# Indivior PLC Court of Appeals for the Federal Circuit  denied motion to stay issuance of the mandate

- Link: https://www.directorstalkinterviews.com/indivior-plc-court-of-appeals-for-the-federal-circuit-denied-motion-to-stay-issuance-of-the-mandate/412766967
- Published: 2019-02-12T07:23:24+00:00
- Author: Charlotte Edwards

**Indivior PLC** (LON: INDV)  today announced that on February 11, 2019, the U.S.
Court of Appeals for the Federal Circuit  denied Indivior’s motion to stay issuance
of the mandate following the CAFC’s ruling vacating the preliminary injunction (“
PI”) granted against Dr. Reddy’s Laboratories (“DRL”) based on U.S. Patent No. 9,931,305.

In response, Indivior filed an emergency motion to stay the mandate pending resolution
of its forthcoming application for an administrative stay to the Supreme Court of
the United States. That stay, if granted, would have permitted the Supreme Court
time to determine whether to administratively stay the CAFC mandate while it considered
Indivior’s application to stay the mandate pending disposition of a petition for
a writ of certiorari in this case. The CAFC denied that motion on February 11, 2019
and ordered that the mandate issue on February 19, 2019. Indivior will file a petition
to stay the mandate with the Supreme Court of the United States.

After the mandate issues, DRL and Alvogen Pine Brook LLC (“Alvogen”) will no longer
be prevented from selling, offering to sell, or importing their generic buprenorphine/
naloxone sublingual film product. Indivior assumes that DRL and Alvogen will launch
their generic buprenorphine/naloxone sublingual film products in the U.S. as soon
as the mandate is issued by the CAFC. Any DRL and Alvogen generic product sales 
in the U.S. would be on an “at-risk” basis, subject to the outcome of the appeal
of the non-infringement judgments related to U.S. Patent No. 8,603,514, (and US 
8,017,150 in the case of DRL), as well as ongoing litigation in the District of 
New Jersey asserting Orange Book-listed patents U.S. 9,931,305 and US 9,687,454.

SUBOXONE® Film is a prescription medicine indicated for treatment of opioid dependence
and should be used as part of a complete treatment plan to include counseling and
psychosocial support.

**About Opioid Use Disorder (OUD)**

Opioid use disorder (OUD), sometimes referred to as opioid addiction, is a chronic
disease1. According to DSM-5, “OUD is characterized by signs and symptoms that reflect
compulsive, prolonged self-administration of opioid substances that are used for
no legitimate medical purpose or, if another medical condition is present that requires
opioid treatment, they are used in doses greatly in excess of the amount needed 
for that medical condition2.”

Based on 2016 data from the National Survey on Drug Use and Health report, approximately
11.8 million Americans (age 12+ years) engaged in misuse of opioids in the past 
year3. From 1999 to 2016, the rate of deadly prescription opioid overdoses increased
five-fold4. In 2016, an average of 115 people died of opioid overdose each day in
the United States5. In addition, in 2016, 935,000 adults used heroin and approximately
625,000 adults had a heroin use disorder3. In 2015, opioids accounted for 70 percent
of the disease burden associated with drug use disorders worldwide6.

**About Indivior**

Indivior is a global specialty pharmaceutical company with a 20-year legacy of leadership
in patient advocacy and health policy while providing education on evidence-based
treatment models that have revolutionized modern addiction treatment. Our vision
is for all patients around the world to have access to evidence-based treatment 
for the chronic conditions and co-occurring disorders of addiction. The name is 
the fusion of the words individual and endeavor, and the tagline “Focus on you” 
makes the Company’s commitment clear. Indivior is dedicated to transforming addiction
from a global human crisis to a recognized and treated chronic disease. Building
on its global portfolio of opioid dependence treatments, Indivior has a strong pipeline
of product candidates designed to both expand on its heritage in this category and
address other chronic conditions and co-occurring disorders of addiction, including
alcohol use disorder and schizophrenia. Headquartered in the United States in Richmond,
VA, Indivior employs more than 900 individuals globally and its portfolio of products
is available in over 40 countries worldwide. Visit www.indivior.com to learn more.

**Forward-Looking Statements**

This press release contains certain statements that are forward-looking and which
should be considered, amongst other statutory provisions, in light of the safe harbor
provisions of the United States Private Securities Litigation Reform Act of 1995.
By their nature, forward-looking statements involve risk and uncertainty as they
relate to events or circumstances that may or may not occur in the future. Actual
results may differ materially from those expressed or implied in such statements
because they relate to future events. Forward-looking statements include, among 
other things, statements regarding the Indivior Group’s financial guidance for 2018
and its medium- and long-term growth outlook, its operational goals, its product
development pipeline and statements regarding ongoing litigation.

Various factors may cause differences between Indivior’s expectations and actual
results, including: factors affecting sales of Indivior Group’s products; the outcome
of research and development activities; decisions by regulatory authorities regarding
the Indivior Group’s drug applications; the speed with which regulatory authorizations,
pricing approvals and product launches may be achieved; the outcome of post-approval
clinical trials; competitive developments; difficulties or delays in manufacturing;
the impact of existing and future legislation and regulatory provisions on product
exclusivity; trends toward managed care and healthcare cost containment; legislation
or regulatory action affecting pharmaceutical product pricing, reimbursement or 
access; claims and concerns that may arise regarding the safety or efficacy of the
Indivior Group’s products and product candidates; risks related to legal proceedings,
including the ongoing investigative and antitrust litigation matters; the Indivior
Group’s ability to protect its patents and other intellectual property; the outcome
of patent infringement litigation relating to Indivior Group’s products, including
the ongoing ANDA lawsuits; changes in governmental laws and regulations; issues 
related to the outsourcing of certain operational and staff functions to third parties;
uncertainties related to general economic, political, business, industry, regulatory
and market conditions; and the impact of acquisitions, divestitures, restructurings,
internal reorganizations, product recalls and withdrawals and other unusual items.

 

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