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April 8, 2010

Inventor Hard On

Vanderbilt University was cocksure that it contributed to the patents behind Cialis®, the currency-squirting erectile energizer. So it sued ICOS, current owner of 5,859,006 and 6,140,329, under 35 U.S.C. § 256, to correct inventorship. The district court decreed that Vanderbilt was pumping dog water. The CAFC affirmed that Vanderbilt had shot its wad.

Vanderbilt University v. ICOS Corp. (CAFC 2009-1258) precedential

The statutory requirements for joint inventorship are found in 35 U.S.C. § 116 which states, in pertinent part:

When an invention is made by two or more persons jointly, they shall apply for patent jointly and each make the required oath, except as otherwise provided in this title. Inventors may apply for a patent jointly even though (1) they did not physically work together or at the same time, (2) each did not make the same type or amount of contribution, or (3) each did not make a contribution to the subject matter of every claim of the patent.

35 U.S.C. § 116 (1988).

Section 116 was amended, in relevant part, in 1984 to clarify the law of joint inventorship by codifying the principles set forth in Monsanto Co. v. Kamp, 269 F. Supp. 818 (D.D.C. 1967). See Kimberly-Clark Corp. v. Proctor & Gamble Distrib. Co., Inc., 973 F.2d 911, 916 (Fed. Cir. 1992). The court in Monsanto stated:

A joint invention is the product of collaboration of the inventive endeavors of two or more persons working toward the same end and producing an invention by their aggregate efforts. To constitute a joint invention, it is necessary that each of the inventors work on the same subject matter and make some contribution to the inventive thought and to the final result. Each needs to perform but a part of the task if an invention emerges from all of the steps taken together. It is not necessary that the entire invention concept should occur to each of the joint inventors, or that the two should physically work on the project together. One may take a step at one time, the other an approach at different times.

Monsanto, 269 F. Supp. at 824.

In Kimberly-Clark, we applied section 116 to a situation where Proctor & Gamble wished to attribute inventor status to one of its employees who did not collaborate with the named inventor. 973 F.2d at 912-13. While both employees worked on the same subject matter, the court noted that the named inventor "worked alone and was completely unaware of earlier work done by other [] employees." Id. at 913. The court reviewed the amendments and Monsanto and stated that:

For persons to be joint inventors under Section 116, there must be some element of joint behavior, such as collaboration or working under common direction, one inventor seeing a relevant report and building upon it or hearing another's suggestions at a meeting. Here there was nothing of that nature. Individuals cannot be joint inventors if they are completely ignorant of what each other has done until years after their individual efforts. They cannot be totally independent of each other and be joint inventors.

Kimberly-Clark, 973 F.2d at 917.

A primary focus of section 116 has thus always been on collaboration and joint behavior. A person must contribute to the conception of the claimed invention to qualify as a joint inventor. Eli Lilly & Co. v. Aradigm Corp., 376 F.3d 1352, 1359 (Fed. Cir. 2004). Yet, each contributor need not have their own contemporaneous picture of the final claimed invention in order to qualify as joint inventors. See Fina Oil & Chem. Co. v. Ewen, 123 F.3d 1466, 1473 (Fed. Cir. 1997) ("One need not alone conceive of the entire invention, for this would obviate the concept of joint invention."). Rather, "the qualitative contribution of each collaborator is the key - each inventor must contribute to the joint arrival at a definite and permanent idea of the invention as it will be used in practice." Burroughs Wellcome Co. v. Barr Labs. Inc., 40 F.3d 1223, 1229 (Fed. Cir. 1994). The interplay between conception and collaboration requires that each co-inventor engage with the other co-inventors to contribute to a joint conception.

Glaxo had transferred ownership of the patents-in-suit to ICOS.

In its analysis, the district court noted that 35 U.S.C. § 116, the applicable section for joint inventorship, sets "no explicit lower limit on the quantum or quality of inventive contribution required for a person to qualify as a joint inventor." Vanderbilt Univ. v. ICOS Corp., 594 F. Supp. 2d 482, 504 (D. Del. 2009) (quoting Fina Oil & Chem. Co. v. Ewen, 123 F.3d 1466, 1473 (Fed. Cir. 1997)). The district court further noted that "a person is a joint inventor 'only if he contributes to the conception of the claimed invention.'" Id. (quoting Eli Lilly & Co. v. Aradigm Corp., 376 F.3d 1352, 1458-59 (Fed. Cir. 2004)). After a summary of the law regarding conception of chemical compounds, the district court concluded that "conception of a chemical substance includes knowledge of both the specific chemical structure of the compound and an operative method of making it" and "does not occur unless one has a mental picture of the structure of the chemical." Id. (quoting Burroughs Wellcome Co. v. Barr Labs., Inc., 40 F.3d 1223, 1230 (Fed. Cir. 1994) and Amgen, Inc. v. Chugai Pharm. Co., Ltd., 927 F.2d 1200, 1206 (Fed. Cir. 1991)). The district court determined that the Vanderbilt Scientists could not be co-inventors because they never "conceived the specific chemical structure of the compound claimed or the compound with all of its components." Id. at 505 (citations omitted).

To guide its analysis, the district court reviewed our decision in American BioScience and concluded the case contained similar facts and thus controlled its decision. Id. at 504-05. 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.

The district court concluded that "[b]ecause there is no evidence that [the Vanderbilt Scientists] ever conceived the 'specific chemical structure of the compound' claimed, Burroughs Wellcome, 40 F.3d at 1230, or 'the compound with all of its components,' American BioScience, 333 F.3d at 1340, or communicated that compound to Glaxo, plaintiff has failed to demonstrate by clear and convincing evidence, that Corbin, Francis and Konjeti are coinventors of the patents at issue." Id. The district court noted that "even if the court were to find that plaintiff's disclosure of [the Vanderbilt Structural Features] led to the identification of GR30040x and the subsequent discovery of tadalafil, American BioScience precludes the result plaintiff seeks: namely, that the contribution of a molecular scaffold in the context of one molecule . . . renders the disclosing party or parties inventors of a different family of molecules containing the same scaffold." Id. at 506-07.

Vanderbilt admitted in the district court that it had no direct evidence to support its view of the facts; instead Vanderbilt argued that it "need not prove specifically how that occurred, but simply how it logically could have occurred."

To succeed on its claim to joint inventorship, Vanderbilt must prevail by clear and convincing evidence. Our precedent has long required proof of misjoinder or nonjoinder of co-inventors by clear and convincing evidence. See Eli Lilly & Co. v. Aradigm Corp.,376 F.3d 1352, 1364 (Fed. Cir. 2004); Ethicon v. U.S. Surgical Corp., 135 F.3d 1456, 1460-61 (Fed. Cir. 1998); Hess v. Advanced Cardiovascular Sys., Inc., 106 F.3d 976, 980 (Fed. Cir. 1997). The district court correctly concluded that Vanderbilt failed to meet its burden.

Affirmed.

The district court wasn't entirely on target. There were stains on the sheets.

Vanderbilt is correct that the district court erred in reading American BioScience to find that each co-inventor must have an independent mental picture of the complete compound claimed. Such an interpretation is clearly wrong under our established precedent. Instead, a group of co-inventors must collaborate and work together to collectively have a definite and permanent idea of the complete invention. Similarly, the district court's statement that "the contribution of a molecular scaffold in the context of one molecule" could never rise to the level of joint inventorship for "a different family of molecules containing the same scaffold" is in error. Vanderbilt Univ., 594 F. Supp. 2d at 506-07. "The determination of whether a person is a joint inventor is fact specific, and no bright-line standard will suffice in every case." Fina Oil & Chem. Co. v. Ewen, 123 F.3d 1466, 1473 (Fed. Cir. 1997). Our case law was not intended to create such a bright line rule as was used by the district court.

DYK dissented, finding "the findings are either contradictory or infected by the court's legal error. I would vacate the judgment and remand, requiring the district court to make findings of fact in light of the correct law."

Posted by Patent Hawk at April 8, 2010 4:21 PM | Case Law

Comments

Got to give you a hand, Hawk - nice job.

Of course, with such titilating subject matter, I expect this to be blown out of all proportion to the rather straight forward legal underpinnings.

I also expect a few Beavis-Butthead jokes along the way.

Posted by: Pedantic Pete at April 9, 2010 6:05 AM

The thought of naked profits was enough to arouse Vanderbilt's desire to pitch a tent on ICOS' intellectual property, but the cold hand of the CAFC left their once swollen members limp with frustration. Their position was pure legal wankery to begin with. Perhaps some extra legal lotion would have helped keep their points going. After an initially solid start, in the heat of the action their big gun started to droop, and now it looks like their general counsel won't be able to perform where it counts. Since they weren't able to score a piece of Cialis, one has to wonder how long before their Office of Technology becomes unsatisfied with the relationship and starts looking for less flaccid representation?

Posted by: Lazy Willy at April 9, 2010 5:05 PM

Vanderbilt's reaction and prospects for a SCOTUS appeal here:
http://www.nashvillepost.com/news/2010/4/14/moment_is_not_right_for_vus_drug_patent_bid.

Posted by: Tom Wood at April 14, 2010 4:44 PM