The district court recognized that in American BioScience we declined to add inventors who provided the "starting materials" for a chemical compound. See Bd. of Educ. ex rel. Bd. of Trustees of Fla. State Univ. v. Am. BioScience Inc., 333 F.3d 1330 (Fed. Cir. 2003) (" American BioScience"). The district court found that "[t]he `Vanderbilt Structural Features' constitute no more than a `specific portion[] of a claimed compound' in the language of American BioScience." Vanderbilt Univ., 594 F.Supp.2d at 505.
In step one, the Court must first determine whether Defendants have proven a threshold level of both materiality and intent. Board of Educ. ex rel. Bd. of Trs. of Fla. State Univ. v. Am. Bioscience, Inc., 333 F.3d 1330, 1343 (Fed. Cir. 2003) ("First, the trial court must determine whether the conduct meets a threshold level of materiality. The trial court must then also determine whether the evidence shows a threshold level of intent to mislead the PTO."); B.F. Goodrich Co. v. Aircraft Braking Sys. Corp., 72 F.3d 1577, 1584 (Fed. Cir. 1996) ("One alleging inequitable conduct must prove the threshold elements of materiality and intent by clear and convincing evidence.").
โ Id. โBecause the issuance of a patent creates a presumption that the named inventors are the true and only inventors, the burden of showing misjoinder or nonjoinder of inventors is a heavy one and must be proved by clear and convincing evidence.โ Bd. of Educ. v. Am. BioSci., Inc., 333 F.3d 1330, 1337 (Fed.Cir.2003) (citations omitted). โA joint invention is the product of a collaboration between two or more persons working together to solve the problem addressed.โ
]" Amgen, Inc. v. Chugai Pharm. Co., Ltd., 927 F.2d 1200, 1206 (Fed. Cir. 1991). 84. Indeed, on facts analogous to those at bar, the Federal Circuit in The Boardof Education of the Board of Trustees of Florida State University v. American Bioscience, Inc., 333 F.3d 1330 (Fed. Cir. 2003) (hereinafter, " American Bioscience"), declined to add as inventors scientists who contributed the "starting materials" for a chemical compound. The Court there held that conception of a chemical compound requires "a conception of the specific compounds being claimed, with all of their component substituents."
Moreover, "[o]ne does not qualify as a joint inventor merely by assisting the actual inventor." Bd. of Educ. ex rel. Bd. of Trs. of Florida State Univ. v. Am. Bioscience, Inc., 333 F.3d 1330, 1338 (Fed. Cir. 2003) (citation omitted). The issuance of a patent creates a presumption that the named inventors are the true and only inventors.
To the extent Plaintiff's assertion can be viewed as a contention Dr. Herkowitz had so little involvement in the invention of the patent that he could not have subjectively believed he was a joint inventor, the argument fails. Inventorship is a question of law. Bd. of Educ. ex rel. Bd. of Trs. v. Am. Bioscience, Inc. , 333 F.3d 1330, 1337 (Fed. Cir. 2003). A joint inventor is a person who makes a significant contribution to the conception or reduction to practice of the invention.
21. To judge the significance of an alleged joint inventor's contribution to the complete invention, a court may consider whether the alleged joint inventor was able at the relevant time period to understand and articulate the inventive team's final operative embodiments. See, e.g., BJ Services Co. v. Halliburton Energy Services, Inc., 338 F.3d 1368, 1373 (Fed. Cir. 2003) Board of Ed. v. American Bioscience, Inc., 333 F.3d 1330, 1340 (Fed. Cir. 2003).3) Ideas Beyond Prior Art
As an initial matter, the "court must determine whether the conduct meets a threshold level of materiality."Florida State University Board of Educ. v. American Bioscience, Inc., 333 F.3d 1330, 1343 (Fed. Cir. 2003). Then, the court must insure that the "threshold level of intent to mislead the PTO" is also present.
Patent issuance "creates a presumption that the named inventors are the true and only inventors." Bd. of Educ. v. Am. Bioscience, Inc., 333 F.3d 1330, 1337 (Fed. Cir. 2003). While a patented invention may be the work of "two or more persons jointly," 35 U.S.C. ยง 116 (2000), each inventor must "generally contribute to the conception of the invention[,]" Bd. of Educ., 333 F.3d at 1337.
"Inequitable conduct includes affirmative misrepresentation of a material fact, failure to disclose material information, or submission of false material information, coupled with an intent to deceive." Board of Educ. ex rel. Bd. of Trustees of Fla. State Univ. v. Am. Bioscience, Inc., 333 F.3d 1330, 1343 (Fed. Cir. 2003). The standard for establishing inequitable conduct is a demanding one: