United States: New Jersey District Court Holds That A Claim For Infringement Under 35 U.S.C. § 271(e)(2) May Be Stated Without A Paragraph IV Certification

On February 14, 2013, the District of New Jersey held that, under 35 U.S.C. § 271(e)(2),¹ a court may exercise jurisdiction in a Hatch-Waxman Act case over claim of patent infringement where the Abbreviated New Drug Application ("ANDA") filer did not make a Paragraph IV ("PIV") certification for that patent. Merck Sharp & Dohme Corp. v. Sandoz Inc., C.A. No. 12-3289; Merck Sharpe & Dohme Corp. v. Accord Healthcare, Inc. USA, et al., C.A. No. 12-3324, slip op. at 7 (D.N.J. Feb. 14, 2013) ("Sandoz/Accord"). In issuing its decision, the Court declined to follow two prior decisions from the District of New Jersey that found no jurisdiction. Id. at 6. The Court's most recent decision confirms the statutory protection afforded by § 271(e)(2) and the policy goals of litigating infringement by ANDA filers prior to their commercial launch. 1 a court may exercise jurisdiction in a Hatch-Waxman Act case over claim of patent infringement where the Abbreviated New Drug Application ("ANDA") filer did not make a Paragraph IV ("PIV") certification for that patent.

In the Sandoz/Accord cases, the United States Food and Drug Administration ("FDA") had listed several patents in its Orange Book, including U.S. Patent Nos. 5,691,336 and 5,716,942 ("the '336 and '942 patents") as covering a 115 mg dosage form of the product at issue. The FDA, however, had not listed the '942 patent in its Orange Book as covering a 150 mg dosage form of the product at the time that two generic companies filed ANDAs. The two generic companies filed ANDAs allegedly to market copies of only the 150 mg dosage form and they made PIV certifications as to only the '336 patent. In response, Plaintiff brought an action under § 271(e)(2) alleging infringement of both the '336 and the '942 patents. Defendants filed motions to dismiss alleging a lack of subject matter jurisdiction as to the infringement claims based upon the '942 patent, since it was not listed in the Orange Book when the ANDAs were filed and the PIV letters with respect to the '336 patent were sent to the Plaintiff.

In their motions, Defendants cited two prior New Jersey court decisions that had dismissed infringement claims where a PIV certification had not been made. Id.; see Eisai Co. v. Mutual Pharm. Co., C.A. No. 06-3613, 2007 WL 455958 (D.N.J. Dec. 20, 2007); Novo Nordisk Inc. v. Mylan Pharm. Inc., C.A. No. 09-2445, 2010 WL 1372437 (D.N.J. Mar. 31, 2010). The Court in Sandoz/Accord, however, rejected Defendants' arguments, analyzing the Hatch-Waxman Act and case law and noting recent precedent from the Federal Circuit that rejected the notion that a case or controversy under § 271(e)(2) only exists when an ANDA filer makes a PIV certification. Merck, C.A. No. 12-3289, slip op. at 6-7; see AstraZeneca Pharm. LP v. Apotex Corp., 669 F.3d 1370, 1376-77 (Fed. Cir. 2012).

In AstraZeneca, the Federal Circuit explained that:

Id. at 1377 (internal citations and quotations omitted). Consistent with the Federal Circuit's precedent, the New Jersey court held that "Defendants' arguments that paragraph IV certifications are needed . . . are belied by the plain language of 35 U.S.C. § 271, and by Federal Circuit and District of New Jersey case law" such that Plaintiff's allegations of infringement are sufficient to establish subject matter jurisdiction. Merck, C.A. No. 12-3289, slip op. at 6.

Citing the text of the statute, the Court also found that "[n]othing in the plain language suggests infringement actions against ANDA filers must be based only on Orange Book listed patents." Id.

Further, the Court noted that "the concept of judicial efficiency and common sense" supported proceeding where the '336 patent claim was proceeding in any event. Id. at 7-8. Moreover, in denying Defendants' motions, the Court noted that its ruling was consistent with a purpose of § 271(e)(2) "to promote the early resolution of patent disputes relating to an ANDA." Id.

The District of New Jersey's ruling should be of use for patentees in Hatch-Waxman Act cases who seek resolution of patent infringement disputes before generic drug launch, and, in particular, in opposing arguments that § 271(e)(2) is limited to Orange Book listed patents addressed in a Paragraph IV certification.

Footnote

1 Under 35 U.S.C. § 271(e)(2)(A): "It shall be an act of infringement to submit . . . an application under section 505(j) of the Federal Food, Drug, and Cosmetic Act or described in section 505(b)(2) of such Act [codified at 21 U.S.C. § 355(j), (b)(2), respectively] for a drug claimed in a patent or the use of which is claimed in a patent . . . if the purpose of such submission is to obtain approval under such Act to engage in the commercial manufacture, use, or sale of a drug . . . claimed in a patent or the use of which is claimed in a patent before the expiration of such patent."

The content of this article does not constitute legal advice and should not be relied on in that way. Specific advice should be sought about your specific circumstances.