I’ve said it before and I’ll say it again, if you do research you must keep meticulous notes of the inventive process. Laboratory notebooks often play an important role during the patent prosecution process and even after a patent has issued. A properly kept notebook is invaluable in cases in which another party claims a patent to be invalid or in interference cases in which two or more patents have been issued on the same invention and the true inventor must be ascertained.

In Yeda Research And Development Co. v. ImClone Systems and Aventis Pharmaceuticals (03 Civ. 8484), a federal judge ruled that three scientists from Israel are the true inventors of a patent used for ImClone Systems‘ cancer drug Erbitux rather than the seven people listed on the patent after finding no documentary evidence suggesting that any of the other named inventors contemplated the claimed invention. ImClone, as you know, is the company whose founder, Sam Waksal, is serving a prison sentence for his role in the stock scandal that also involved Martha Stewart. In a lengthy, 140-page opinion the court found the Yeda scientists had proved they were entitled to sole inventorship of the patent.

Yeda sued ImClone and Aventis alleging improper inventorship of U.S. Pat. No. 6,217,866, entitled “Monoclonal Antibody Specific to Human Epidermal Growth Factor Receptor and Therapeutic Methods Employing Same.” Yeda is the assignee of the legal interests of three scientists (Sela, Pirak and Hurwitz – collectively, the “Weizmann scientists”), who maintain that they are the true inventors of the ‘866 patent. ImClone is the assignee of the interests from the named inventors.

Earlier, the named inventors created two monoclonal antibodies for use as research tools and gave samples of the antibodies to the Weizmann scientists. The Weizmann scientists performed experiments with the antibodies and discovered that when one of the two antibodies, known as mAb 108, was administered in vivo in a mixture with chemotherapy drugs, the effect on human tumor cells was synergistic.

One named inventor, Schlessinger, testified that he “knew” that this mixture experiment would be performed based on his knowledge of Hurwitz’s prior work. Hurwitz, however, testified that the Weizmann scientists only decided to conduct the mixture experiment more than a year after the research began.

Soon after the discovery, Schlessinger was told of the discovery and sent a draft manuscript. Meloy Labs (later became Rorer then part of Aventis) began pursuing patent protection for both the antibodies themselves and for the method of administering them with chemotherapy drugs that had been developed by the Weizmann scientists. Only the scientists employed by Meloy/Rorer were included as inventors on its patent applications. Not only that, Meloy/Rorer and later, ImClone, directly copied the text and figures from the manuscript into their patent applications.

During prosecution, the USPTO also raised questions about the fact that the patent application seemed to be drawn directly from work done by the Weizmann scientists. Defendants overcame this objection by suggesting that they had entirely conceived of the research conducted by the Weizmann scientists, who had simply followed their directions as to what experiments to perform.

The issued patent only included those claims drawn to the method of administering an antibody in a mixture with chemotherapy drugs; the PTO did not permit the antibodies themselves to be patented. The issued ‘866 patent claims:

1. A method for inhibiting the growth of human tumor cells that express human EGF receptors and are mitogenically-stimulated by EGF, the method comprising administering an effective amount of an anti-neoplastic agent to a human cancer patient having said tumor cells; (i) wherein said antibody binds to the extra-cellular domain of the human EGF receptor of said tumor cell; (ii)wherein the antibody is not conjugated to the anti-neoplastic agent; and (iii) wherein the antibody inhibit [sic] the binding of EGF to the EGF receptor.

ImClone obtained FDA approval for the treatment of certain types of human cancer, permitting it to distribute Erbitux under the protection of the ‘866 patent. As of the date of trial, ImClone had received about $900 million in revenues under a distribution agreement with Bristol Myers Squibb.

The court looked at (a) which scientists invented the subject matter of the ‘866 patent; and (b) whether the affirmative defense of laches is available to ImClone.

In looking at inventorship, the court said it must begin “with a construction of each asserted claim to determine the subject matter encompassed thereby.” Trovan Ltd. v. Sokymat SA, Irori, 299 F.3d 1292, 1302 (Fed. Cir. 2002) (citations omitted). After defining the invention, the Court “is then to compare the alleged contributions of each asserted co-inventor with the subject matter of the properly construed claim to then determine whether the correct inventors were named.” Id. (citing Ethicon, Inc. v. U.S. Surgical Corp., 135 F.3d 1456 (Fed. Cir. 1998)).”

Disturbingly, one of the determining factors cited by the court was the defendant having too good of a memory! The court stated that:

We find Schlessinger’s account of this conversation not credible for several reasons. First, nearly twenty years have passed since the conversation occurred, such that we doubt Schlessinger remembers its details, especially considering the contorted testimony Schlessinger offered on cross-examination, in which he seemingly attempted to “remember” those details that would bolster defendants’ case.

I’m not sure what that means for future cases – perhaps prepping witnesses to not remember so good? However, the court also noted that “despite providing the Court with hundreds of exhibits, defendants have failed to present a single piece of physical or documentary evidence suggesting that Schlessinger or any of the other named inventors contemplated that any particular type of testing would be conducted.”

ImClone also argued that the legal doctrine of laches bars Yeda’s claims in light of the fact that the lawsuit was initiated more than a decade after defendants first submitted an application for a patent. The affirmative defense of laches applies when: (1) a plaintiff unreasonably delays bringing suit; and (2) the delay results in material prejudice to a defendant.

Laches is an equitable defense, and is thus committed to the sound discretion of the trial judge. The period of delay is measured from when the claimant had actual notice of the claim or would have reasonably been expected to inquire about the subject matter, i.e., “knew-or-should-have-known.” But, ImClone was sunk given that the court found the defendants at fault, stating:

Because we find that defendants’ hands are unclean, i.e., they are responsible for plaintiff not finding out about their patent applications, the laches defense is unavailable to defendants.

In finding for Yeda, the court held that:

Having considered all of the evidence, we now find that the Weizmann scientists are entitled to sole inventorship of the ‘866 patent. In so holding, we make the following factual determinations, all of which are discussed at length infra: (1) Schlessinger did not give Hurwitz specific information regarding the properties of the antibodies or any intended uses; (2) Schlessinger did not specifically contemplate that the Weizmann scientists would perform the mixture experiment that forms the basis for the ‘866 patent; (3) the named inventors’ creation of the antibodies used by the Weizmann scientists does not entitle them to inventorship; (4) the Weizmann scientists solely conceived of the idea embodied in the ‘866 patent; and (5) in light of the defendants’ unclean hands, i.e., their copying from the Weizmann scientists’ draft paper and their efforts to prevent Yeda from discovering defendants’ patent applications, Yeda did not unreasonably delay asserting its rights relative to the ‘866 patent.

ImClone is now considering a three-way strategy for dealing with the decision including an appeal of the court decision, a motion to invalidate the patent turned over to three Israelis and exercising an option to license the patent from Yeda Research & Development Co.

See my suggestions on documenting inventions here.

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