Prometheus Labs. Inc. v. Roxane Labs., Inc.

Section 305 requires that the patent applicant subjectively believes that he or she is submitting prior art to the USPTO and that such belief is objectively reasonable.

Winter 2013

GENERICally Speaking: A Hatch Waxman Litigation Bulletin

Case Name: Prometheus Labs. Inc. v. Roxane Labs., Inc., Civ. Nos. 11-230, 11-1241 (FSH), 2013 U.S. Dist. LEXIS 176054 (D.N.J. Dec. 16, 2013) (Hochberg, J.) (Section 305 requires that the patent applicant subjectively believes that he or she is submitting prior art to the USPTO and that such belief is objectively reasonable.)

Drug Product and Patent(s)-in-Suit: Lotronex® (alosetron hydrochloride); U.S. Patent No. 6,284,770 (“the ’770 patent”)

Nature of the Case and Issue(s) Presented: In 2009, Prometheus filed a request with the USPTO for ex parte reexamination of the ’770 patent, identifying “Magnet” and “Rubicon” as non-patent literature documents. Prometheus’ request for reexamination did not cite any prior art references other than Magnet and Rubicon. On December 30, 2009, the USPTO granted Prometheus’ petition seeking review of the denial of its request for reexamination. On February 24, 2010, the USPTO rejected claims 2, 3, 5, 6, and 8-18 under 35 U.S.C. § 103(a) as being unpatentable over Rubicon in view of the Magnet, Bardhan, Hsyu, Drossman, and Saxena references. During the subsequent reexamination, all of the original claims of the ’770 patent were either cancelled (claims 1-4 and 7-9) or amended (claims 5-6) in response to the February 24, 2010 office action. The reexamination certificate of the ’770 patent was issued on October 19, 2010 with amended claims 5-6 and new claims 10-16. But in this litigation, the parties now agree that Rubicon and Magnet are not prior art.

Prometheus and Cipla filed dueling motions for summary judgment related to invalidity under 35 U.S.C. § 305. Prometheus argues it is entitled to summary judgment of no invalidity under § 305 with respect to the ’770 patent for two reasons: first, it argues that whether or not claims were changed in light of prior art should be evaluated based on the record at the time of reexamination using a subjective standard, which it argues is met here; and second, it argues that the latter half of § 305 allows for amendments in response to an adverse action by the USPTO, and there is no dispute that Prometheus amended the ’770 patent in response to an adverse action by the USPTO. Cipla argues that it is entitled to summary judgment of invalidity under § 305 regarding the ’770 patent because, as the parties now agree, Magnet and Rubicon are not prior art. The court denied Cipla’s motion and granted Prometheus’ motion.

Why Prometheus Prevailed: Neither party was able to cite a case in support of its respective position. “In the absence of case law, the Court [was] guided by the language of the statute and its legislative history.” Cipla does not dispute that Prometheus’ reexamination counsel subjectively believed Magnet and Rubicon were prior art at the time of reexamination and that his belief was objectively reasonable. Rather, Cipla argued that it is the current litigation status of the alleged prior art, “viewed with the benefit of hindsight and new discovery,” that controls whether a party complied with §§ 301, 302, and 305 in the past, at the time of reexamination. The court found that the plain language of § 301 supports finding that the statute requires only a good-faith subjective belief that is objectively reasonable. Section 301 states that any person may cite to the USPTO “prior art consisting of patents or printed publications which that person believes to have a bearing on the patentability of any claim of a particular patent….” (emphasis in original). Therefore, the “focus of § 301 is on the belief of the person citing the prior art.”Cipla’s argument therefore does not comport “with the plain language of the statute or common sense.” Because there was a subjective belief that was objectively reasonable at the time of the reexamination request that Magnet and Rubicon were prior art, Prometheus’ reexamination complied with § 305, and the ’770 patent is not invalid under § 305.



Oren D. Langer


Managing Partner, New York Office
Member of Executive Board

Ryan M. Schultz


Pronouns: he/him

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