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

June 25, 2014

LEXINGTON, Massachusetts, June 25, 2014 /PRNewswire/ –

Shire plc (LSE: SHP, NASDAQ: SHPG) 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.


        - 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
        - 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.


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.



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
        - 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

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

SOURCE Shire plc

Source: PR Newswire

comments powered by Disqus