Friday, April 09, 2010

Vanderbilt University loses in tadalafil case

In Vanderbilit University v. ICOS on an assertion of joint inventorship by Vanderbilt scientists, Vanderbilt lost at the CAFC:
The district court entered final judgment on January 29, 2009, concluding that Vanderbilt failed to prove that the Vanderbilt Scientists are joint inventors of the '006 and '329 patents. Vanderbilt appeals the district
court's final judgment. For the reasons stated below, we affirm.

Evidence of dates arose in the case:

Vanderbilt takes issue with Glaxo's story because Glaxo's internal testing records
indicate that GR30040x was first tested by Glaxo on April 23, 1992. The Elgoyhen
article was not published until May 8, 1992. As the district court found, GR30040x could
not have been identified based upon the Elgoyhen reference.

Minutes of internal meetings came up:

ICOS also points to Glaxo documents to corroborate various details of its story.
For example, the minutes of a Glaxo Cardiovascular Research Management Committee
meeting in April 1992 describe GR35273x as a compound used in a different study. In
the June 1992 minutes, the same committee noted that GR35273x displayed a high
PDE5 inhibition activity and noted that Glaxo was starting a program testing GR35273x
analogs. At the same meeting, GR30040x was identified as a new PDE5 inhibitor.

One has an issue "university input vs. standard approach":

Vanderbilt argues that this modification
directly uses the results of the Vanderbilt Scientists' research. ICOS responds that the
modifications were all part of a standard trial and error procedure that would be tried
with any molecules of interest.

IPBiz notes that arguing something is obvious (to get rid of a joint inventorship claim)
could be dangerous in a KSR world:

Dr. Labaudiniere characterizes the modifications leading to tadalafil as
"obvious" and conducted in a "trial-and-error" fashion. There is no testimony or
documentary evidence demonstrating a link between the Vanderbilt Scientists and
Dr. Daugan prior to the identification of tadalafil.

Here, Vanderbilt needed to prove its assertion, and it did not have the evidence:

Vanderbilt admits that no direct evidence supports its claims to joint
inventorship. (...)

Our precedent has long required proof of misjoinder or nonjoinder
of co-inventors by clear and convincing evidence.3 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.

Vanderbilt lost EVEN THOUGH the district court got the law wrong:

The district court understood our decision in American BioScience to require that
each co-inventor have an independent conception of the final compound for a chemical
invention. The district court ruled that because the Vanderbilt Structural Features
constitute no more than a portion of a claimed compound, the Vanderbilt Scientists
cannot, as a matter of law, be joint inventors. Vanderbilt Univ., 594 F. Supp. 2d at 505.


In American BioScience the court was faced with choosing between two competing groups of

Prior to the invention of the compounds at issue in American BioScience,
Dr. Tao, a scientist at Florida State University ("FSU"), left FSU to join a group of
scientists at American BioScience that were working on similar subject matter. Id. at
1333-35. Shortly after Dr. Tao joined American BioScience, the company filed a patent
application that led to the patent in suit, which claimed three taxol analog compounds.
The patent named Dr. Tao and three American BioScience scientists as joint inventors.
In the district court, FSU claimed that the patent named the wrong inventors.


Properly understood, American BioScience correctly states the law
governing joint inventorship. Absent conception within an inventorship team, there can
be no invention.

This court began its inquiry with the statement that "[i]nvention requires
conception, and 'conception does not occur unless one has a mental picture of the
structure of the chemical . . . or whatever characteristics sufficiently distinguish it. It is
not sufficient to define it solely by its principal biological property.'" American
BioScience, 333 F.3d at 1340 (quoting Amgen Inc. v. Chugai Pharm. Co., 927 F.2d
1200, 1206 (Fed. Cir. 1991)). This court held that the FSU group could not have been
the true inventors unless the group had a complete mental picture of the structure of the
chemical compounds at issue, and continued its analysis with the language relied upon
by the district court. See id. at 1340 ("One must have a conception of the specific
compounds being claimed, with all of their component substituents, and the record does
not support a finding that [anyone in the FSU group] conceived the three claimed
compounds . . . .").


The court's finding in American
BioScience was premised on the fact that the FSU and American BioScience scientists
were not working together, but rather competing for the patent rights in the compounds
at issue. There was no evidence of conception within the FSU group, and this court
found sufficient evidence of conception within the American BioScience group.

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.

**Discussion of case on patenthawk blog:

**Think IP Strategy [Marie Louise Mortimer]


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