This Day On The Street
Continue to site
ADVERTISEMENT
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here

Shire Wins Patent Trial Against Watson Concerning LIALDA®

PHILADELPHIA, May 9, 2013 /PRNewswire/ --

Shire plc (LSE: SHP, NASDAQ: SHPG), announces that its subsidiary, Shire Development LLC, has prevailed in its litigation against Watson Pharmaceuticals Inc., Watson Laboratories, Inc.- Florida, Watson Pharma, Inc. and Watson Laboratories, Inc. (collectively " Watson", now "Actavis") in connection with their Abbreviated New Drug Application ("ANDA") for a generic version of Shire's LIALDA ® (mesalamine) delayed release tablets for the induction of remission in adults with active, mild to moderate ulcerative colitis and for the maintenance of remission of ulcerative colitis.

Following a five day bench trial in the Southern District of Florida, Judge Middlebrooks issued a ruling upholding the validity of the patent covering LIALDA, US Patent No. 6,773,720 (the "'720 patent), and holding that the proposed ANDA formulation infringes the claims of that patent.  Accordingly, Judge Middlebrooks confirmed that Shire is entitled to an injunction, which he will issue separately, which prohibits the FDA from approving the ANDA formulation until the expiration of the '720 patent.

"Shire is very pleased that the court has ruled in our favor.  We rely on our patents to be able to continue to invest in therapies that bring value to our patients and their caregivers.  This ruling supports the innovative therapies that we develop in order to improve the lives of ulcerative colitis patients," stated Roger Adsett, head of Shire's GI Business Unit.

Shire's LIALDA remains the only once-daily mesalamine product indicated for both the induction of remission of mild to moderate ulcerative colitis and for the maintenance of remission of ulcerative colitis.  No ANDA's have been approved for generic versions of LIALDA.

NOTES TO EDITORS

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

1 of 2

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Submit an article to us!
SYM TRADE IT LAST %CHG

Markets

DOW 18,070.40 +46.34 0.26%
S&P 500 2,114.41 +6.12 0.29%
NASDAQ 5,018.37 +12.9790 0.26%

Partners Compare Online Brokers

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs