n Dawson v. Dawson
[an enhanced version of this opinion is available to lexis.com
subscribers], the Federal Circuit considered an unusual case with a
question that often arises in interferences: when did the inventor invent the
subject matter at issue. While the decision does not break new ground in the
law of conception, it highlights the issues that can arise when an inventor changes
employment before an invention has been reduced to practice.
The Invention at Issue
The invention at issue relates to methods of treating eye
infections using topical azalide antibiotics. Dr. Dawson worked on the
invention while he was at the University of California, San Francisco ("UCSF"),
but did not file a patent application directed to the invention until he was at
InSite Vision Incorporated. The basic question presented by this case is
whether Dr. Dawson had conceived the invention while he still was at UCSF.
Dr. Dawson was working at UCSF in the summer of 1997,
when he attended "the inaugural meeting of the World Health Organization
("WHO") Alliance for the Elimination of Trachoma." As noted by the Federal
Circuit, Dr. Dawson gave a presentation at the meeting "related to the topical
use of an antibiotic called azithromycin to control trachoma."
According to the Federal Circuit opinion, soon after the
WHO meeting, Dr. Dawson asked a colleague affiliated with UCSF, Dr. Chern, to
seek the assistance of Lyle Bowman, an employee at InSite Vision Incorporated,
to develop a topical ophthalmic azithromycin composition.
In late July, Dr. Chern also reached out to Dr. Leiter,
another colleague affiliated with UCSF who was a pharmacist. By August 4, 1997,
Dr. Leiter had prepared a 0.5% azithromycin ointment with a mineral oil and
petrolatum carrier. According the Federal Circuit decision, there was no
evidence that Dr. Chern had contacted Dr. Leiter at Dr. Dawson's request.
By 1998, Dr. Dawson was working at InSite. On March 31,
1999, Dr. Dawson and Dr. Bowman filed a patent application directed to "Topical
Treatment or Prevention of Ocular Infections." The application named both
Dawson and Bowman as joint inventors, and was assigned to InSite. The application
eventually led to the two patents at issue in the interference: U.S. Patent
6,239,113 (granted May 29, 2001) and U.S. Patent 6,569,443 (granted May 27,
On May 8, 2007, UCSF filed its own patent application
naming only Dr. Dawson as the inventor and claiming priority to the InSite
patent applications, in order to provoke an interference with the InSite
patents. According to the Federal Circuit decision, UCSF "generally copied the
specification and claims from the '113 and '443 patents." Dr. Dawson did not
sign an Inventor's Declaration for the UCSF application, but it was filed on
his behalf under the procedures of 35 USC § 118.
The USPTO declared two interferences between the UCSF
application and each of the InSite patents.
Interference 105,719 involved the '113 patent and
contained the following count:
A process for treating an eye, which comprises:
topically applying an aqueous polymeric suspension of an azalide antibiotic,
wherein said suspension comprises water, 0.01% to 1.0% of an azalide
antibiotic, and 0.1 to 10% of a polymeric suspending agent which is a
water-swellable water-insoluble cross-linked carboxy-vinyl polymer which
comprises at least 90% acrylic acid monomers and 0.1% to 5% crosslinking agent.
Interference 105,729 involved the '443 patent and
contained the following count:
A process for treating an eye, comprising:
topically applying an azalide antibiotic to an eye in an amount effective to
treat infection in a tissue of the eye, wherein said topically applying comprises
supplying a depot of a composition containing said azalide antibiotic on the
Because the UCSF application had the latest priority
date, UCSF was the junior party in both interferences. Thus, UCSF "bore the
burden of proving, by a preponderance of the evidence, that Dr. Dawson alone
had conceived of the inventions recited in the counts prior to March 1999."
The USPTO Board found that UCSF failed to carry its
burden, and the Federal Circuit found no reason to overturn the Board decision.
As the Federal Circuit noted, UCSF's case was unusual in that it did not put on
any testimony from Dr. Dawson, but relied on contemporaneous disclosures, such
as those made at the WHO meeting.
Establishing a Date of Conception
The Federal Circuit began its analysis with a restatement
of settled law surrounding conception:
[Conception] is the "'formation in the mind of the
inventor, of a definite and permanent idea of the complete and operative
invention, as it is hereafter to be applied in practice.'" Hybritech Inc. v.
Monoclonal Antibodies, Inc., 802 F.2d 1367, 1376 (Fed. Cir. 1986) (quoting 1
Robinson on Patents 532 (1890)) [enhanced version].
[Conception is complete when] "all that remains to be
accomplished, in order to perfect the art or instrument, belongs to the
department of construction, not creation." 1 Robinson 532.
"Conception is complete only when the idea is so clearly
defined in the inventor's mind that only ordinary skill would be necessary to
reduce the invention to practice, without extensive research or experimentation."
Burroughs Wellcome Co. v. Barr Labs., Inc., 40 F.3d 1223, 1228 (Fed. Cir.
"An idea is definite and permanent when the inventor has
a specific, settled idea, a particular solution to the problem at hand, not
just a general goal or research plan he hopes to pursue." Burroughs Wellcome
Co. v. Barr Labs., Inc., 40 F.3d 1223, 1228 (Fed. Cir. 1994) [enhanced version].
"Because it is a mental act, courts require corroborating
evidence of a contemporaneous disclosure that would enable one skilled in the
art to make the invention." Burroughs Wellcome Co. v. Barr Labs., Inc., 40 F.3d
1223, 1228 (Fed. Cir. 1994).
The Federal Circuit found no reason to disturb the
Board's finding that UCSF had not shown that Dr. Dawson had a complete
conception of the invention before the InSite application was filed. The court
At best, as the Board found, the WHO Report and WHO
document announce a general idea, acknowledge many of the difficulties
associated with making that idea operative, and offer some thoughts on how one
might proceed (including by listing a few potential delivery vehicles). The WHO
document is entitled "Potential Use of Topical Azithromycin in Trachoma Control
Programmes," and the WHO Report describes Dr. Dawson's presentation as a "preliminary
report on the possibility of developing a topical application of azithromycin,"
while "recommend[ing] that [Dr.] Dawson continue to work with [others] to
develop a topical application and report back at the next meeting."
As the court noted, "a 'preliminary' statement about a
'possibility' or 'potential use,' alongside a recommendation for continued work
and a 'report back' in the future, falls short of a 'definite and permanent
idea of the complete and operative invention, as it is hereafter to be applied
The Federal Circuit also noted a lack of evidence of
conception of specific aspects of the interference counts, such as the strength
of the formulations and the specific carriers.
Conception Versus Reduction to Practice
One of UCSF's arguments on appeal was that "the Board
improperly required a showing of reduction to practice in order to prove
conception." This arguments was based on the Board's requirement for a showing
that "Dr. Dawson knew his invention would be effective to treat an actual
infection." According to UCSF, Dr. Dawson "did not need to know that his
invention would work to satisfy conception [but] need[ed] only to have
conceived that his topical use of azithromycin would be effective."
The Federal Circuit found that this line of argumentation
was "based on an erroneous view of what is needed to prove conception." The
Federal Circuit explained:
Quite apart from reduction to practice, conception
requires that the inventor know how his "'definite and permanent idea of the
complete and operative invention . . . is hereafter to be applied in
practice.'" ... In other words, part of the conception inquiry asks whether the
inventor "possess[ed] an operative method of making [the invention]." .... So
while UCSF is correct that "an inventor need not know that his invention will
work for conception to be complete," ... there is a critical difference between
conceiving a way to make an idea operative and knowing that a completed
invention will work for its intended purpose. The Board held that UCSF's
evidence of sole conception by Dr. Dawson was insufficient to prove the former.
Clear as mud, right?
Judge Reyna's Dissent
Judge Reyna dissented from the majority opinion. In his
view, UCSF had presented sufficient evidence to show that Dr. Dawson had
conceived of the invention while still employed by UCSF, and that his later
work at InSite related to reduction to practice.
How Did This Case Get This Far?
The Federal Circuit notes that InSite filed
"cross-appeals from the Board's failure to rule that all of the claims in
UCSF's application are unpatentable under 35 U.S.C. §§ 102(b) and 135(b)."
While the court ruled that the cross-appeals were "inappropriate because they
do not present the prospect of enlarging InSite's rights or lessening those of
UCSF," they seem to be compelling arguments on the merits.
The InSite patents were granted years before the UCSF
application was filed. How could the InSite patents not anticipate the claims
under 35 USC § 102(b)? How could the copied claims not be barred by 35 USC §
132(b)? Isn't 35 USC § 132(b) meant to be a statute of repose that spares a
party from having to defend its claims in an interference proceeding brought
years too late?
The answer appears to lie in the priority claim in the
UCSF application to the earlier InSite patent applications. Because the UCSF
application was filed while an InSite application still was pending and named
Dr. Dawson as the inventor, UCSF was able to claim priority under 5 USC § 120
to the earlier InSite applications, and avoid the consequences of both § 102(b)
and § 135(b).
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