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

September 15, 2008


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

Document Nos.: 107, 108, 109




This case comes before the court on the parties' cross motions for summary judgment and the defendant's motion to exclude evidence. The plaintiff, Abbott GmbH & Co. KG, is the owner of U.S. Patent No. 5,344,915, also known as the "LeMaire patent." The patent describes a protein called TBP-II, which is found in the urine of patients with a fever and binds to, and thereby neutralizes, potentially harmful polypeptides. The plaintiff requests that the court set aside the final decision made by the Board of Patent Appeals and Interferences of the United States Trademark Office (the "Board") holding that the claims in the LeMaire patent are unpatentable for failing to remove an article, the Engelmann reference,*fn1 as prior art. Specifically, the plaintiff contends that the Board's reasoning is flawed and that new evidence resoundingly favors removal of the article as prior art. The defendant disagrees on both accounts, submitting expert testimony of its own to rebut the plaintiff's evidence and also filing a motion to exclude the new evidence altogether. Because the defendant failed to comply with Local Civil Rule 7(m), the court denies its motion to exclude evidence. And because the Board's determination is clearly erroneous, the court vacates its decision and remands for further proceedings.


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 LeMaire patent describes the TBP-II protein by listing 22 of the amino acids located at the N-terminus.*fn2 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 LeMaire 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) 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.

C. The Board's Decision

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 in violation of 35 U.S.C. § 102(b)*fn3 and, therefore, invalid because it was described in the Engelmann reference. Id. The plaintiff conceded that the Engelmann reference constituted prior art, Pl.'s Mot., Ex. D ("Bd. Dec.") at 8, but argued that it had patented the protein before the article was published through its '072 and '089 applications in Germany, Mem. Op. (June 13, 2005) at 2. Therefore, the plaintiff insisted that it was entitled to the benefit of the earlier filing dates of the '072 and 0'089 applications 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." Bd. Dec. at 8. Noting the omission of three amino acids in positions 20-22 in the '089 application, the Board rejected the plaintiff's argument that these three amino acids are an inherent characteristic of the truncated sequence. Id. at 15-18. The Board reasoned that the "N terminal sequence analysis indicates the inhomogeneity of the amino acid sequences found," and "[t]herefore, the N terminus sequences of the proteins are unpredictable." Id. at 18. The Board also noted that the sequences described in the '089 application may describe either the TBP-I or the TBP-II protein. Id. at 19. Because "inherency may not be established by probabilities or possibilities," the Board ruled that the '089 application did not sufficiently describe the TBP-II protein, and therefore, the plaintiff's patent was invalid.

D. Procedural Background

The plaintiff now appeals the Board's decision to this court under 35 U.S.C. § 146.*fn5 In 2005, the defendant filed a preliminary motion for summary judgment, agreeing for purposes of that motion to adopt the plaintiff's interpretation of the LeMaire patent. Mem. Op. (June 13, 2005) at 3. After clarifying that the plaintiff's interpretation limits the scope of the LeMaire patent to the TBP-II protein (as opposed to the TBP-II protein and a partial amino acid sequence), the court denied the ...

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