By Kevin E. Noonan --
Before Hoffmann-LaRoche filed its Notice of Appeal in the Court of Appeals for the Federal Circuit last week, appealing the preliminary injunction Judge William Young entered that prevents Roche from selling its Mircera® drug product (a form of recombinant EPO that has been covalently linked to polyethylene glycol), Roche filed a brief with the District Court regarding its interpretation of the Federal Circuit's recent decision in Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc. This filing was in part a response to Amgen's brief, filed in the District Court on March 14th regarding the effect of the Federal Circuit's Pfizer decision on the propriety of the preliminary injunction and the underlying competence of Amgen's verdict that its claims are not invalid (see Patent Docs report).
Roche's position is simple: the Pfizer decision limits the application of the "safe harbor" provisions of 35 U.S.C. § 121 to divisional applications. Roche's brief cites the multiple instances where the Court recited this proposition:
• Pfizer argues that the terms "divisional" and "continuation-in-part" are merely labels used for administrative convenience, and that accordingly, although . . . termed a CIP, [its application] is in effect a divisional for purposes of section 121. In other words, Pfizer contends that the term "divisional application" as it is used in section 121 refers broadly to any type of continuing application filed as a result of a restriction, regardless of whether it is labeled by the PTO, for administrative purposes, as a divisional, a continuation, or a CIP. We disagree. Pfizer, 2008 U.S. App. LEXIS 4969, at *14 (emphasis added).
• As the Federal Circuit explicitly held: "We conclude that the protection afforded by section 121 to applications (or patents issued therefrom) filed as a result of a restriction requirement is limited to divisional applications." Pfizer, 2008 U.S. App. LEXIS 4969, at *21-22 (emphasis added).
• As the Federal Circuit reasoned:
Section 121 explicitly refers to "divisional applications." [Quoting statute and emphasizing each use of the term "divisional application"] . . . . That safe harbor, by its literal terms, protects only "divisional application[s]" . . . and patents issued on such applications.
The legislative history of section 121, like section 121 itself, refers specifically to "divisional application[s]." . . . There is no suggestion . . . in the legislative history of section 121 that the safe-harbor provision was, or needed to be, directed at anything but divisional applications. Id. at *14-19.
• Amgen correctly notes that the Federal Circuit "stressed that [the] difference between a divisional application and a CIP application 'was well known at the time that Congress enacted the 1952 Patent Act,' and therefore '[i]f the drafters wanted to include CIPs within the protection afforded by section 121, they could have easily done so.'" What Amgen fails to point out, however, is that the difference between a divisional application and a continuation application was equally well known. Thus, for the identical reason, "[i]f the drafters wanted to include" continuation applications "within the protection afforded by section 121, they could have easily done so." They did not: "Despite this awareness . . . the drafters of section 121 chose to refer specifically and only to divisional . . . applications."
• As the text of the opinion makes clear:
Although the legislative history reveals no reason why Congress drafted section 121 only to benefit divisional applications, there are certainly plausible reasons why Congress would have concluded that section 121 should be limited to divisional applications, and not include CIPs. Pfizer, 2008 U.S. App. LEXIS 4969, at *19.
The argument is straightforward: the statute only encompasses divisional applications. This is in direct contradiction to Amgen's position, which was that this decision has no bearing on the District Court's decision that Amgen's patents-in-suit are not invalid under the judicially-created obviousness-type double patenting doctrine. Amgen argued that its applications were not CIPs, but continuations, and that the Pfizer decision was limited to precluding the § 121 safe harbor from encompassing CIP applications. Amgen also argued that its patents-in-suit were continuation applications in name only, and satisfied the conditions of the statute for benefiting from the safe harbor ("later application[s] carved out of a pending application," containing claims to "a distinct and independent invention" and "disclosing and claiming only subject matter disclosed in the earlier or parent application"). Roche's brief does not deign to address these contentions directly, taking the more direct route of asserting sub silentio that Amgen's arguments were irrelevant in the face of the Pfizer decision's simple holding.
Roche's brief does seek to refute Amgen's contention that the interpretation Roche wishes to have applied to the Pfizer decision -- that the § 121 safe harbor is limited to divisional applications -- is inconsistent with the Federal Circuit's earlier decisions in Applied Materials, Inc. v. Advanced Semiconductor Materials Am., Inc., 98 F.3d 1563 (Fed. Cir. 1996) and Symbol Technologies, Inc. v. Opticon, Inc., 935 F.2d 1569 (Fed. Cir. 1991). Amgen argued that any interpretation (such as the one Roche argues here) cannot be correct in view of this purported inconsistency, since three-judge panels of the Federal Circuit are bound by the earlier decisions, citing Newell Cos. v. Kenney Mfg. Co., 864 F.2d 757, 765 (Fed. Cir. 1988) ("This court has adopted the rule that prior decisions of a panel of the court are binding precedent on subsequent panels unless and until overturned in banc. Where there is direct conflict, the precedential decision is the first."). Roche argues that there is no inconsistency, since neither Applied Materials nor Symbol Technologies involved continuation applications, but rather concerned divisional applications (albeit the patents-in-suit were continuations claiming priority to divisional applications). This approach is consistent with positions Roche asserted before the District Court, to the effect that Amgen was precluded from the safe harbor under § 121 because it designated its applications as continuations rather than divisionals. Roche does not reach the substance of Amgen's argument regarding whether the relevant patents-in-suit satisfy the requirements for divisional applications.
Finally, Roche argues that the Pfizer decision also expressly supports its interpretation of the decision in Geneva Pharmaceuticals, Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373 (Fed. Cir. 2003), that the District Court's determination of whether claims in the patents-in-suit fall within the ambit of obviousness-type double patenting can rely on disclosure in the parent specification as well as the parent's granted claims.
As noted in an earlier post, the lawyer representing Pfizer before the Federal Circuit, Leora Ben-Ami, Kaye Scholer LLP, is also the lead trial attorney representing Hoffman-LaRoche against Amgen. Roche's brief was filed by local counsel, Bromberg & Sunstein LLP.
For additional information regarding this topic, please see:
• "Hoffmann-LaRoche Can't Wait, Files Notice of Appeal to the Federal Circuit," April 11, 2008
• "Will the Federal Circuit's Pfizer v. Teva Decision Spell the End of Amgen's Patent Rights to Recombinant Human Erythropoietin?" March 31, 2008
• "Court Still Cannot Decide on Amgen's Permanent Injunction," March 26, 2008
• "Amgen Inc. v. International Trade Commission (Fed. Cir. 2008)," March 20, 2008
• "Roche Agrees to Court's Conditions for Modifying Preliminary Injunction," March 20, 2008
• "Roche's Mircera® Remains Off the Market (For Now)," March 2, 2008
• "Amgen Survives Another EPO Challenge," October 28, 2007
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