HERTFORDSHIRE, England and
PITTSBURGH, May 29, 2020 /PRNewswire/ -- Mylan
N.V. (NASDAQ: MYL) today announced that the U.S. Patent and
Trademark Appeal Board (PTAB) has ruled in favor of Mylan in inter
partes review (IPR) proceedings finding all challenged claims of
Sanofi's Lantus® SoloSTAR® device patents, U.S. Patent Nos.
8,603,044, 8,992,486, and 9,526,844 unpatentable. The PTAB found
three claims of the 9,604,008 patent unpatentable, and two claims
to be patentable. However, Mylan has previously obtained a covenant
not to sue from Sanofi on the '008 patent and therefore this ruling
does not impact Mylan's ability to launch upon final approval from
the U.S. Food and Drug Administration. The PTAB also found Sanofi's
proposed amended claims for the '486 and '844 patents
unpatentable.
Mylan CEO Heather
Bresch commented, "Today's decision by the U.S. Patent
and Trademark Appeal Board invalidating Sanofi's Lantus device
patents is another significant milestone clearing the pathway for
our insulin glargine product Semglee to come to market for the
millions of Americans living with diabetes. We're pleased with the
PTAB's decision, which will help bring competition to the
marketplace and should reduce the cost of this critical medication.
Today's decision is likely the final defeat of Sanofi's attempts to
prevent generic competition. With this final victory in hand,
we now look forward to working with FDA to complete the regulatory
review process and introduce Semglee in the U.S. as soon as
possible."
Mylan President Rajiv Malik added, "We have always
maintained that the science behind this product, and Mylan's
overall capabilities in bringing complex, higher value chain
products to the market, is a cornerstone of the strength and
foundation of the future growth of our company. While we remain on
track to launch Semglee following FDA approval, we will continue to
explore all pathways of interchangeability for both dosage forms to
achieve the broadest level of access possible for patients in the
U.S. and around the world."
Last month, the PTAB invalidated the sole challenged claim of
another Lantus SoloSTAR device patent, U.S. Patent No. 8,679,069,
and, in March, Mylan announced that the U.S. District Court of
New Jersey found the asserted
claims of the '844 patent not infringed by Mylan's insulin glargine
product and invalid for lack of written description. Sanofi's
formulation patents (U.S. Patent Nos. 7,476,652 and 7,713,930) were
previously affirmed to be invalid by the Federal Circuit. The '844
and '652 patents are the only remaining patents asserted by Sanofi
against Mylan's insulin glargine products.
Lantus is a long-acting insulin used to treat adults with type 2
diabetes and adults and pediatric patients with type 1 diabetes for
the control of high blood sugar. Mylan's 505(b)(2) New Drug
Application (NDA) is under active review by the U.S. Food and Drug
Administration.
Sanofi sells the product in vials (Lantus) and as a disposable
injection pen (Lantus SoloSTAR®).
Sanofi's total IQVIA sales for the 12 months ending March 31, 2020, were approximately $1.71 billion for Lantus 100 Units/mL and about
$4.32 billion for Lantus
SoloSTAR.
About Mylan
Mylan is a global pharmaceutical company
committed to setting new standards in healthcare. Working together
around the world to provide 7 billion people access to high quality
medicine, we innovate to satisfy unmet needs; make reliability and
service excellence a habit; do what's right, not what's easy; and
impact the future through passionate global leadership. We offer a
portfolio of more than 7,500 marketed products around the world,
including antiretroviral therapies on which approximately 40% of
people being treated for HIV/AIDS globally depend. We market our
products in more than 165 countries and territories. We are one of
the world's largest producers of active pharmaceutical ingredients.
Every member of our approximately 35,000-strong workforce is
dedicated to creating better health for a better world, one person
at a time. Learn more at Mylan.com. We routinely post information
that may be important to investors on our website at
investor.mylan.com.
Forward-Looking Statements
This press release
includes statements that constitute "forward-looking statements,"
including with regard to the outcome of litigation; the timing of
regulatory approvals; that Mylan is prepared to bring its insulin
glargine products to market after FDA approval; that Mylan has
previously obtained a covenant not to sue from Sanofi on the '008
patent and therefore this ruling does not impact Mylan's ability to
launch upon final approval from the U.S. Food and Drug
Administration; that today's decision by the U.S. Patent and
Trademark Appeal Board invalidating Sanofi's Lantus device patents
is another significant milestone clearing the pathway for our
insulin glargine product, Semglee™, to come to market for the
millions of Americans living with diabetes; Mylan is pleased with
the PTAB's decision, which will help bring competition to the
marketplace and should reduce the cost of this critical medication;
today's decision is likely the final defeat of Sanofi's attempts to
prevent generic competition; with this final victory in hand, we
now look forward to working with FDA to complete the regulatory
review process and introduce Semglee in the U.S. as soon as
possible; we have always maintained that the science behind this
product, and Mylan's overall capabilities in bringing complex,
higher value chain products to the market, is a cornerstone of the
strength and foundation of the future growth of our company; and
while we remain on track to launch Semglee following FDA approval,
we will continue to explore all pathways of interchangeability for
both dosage forms to achieve the broadest level of access possible
for patients in the U.S. and around the world. Because
forward-looking statements inherently involve risks and
uncertainties, actual future results may differ materially from
those expressed or implied by such statements. Factors that could
cause or contribute to such differences include, but are not
limited to the potential widespread and highly uncertain impact of
public health outbreaks, epidemics and pandemics, such as the
COVID-19 pandemic; any changes in, interruptions to, or
difficulties with Mylan's or its partners' ability to develop,
manufacture, and commercialize products; the effect of any changes
in Mylan's or its partners' customer and supplier relationships and
customer purchasing patterns; other changes in third-party
relationships; the impact of competition; changes in the economic
and financial conditions of the businesses of Mylan or its
partners; the scope, timing, and outcome of any ongoing legal
proceedings and the impact of any such proceedings on Mylan's or
its partners' business; any regulatory, legal, or other impediments
to Mylan's or its partners' ability to bring products to market;
actions and decisions of healthcare and pharmaceutical regulators,
and changes in healthcare and pharmaceutical laws and regulations,
in the United States and abroad;
Mylan's and its partners' ability to protect intellectual property
and preserve intellectual property rights; risks associated with
international operations; other uncertainties and matters beyond
the control of management; and the other risks detailed in Mylan's
filings with the Securities and Exchange Commission. Mylan
undertakes no obligation to update these statements for revisions
or changes after the date of this release.
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SOURCE Mylan N.V.