estimate,” “continue,”
“anticipate,” “intend,” “expect,” “plans,” and similar expressions
are intended to identify forward-looking statements. Such
forward-looking statements are not guarantees of future
performance, and you are cautioned not to place undue reliance on
these forward-looking statements. Our business and operations are
subject to a variety of risks and uncertainties and, consequently,
actual results may differ materially from those projected by any
forward-looking statements. Factors that could cause actual results
to differ from those projected include, but are not limited to: the
impact of the COVID-19 pandemic on our operations,
financial results, and liquidity and capital resources, including
on sales, expenses, supply chain, manufacturing, research and
development activities, clinical trials and employees; our ability
to design, develop, manufacture and market innovative products to
treat patients with challenging medical conditions, particularly in
peripheral artery disease, coronary artery disease and aortic
stenosis; our expected future growth, including growth in
international sales; the size and growth potential of the markets
for our products, and our ability to serve those markets; the rate
and degree of market acceptance of our products; coverage and
reimbursement for procedures performed using our products; the
performance of third parties in connection with the development of
our products, including third-party suppliers; regulatory
developments in the United States and foreign countries; our
ability to obtain and maintain regulatory approval or clearance of
our products on expected timelines; our plans to research, develop
and commercialize our products and any other approved or cleared
product; our ability to scale our organizational culture of
cooperative product development and commercial execution; the
development, regulatory approval, efficacy and commercialization of
competing products; the loss of key scientific or management
personnel; our expectations regarding the period during which we
qualify as an emerging growth company under the JOBS Act; our
ability to develop and maintain our corporate infrastructure,
including our internal controls; our financial performance and
capital requirements; and our expectations regarding our ability to
obtain and maintain intellectual property protection for our
products, as well as our ability to operate our business without
infringing the intellectual property rights of others. These risks
and uncertainties, as well as others, are discussed in greater
detail in our filings with the Securities and Exchange Commission
(SEC), including in Part I, Item IA - Risk Factors in our most
recent Annual Report on Form 10-K filed with the SEC, and in our
other periodic and other reports filed with the SEC. There may be
additional risks of which we are not presently aware or that we
currently believe are immaterial which could have an adverse impact
on our business. Any forward-looking statements are based on our
current expectations, estimates and assumptions regarding future
events and are applicable only as of the dates of such statements.
We make no commitment to revise or update any forward-looking
statements in order to reflect events or circumstances that may
change.
Media Contact: Scott Shadiow
+1.317.432.9210sshadiow@shockwavemedical.com
Investor Contact:Debbie Kasterinvestors@shockwavemedical.com
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