SNY » Topics » • Allegra Patent Litigation

This excerpt taken from the SNY 20-F filed Mar 4, 2009.

•  Allegra® Patent Litigation

 

United States. Sanofi-aventis has been engaged in patent infringement actions concerning Allegra® since the first ANDA referring to this product was submitted to the FDA in 2001. In 2005, Barr Laboratories Inc. and Teva launched a generic version of Allegra® “at risk”, despite the patent infringement litigation pending against them and other ANDA filers. In November 2008, sanofi-aventis U.S. entered into agreements to settle the U.S. patent infringement suits related to Barr and Teva’s generic version of Allegra® (fexofenadine hydrochloride), as well as the U.S. patent infringement suit related to Barr’s proposed generic version of Allegra® D-12 Hour (fexofenadine hydrochloride; pseudoephedrine hydrochloride). The respective settlements each took effect on January 2, 2009.

 

Under the settlement agreements, the U.S. patent suits, including any damage claims, against Barr and Teva related to sanofi-aventis’ U.S. Allegra® patent and against Barr related to its U.S. Allegra® D-12 Hour patent were dismissed without prejudice; the Barr/Teva generic version of Allegra® product remains on the market under a non-exclusive license and Barr has been granted a non-exclusive license starting in November 2009 for the commercialization of Allegra® D-12 Hour in the United States (this date may be accelerated under certain circumstances), in each case with royalties paid to sanofi-aventis.

 

Sanofi-aventis U.S. continues to be involved in ongoing U.S. patent litigation against other parties in relation to the Allegra® single entity formulation (Mylan, Dr. Reddy’s, Sandoz), Allegra® D-12 Hour (Impax, Mylan, Dr. Reddy’s, Sandoz and Sun Pharma Global) as well as Allegra® D-24 Hour (Dr. Reddy’s). These other suits were not settled by the agreements described above. The previously disclosed Israeli litigation against Teva has been resolved favorably for the Group.

 

This excerpt taken from the SNY 20-F filed Mar 7, 2008.

•  Allegra® Patent Litigation

 

United States. In June 2001 Aventis Pharmaceuticals Inc. (API), a sanofi-aventis subsidiary, was notified that Barr Laboratories Inc. (Barr) filed an Abbreviated New Drug Application (ANDA) with the FDA seeking approval to market a generic version of Allegra® 60 mg capsules in the United States and challenging certain of API’s patents. In August 2001, API filed a patent infringement lawsuit against Barr in U.S. District Court claiming that marketing of Allegra® by Barr prior to the expiration of certain API patents would constitute infringement of those patents. API subsequently received similar ANDA notifications from Barr and seven additional generic companies relating variously to Allegra® 30 mg, 60 mg and 180 mg tablets and Allegra®-D (12H and 24H) as well as notice of Section 505(b)(2) applications by Dr. Reddy’s Pharmaceuticals on Allegra® 30 mg, 60mg and 180 mg tablets and Allegra® D 12H. In each case, API has filed additional patent infringement lawsuits against the generic companies. These Allegra® patent infringement suits are pending in the U.S. District Court for New Jersey. There is no date currently set for trial.

 

In 2005, Barr and Teva launched a generic version of Allegra® despite the pending litigation.

 

On November 14, 2006 a new patent covering a crystalline form of the active ingredient of Allegra® (fexofenadine hydrochloride) was granted and API brought suit against Teva and Barr for infringement of this patent in the U.S. District Court for the Eastern District of Texas. On November 15, 2006, Barr and Teva filed an action against API in the U.S. District Court for the District of New Jersey seeking a declaratory judgment that the patent subject to the Texas action is invalid, unenforceable or not infringed. On November 21, 2006, a new patent covering an additional crystalline form of the active ingredient of Allegra® (fexofenadine hydrochloride)

 

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Table of Contents

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)

Year ended December 31, 2007

 

was granted and API amended its action in the Eastern District of Texas to assert infringement of that second patent by Barr. Subsequently, on August 9, 2007, sanofi-aventis brought a similar suit against Mylan for infringement of the second patent in the Eastern District of Texas. These crystalline form patent cases against Teva, Barr and Mylan have since been transfered to United States District Court, District of New Jersey. On January 11, 2008, sanofi-aventis filed suit against Sandoz for infringement of U.S. patent 7,135,571 in the United States District Court for the District of New Jersey.

 

Israel. On January 22, 2006, sanofi-aventis filed a patent infringement lawsuit in Israel against Teva Pharmaceuticals relating to a crystalline form of the active ingredient of Allegra® (fexofenadine hydrochloride). Sanofi-aventis is seeking a court order prohibiting Teva’s manufacture, export and marketing of fexofenadine hydrochloride in infringement of sanofi-aventis’ Israeli patent rights.

 

This excerpt taken from the SNY 20-F filed Apr 3, 2007.

•  Allegra® Patent Litigation

 

United States. In June 2001 Aventis Pharmaceuticals Inc. (API), a sanofi-aventis subsidiary, was notified that Barr Laboratories Inc. (Barr) filed an Abbreviated New Drug Application (ANDA) with the FDA seeking approval to market a generic version of Allegra® 60 mg capsules in the United States and challenging certain of API’s patents. In August 2001, API filed a patent infringement lawsuit against Barr in U.S. District Court claiming that marketing of Allegra® by Barr prior to the expiration of certain API patents would constitute infringement of those patents. API subsequently received similar ANDA notifications from Barr and six additional generic companies relating variously to Allegra® 30 mg, 60 mg and 180 mg tablets and Allegra®-D as well as notice of a Section 505(b)(2)(1) application by Dr. Reddy’s Pharmaceuticals. In each case, API has filed additional patent infringement lawsuits against the generic companies. These Allegra® patent infringement suits are pending in the U.S. District Court for New Jersey. There is no date currently set for trial.

 

On September 6, 2005, Barr and Teva announced that they were collaborating to launch a generic version of Allegra® despite the pending litigation. As a result sanofi-aventis submitted a motion for a preliminary injunction to halt Barr and Teva’s marketing of generic Allegra®, which the district court denied. On November 8, 2006 the Appeals Court affirmed the District Court’s denial of the preliminary injunction motion.

 

On November 14, 2006 a new patent covering a crystalline form of the active ingredient of Allegra® (fexofenadine hydrochloride) was granted and API brought suit against Teva and Barr for infringement of this patent in the U.S. District Court for the Eastern District of Texas. On November 15, 2006, Barr and Teva filed an action against API in the U.S. District Court for the District of New Jersey seeking a declaratory judgment that the patent subject to the Texas action is invalid, unenforceable or not infringed. On November 21, 2006, a new patent covering an additional crystalline form of the active ingredient of Allegra® (fexofenadine hydrochloride) was granted and API amended its action in the Eastern District of Texas to assert infringement of that second patent by Barr.

 

Israel. On January 22, 2006, sanofi-aventis filed a patent infringement lawsuit in Israel against Teva Pharmaceuticals relating to a crystalline form of the active ingredient of Allegra® (fexofenadine HCl). Sanofi-aventis is seeking a court order prohibiting Teva’s manufacture, export and marketing of fexofenadine HCl in infringement of sanofi-aventis’ Israeli patent rights.

 

This excerpt taken from the SNY 20-F filed Mar 31, 2006.

•  Allegra® Patent Litigation

 

United States. In June 2001 Aventis Pharmaceuticals Inc. (“API”), a sanofi-aventis subsidiary, was notified that Barr Laboratories Inc. (“Barr”) filed an Abbreviated New Drug Application (ANDA) with the FDA seeking approval to market a generic version of Allegra® 60 mg capsules in the United States and challenging certain of API’s patents. In August 2001, API filed a patent infringement lawsuit against Barr in U.S. District Court claiming that marketing of Allegra® by Barr prior to the expiration of certain API patents would constitute infringement of those patents. API subsequently received similar ANDA notifications from Barr and six additional generic companies relating variously to Allegra® 30 mg, 60 mg and 180 mg tablets and Allegra®-D as well as notice of a Section 505(b)(2) application by Dr. Reddy’s Pharmaceuticals. A section 505(b)(2) application may be used to seek approval for, among other things, combination products, products that do not demonstrate bioequivalence to a listed drug and over-the-counter versions of prescription drugs. Dr. Reddy’s has not notified API of the contents of its application. In each case, API has filed additional patent infringement lawsuits against the generic companies. All of the Allegra® patent infringement suits are pending in the U.S. District Court for New Jersey. No date is currently set for trial.

 

On September 6, 2005, Barr and Teva announced that they were collaborating to launch a generic version of Allegra® despite the pending litigation. As a result sanofi-aventis submitted a motion for a preliminary injunction to halt Barr and Teva’s marketing of generic Allegra®, which the district court denied. Sanofi-aventis is appealing this decision. Sanofi-aventis’ motion for an expedited trial, which was also filed as a result of the generic launch, was not addressed in the court’s opinion

 

Israel. On January 22, 2006, sanofi-aventis filed a patent infringement lawsuit and motion for a preliminary injunction in Israel against Teva Pharmaceuticals relating to a crystalline form of the active ingredient of Allegra® (fexofenadine HCl). Sanofi-aventis is seeking a court order prohibiting Teva’s manufacture, export and marketing of fexofenadine HCl in infringement of sanofi-aventis’ Israeli patent rights.

 

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