Takeda Pharm. Co., Ltd. v. TWI Pharm., Inc.
There is no requirement under the Hatch-Waxman Act that a patent must be listed in the Orange Book in order for a drug manufacturer to bring an infringement action.
July 15, 2013
Case Name: Takeda Pharm. Co., Ltd. v. TWI Pharm., Inc., Civ. Nos. C-11-01609, C-11-0840, C-11-01610, 2013 U.S. Dist. LEXIS 72958 (N.D. Cal., April 8, 2013) (Spero, J.)
Drug Product and Patent(s)-in-Suit: Dexilant® (dexlansoprazole); U.S. Patent Nos. 7,737,282 (“the ’282 patent”) and 7,790,755 (“the ’755 patent”)
Nature of the Case and Issue(s) Presented: The claims of the ‘282 and ‘755 patents cover Takeda’s branded drug, Dexilant, which is used in the treatment of gastroesophageal reflux disease (“GERD”). Takeda sued TWi, alleging that TWi’s generic dexlansoprazole tablets infringed the claims of Takeda’s ‘755 and ‘282 patents. TWi asserted counterclaims seeking declaratory judgment that no valid claims of the ‘755 or ‘282 patents would be infringed by the generic product. After discovery, the parties filed cross motions for summary judgment. In its motion, TWi contended that its ANDA product did not infringe the ‘755 patent because Takeda could not prove that the ANDA product “begins to release” the active ingredient at a pH level of no less than 5.0 and no more than 6.0. TWi further contended that there was no subject matter jurisdiction over Takeda’s patent infringement claims related to the ‘282 patent because it was not listed in the Orange Book. TWi also posited invalidity arguments concerning the ’282 patent based on anticipation and lack of written description.
Why Takeda Partially Prevailed: The Court denied TWi’s motion for summary judgment that there was no subject matter jurisdiction over Takeda’s ‘282 patent infringement claim because it was not listed in the Orange Book. At the outset, it should be noted that TWi did not file a Paragraph IV certification against the ‘282 patent in conjunction with its ANDA, which some courts have found to be a jurisdictional requirement for a patentee to bring a claim under the Hatch-Waxman Act. TWi relied on a New Jersey district court opinion in Eisai Co. v. Mutual Pharmaceutical Co., Inc., where it held that although the plain text of § 271(e)(2) does not require that the alleged infringer file an ANDA with a Paragraph IV certification, a Paragraph IV requirement should be “read into” § 271(e)(2). But the court took exception to Eisai, noting that none of the Federal Circuit cases addressed in Eisai directly addressed the question of whether a Paragraph IV certification was required in order for a patentee to bring an infringement claim under the Hatch-Waxman Act. The court, instead, found the opinion in AstraZeneca Pharms. LP v. Apotex Corp. more persuasive. In AstraZeneca, the Federal Circuit concluded that the requirements for jurisdiction in the district courts were met once a patent owner alleged that another’s filing of an ANDA infringed its patent under § 271(e)(2), and this threshold jurisdictional determination did not depend on the ultimate merits of the claims. The district court supported its decision further by citing to the Supreme Court’s opinion in Caraco Pharm. Labs.., Ltd. v. Novo Nordisk A/S. In that case, Novo had argued that Caraco’s filing of a section viii statement did not constitute an act of infringement in the same way that a Paragraph IV certification would. The Supreme Court dismissed this line of reasoning, noting that the want of an infringing act was a merits problem, not a jurisdictional one, and that nothing in 35 U.S.C. § 271(e)(2)(A) defining certain filings as acts of infringement suggests anything to the contrary. The Supreme Court concluded that it was not inclined to interpret statutes as creating a jurisdictional bar when they were not framed as such. In light of this precedent, and joining a number of other district courts that have looked at the issue, the court found that there is no requirement under the Hatch-Waxman Act that a patent must be listed in the Orange Book in order for a drug manufacturer to bring an infringement action.
The Court next granted Takeda’s summary-judgment motion of infringement of the ’282 patent. TWi had made several admissions and statements indicating that its ANDA product contained amorphous dexlansoprazole: first, in its ANDA when describing the choice of layering process; second, during the litigation in deposition testimony, interrogatory responses, and TWi’s Paragraph IV letter to Takeda. In light of those admissions, TWi failed to establish the existence of a genuine issue of material fact as to whether its ANDA products contained the claimed amorphous dexlansoprazole. Summary judgment was therefore warranted.
The court denied TWi’s summary-judgment motion of invalidity based on anticipation and lack of written description. TWi’s relied on two allegedly anticipatory references. TWi argued that one prior art reference had inherently disclosed an amorphous salt of dexlansoprazole while a second reference allegedly enabled that inherent disclosure. But the court found genuine issues of fact remained as to whether the cited prior art reference was sufficiently enabled. TWi’s argument concerning a lack of written description contended that the ’282 patent did not adequately describe how the solid salt of dexlansoprazole is created. This argument was rejected, however, because a person of skill in the art would know how to derive the salt of amorphous dexlansoprazole at the time of invention.
Finally, the court granted TWi’s summary-judgment motion of non-infringement of the ’755 patent. Takeda’s expert witness, Dr. Chaman, ran tests that showed that TWi’s ANDA product did not infringe the claims of the ‘755 patent. The test results indicated that the ANDA capsule formulation exhibited a measurable release of active drug at a pH below 5.0, and thus outside the claimed range of a pH between 5.0 and 6.0.
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