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® (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® (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
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.
The most common side effects reported in studies of Vyvanse were:
For additional safety information, click here for Prescribing Information and Medication Guide and discuss with your doctor.
For further information please contact:
+1 781 482 0945
+1 484 595 9836
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.
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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:
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.