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Abbott GMBH & Co. KG v. Yeda Research and Development Co.

June 28, 2007


The opinion of the court was delivered by: Ricardo M. Urbina United States District Judge

Document Nos.: 93, 94




The plaintiff, Abbott GmbH & Co. KG, is the owner of U.S. Patent No. 5,344,915, also known as the LeMaire patent. Pursuant to 35 U.S.C. § 146, the plaintiff seeks to set aside decisions made by the Board of Patent Appeals and Interferences of the United States Trademark Office (the "Board") holding that the claims of the LeMaire patent are unpatentable and that therefore any interference claims are void. This matter is before the court on the issue of claim construction. The primary issue of this claim construction is whether the LeMaire patent covers a single protein, TBP-II, or if the LeMaire patent covers the TBP-II protein and all of its naturally occurring muteins. Based on the intrinsic record, the court concludes that the LeMaire patent covers only one protein, TBP-II, described in the plaintiff's patent application. That is, the patent includes neither man-made nor naturally occurring muteins. For this reason, the court adopts the plaintiff's claim interpretation.


A. Proteins

Generally speaking, proteins are long chains of amino acids like beads on a string. See In re O'Farrell, 853 F.2d 894, 895-99 (Fed. Cir. 1980). "Any sequence of amino acids of a significant length within a given protein will be unique to that protein." Pl.'s Claim Construction Br. ("Pl.'s Br." at 4). The chain begins at the N-terminus, the location of an amino group to which all other amino acids are sequentially attached. Id. The long chains of amino acids fold on themselves to form an often complex shape determined by the interplay of the amino acids in the chain. Both the sequence of amino acids and the folded structure are unique to each protein. Because a protein can be made up of a very long sequence of amino acids, scientists identify each protein by listing the sequence of amino acids beginning at the N-terminus. Id. The number of amino acids necessary to uniquely identify a protein varies. Id. (stating that amino acid sequences of varying lengths can be characteristic of a single protein). For example, the TBP-II protein is described in the patent by listing 22 of the amino acids located at the N-terminus.*fn1 Id. at 7. The sole requirement in identifying a protein by a sequence of amino acids in a patent is that "one skilled in the art" be able to recreate the protein without experimentation. In re Fisher, 427 F.2d 833, 836 (C.C.P.A. 1970); see generally In re O'Farrell, 853 F.2d at 895-99.

B. The LeMarie Patent

On May 4, 1990, Hans-Georg LeMaire, Heinz Hillen, Achim Moeller, Lothar Daum, Thomas Doerper, and Thomas Subkowski filed an international patent application, PCT/EP90/00719, for a protein, called the TBP-II protein, that is isolated from the urine of individuals with a fever and from the ascites fluid of individuals with ovarian carcinomas. Mem. Op. (June 13, 2005) ("Mem. Op.") at 1. After the patent application entered the United States, on September 6, 1994, the Patent and Trademark Office ("the PTO") issued the LeMaire patent to BASF, a previous owner of the patent. Id. at 2. The plaintiff is now the owner of this patent.

Seeking to patent the same protein, the defendant, Yeda Research and Development, challenged the plaintiff's patent in an interference proceeding before the Board. Id. During the interference proceeding, the defendant argued that the LeMaire patent was invalid because it was described in an article,*fn2 in violation of 35 U.S.C. § 102(b).*fn3 Id. In response, the plaintiff argued that it had patented the protein in Germany before the article was published and was therefore entitled to the benefit of the earlier filing dates under 35 U.S.C. § 119.*fn4 Id. The Board held that the LeMaire claims were unpatentable because "the party LeMaire [did] not sustain[] its burden of establishing, by a preponderance of the evidence, that their earlier filed German applications satisf[ied] the first paragraph description requirement of 35 U.S.C. § 112." Def.'s Claim Construction Br. ("Def.'s Br.") Ex. C at 8. In other words, the Board ruled that the German patent did not sufficiently describe the invention in the LeMaire patent and that the plaintiff's patent was invalid because it was described in the Engelmann article. The plaintiff now appeals the Board's decision to this court under 35 U.S.C. § 146.*fn5

C. Procedural Background

Both parties filed claim construction briefs to propose how the court should interpret the claims of the LeMaire Patent. Because the parties represented to the court that it could construe the claims without expert testimony, the court vacated the scheduled Markman hearing in favor of deciding on the ...

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