Vyvanse® Patents Found to Be Infringed and Valid by U.S. District Court

Lexington, Massachusetts (ots/PRNewswire) -

Shire plc announces that Judge Stanley R. Chesler of the U.S.
District Court for the District of New Jersey granted Shire's summary
judgment motion in a patent infringement lawsuit, holding that
certain claims of the patents protecting Vyvanse(R) (lisdexamfetamine
dimesylate) were both infringed and valid.

The ruling prevents the five pharmaceutical manufacturers (the
ANDA Defendants) who have filed Abbreviated New Drug Applications
(ANDAs) from launching generic versions of Vyvanse until the earlier
of either a successful appeal to the U.S. Court of Appeals for the
Federal Circuit, or the expiration of these patents in 2023. To
appeal successfully, the ANDA Defendants must overturn the Court's
rulings for each of the 18 patent claims.

The Court's summary judgment ruling concerning Shire's motion
included 18 patent claims from four of the FDA Orange Book-listed
patents for Vyvanse, which cover Vyvanse's active ingredient, the
lisdexamfetamine dimesylate compound, and a method of using
lisdexamfetamine dimesylate for the treatment of ADHD.

"We are extremely pleased with the Court's ruling, which affirms
Shire's belief that it has strong patents protecting Vyvanse," said
Flemming Ornskov, MD, Chief Executive Officer for Shire.

Shire's Vyvanse patents expire in 2023 but Shire recently
announced that it has agreed to a Written Request by the Food and
Drug Administration to conduct pediatric clinical studies to
investigate the potential use of Vyvanse for the treatment of
Attention-Deficit/Hyperactivity Disorder (ADHD) in preschool-age
children, ages 4 to 5. Upon FDA confirmation of a timely submission
and review of data that adheres to the requirements of the Written
Request, Shire will be entitled to the benefits of the Best
Pharmaceuticals for Children Act, including a six-month extension to
the exclusivity afforded by Shire's patents for Vyvanse.

Shire's lawsuit is against the five ANDA Defendants that filed
ANDAs with the U.S. Food and Drug Administration (FDA) seeking to
market generic versions of Vyvanse, and their Active Pharmaceutical
Ingredient (API) manufacturer of lisdexamfetamine dimesylate API. The
ANDA Defendants are Actavis LLC/Actavis Elizabeth LLC; Amneal
Pharmaceuticals, LLC; Mylan Pharmaceuticals Inc./Mylan Inc.; Roxane
Laboratories Inc.; and Sandoz Inc. The API manufacturer and supplier
to each of the ANDA Defendants is Johnson Matthey Inc./Johnson
Matthey Pharmaceutical Materials. This lawsuit includes all of the
known ANDAs that are currently pending for Vyvanse.

The Court found that "[t]here is no real dispute about the ANDA
Defendants' direct infringement of the compound claims," Johnson
Matthey "is liable for inducing the ANDA Defendants' direct
infringement of the compound claims," and "the ANDA Defendants have
induced infringement" of a claimed method of treating ADHD. As to
validity, the Court found that "Defendants have not shown that
lisdexamfetamine was disclosed in the prior art" and "Defendants have
failed to point to evidence sufficient to persuade a reasonable jury
that [prior art reference] AU '168 anticipates by disclosing
lisdexamfetamine dimesylate," and "have failed to defeat the motion
for summary judgment regarding invalidity due to obviousness of the
compound patents." Additionally, the Court found that "Defendants
have not offered evidence sufficient to prove [method of treating
ADHD] claim 4 of the '486 patent is invalid due to obviousness or
anticipation."

Shire's summary judgment motion did not include every patent claim
in the litigation and, accordingly, the Court's decision did not
dispose of the litigation in its entirety. In addition to Shire's
motion, the Court also ruled on five summary judgment motions filed
by the defendants. The Court's rulings denied API supplier Johnson
Matthey's motion to dismiss certain indirect infringement claims,
dismissed Shire's willful infringement claims, granted defendants'
motion concerning noninfringement of certain method of use claims,
and denied defendants' two invalidity motions. At this point, the
Court must decide whether to conduct a trial on the remaining patent
claims, or allow the defendants to immediately appeal this ruling to
the Federal Circuit. Shire maintains its belief that it has strong
infringement claims against each of the six defendants for the patent
claims that were not included in Shire's motion, and strongly
believes that the asserted patent claims are valid.

ABOUT Vyvanse(R) (lisdexamfetamine dimesylate)

Information about Vyvanse

Vyvanse is a federally controlled substance (CII) because it can
be abused or lead to dependence. Keep in a safe place to prevent
misuse and abuse. Selling or sharing Vyvanse may harm others and is
illegal.

Vyvanse is indicated for the treatment
Attention-Deficit/Hyperactivity Disorder (ADHD) in patients 6 years
and above. Vyvanse capsules are currently available in six once-daily
dosage strengths of 20mg, 30mg, 40mg, 50mg, 60mg, and 70mg.

ADDITIONAL IMPORTANT SAFETY INFORMATION

- Do not take Vyvanse if you or your child:
- is taking or has taken within the past 14 days an anti-depression medicine
called a monoamine oxidase inhibitor or MAOI
- is sensitive to, allergic to, or had a reaction to other stimulant
medicines
- Some people have had the following problems when taking stimulant
medicines, such as Vyvanse:
- Heart-related problems including:
- sudden death in people who have heart problems or heart defects
- sudden death, stroke and heart attack in adults
- increased blood pressure and heart rate

Tell your doctor if you or your child has any heart problems, heart
defects, high blood pressure, or a family history of these problems. The
doctor should check your or your child's blood pressure and heart rate
regularly during treatment. Call your doctor right away if you or your child
has any signs of heart problems such as chest pain, shortness of breath, or
fainting while taking Vyvanse.
- Mental (psychiatric) problems including:
- new or worse behavior and thought problems
- new or worse bipolar illness
- In Children and Teenagers
- new psychotic symptoms such as:
- seeing things or hearing voices that are not real
- believing things that are not true
- being suspicious
- new manic symptoms

Tell your doctor about any drug abuse, alcohol abuse or mental
problems that you or your child has had, or about a family history of
suicide, bipolar illness, or depression. Call your doctor right away if
you or your child has any new or worsening mental symptoms or problems
while taking Vyvanse.
- Circulation problems in fingers and toes [Peripheral vasculopathy,
including Raynaud's phenomenon]:
- Fingers or toes may feel numb, cool, painful, sensitive

Call your doctor right away if you have or your child has any of
these signs or symptoms or develops unexplained wounds on fingers or
toes while taking Vyvanse.

- Tell the doctor if you or your child is pregnant, breast-feeding, or plans
to become pregnant or breast-feed.
- Vyvanse may cause serious side effects, including:
- slowing of growth (height and weight) in children. Your child should have
his or her height and weight checked often while taking Vyvanse. The doctor may
stop treatment if a problem is found during these check-ups.

The most common side effects reported in studies of Vyvanse were:

- anxiety
- decreased appetite
- diarrhea
- dizziness
- dry mouth
- irritability
- loss of appetite
- nausea
- trouble sleeping
- upper stomach pain
- vomiting
- weight loss

For additional safety information, click here
[http://pi.shirecontent.com/?product=Vyvanse&country=usa&language=eng
] for Prescribing Information and Medication Guide and discuss with
your doctor.

NOTES TO EDITORS

Shire enables people with life-altering conditions to lead better
lives.

Our strategy is to focus on developing and marketing innovative
specialty medicines to meet significant unmet patient needs.

We focus on providing treatments in Neuroscience, Rare Diseases,
Gastrointestinal, and Internal Medicine and we are developing
treatments for symptomatic conditions treated by specialist
physicians in other targeted therapeutic areas, such as
Ophthalmology.

http://www.shire.com

FORWARD - LOOKING STATEMENTS - "SAFE HARBOR" STATEMENT UNDER THE
PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

Statements included in this announcement that are not historical
facts are forward-looking statements. Forward-looking statements
involve a number of risks and uncertainties and are subject to change
at any time. In the event such risks or uncertainties materialize,
Shire's results could be materially adversely affected. The risks and
uncertainties include, but are not limited to, that:

- Shire's products may not be a commercial success;
- revenues from ADDERALL XR are subject to generic erosion and revenues from
INTUNIV will become subject to generic competition starting in December 2014;
- the failure to obtain and maintain reimbursement, or an adequate level of
reimbursement, by third-party payors in a timely manner for Shire's products may
impact future revenues, financial condition and results of operations;
- Shire conducts its own manufacturing operations for certain of its Rare
Diseases products and is reliant on third party contractors to manufacture other
products and to provide goods and services. Some of Shire's products or ingredients
are only available from a single approved source for manufacture. Any disruption to
the supply chain for any of Shire's products may result in the Shire being unable to
continue marketing or developing a product or may result in Shire being unable to do
so on a commercially viable basis for some period of time.
- the development, approval and manufacturing of Shire's products is subject to
extensive oversight by various regulatory agencies. Submission of an application for
regulatory approval of any of our product candidates, such as our planned submission
of a New Drug Application to the FDA for Lifitegrast, may be delayed for any number of
reasons and, once submitted, may be subjected to lengthy review and ultimately
rejected. Moreover, regulatory approvals or interventions associated with changes to
manufacturing sites, ingredients or manufacturing processes could lead to significant
delays, increase in operating costs, lost product sales, an interruption of research
activities or the delay of new product launches;
- the actions of certain customers could affect Shire's ability to sell or
market products profitably. Fluctuations in buying or distribution patterns by such
customers can adversely impact Shire's revenues, financial conditions or results of
operations;
- investigations or enforcement action by regulatory authorities or law
enforcement agencies relating to Shire's activities in the highly regulated markets in
which it operates may result in the distraction of senior management, significant
legal costs and the payment of substantial compensation or fines;
- adverse outcomes in legal matters and other disputes, including Shire's
ability to enforce and defend patents and other intellectual property rights required
for its business, could have a material adverse effect on Shire's revenues, financial
condition or results of operations;
- Shire faces intense competition for highly qualified personnel from other
companies, academic institutions, government entities and other organizations. Shire
is undergoing a corporate reorganization and the consequent uncertainty could
adversely impact Shire's ability to attract and/or retain the highly skilled personnel
needed for Shire to meet its strategic objectives;
- failure to achieve Shire's strategic objectives with respect to the
acquisition of ViroPharma Incorporated may adversely affect Shire's financial
condition and results of operations;

and other risks and uncertainties detailed from time to time in
Shire's filings with the U.S. Securities and Exchange Commission,
including its most recent Annual Report on Form 10-K.

For further information please contact:

Investor Relations
Jeff Poulton, jpoulton@shire.com, +1-781-482-0945
Sarah Elton-Farr, seltonfarr@shire.com, +44(0)1256-894157

Media
Stephanie Fagan, sfagan@shire.com, +1-201-572-9581
Gwen Fisher, gfisher@shire.com, +1-484-595-9836

ots Originaltext: Shire Pharmaceuticals Group Plc
Im Internet recherchierbar: http://www.presseportal.de