In Re Relafen Antitrust Litigation

346 F. Supp. 2d 349, 2004 U.S. Dist. LEXIS 26996, 2004 WL 2750101
District Court, D. Massachusetts·Decided November 29, 2004·No. MASTER FILE, 01-12239-WGY·Published·Cited by 20 cases

Opinion

MEMORANDUM

YOUNG, Chief Judge.

I. INTRODUCTION

On December 19, 2003, this Court issued an order stating its conclusions regarding SmithKline’s Motions for Summary Judgment [Doc. Nos. 169, 187, 193, 197, 202, 206], Order of 12/19/03 [Doc. No. 229]. Since then, the parties to this action have largely settled their claims. See Order of 4/9/04 [Doc. No. 297]; Order of 1/20/04 [Doc. No. 28 in Walgreen Co. v. SmithKline Beecham Corp., Civ. A. No. 02-10588-WGY]; Order of 1/20/04 [Doc. No. 11 in CVS Meridian, Inc. v. SmithKline Beecham Corp., Civ. A. No. 03-10040-WGY]; Order of 2/13/04 [Doc. No. 62 in Eon Labs., Inc. v. SmithKline Beecham Corp., Civ. A. No. 03-10506-WGY], Nevertheless, in light of its implications for the role of civil juries generally, and for future antitrust cases more specifically, the Court sets forth a portion of the analysis that led to its order.

*353 II. BACKGROUND

The background of this case is detailed more completely in Judge Lindsay’s opinion resolving the underlying patent infringement action, In re ’639 Patent Litig., 154 F.Supp.2d 157 (D.Mass.2001) (Lindsay, J.), and in this Court’s previous Memoran-da and Orders, In re Relafen Antitrust Litig., 286 F.Supp.2d 56 (D.Mass.2003); In re Relafen Antitrust Litig., 218 F.R.D. 337 (D.Mass.2003); Eon Laboratories, Inc. v. SmithKline Beecham Corp., 298 F.Supp.2d 175 (D.Mass.2003); and In re Relafen Antitrust Litig., 221 F.R.D. 260 (D.Mass.2004). For purposes of the present motions, the relevant background is as follows.

A. Factual Background

On November 2, 1982, the U.S. Patent and Trademark Office (the “Patent Office”) rejected SmithKline’s sixth application to patent nabumetone, a non-steroidal anti-inflammatory drug also described as methoxy ketone. In re '639 Patent Litig., 154 F.Supp.2d at 161, 169. In doing so, the Patent Office cited a 1973 article authored by J.N. Chatterjea and R. Prasad (“Chatterjea & Prasad”), who had previously named methoxy ketone and described a method for its synthesis. Id. at 162-63, 169. In light of Chatterjea & Pra-sad’s prior publication, the Patent Office concluded that SmithKline’s claims to solid nabumetone were invalid for obviousness and its claim to nabumetone per se was invalid for anticipation. Id. at 169. These conclusions were consistent with the early reports of SmithKline scientists, who had, in internal communications, also identified the Chatterjea & Prasad publication as an “existing literature procedure” and described the preparation of nabumetone “following the published methods.” Id. at 165-66.

Yet in its interactions with the Patent Office, SmithKline maintained that the Chatterjea & Prasad publication was distinguishable on two bases. First, Smith-Kline argued before the Board of Patent Appeals that the Chatterjea & Prasad procedure produced a “thick pale yellow oil” unlike the solid nabumetone claimed by SmithKline. See Defs.’ Noerr-Pennington App., Tab 11 (Decision of the Board of Patent Appeals) at 2. SmithKline scientist Dr. Carl Rose (“Dr.Rose”) declared that he had obtained solid nabumetone only because he “diverged from [Chatterjea & Prasad’s] described processes in that [he] purified the compounds carefully at each stage.” Id. at 5 (quoting Rose Deck ¶ 5). On the issue of anticipation, the Board of Patent Appeals ruled in SmithKline’s favor, concluding, without reference to Dr. Rose’s declaration, that the Chatterjea & Prasad, publication did not disclose na-bumetone in “solid form” and therefore did not anticipate SmithKline’s solid-form claim. Id. On the issue of obviousness, however, the Board of Appeals ruled against SmithKline in favor of rejection. Id. at 7. The Board of Patent Appeals cited evidence, including Rose’s declaration and SmithKline’s report of obtaining solid na-bumetone “after purification,” which “suggested] that Chatterjea’s ‘thick pale yellow oil’ may well have been an impure form of the claimed compound.” Id. at 6. Because “correct and normal chemical procedure” included purifying intermediate and final compounds, the Board of Patent Appeals reasoned that it would have been obvious to the ordinary chemist to purify the oil described by Chatterjea & Prasad “and thereby obtain the compound ... in solid form.” Id. at 6. SmithKline subsequently challenged this finding with an affidavit sworn by J.N. .Chatterjea (“Dr.Chatterjea”), who stated that R. Pra-sad had originally synthesized nabumetone only to convert it to a corresponding deriv *354 ative. See Defs.’ Noerr-Pennington App., Tab 13 (Chatterjea Aff. ¶¶4, 5(b)). For this purpose, SmithKline urged, there was no reason to purify the nabumetone.

Second, SmithKline asserted more broadly that the Chatterjea & Prasad publication did not disclose nabumetone at all. SmithKline stated that further review of the Chatterjea & Prasad publication had revealed a flaw. In re ’639 Patent Litig., 154 F.Supp.2d at 163. Although Chatter-jea & Prasad described their starting material as methoxy acetate, they then cited an article authored by R.G. Jones who, due to an error (the “Jones error”), described the synthesis of hydroxy acetate rather than methoxy acetate. Id. SmithKline argued that the ordinary chemist, cognizant of the Jones error, would understand Chatterjea & Prasad to describe a series of reactions that started with hydroxy acetate and ended with hydroxy ketone, not the methoxy ketone claimed by Smith-Kline’s application. Id.

The Patent Office subsequently reversed its position and on December 13, 1983, issued SmithKline U.S. Patent No. 4,420,-639 (the “ ’639 patent”). Id. at 169. SmithKline submitted a new drug application to the Food and Drug Administration (the “FDA”), and filed with its application a notice that the ’639 patent claimed na-bumetone. See 21 U.S.C. § 355(b)(1). In February 1992, after receiving FDA approval, SmithKline commenced sales of na-bumetone under the brand name “Relaten.” See In re ’639 Patent Litig., 154 F.Supp.2d at 159.

In 1997, several generic drug manufacturers filed abbreviated new drug applications (“ANDAs”) seeking approval to market generic nabumetone. Id. at 159-60. Copley Pharmaceutical, Inc. (“Copley”) and Teva Pharmaceuticals USA (“Teva”) filed first, submitting ANDAs for 750 and 500 milligram tablets on August 5, and August 18,1997, respectively. Defs.’ Stmt, of NoerrPennington Facts, App. [Doc. No. 180], Tabs 23-24. Eon Labs, Inc. (“Eon”) then filed its ANDA for 500 and 750 milligram tablets on December 18, 1997. Id., Tab 25. In each of their ANDAs, Copley, Teva, and Eon certified that the ’639 patent was, to the best of their knowledge, invalid or unenforceable.

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In Re Relafen Antitrust Litigation, 346 F. Supp. 2d 349, 2004 U.S. Dist. LEXIS 26996, 2004 WL 2750101 (D. Mass. 2004).

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