Summary

Hahn Loeser has one of the most experienced Hatch-Waxman/ANDA generic drug groups in the country. We recognize that our clients benefit most by getting their products to market fast, and remain focused on that goal in developing strategies that position our clients for a successful product launch, be it through summary judgment, trial, Inter Partes Review (IPR) at the Patent Office, licensing, settlement or just good advice.

We pride ourselves on getting the science right and building our legal theories around technically sound arguments.  In the courtroom, our litigators have a long history of success in getting our client’s products to market.   We have invalidated patents on a number of major drugs, including Norvasc®, Actonel®, Floxin Otic® (resulting in a $5 million judgment to our generic client) and Boniva®. Other cases of note include Treanda ®,  Antara®, Abilify® (oral solution), Plavix®, Benicar®, Benicar® HCT, Uroxatral®, Eloxatin®, Treanda®, Zometa®, Reclast® and Ultracet®.  Our group is equally sophisticated at counseling clients outside of the courtroom.  We regularly prepare opinion letters and assist clients in developing formulation and design around ANDA strategies.  We also have experience in related FDA and regulatory litigation and counseling directed to obtaining marketing approval for generic drugs. This experience and understanding of the Hatch-Waxman Act regulatory scheme is critical in crafting a successful patent litigation and product development strategy.  We also have experience with advising clients on supply agreements and partnering strategies.

OPENING MARKETS FOR GENERIC PHARMACEUTICALS

Apotex Inc. v. Daiichi Sankyo Co., 781 F.3d 1356 (Fed. Cir. 2015). We obtained a significant jurisdictional decision from the Court of Appeals for the Federal Circuit, which held that a generic manufacturer has standing as a subsequent ANDA filer to challenge one of the Daiichi’s Orange Book listed patents for the drug Benicar® (olmesartan medoxomil).  Thereafter we successfully defeated Daiichi’s and Mylan’s efforts to obtain review of the case by the U.S. Supreme Court.   Daiichi Sankyo, Inc. v. Apotex, Inc. --- S.Ct. ----, 2015 WL 5176392, 84 USLW 3123 (2015); Mylan v. Apotex,  Inc. cert. denied , --- S.Ct. ----, 2015 WL 5310047, 84 USLW 3123 (2015).  We then were successful in obtaining summary judgment of noninfringement for Apotex’s ANDAs on olmesartan medoxomil and olmesartan medoxomil + hydrochlorothiazide.  2016 WL 98572 (N.D. Ill. 2016). 

Warner Chilcott Co. v. Teva Pharm USA, Inc., et al., 2014 WL 645042 (Fed. Cir. 2014).We obtained summary judgment invalidating patents claiming methods of treating osteoporosis using Warner Chilcott’s osteoporosis drug risedronate (Actonel®). Warner Chilcott v. Teva Pharmaceuticals, et al., 37 F.Supp.3d 731 (D. Del. 2014).  The decision was affirmed on appeal by the Court of Appeals for the Federal Circuit. 

Hoffmann LaRoche v. Apotex Inc., et al., 748 F.3d 1326 (Fed. Cir. 2014); 496 Fed. Appx. 46, Case Nos. 2012-1270, -1271, -1272 (Fed. Cir. Oct. 11, 2012). After successfully defeating Hoffmann LaRoche’s motion for summary preliminary injunction to prevent the launch of a generic version of the osteoporosis drug Boniva® (ibandronate), we obtained summary judgment that Roche’s patents relating to a once monthly treatment regimen were obvious. Both decisions were affirmed on appeal to the Federal Circuit.

In re Fenofibrate Patent Litigation (S.D.N.Y. Dec. 28, 2012). We obtained summary judgment of non-infringement of Lupin’s Orange Book listed patents, thereby avoiding prolonged discovery, while demonstrating that our client’s formulation did not infringe.

Pfizer Inc. v. Apotex Inc., 480 F.3d 1348 (Fed. Cir. 2007). We invalidated as obvious Pfizer’s patent covering its blockbuster drug Norvasc® (amlodipine besylate).  Critical to demonstrating the obviousness of the claimed salt form was identifying a prior art example of a besylate salt of a prior art dihydropyridine compound.  We also represented our client Apotex in follow on litigation before the FDA in the District of D.C. and the D.C. Circuit concerning first filer exclusivities including litigating issues of first impression at the time concerning whether the first filer exclusivity could extend beyond expiration of the Orange Book listed patent and the applicability of pediatric exclusivity to a non-first filer who obtained a judgment of patent invalidity. 

Daiichi Pharmaceutical Co., Ltd. v. Apotex Inc., 501 F.3d 1254 (2007). We invalidated Daiichi’s patent claiming a method of treating bacterial ear infections by topically administering the antibiotic ofloxacin (marketed by Daiichi as Floxin® Octic solution 0.3%). The case resulted in a $5 million award to our generic client.

Capabilities Within Our Practice