Navigation Links
Shire Files Lawsuit Against Natco Pharma for Infringement of FOSRENOL(R) (lanthanum carbonate) Patents
Date:4/2/2009

PHILADELPHIA, April 2 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY) announces that it has filed a lawsuit in the U.S. District Court for the Southern District of New York against Natco Pharma Limited ("Natco") for infringement of two of Shire's patents: U.S. Patent No. 5,968,976 ("'976 Patent"); and U.S. Patent No. 7,381,428 ("'428 Patent");

The lawsuit was filed in response to an ANDA (Abbreviated New Drug Application) filed by Natco seeking FDA approval to market and sell generic versions of Shire's 500 mg, 750 mg, and 1 g FOSRENOL(R) (Lanthanum Carbonate) products.

Under the Hatch-Waxman Act, because Shire filed its patent infringement lawsuit within 45 days of receiving Natco's Paragraph IV notification letter, the FDA must refrain from approving Natco's ANDA for 30 months, or until a district court decision finding that the patents are invalid or not infringed, whichever occurs earlier. The stay on generic approval will expire on April 26, 2012 unless terminated earlier.

Shire has asserted the '976 and '428 patents based upon information provided to it by Natco. Shire will continue to evaluate the situation throughout the litigation and will take all necessary actions to protect its rights to the fullest extent possible. Shire has a robust patent estate and is confident that it will protect the FOSRENOL franchise.

Shire Plc

Shire's strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on attention deficit hyperactivity disorder (ADHD), human genetic therapies (HGT) and gastrointestinal (GI) diseases as well as opportunities in other therapeutic areas to the extent they arise through acquisitions. Shire's in-licensing, merger and acquisition efforts are focused on products in specialist markets with strong intellectual property protection and global rights. Shire believes that a carefully selected and balanced portfolio of products with strategically aligned and relatively small-scale sales forces will deliver strong results.

For further information on Shire, please visit the Company's website: http://www.shire.com.

"SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

Statements included herein that are not historical facts are forward-looking statements. Such 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, the Company's results could be materially adversely affected. The risks and uncertainties include, but are not limited to, risks associated with: the inherent uncertainty of research, development, approval, reimbursement, manufacturing and commercialization of the Company's Specialty Pharmaceutical and Human Genetic Therapies products, as well as the ability to secure and integrate new products for commercialization and/or development; government regulation of the Company's products; the Company's ability to manufacture its products in sufficient quantities to meet demand; the impact of competitive therapies on the Company's products; the Company's ability to register, maintain and enforce patents and other intellectual property rights relating to its products; the Company's ability to obtain and maintain government and other third-party reimbursement for its products; and other risks and uncertainties detailed from time to time in the Company's filings with the Securities and Exchange Commission.


'/>"/>
SOURCE Shire Plc
Copyright©2009 PR Newswire.
All rights reserved

Related biology technology :

1. Shire Appoints Sylvie Gregoire President of Human Genetic Therapies Business
2. Shires ELAPRASE(R) (idursulfase) Approved in Japan for the Treatment of Hunter Syndrome
3. Shire Divests Non-Core Product Portfolio to Almirall
4. Correction: Shire plc: Third Quarter 2007 results date notification November 1, 2007
5. David Mott Appointed Non Executive Director at Shire
6. Shire plc: Board Changes
7. Alba Therapeutics Corporation and Shire plc Enter Into $325 Million ex-US, ex-Japan Licensing Agreement to Develop and Commercialize AT-1001
8. Shire Expands its Gastrointestinal Portfolio Through In-Licensing Celiac Disease Phase 2 Product From Alba Therapeutics Corporation
9. FDA Approves Additional Dosage Strengths of Shires ADHD Treatment VYVANSE(TM) (lisdexamfetamine dimesylate) Which May Help Physicians Tailor Treatment for Individual Patients
10. Texas Boy Receives Wheelchair From New Hampshire Couples Recently Deceased Granddaughter
11. Shire Engages Palio
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/21/2017)... CA (PRWEB) , ... May 19, 2017 , ... ... annual meeting and educational conference of the American Association of Bioanalysts (AAB) and ... Galleria Hotel in Houston. The conference reinforces AAB’s commitment to excellence in clinical ...
(Date:5/18/2017)... (PRWEB) , ... May 18, 2017 , ... ... procedure on April 28, 2017 at the Prince Of Wales Private Hospital. The ... disc at level C6-C7. The patient failed conservative treatments prior to undergoing surgery. ...
(Date:5/18/2017)... ... May 17, 2017 , ... ... expertise, and further enhances its scientific power by providing investigators access to ... has agreed to join the scientific advisory board. “We are committed to ...
(Date:5/18/2017)... ... 17, 2017 , ... G-CON Manufacturing, Inc., the leader in ... Jornitz, was recognized as a Top 10 Industry Influencer on The Medicine Maker’s ... bettering the pharma industry and bringing life-changing medicines to market” across four categories. ...
Breaking Biology Technology:
(Date:4/5/2017)... , April 4, 2017 KEY FINDINGS ... anticipated to expand at a CAGR of 25.76% during ... diseases is the primary factor for the growth of ... report: https://www.reportbuyer.com/product/4807905/ MARKET INSIGHTS The global ... product, technology, application, and geography. The stem cell market ...
(Date:3/30/2017)... 30, 2017 The research team of The ... (3D) fingerprint identification by adopting ground breaking 3D fingerprint minutiae recovery ... of speed and accuracy for use in identification, crime investigation, immigration ... ... A research team ...
(Date:3/27/2017)... , March 27, 2017  Catholic Health Services ... Management Systems Society (HIMSS) Analytics for achieving Stage ... Model sm . In addition, CHS previously earned ... hospitals using an electronic medical record (EMR). ... high level of EMR usage in an outpatient ...
Breaking Biology News(10 mins):