CPLRG™ 0044 - Vanderbilt University v. ICOS Corp. - Apr. 7, 2010

Vanderbilt University v. ICOS Corp., 601 F.3d 1297 (Fed. Cir. 2010) (CLEVENGER & Michel; DYK, concurring-in-part & dissenting-in-part)Vanderbilt04072010

MAJOR ISSUES: inventorship correction; joint inventors of chemical compound; conception

COMMENT.  “Conception” is a key element for determining an invention date.  Many decisions dating back more than a century address what constitutes a “conception” for purposes of determining priority in implementing the United States first-to-invention priority system.  However, as this case illustrates, conception is as important for determining the “who” of an invention as it is for the “when.” Thus, the currently discussed transition to a first-to-file priority system will not eliminate “conception” from the realm of United States patent law.
     At issue in this case is the standard of conception when the claimed invention is a chemical compound or composition.  A district court interpreted a passage in Bd. Of Educ. ex rel. Bd. of Trustees of Fla. State Univ. v. American BioScience Inc., 333 F.3d 1330 (Fed. Cir. 2003), as requiring that, to be a joint inventor of a claimed chemical compound, a person must have conceived and communicated the compound’s specific structure or the compound with all its components.  The Federal Circuit held that district erred in that interpretation.
     The passage in American BioScience recited:  “Having in mind specific portions of a claimed compound is not the same as conceiving the compound with all of its components.  One must have a conception of the specific compounds being claimed, with all of their component substituents ….” 333 F.3d at 1340 (emphasis added).  American BioScience involved a choice between “two competing groups of inventors”: scientists at a university (FSU) and scientists at a company who were named as inventors on a patent.  There was no evidence that the FSU group, individually or as a group, had a conception of the complete structure of the compound as claimed.  Reading American BioScience as requiring that “co-inventor must have an independent mental picture of the complete compound claimed” was contrary to precedent.  Instead, the law is that “a group of co-inventors must collaborate and work together to collectively have a definite and permanent idea of the complete invention.”
     Also, the district court erred in stating that contributing a “molecular scaffold” from one molecule could never be joint inventorship for a different molecule.   For joint inventorship, there is “no bright-line standard.”  A joint inventor’s contribution to a conception of an invention must be “not insignificant,” but here is no qualitative or quantitative threshold.
     It turned out that the district court’s erroneous interpretation of American Bioscience was harmless error because its factual finding of no contribution to conception and, therefore, no joint inventorship was not clearly erroneous.

1. TADALAFIL; PDE5 INHIBITOR.  Two patents claimed a chemical compound, tadalafil, a “PDE5” inhibitor. U.S. Pat. No. 5,859,006 USPatNo5859006; U.S. Pat. No. 6,140,329 USPatNo6140329.
     a. NAMED INVENTOR: DAUGAN; BILLION DOLLAR “ERECTILE DYSFUNCTION DRUG.”  Tadalafil is the active ingredient in the “erectile dysfunction” drug, Cialis®.  Glaxo obtained the patent, naming its scientist, Daugan, as the inventor.  and in 1991 assigned ownership to ICOS.  EDITORIAL NOTE:  Estimated sales of the drug Cialis® for 2010 exceed $1 billion.  See “Lilly Buys Out Cialis Partner,” http://www.forbes.com/2006/10/17/lilly-icos-cialis-markets-equity-cx_mh_pk_1017markets12.html.
     b. BACKGROUND:  cGMP; KINASE; PDE5; PDE5 INHIBITORS.  A cyclic nucleotide cGMP binds to and activates a protein (kinase), which dilates smooth muscle cells.  PDE5 binds to and breaks down cGMP.   A PDE5 inhibitor, such as the claimed compound tadalafil, binds to the PDE5 and prevents it from breaking down cGMP.
     c. VANDERBILT SCIENTISTS: EARLY DISCOVERERS OF PDE5; VANDERBILT-GLAXO RESEARCH PROGRAM.  Vanderbilt’s scientists Corbin and Francis were among the first to discover PDE5.  From 1989 to 1991, Glaxo underwrote the Vanderbilt scientists’ research on cGMP analogs.  During the program, the Vanderbilt scientists made presentations to Glaxo.   After the program, the Vanderbilt scientists continued their work.  They modified a compound IBMX to obtain a more potent PDE5 inhibitor.
      In January 1992, Vanderbilt scientist Corbin sent a research proposal concerning its IBMX analog to Glaxo’s scientist Ross in the United Kingdom.  On February 24 1992, Corbin sent a more detailed proposal, which included what Vanderbilt later referred to as the “Vanderbilt Structural Features.”
     In France, beginning in March 1992, Glaxo scientists began testing compounds for PDE5 inhibition.  On March 11 and 12, 1992, they tested 26 compounds, including GR35273x.  On April 8, 1992, UK Glaxo scientist Ross forwarded the February Vanderbilt proposal to Glaxo France scientist Labaudiniere.   On April 23, 1992, the Glaxo France scientists tested 29 compounds, including GR30040x.  All 29 compounds had some of the “Vanderbilt Structural Features”; 11 had nearly all of them.  Glaxo France scientist Labaudiniere selected GR30040x as the lead compound for further PED5 inhibition research and delegated the work to named inventor Daugan.  Daugan made modifications to the lead compound, resulting in the patented compound tadalafil.

2. INVENTORSHIP CORRECTION SUIT.  In 2005, Vanderbilt University brought a Section 256 suit against ICOS to correct inventorship of the patent by adding three of its scientists (Corbin, Francis, Konjet) as joint inventors along with the Glaxo scientist Daugan.
     a. TWO STORIES.  The district court noted that Vanderbilt and the patent owner presented two conflicting stories at trial.
          i.  Vanderbilt’s story was that it had disclosed to Glaxo, as part of a research funding proposal, compounds with a structure (the “Vanderbilt Structural Features”) and that the Glaxo used those structures in two ways.
     First, Vanderbilt argued that Glaxo scientist Labaudiniere used the Vanderbilt information to select a lead compound, GR30040x.
     Second, Vanderbilt argued that the named inventor Daugan used Vanderbilt information to make molecular modifications to GR30040x to achieve the claimed compound, tadalafil.
          ii. The patent owner ICOS’ story was that its scientists selected the lead compound and modified it independently of any Vanderbilt information.  The Vanderbilt scientists only direct contact was with the Glaxo scientist in UK and not with the Glaxo scientists in France.  Originally, ICOS’s theory was that Labaudiniere discovered the lead compound based on a review of two articles including a 1992 “Elgoyhen article.”  Vanderbilt impeached that the theory by showing that the article was dated May 1992 whereas records showed that the lead compound GR30040x was tested on April 23, 1992.  ICOS shifted to another theory: that Labaudiniere selected from another Glaxo project a compound GR35273x, tested it in March 1992, the tests showing good results, and then did a search using GR35273x’ “tetrahydro beat-carboline scaffold”, thereby identifying GR30040x.  Internal Glaxo documents collaborated the revised story: minutes of an April 1992 meeting described GR35273x and those of a June 1992 meeting reported favorable PDE5 inhibition for GR35273x and identified GR30040x as a new PDE5 inhibitor.
     b. DISTRICT COURT.  After a trial, a district court denied correction.  Vanderbilt Univ. v. ICOS Corp., 594 F. Supp. 2d 482, 504 (D. Del. 2009).
     The district court reasoned that American BioScience was controlling, that it required that a co-inventor have “conceived the specific structure of the compound claim,” and that Vanderbilt failed to establish that the Vanderbilt scientists had conceived the claimed compound.  Under BioScience, “the contribution of a molecular scaffold in the context of one molecule” did not make a disclosing party an inventor of “a different family of molecules containing the same scaffold.”
     Having concluded that American BioScience was controlling, the district court went on to analyze in detail “the remaining facts.”   On the Labaudiniere’s identification of GR30040x, the district court found that there were the two “equally plausible” stories.  On Daugan’s identification of tadalafil, the district court found that there was no direct evidence of any communication of the Vanderbilt Structural features to Daugan or any facts supporting an inference of such communication.

3. As noted above, the Federal Circuit held that the district court misunderstood “the relevance of American BioScience to the facts of this case.”

4. However, the district court’s errors were “harmless in context.”
     a. The Section 256 claimant Vanderbilt had the burden of proving nonjoinder of inventorship by clear and convincing evidence.
     b. EQUALLY PLAUSIBLE STORES.  The district court found that “the parties’ respective stories about whether the Vanderbilt Scientists contributed to the identification of GR30040x were `equally plausible’ and that Vanderbilt failed to produce any evidence of joint invention of tadalafil.”  Its findings were not clearly erroneous.

CROSS REFERENCES.  On the standards for joint inventorship, see Chisum Patent Law Digest 1810; Chisum on Patents 2.03

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