University of Colorado Foundation, Inc. v. American Cyanamid Co.

342 F.3d 1298, 2003 WL 22052034
CourtCourt of Appeals for the Federal Circuit
DecidedSeptember 3, 2003
DocketNo. 02-1587
StatusPublished
Cited by6 cases

This text of 342 F.3d 1298 (University of Colorado Foundation, Inc. v. American Cyanamid Co.) is published on Counsel Stack Legal Research, covering Court of Appeals for the Federal Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
University of Colorado Foundation, Inc. v. American Cyanamid Co., 342 F.3d 1298, 2003 WL 22052034 (Fed. Cir. 2003).

Opinion

GAJARSA, Circuit Judge.

Drs. Robert H. Allen and Paul A. Selig-man (collectively, “the Doctors”) developed an idea to reformulate a prenatal multivitamin/mineral supplement. The Doctors described their idea in a confidential manuscript to American Cyanamid Company’s (“Cyanamid’s”) Chief of Nutritional Science, Dr. Leon Ellenbogen, who copied parts of that manuscript to obtain U.S. Patent No. 4,431,634 (“the '634 patent”). The United States District Court for the District of Colorado held, inter alia, Cyan-amid liable for fraudulent nondisclosure and unjust enrichment. Univ. of Colo. Found., Inc. v. Am. Cyanamid Co., 216 F.Supp.2d 1188 (D.Colo.2002) (“Cyanamid V”). In addition to compensatory damages, the district court awarded exemplary damages of $500,000 to each of the Doctors. Because the district court did not err in its determination of unjust enrichment and calculation of damages, we affirm.

[1301]*1301I. BACKGROUND

A. The Patented Claims

We briefly revisit the long and storied history of this litigation1 as a preface to the discussion of the issues on appeal. Our recitation of the facts is based on the findings made by the district court after trial.

Prenatal supplements containing 60-65 mg of iron are widely used to ensure that pregnant women absorb the approximately 3.5 mg of supplemental iron per day they require because iron deficiency is a serious concern for pregnant and lactating women. Cyanamid’s Lederle Laboratories manufactures and markets Materna 1.60 (“Ma-terna”), a prenatal multivitamin/mineral supplement containing 60 mg of iron.

In 1979, Stuart Pharmaceutical, the manufacturer of a competing prenatal supplement Stuartnatal 1 + 1 (“Stuartnatal”), began advertising that its product provided superior iron absorption to that of Ma-terna. To refute these claims and protect Cyanamid’s market share,2 Dr. Ellenbogen asked his friend and long-time professional colleague, Dr. Allen, a professor of medicine, professor of biochemistry, and Director of hematology at the University of Colorado Health Sciences Center, if he would be interested in performing a study to compare the iron absorption in women of Stuartnatal to that of Materna. Dr. Allen together with his colleague Dr. Selig-man, .a hematologist and professor of medicine at the University of Colorado Health Sciences Center, conducted the comparison study (“Study I”) in the summer of 1979.

Study I, which determined that pregnant women taking Stuartnatal absorbed 2.0 mg of supplemental iron per day while women taking Materna absorbed 2.8 mg of supplemental iron per day, concluded that the amount of iron absorbed by pregnant women taking Materna was no less, and in fact, slightly better, than by those taking Stuartnatal. Study I also indicated, however, that neither product provided iron absorption in an amount approaching the 3.5 mg of supplemental iron per day recommended for pregnant women.

The Doctors conducted three follow-up studies (“Studies IA, II, and' TIA”) and determined that large amounts of calcium carbonate and magnesium oxide in Mater-na were inhibiting iron absorption and that Materna could be reformulated to reduce or eliminate this effect. Studies IA, II, and IIA, were conceived of, designed and conducted by the Doctors independently of Dr. Ellenbogen and Cyanamid. Test subjects were paid from the University of Colorado (“University”) hematology division’s general account.

[1302]*1302Importantly, Study IIA, conducted in February of 1980, revealed that there was an inhibitory “threshold effect with calcium carbonate” and determined the specific levels of calcium carbonate and magnesium oxide at which the inhibitory effect occurs. As Dr. Allen explained at trial, “It wasn’t [that] you got inhibition increasing at every level, but at 200 milligrams, somewhat more than that, you did not get inhibition, and that led to the second reformulation, the one I described in the March 1980 letter.” Dr. Allen sent a letter to Dr. Ellenbogen in March of 1980 referencing the enclosed results of Study IIA:

The data indicate that there is no significant inhibition of iron absorption by either 350 mg of calcium in the form of calcium sulfate or 200 mg of calcium in the form of calcium carbonate. As we have discussed previously, I believe that the next step would be for Lederle to reformulate their Materna preparation .such that it contains 200 mg of calcium in the form of calcium carbonate and 25 mg of magnesium in the form of magnesium sulfate or magnesium oxide. Once this is done, we will test this preparation versus iron alone and I would expect that the absorption of iron from the new Materna should be similar to that of iron alone.

While there is no dispute that the Doctors communicated with Dr. Ellenbogen throughout this process, and designed their studies, in part, around Cyanamid’s marketing interests with respect to Stuart-natal, the idea for reformulating Materna, and the research concepts and ideas for reformulating Materna with the appropriate combinations of calcium carbonate and magnesium oxide were entirely the Doctors’.

After receiving Dr. Allen’s letter in March 1980, Dr. Ellenbogen drafted a “protocol” for the already completed Study IIA, which he sent to Dr. Allen, and asked Dr. Allen, if he would be interested in performing a new study comparing the iron absorption of Stuartnatal with the various reformulations of Materna suggested by the Doctors. Dr. Allen agreed and in October of 1980, Study III was conducted using two reformulations of Ma-terna suggested by the Doctors’ work in Studies IA, II, and IIA. Reformulation A kept the 350 mg of calcium carbonate present in original Materna but reduced the amount of magnesium oxide from 100 mg to 25 mg. Reformulation B, the formulation ultimately manufactured and marketed as “reformulated Materna,” reduced the amount of calcium carbonate from 350 mg to 250 mg and also reduced the amount of magnesium oxide from 100 mg to 25 mg of magnesium oxide. Study III,'as predicted by the Doctors based on the results of Study IIA, concluded that the reduction in calcium carbonate in the Reformulation B improved iron absorption to 5.0 mg, which was greater than the 3.5 mg recommended for pregnant women.

Subsequently, Cyanamid asked the Doctors to perform another study (“Study IV”) comparing the absorption of iron alone with the absorption of iron from reformulated Materna, Stuartnatal, and two other competing prenatal multivitamin/mineral supplements. Study IV, performed in March of 1981, confirmed that reformulated Materna provided the highest iron absorption of the four prenatal multivitamin/mineral supplements tested.

The Doctors wrote up the results of their studies in an article entitled, “Inadequate Iron Absorption from Many Prenatal Multivitamin-Mineral Supplements.” The focal point of scientific interest in the article was Table I, which presented the results of the Studies I, II, III, and IV in a distinctive format with four main columns, nine subcolumns, and 12 rows. The Doctors submitted a manuscript of the article to the New England Journal of Medicine [1303]*1303for consideration in July of 1981, and sent a confidential copy to Dr. Ellenbogen.3

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