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MORPHOSYS AG v. CAMBRIDGE ANTIBODY TECHNOLOGY LIMITED

August 17, 2001

MORPHOSYS AG, PLAINTIFF,
V.
CAMBRIDGE ANTIBODY TECHNOLOGY LIMITED, DEFENDANT.



The opinion of the court was delivered by: Robertson, United States District Judge

MEMORANDUM OPINION

In April 1999, MorphoSys sued for a declaratory judgment that it does not infringe U.S. Patent Number 5,885,793 (the '793 patent), owned by Cambridge Antibody Limited (CAT) and the Medical Research Council (of the United Kingdom), and that the '793 patent is invalid under 35 U.S.C. § 102, 103, and 112. CAT counterclaimed for infringement. After and in light of this Court's claim construction memorandum of August 22, 2000, MorphoSys moved for summary judgment as to CAT's counterclaim. The claim construction was then amended by memorandum issued October 11, 2000. The amendment effectively doomed the summary judgment motion, which was denied. The infringement and invalidity claims were tried in March 2001. The only issue the jury was able to decide was that CAT's patent application is entitled to a priority date of December 2, 1991. The jury was not able to reach a unanimous verdict as to whether the MorphoSys technology or the antibodies obtained using the MorphoSys technology infringed the '793 patent, or whether the '793 patent was invalid due to obviousness, anticipation, or lack of written description. Both parties moved after trial for judgment as a matter of law on a variety of grounds. MorphoSys also moved for reinstatement of the Court's original claim construction and conditionally renewed its motion for summary judgment as to CAT's infringement claim.

After careful consideration of the post-trial motions and of the record developed so far, it appears that MorphoSys should prevail on the issue of infringement, but because it is not clear that CAT has been "fully heard" on the issue, Fed.R.Civ.P. 50(a), the MorphoSys motions for summary judgment and for judgment as a matter of law on infringement will be in abeyance pending further proceedings or briefings. I have decided that CAT's motion for judgment as a matter of law must be granted as to MorphoSys's invalidity defenses of anticipation, written description, indefiniteness, and enablement. All other post-trial motions will be denied (except for CAT's motion to file surreply, which will be granted). The findings and conclusions that form the basis of these decisions are set forth below.

Findings of Fact

1. The '793 patent (PX 1) describes a method for obtaining antibodies to specific human self antigens by the use of phage display libraries. The patent also covers the antibodies obtained using this method. The claims at issue in this case are the independent claim 1 and the dependent claims 2-6, 10-17, 31 and 37.*fn1 Claim 1 of the '793 patent claims:

A method for obtaining a member of a specific binding pair, the specific binding pair member being an antibody or antibody fragment and having an antigen binding site comprising an antibody light chain variable region and an antibody heavy chain variable region, the antigen binding site having binding specificity for an antigen which is a human self antigen for which specific antibodies are not found in sera of humans unimmunized with said self antigen the method comprising: (a) providing a library of filamentous bacteriophage, each filamentous bacteriophage displaying at its surface a specific binding pair member, and each filamentous bacteriophage containing nucleic acid with sequence derived from a human unimmunized with said self antigen and not having antibodies specific for said self antigen found in the sera and encoding a polypeptide chain which is a component part of the specific binding pair member displayed at the surface of that filamentous bacteriophage; and (b) selecting, by binding with said self antigen, one or more specific binding pair members with binding specificity for said self antigen.
2. The words "are not found" in the phrase "are not found in sera of humans" mean "are not present" in sera of any humans and not "were not found" or "have not yet been found." Cl. Constr. Mem. at 1 (Aug. 22, 2000). The words "derived from" in the phrase "nucleic acid with sequence derived from a human" mean "acquired or obtained, actually or theoretically, directly from, or by modification of," but not "by reference to," human material. Order on Recons. at 4 (Oct. 11, 2000).

3. When CAT filed its patent application, it was working with "natural" libraries, using lymphocytes taken physically from the blood of one or two individuals. (Trial Tr. 251-52, 640 (videotape of Winter dep. 173).) Examples 1-4 in the '793 patent (Plf.'s Ex. 1: col. 22, 1.1-col. 30, 1.7) are experiments using the "natural" library.

4. CAT also developed what it called a "synthetic" library, using a human donor, cloning capital V-gene segments, and amplifying them by the use of synthetic primers. (Trial Tr. 640 (videotape of Winter dep. 181).) Examples 5-7 in the '793 patent (Plf.'s Ex. 1: col. 80, 1.18-col. 36, 1.45) are experiments using the "synthetic" library.

5. Although there is a substantial dispute about whether, and to what extent, the '793 specification, drawings, and descriptions enable a "fully synthetic" library to one of ordinary skill in the art (Compare MorphoSys's Proposed Findings of Fact (Enablement) ¶¶ 16, 17, 21, with CAT's Resp. Proposed Findings of Fact (Enablement), Resp. to ¶¶ 16, 17, 18) CAT does not contend that the '793 specification, drawings, and descriptions enable a phage display library derived by "theoretical analysis" (see CAT Combined Opp. Fed.R.Civ.P. 50(b) & 52, at 24-25).*fn2

6. The MorphoSys HuCAL library starts, not with human blood, but with data — amino acid sequences reported on Internet-accessible databases. The sequences are grouped and analyzed "in silico" (in the computer) and then synthesized on the DNA synthesizer. (Trial Tr. 737-51; Knappik et al., "Fully Synthetic Human Combinatorial Antibody Libraries (HuCAL) Based on Modular Consensus Frameworks and CDRs Randomized with Trinucleotides," J. Mol. Biol (2000) 296, 57-86 (Ex. A to MorphoSys Mot. for Partial Summ. J.).)

7. The accused antibodies or antibody fragments specific to human self antigens KGF-R, ICAM-1, PD-1, FLICE, TrkA, alpha e beta 7 integrin, and sprouty were obtained from MorphoSys HuCAL libraries and shipped to customers of MorphoSys. (Stipulation Establishing Facts for Trial ¶¶ 5, 7, 10, 13, 15, 17, 19.) The antibody fragments against human self antigens FGF-18 and CHK-1 were obtained by a MorphoSys customer from a MorphoSys HuCAL library. (Id. ¶ 30.)

8. Applications for British patents filed by CAT on December 2, 1991, include a written description of the entire scope of the invention claimed in the '793 patent and provide sufficient information to enable a person of ordinary skill in ...


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