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BOEHRINGER INGELHEIM VETMEDICA v. SCHERING-PLOUGH
October 26, 1999
BOEHRINGER INGELHEIM VETMEDICA, INC., BOEHRINGER INGELHEIM/NOBL LABORATORIES, INC., REGENTS OF UNIVERSITY OF MINNESOTA AND SOUTH DAKOTA STATE UNIVERSITY, PLAINTIFFS,
SCHERING-PLOUGH CORPORATION AND SCHERING CORPORATION, DEFENDANTS.
The opinion of the court was delivered by: Harold A. Ackerman, District Judge.
This matter comes before the court on a motion filed by
Boehringer Ingelheim Vetmedica, Inc. Boehringer Ingelheim/Nobl
Laboratories, Inc., Regents of University of Minnesota and South
Dakota State University (hereinafter collectively "Plaintiffs" or
"Boehringer") seeking a preliminary injunction against
Schering-Plough Corporation and Schering Corporation (hereinafter
collectively "Defendants" or "Schering") pursuant to
35 U.S.C. § 283 (1988) for violating its patent.*fn1 For the reasons
discussed below, Plaintiffs' motion is DENIED.
This action and Plaintiffs' motion for a preliminary injunction
follows this Court's denial of Plaintiffs' motion for a
preliminary injunction with respect to Patent No. 5,476,778 ("the
'778 Patent"), see Boehringer Ingelheim v. Schering-Plough,
984 F. Supp. 239 (D.N.J. 1997) (hereinafter "Boehringer I"), and
denial of both parties' motions for summary judgment regarding
that patent. See Boehringer Ingelheim v. Schering-Plough,
6 F. Supp.2d 324 (D.N.J. 1998) (hereinafter "Boehringer II").
Although the current action addresses Patent No. 5,840,563 ("the
'563 Patent") rather than the '778 Patent, this action is based
upon the same conflict between the parties over a vaccine for a
disease known as Porcine Reproductive Respiratory Syndrome
("PRRS"). Familiarity with the Court's previous opinions is
Shortly after the denial of Boehringer's motion for preliminary
injunction, Schering filed a motion for summary judgment,
Boehringer filed its own summary judgment motion and Boehringer
renewed its motion for a preliminary injunction. By written
opinion issued on April 27, 1998, this Court denied each of those
motions. See Boehringer II, 6 F. Supp.2d 324. First, the Court
denied Boehringer's motion for summary judgment finding that
genuine issues of material fact remained regarding obviousness
and infringement pursuant to the doctrine of equivalents. The
Court also rejected Boehringer's renewed preliminary injunction
motion finding that Boehringer still had not demonstrated either
irreparable harm or that Schering's validity defense was devoid
of substantial merit and thus it was "far from certain that
Boehringer would be likely to succeed on the merit of its
infringement claim." Id. at 338.
While the '778 Patent litigation was pending, Boehringer's
patent application with the United States Patent Office
(hereinafter either "Patent Office" or "USPO") for its '563
Patent was also pending. In November 1998, after the motion
practice in the '778 Patent litigation was completed, the Patent
Office issued to Boehringer the '563 Patent entitled "Method for
Growing Swine Infertility and Respiratory Syndrome Virus" which
named Danny Chladek, David Gorcyca and Louis Harris as inventors.
Shortly thereafter on December 17, 1998, Boehringer commenced the
present action alleging that Schering had infringed its
newly-issued '563 and '805 Patents and by motion filed on January
22, 1999 Boehringer moved for a preliminary injunction to
preclude Schering from selling its allegedly infringing swine
vaccine. Schering opposes Boehringer's newest request for a
preliminary injunction and another preliminary injunction hearing
was held before this Court in June 1999.
The disease at the center of this dispute, PRRS, also known as
Mystery Swine Disease ("MSD") and Swine Infertility and
Respiratory Syndrome ("SIRS"),*fn2 infects pigs and causes them
to give birth to dead or sickly piglets. In addition to these
reproductive failure, PRRS also causes serious respiratory
symptoms and other symptoms such as anorexia, fever, dyspnea, and
neurological impairment. Both Plaintiffs and Defendants have
marketed a vaccine for PRRS since June 1994 and July 1996,
respectively. Tr. at 2.79, 2.92
As discussed supra Boehringer possesses several patents
relating to its PRRS vaccine. According to Plaintiffs, "the '778
patent, . . ., claims methods of growing, isolating, and
attenuating PRRS viruses in simian cells for vaccine preparation.
. . . the '563 patent claims methods of growing the PRRS virus on
simian cells, while the '805 patent claims cultures and
compositions containing the PRRS virus." Pl. Br. at pp. 1-2.
Claim 1 of the '563 Patent, upon which Claim 3 is dependent,
A method of growing swine infertility and respiratory
syndrome virus comprising: (a) inoculating the swine
infertility and respiratory syndrome virus on simian
(b) incubating the inoculated simian cells.
Pl. Br. Ex. A, col. 23, lines 14-18. Claim 2 states, "[t]he
method of claim 1 wherein the simian cells are simian kidney
cells." Id. at lines 19-20. Finally, Claim 3, the Claim in
dispute, states, "[t]he method of claim 2 wherein the simian
kidney cells are MA-104 simian kidney cells." Id. at lines
21-22. Plaintiffs contend that Defendants' swine vaccine
literally infringes the '563 Patent and infringes that patent
under the doctrine of equivalents.
II. Brief Summary of the Arguments
Boehringer has requested a preliminary injunction to enjoin
Schering from selling its swine vaccine and seeks a recall of
Schering's current PRRS vaccines. Boehringer argues that the
prior art which was the basis of this Court's denial of
Boehringer's request for a preliminary injunction in the '778
litigation is not relevant to this patent based upon additional
evidence gathered by Boehringer since the '778 preliminary
injunction hearing. Specifically, Boehringer relies on the
deposition testimony of six of Schering's experts to support its
argument that growing the PRRS virus on MA-104 cells was not
obvious. Therefore, Boehringer argues that this Court should
enjoin Schering from infringing Boehringer's '563 Patent because
there is no longer an issue that its invention is obvious and
because it also satisfies the other requirements necessary for a
In opposition to Boehringer's motion for a preliminary
injunction, Schering challenges the validity and enforceability
of Boehringer's '563 patent as well as Boehringer's ability to
meet the other heavy showing required for a preliminary
injunction. With respect to the likelihood of Boehringer's
success on the merits, Schering asserts three defenses to the
'563 Patent. First, Schering argues that the '563 Patent was not
patentable under 35 U.S.C. § 103(a). Essentially, Schering argues
that since "one of ordinary skill in the art would have a
reasonable expectation that the SIRS virus would grow on simian
cells and in particular MA-104," the '563 Patent is not valid.
Def. Br. at p. 4.
Second, Schering argues that Boehringer's inequitable conduct
during its presentation of the '563 and '778 Patents to the USPO
invalidates the '563 Patent. Specifically, Schering argues that
Boehringer's failure to direct the Patent Office's attention to
the relevant prior art and provide the Patent Office with the
pleadings, briefs and opinions of this Court from the '778
litigation amounted to inequitable conduct which invalidates the
'563 Patent. Schering also argues that Boehringer's inequitable
conduct before the USPO in its prosecution of the '778 Patent
taints the '563 patent rendering it unenforceable. Third,
Schering argues that the '563 Patent violates the written
description requirement for a patent as articulated in
35 U.S.C. § 112 (hereinafter "section 112") because, in part, the
specification is limited to virus ATCC-VR2322 and does not
support Boehringer's broad generic claim.
In response to Schering's obviousness challenge, Boehringer
argues that the prior art relied upon by Schering "relates only
to `simian cells' generally, with MA-104 cells receiving only
parenthetical treatment," Pl. Rep. Br. at p. 1, whereas the
non-obvious innovation within Claim 3 is the growing of PRRS on
M-104 cells, specifically. Id. Boehringer goes on to argue that
the prior success growing viruses on MA-104 cells is restricted
to the four examples shown by Schering which fails to satisfy the
test set forth in section 103(a) and that those four examples are
not instructive with respect to the PRRS virus. Boehringer also
argues that (a) the USPO's issuance of the '563 Patent should be
given deference by this Court, (b) that two of the articles
relied upon by Schering actually "taught away" rather than
encouraged the use of MA-104 cells in PRRS research and (c) the
other prior art relied upon by Schering does not satisfy section
103. Boehringer also responds to Schering's inequitable conduct
accusation by arguing that (a) the prior art relied upon by this
Court in the '778 litigation, other pertinent prior art
references and the existence of the '778 litigation to the Patent
Office and the two patent examiners who reviewed the application
for the '563 Patent (and not buried among irrelevant materials)
and (b) Schering's argument is devoid of any allegation of
intent, a required element for a successful claim of inequitable
conduct. Pl. Rep. Br. at pp. 6-7. In response to Schering's claim
that the '563 Patent is invalid under section 112, Boehringer
argues that both examiners of the USPO believed that Claim 3 was
valid under that section and that the specification is not
limited in the ways argued by Schering. Finally, Boehringer
renews its arguments that it is entitled to a presumption of
irreparable harm and that even without this presumption it has
proven that it will suffer further irreparable harm if its
request for a preliminary injunction is denied.
III. Summary of Testimony
At the preliminary injunction hearing held before this Court in
June 1999, Boehringer called the following witness: Dr.
Easterday, Dr. Michael Murtaugh, Paul Hays and George Gould.
Schering called Dr. Richard Steece, Dr. Robert Rowland and Harry
Manbeck on its behalf. The following is a summary of the
A. Boehringer's Witnesses
Dr. Easterday, an expert in virology with a long-standing
history in the field of animal virology, testified about the
state of the art of virology in 1991 and 1992. Dr. Easterday
stated that at that time, the normal procedure a virologist would
employ to grow a new unknown virus on a culture would be to first
attempt to grow the virus on that homologous species. Tr. at
1.79-1.80.*fn4 The term "homologous species" means that species
in which the virus in known to effect. For example, in this case
since the virus effected swine, the first step would be to
attempt to grow PRRS on swine cells. Tr. at 1.80. Thus, as Dr.
Easterday explained, the first step would be to attempt to grow
the new unknown virus on a cell line from the species which the
virus is known to effect. Id. If this proves unsuccessful, Dr.
Easterday said, the next step is to attempt to grow the unknown
virus on whatever cell
lines are available to the research virologist and it is a matter
of "trial and error." Tr. at 1.80-1.81.
With respect to the prior art that existed in 1991 on the use
of MA104 cells to grow viruses, Dr. Easterday testified that the
use of MA-104 cells was not obvious based upon prior art
available at that time. Specifically, Dr. Easterday testified
that the preeminent book of swine diseases, Diseases of Swine,
available in 1991 taught that only one identified porcine virus
was known at that time to grow on MA-104 cell lines. Tr. at
1.85-1.86; Pl. Exh. 16. Dr. Easterday identified that virus as
porcine rotavirus which is "one of the viruses that infect swine
responsible for enteric disease causing diarrhea of swine." Tr.
at 3.5. Dr. Easterday testified that in 1991 a person of ordinary
skill in the art would not have tried to grow PRRS on MA-104
cells because "there is one — one virus of a very different kind
of disease that was demonstrated to have grown on MA-104 cells,
and given the preponderance of other kinds of things, I don't
think there is anything that leads one to consider that the
MA-104 would have been a cell to try." Tr. at 3.5.
Dr. Easterday then reviewed three articles published prior to
1991 which discuss the mystery surrounding PRRS and the number of
premier investigators of swine diseases who were unable to
determine the cause of PRRS or successfully isolate and grow the
virus. Tr. at 3.11-3.14. Dr. Easterday also discussed an article
"Porcine Reproductive and Respiratory Syndrome" published in the
Seventh Edition of the Diseases of Swine periodical in 1992. Tr.
at 3.15. The etiology of the disease, as described by Dr.
Easterday based upon this article, was premised upon discrediting
several hypothesis that certain known infectious agents were the
likely primary cause of PRRS such as African swine fever,
cholera, hemagglutinnating encephalitis, porcine parvoviruus,
classical swine influenza, encephalomyocarditis virus (commonly
referred to as EMC or EMCV), pseudorabies, porcine enterovirus or
transmissible gastroenteritis virus. Tr. at 3.16-3.18; Pl. Exh.
76. Dr. Easterday explained that based upon this article, one who
was trying to ascertain the causative agent of PRRS would not
pursue any information regarding these eliminated causative
agents. Tr. at 3.18.
Dr. Easterday also referred to four articles which Schering's
experts relied upon in support of their obviousness argument. Tr.
at 3.20; Pl. Exhs. 18-21. He summarized that Exhibit 18, the
"Isolation and Serotyping of Porcine Rotaviruses and Antigenic
Comparison with other Rotaviruses," published in 1984 speaks to
rotaviruses "that were isolated from the intestinal contents of
piglets, pigs with diarrhea using MA-104 cells." Tr. at 3.20; Pl.
Exh. 18. Dr. Easterday explained that Exhibit 19 entitled "Simian
Hemorrhagic Fever, Isolation and Characterization of a Viral
Agent," published in 1968 relates to the isolation and
characterization of a viral agent from rhesus monkeys which
suffered a febrile hemorrhagic disease. Tr. at 3.20-3.21; Pl.
Exh. 19. He explained that Exhibit 20 entitled "Use of
Immunoelectron Microscopy to Show Ebola Virus during 1989 United
States Epizootic," published in 1990, relates to the growth of a
group of viruses related to Ebola that use MA-104 cells. Tr. at
3.21; Pl. Exh. 20. Finally, Dr. Easterday explained that Exhibit
21 entitled "Replication of Infectious Bursal Disease Virus in
Continuous Cell Lines," published in 1986 relates to a chicken
disease which was grown on three mammalian continuous cell lines
including MA-104. Tr. at 3.21; Pl. Exh. 21.
Dr. Easterday said that at the time of Boehringer's invention,
he did not know that swine influenza virus grew on MA-104 cells
even though there was a report by Dr. Mark Goldstein, et al.
(hereinafter referred to as the "Goldstein article") in 1970 that
swine influenza grew on simian cells. Tr. at 3.23; Pl. Exh. 22.
Dr. Easterday explained that the Goldstein article taught that
the simian cells were the least desirable of three cell lines
tested by Dr. Goldstein to grow the swine influenza virus. Tr. at
3.24. Dr. Easterday also testified that it is was more common
that swine influenza was cultured on embryonated chicken eggs and
in fact, he could not recall any other articles documenting the
growth of swine influenza on simian cells. Tr. at 3.23-3.24.
Moreover, Dr. Easterday testified that nobody of ordinary skill
in the art in 1991 would have looked to the swine influenza
literature in researching PRRS because at that time, swine
influenza "had been ruled out as a cause of the PRRS syndrome."
Tr. at 3.25.
In addition, Dr. Easterday reviewed the Drs. Dea and Van
Alstine articles relied upon by Schering and opined that neither
article would have led one to grow PRRS on MA-104 and in fact,
Dr. Van Alstine's failed attempts to grow PRRS on MA-104 cells
would have steered investigators away from MA-104 cells. Tr. at
3.26-3.32. Dr. Easterday rendered the same opinion with respect
to the 1990 Conference of Research Workers in Animal Disease
which documented the successful inoculation of young pigs from
PRRS, the unsuccessful attempts to locate the causative agent of
PRRS but the successful attempts to rule out certain causative
agents. Tr. 3.34-3.36. Dr. Easterday emphasized that without
knowing what the causative agent of PRRS was, one would not know
on what to grow PRRS. Tr. at 3.36.
On cross-examination, Dr. Easterday testified that in 1991,
people seeking the cause of PRRS were not only using porcine cell
lines but were also looking to swine influenza and pseudorabies
as possible causes of PRRS. Tr. at 3.88-3.89. In addition, Dr.
Easterday testified that in January 1991 he was aware that
porcine viruses grew on simian cells from his knowledge of
rotavirus research. Tr. at 3.89. Dr. Easterday also testified
that prior to April 1991, it was common knowledge that one should
try to grow viruses on heterological cells, i.e., from species
other than the host species, and that in October 1990, Dr. Van
Alstine had tried to isolate PRRS by using a small array
including non-homogenous cells and a MA-104 cell line. Tr. at
3.104-3.105. Dr. Easterday concluded from this article, however,
that one should not try the same cells as those tested by Dr. Van
Alstine, including MA-104, because Dr. Van Alstine did not have
success growing PRRS on those cell lines. Tr. at 3.107-3.108. He
also testified that it did not appear that Dr. Van Alstine
included MA-104 cells within the first test array, but added
MA-104 cells after testing cells derived from swine testicles and
baby hamster kidneys. Tr. at 3.115.
Dr. Michael Murtaugh testified at Boehringer's behest regarding
the specification of the '563 Patent as an expert in veterinary
pathobiology with a particular interest in infectious diseases
which effect pigs. Tr. at 2.8-2.9, 2.14. Dr. Murtaugh defined
ATCC VR-2332 ("VR-2332") as "the first PRRS virus, isolated and
characterized in North America. That was the specific virus which
was first isolated by Boehringer on MA-104 cells and then
deposited in the American-type culture." Tr. at 2.23-2.24.
In addition, Dr. Murtaugh opined that the references to VR-2332
as an example of the PRRS/SIRS virus and references in the
specification to the existence of other viruses which were also
examples of the PRRS/SIRS virus communicated to a person of
ordinary skill in the art that VR-2332 was merely one isolate of
the PRRS/SIRS virus such that its being named specifically in the
specification is not a limitation to the invention. Tr. at 2.32.
Finally, Dr. Murtaugh also supported this opinion with a
reference in the specification to the fact that three examples of
the PRRS virus had been cultured on MA-104 cells. Tr. at
With respect to whether the specification of the '563 Patent
only provides a description of a method for growing the PRRS
virus "until CPE is observed,"*fn5 Dr. Murtaugh testified that
the '563 Patent was not so limited. Specifically, Dr. Murtaugh
testified that the specification did not rely on CPE or any
particular period of time for incubation but rather relies on
scientific techniques. Tr. at 2.34-2.41. Dr. Murtaugh further
opined that the specification was sufficient to allow a person of
ordinary skill in the art to grow PRRS viruses other than VR-2332
on MA-104 cells because the "inventors provided a clear generic
description for growth of the virus, which is not limited to
2332." Tr. at 2.41.
On cross-examination, Dr. Murtaugh conceded that the absence of
Drs. Collins and Benfield's names in the '563 Patent as compared
to the '444 application means that the specification no longer
inform a reader who produced what information. Tr. at 2.56-2.59.
Dr. Murtaugh maintained, however, that the reference to three
isolates from three different herds demonstrated that the '563
Patent is not limited by its terms to the VR-2332 isolate, though
he conceded that "[s]ubsequent analysis may reveal whether they
[the three isolates] appear to be identical or not.". Tr. at
Paul Hays, a Vice-President of Boehringer America and Head of
Corporate Marketing at Boehringer Germany, also testified on
Boehringer's behalf. Tr. at 2.77. Mr. Hays's testimony focused on
Boehringer's sale of the PRRS vaccine under the names Respers
ReproTM, Ingelvac PRRS, MLVTM and a combination vaccine which
includes the PRRS vaccine as well as other swine vaccines. Tr. at
2.80. Mr. Hays stated that in 1994, Boehringer sold 7.7 million
doses, in 1996 it sold 25 million doses and in 1998 Boehringer
sold 15.7 million doses. Tr. at 2.81. According to Mr. Hays's
analysis of Boehringer's financial data, after its peak in 1996
when Boehringer sold $19.5 million worth of the PRRS vaccine
products, Boehringer's sales declined in the United States after
Schering introduced its product to the market. Tr. at 2.82.
Specifically, Mr. Hays stated that Boehringer's PRRS sales
dropped from $19.5 million in 1996 to $16.8 million in 1997 and
continued to decline thereafter. Tr. at 2.92-2.93.
Putting aside the recent losses in the latter half of 1998, Mr.
Hays testified that Boehringer had PRRS sales of approximately
$18 million in 1996, $15.7 million in 1997 and $9.8 million in
1998. Tr. at 2.90. Mr. Hays stated that these sales were a
driving force in Boehringer's intentions to become a leader in
the swine industry and represent moneys earned by Boehringer
which in turn were used to further realize that goal by
purchasing Fermenta Animal Health Products which markets a number
of swine products. Tr. at 2.91. In addition, according to Mr.
Hays, Boehringer also acquired NOBL Laboratories, another swine
products company, and built a biological production facility in
Missouri based on the then-existing and anticipated PRRS vaccine
profits. Tr. at 2.91. Mr. Hays described the PRRS vaccine as a
"wild success" which allowed Boehringer to get its "foot in the
door" with swine producers. Tr. at 2.91-2.92. Mr. Hays testified
further that Boehringer's combination PRRS vaccine which was
introduced in 1998 is not countered by a similar product sold by
Schering. Tr. at 2.117.
Mr. Hays testified that Boehringer is one of the largest
privately-held drug companies in the world with 24,000 employees,
business on every continent and revenues in 1998 of approximately
$5.1 billion. Tr. at 2.112-2.114. Mr. Hays stated, however, that
Boehringer's United States sales were $107 million in 1998 and
the PRRS vaccine accounted for $12 million of these sales. Tr. at
2.115-2.116. Mr. Hays testified that Boehringer would neither go
out of business or cease offering the PRRS vaccine if they did
not receive a preliminary injunction in this case. Tr. at 2.116.
Nor did Mr. Hays have any concern that Schering would not be able
to pay any damage award ordered in this case if Boehringer
prevailed after a full trial. Tr. at 2.122. Mr. Hays, however,
expressed concern that if Boehringer did not receive immediate
relief from Schering's infringing product, it would lose its
advantage of having its "foot in the [swine producers'] door." In
addition, Mr. Hays was concerned that swine producer's use of the
PRRS vaccine only on sows may also limit further Boehringer's
market share which is not reparable with money damages. Tr. at
George Gould, an attorney at the law firm of Gibbons, Del Deo
in Newark, New Jersey was the last witness to testify on behalf
of Boehringer. Mr. Gould opined that Claim 3 of the '563 Patent
is not misleading, but rather a "true representation of what a
dependent claim would look like standing alone, when you read
back from the claims on which it depends, what it tells you to
do, which is to substitute certain words for other words." Tr. at
4.79-4.80. Mr. Gould also opined that there is nothing unusual
about Boehringer's proceeding with the '563 Patent several years
after prosecuting its '778 Patent. Tr. at 4.81.
With respect to Schering's inequitable conduct arguments, Mr.
Gould further opined that the post-1992 amendment to the standard
for inequitable conduct in 37 C.F.R. § 1.56 should apply to this
case because the '563 Patent was pending at the time and the
prior test was unworkable. Tr. at 4.83. He also considered the
file history of the '563 Patent and testified that the file
history "demonstrates on multiple occasions these references were
considered by the patent examiner, and no rejection of the claims
based on those references were ever made." Tr. at 4.91. Mr. Gould
further testified that he had not seen any evidence that
Boehringer intentionally buried the Drs. Dea and Van Alstine
references in its '563 Patent application. Tr. at 4.95. He
concluded that Schering did not have a substantial defense of
inequitable conduct. Tr. at 4.82.
With respect to Schering's argument that Boehringer committed
inequitable conduct by not submitting to the Patent Office copies
of Schering's briefs from the '778 Patent litigation, Mr. Gould
did not believe this amounted to inequitable conduct and thought
that Boehringer's actions were consistent with a reasonable
interpretation of its obligations under the law. Tr. at 4.97. Mr.
Gould said that examiners, who have no legal training, do not
want to be overwhelmed with litigation documents because their
primary focus at that point is on the teachings of the prior art.
Tr. at 4.98. He testified that he did not know what Boehringer
should have done with the Court's opinion in the '778 litigation
but thought that an examiner would not know the meaning of it or
what to do with it. Tr. at 4.100. Mr. Gould also thought it was
not necessary for Boehringer to provide the Patent Office with
copies of Schering's briefs, as long as the underlying material
information was made available to the examiner, which occurred in
this case. Tr. at 4.102-4.103. Mr. Gould also suggested that if
Boehringer submitted Schering's brief to the Patent Office
Boehringer would have also had to submit the remainder of the
'778 file to the Patent Office which would have overwhelmed the
Patent Office. Mr. Gould believed that Boehringer had advised the
examiner of the existence of the '778 litigation and its failure
to provide to the Patent Office any documents from the '778
litigation showed its even handedness with respect to the '563
Patent application. Tr. at 4.103-105.
On cross-examination, it was established that this Court's
opinion in Boehringer I denying Boehringer's preliminary
injunction request was issued in October 1997 and Boehringer
cited information to the Patent Office from that opinion but did
not give the Patent Office a copy of the opinion. Tr. at 4.110.
Mr. Gould clarified that in his opinion it is the examiner's
responsibility to review and analyze prior art and the applicant
need not submit to the examiner other people's opinions of the
prior art, even if those opinions are from experts and a federal
district court judge. Tr. at 4.111-4.113. With respect to Manual
of Patent Examining Procedure (hereinafter
"MPEP") section 2001.06(c) entitled "Information from Related
Litigation," Mr. Gould said that this section does not require
the submission of court documents to the Patent Office but merely
requires that an applicant submit to the Patent Office the
underlying material information. Tr. at 4.116. Mr. Gould
acknowledged, however, that if the examiner knew that the work of
Drs. Collins and Benfield (which had been characterized as part
of the invention), was really prior art, and determined that that
research was material, the examiner would have had the right to
rely upon that research in his obviousness determination. Tr. at
4.131. He said the corollary was also true, i.e., if the
examiner did not know that this research was prior art, he could
not have used it in his obviousness determination. Tr. at 4.132.
Mr. Gould conceded that the examiner is the only person who can
view prior art and determine whether it is material, especially
in light of conflicting opinions as to the materiality and
teachings of the prior art. Tr. at 4.137. Mr. Gould stated,
however, that the handout distributed at the Livestock
Conservation Institute Proceedings in October 1990 (hereinafter
referred to as "L.C.I.") containing the Drs. Dea and Van Alstine
references is not material to the '563 Patent and there was no
obligation to disclose its existence to the examiners handling
the '563 Patent. Tr. at 4.142-4.143. Mr. Gould also said that he
would not have cited to the examiner the deposition testimony of
Ms. Devlin, which Mr. Gould found confusing. TR. at 4.144.
Indeed, Mr. Gould opined that Boehringer discharged its duty in
the '563 Patent prosecution under section 2001.06(c) by sending
the examiner the references listed in Gould Exhibit 2, Bates
numbers 58449 through 58451. Tr. at 4.144-4.145.
On re-direct, Mr. Gould re-iterated the fact that the Drs.
Collins and Benfield research as well as the Drs. Dea and Van
Alstine references were presented to the examiner of the '563
Patent and the examiner affixed his initial next to those
articles indicating that he had reviewed them in considering that
patent. Tr. at 4.147.
Schering called Dr. Richard Steece, a virologist, pathogenic
bacteriologist and industrial microbiologist employed at the
Association of Public Health Laboratories which is funded by the
Federal Center for Disease Control to testify as an expert in
human and veterinary virology. 3.129-3.132. Dr. Steece testified
that at the end of 1990 hundreds of different cell cultures
existed on which to grow diseases but that whenever he received
an unknown animal virus, he would typically use a four-cell array
composed of two primary monkey kidney cells, cynolmolgus and
rheses, and two human cells, human diploid fiboblast cells and a
transformed human heteroploid line. Tr. at 3.133-3.134. Dr.
Steece explained that he chose these four cell lines based on his
personal experience and training as well as the current state of
the art regarding cell inoculation. Tr. at 3.134-3.135. He
categorized simian cells as "generally the most permissive cells
that we have available to us in virology." Tr. at 3.135. He
testified that in the late 1970s when he was trained at the CDC,
the CDC was recommending that scientist include a monkey kidney
line in their viral diagnostic laboratory. Tr. at 3.138.
Dr. Steece strongly disagreed with Dr. Easterday's statement
that finding a cell line on which to grow PRRS was a "crap
shoot." Tr. at 4.5. Rather, Dr. Steece testified that cell lines
are arranged because the investigator has a "reasonable
expectation" that they will work and it is neither a matter of
luck nor a "hit or miss situation" how arrays are chosen. Tr. at
4.5. Dr. Steece said that rather than luck, it is a cell line's
permissiveness as well as the relevant science and information
available that determines what cell lines should be used in an
array. Tr. at 4.10. Dr. Steece said that without knowing which of
his standard array would successfully grow a virus, he had a
"reasonable expectation" that he would be successful with at
least one of the cells. Tr. at 4.10. Dr. Steece opined further
that one's expectations would be "very high" that one would
isolate the PRRS virus in the array used by Dr. Van Alstine
because the array contained a number of permissive cells that
grow a wide variety of viruses. Tr. at 4.15.
On cross-examination, Dr. Steece testified that he had only
cultured one virus several times (a pseudorabies virus), had no
experience with the PRRS virus and had never heard of the PRRS
virus until he was contacted in connection with this litigation.
Tr. at 4.18. Dr. Steece also stated that the majority of his
experience with virus isolation was with the isolation of human
viruses and not veterinary viruses. Tr. at 4.20. Dr. Steece
further stated that the majority of isolations he conducted
between 1980 and 1990 while he was the supervisor of the
virology/serology section for the Scientific Laboratory Division
in New Mexico was of human viruses and that the four cell array
used at that lab was selected based on the types of samples that
lab received, which rarely included swine viruses. Tr. at
4.22-4.23. Dr. Steece testified that while he was working at the
laboratory in New Mexico, he sometimes used cell lines other than
his standard four cell lines to isolate a virus but said this
divergence from his usual array was due only to financial burdens
associated with his usual array. Tr. at 4.27.
Dr. Steece admitted that the CDC only concerns itself with
human pathogens and zoonotic viruses.*fn6 and thus only
recommends cell lines for human research. Tr. at 4.28. Dr. Steece
stated that the CDC publication embodied in Defendant's Exhibit
62 was not used by the New Mexico lab to develop its cell arrays
and in fact, he had no knowledge of how the New Mexico lab
developed its four cell array. Tr. at 4.29. He also conceded that
he did not include MA-104 cells in his standard array, nor did
the array contain any continuous simian cell lines and that he
did not even have MA-104 cells in his lab. Tr. at 4.30.
Dr. Steece testified that one reading Dr. Van Alstine's article
might conclude that he had isolated PRRS because he isolated
swine influenza which Dr. Van Alstine suggested might be a
causative agent of PRRS. Tr. at 4.45. Dr. Steece, however, did
not know whether by late 1990 there was "good serological
evidence" that swine influenza did not cause PRRS. Tr. at 4.45.
Dr. Steece further acknowledged that Dr. Van Alstine did not
identify in his article which of the cell lines he used,
successfully grew the swine influenza virus. Tr. at 4.46. Indeed,
Dr. Steece expanded his opinion and said that since Dr. Van
Alstine failed to identify which cell line successfully grew
swine influenza, one skilled in the art would have been motivated
to try each of the cell lines used by Dr. Van Alstine. Tr. at
4.47. He said an investigator would just have to try the cells
and see if they worked without any expectation of which one would
work over the next. Tr. at 4.47. Dr. Steece further testified
that while one skilled in the art would have a high expectation
that the virus would grow on his array he could not "draw on any
one in particular," and would not have expected the simian cells
to work to the "exclusion of all others." Tr. at 4.52. He also
said that PRRS was not easily discovered, there were many
theories as to its causative agent and nobody had been able to
grow the PRRS virus and identify it as such. Tr. at 4.54.
With respect to Dr. Collins's article upon which Dr. Steece
relied in developing his opinions regarding inequitable conduct,
Dr. Steece testified first that this article conclusively showed
that PRRS was caused by a virus but later stated that Dr.
Collins's statement that "[t]o date, no microorganism has been
isolated from the tissue homogenate used as the inoculum or from
tissues collected from gnotobiotic piglets," does not use the
word "virus" such that there is no written conclusion that Dr.
Collins did in fact have a virus. Tr. at 4.49-4.50.
On re-direct, Dr. Steece clarified the basis for his opinion
that the Dr. Van Alstine article made clear that he was dealing
with a virus based on the filtering studies discussed in the
articles. Tr. at 4.57.
Dr. Rowland testified that prior to 1991 there were at least a
thousand references to animal viruses being grown on cells
derived from other animals. Tr. at 5.13-5.14. After the
preliminary injunction hearing in the '778 litigation, Dr.
Rowland also researched the literature available prior to April
1991 which described MA-104 as a permissive cell line and
attached those articles to his expert report. Tr. at 5.15; Def.
Exh. 7-21. He also researched references available prior to April
1991 demonstrating the culturing of porcine viruses on simian
cells and found that swine influenza, pseudorabies, African swine
fever virus, porcine enterovirus, swine vesicular disease virus,
vesicular stomatitis virus, vesicular exanthema, porcine
rotavirus, EMCV and porcine epidemic diarrhea virus and Japanese
B encephalitis virus were known porcine viruses which were
cultured on simian cells prior to April 1991. Tr. at 5.17-5.18;
Schering Exh. 25-39.
Specifically, Dr. Rowland referred to an article by Goldstein,
et al. published in 1969/1970 which discussed the growth of swine
influenza on simian cells after it was passaged in eggs. Tr. at
5.21-5.22; Schering Exh. 37. He also referred to a book
Symposium of Diagnosis and Treatment of Swine Diseases
published in 1982 which includes a list of swine respiratory
diseases, a number of which, according to Dr. Rowland, were known
by 1991 to grow on simian cells. Tr. at 5.23. In addition, Dr.
Rowland referred to references, such as an article published in
1986 in a book called Veterinary Obstetrics and Genital
Diseases, which detailed swine reproductive diseases which were
known by 1991 to grow on simian cells. Tr. at 5.24-5.25. Dr.
Rowland said that if one were to have "hit the books" to learn
how to grow PRRS, one would have reviewed these articles and
books. Tr. at 5.28. In light of these references Dr. Rowland
opined that the reason investigators had trouble solving the PRRS
problem was that there was a lack of money or lack of interest
dedicated to PRRS research prior to 1990 and because the disease
displayed so many different symptoms it was difficult for
investigators to understand the disease. Tr. at 5.25.
Dr. Rowland testified with respect to the claim description
that the fact that the viral agent was recovered from three herds
would not necessarily mean that more than the VR-2332 strain was
involved. Tr. at 5.31. He explained that he based this opinion on
the fact that the claim paragraph did not specify that anything
other than VR-2332 was recovered, so he concluded that nothing
else was recovered. Tr. at 5.31. He said that the fact that three
herds were used to obtain isolates did not change his mind
because if the herds were geographically close to each other,
they may have been infected with the same virus. Tr. at 5.31. Dr.
Rowland said that even if the specification made clear that the
herds were on different farms, he still would not conclude that
anything other than VR-2332 was recovered because it was not
specified in the paragraph. Tr. at 5.32. He further testified
that the nomenclature of virology at the time of the hearing,
"strain" is used to describe isolates that are different, and
isolates are not considered different isolates even if they are
taken from several homogenates taken from a single pig. Tr. at
5.33. Therefore, he concluded that the claim description did not
indicate that Boehringer was in possession of any strain of PRRS
other than VR-2332. Tr. at 5.33-5.34.
Moreover, Dr. Rowland considered column 3 of the '563 Patent,
lines 21 through 28 which defines "infectious agent" and
concluded that the description does not demonstrate that the
inventors had in fact, isolated any other strain of the virus
other than VR-2332. Tr. at 5.34. He proffered
this same conclusion with respect to lines 34 and 35 of column 3,
lines 1 through 7 of column 2, lines 27 and 28 of column 2, line
19 of column 6, line 1 through 6 of column 9, column 9 line 27,
column 10 lines 58 and 59, column 11, and column 12 line 56. Tr.
at 5.34-5.37. Dr. Rowland testified that no strain other than
VR-2332 was mentioned in the patent and there is nothing in the
material that would convey to one skilled in the art that the
patent related to anything other than VR-2332. Tr. at 5.37. Dr.
Rowland testified further that Dr. Murtaugh's reliance on column
8, starting at line 52 which refers to recovery of the viral
agent after culturing, was misplaced because that passage does
not indicate that anything other than VR-2332 was recovered. Tr.
On cross-examination, Dr. Rowland admitted that he had never
heard of PRRS until 1992, after its cause was discovered and
prior to 1991, he had not cultured any significant veterinary
viruses. Tr. at 5.41. With respect to his testimony regarding the
virus being extracted from three herds, Dr. Rowland said that it
is not his testimony that a person of ordinary skill would think
that exactly the same form of PRRS had been taken from the three
herds as VR-2332. Tr. at 5.42. Dr. Rowland, however, conceded
that it would have been reasonable for a person of ordinary skill
to conclude based upon all of the information in column 8, that
the recovery method used on the virus derived from the three
herds was the same recovery method that was used to get VR-2332
in the first instance. Tr. at 5.45-5.46. He agreed that, in fact,
no other cell other than simian cells was disclosed anywhere in
the '563 Patent capable of growing PRRS such that one could
reasonably infer that simian cell technology was used to recover
the viruses from the three herds. Tr. at 5.46. Dr. Rowland
further conceded that the definition of "infectious agent"
contained in the '563 Patent was broad enough to include any
agent causing PRRS and therefore, that the use of "infectious
agent" rather than reference to VR-2332 in the "Detailed
Description of the Invention," would imply that any virus capable
of causing PRRS was within this definition and that the invention
was not restricted to VR-2332. Tr. at 5.46-5.48.
In addition, although on direct examination Dr. Rowland
testified that column 6, lines 19 through 22 does not support a
conclusion that the '563 Patent includes more than VR-2332, on
cross-examination he admitted that those lines support a
conclusion that the inventors did not intend to limit the patent
to their specific examples. Tr. at 5.49. He also admitted that
lines 1 through 6 in column 9, previously discounted by him in
his direct testimony, tells a person of ordinary skill that
VR-2332 is but an example of the virus causing PRRS. Tr. at
With respect to the issue of obviousness, on cross-examination
Dr. Rowland conceded that he found only two references to porcine
viruses being grown on MA-104 cells prior to 1991 and that,
indeed, those articles would not have given a person of ordinary
skill in the art a reasonable expectation that the PRRS virus
would grow on MA-104 cells in 1991. Tr. at 5.53. With respect to
the articles Dr. Rowland referred to in his expert report,
Schering Exh. 25 through 39, which report the growth of certain
porcine viruses on simian cells, Dr. Rowland admitted that only
one of those articles, Schering Exhibit 29, referred to a swine
virus being grown on MA-104 cells. Tr. at 5.53-5.54.
Dr. Rowland testified that several of the viruses listed in
Schering's Exhibits 7 through 24 and 41 have both respiratory and
reproductive symptoms. Tr. at 5.56-557. With respect to swine
influenza, however, Dr. Rowland said that influenzas in general
are "known to cross the placental barrier and infect the fetus,
so they have been implicated in some reproductive disorders," but
ultimately deferred to Boehringer's expert, Dr. Easterday, and
his opinion that swine influenza has not conclusively been shown
to have a reproductive
component. Tr. at 5.57. Dr. Rowland said that psuedorabies,
African swine fever, porcine enterovirus and reoviruses each have
both respiratory and reproductive symptoms but prior to January
1991 nobody skilled in the art would have confused the symptoms
caused by those viruses with PRRS. Tr. at 5.57-5.58. He also
acknowledged that even looking at the complete set of literature
attached to his expert report, Schering Exhibits 7 through 39,
would not have pointed a person of ordinary skill in 1991 to use
simian cells exclusively to grow the PRRS virus. Tr. at 5.58. Dr.
Rowland further testified that the art at the time taught that if
one included simian cells in their array, one would have a
reasonable probability that the array would work but that one
would not have a "specific probability" that the simian cells
would "be more apt to be successful . . . than the other cells in
your array." Tr. at 5.64.
With respect to Dr. Collins' abstract referring to his
homogenate work, Pl. Exh. 29, Dr. Rowland agreed that Dr. Collins
did not reach a conclusion that he had a virus in his homogenate.
TR. at 5.59. Dr. Rowland said that after he reviewed Dr. Collins
article, he concluded with 90% certainty that what Dr. Collins
had was a virus, but that there was a chance that it was not a
virus. Tr. at 5.59.
Harry Manbeck, former General Patent Counsel for General
Electric, former United States Commissioner of Patents and
Trademarks, and Assistant Secretary of Commerce, testified as an
expert in patent law, the United States Patent Office and its
procedures. With respect to Claim 3 of the '563 Patent, Mr.
Manbeck testified that Claim 3 does not appear in the '563 Patent
as it does on Boehringer's Exhibit 1. Tr. at 5.78. He testified
that in a independent and dependent claim situation, if a patent
examiner finds the independent claim patentable, he will "allow a
reasonable number of dependent claims without consideration of
whether they actually add further patentability." Tr. at
5.80-5.81. Mr. Manbeck testified that this means that in
authorizing the broader claim, the examiner may not have focused
on the dependent claims. Tr. at 5.81.
On the issue of disclosure to the Patent Office, Mr. Manbeck
testified that the process of full disclosure to the Patent
Office is necessary since the patent procedure is an ex parte
procedure. Tr. at 5.82-5.83. He re-iterated that the Patent
Office's only access to prior art is its own discovery and the
information provided by the applicant. Tr. at 5.82-5.83. Mr.
Manbeck explained, however, that an examiner's ability to
discover prior art for himself is limited by the technological
limitations of the Patent Office and the fact that technical
publications are not classified for the examiner's benefit. Tr.
at 5.84-5.85. The examiner also only dedicates 15 to 17 hours to
each patent and therefore, relies heavily on the information
provided by the applicant. Tr. at 5.88-5.89.
Mr. Manbeck explained that rules of the Patent Office require a
duty of candor and good faith and a subset of that duty is the
duty of disclosure. Tr. at 5.89. He testified that he had
considerable input in changing the standard for disclosure
contained in 37 C.F.R. § 1.56 which was changed to make the
standard of materiality under the rule "more precise." Tr. at
5.90-5.91. He said that the change in 1992 was not meant as a
substantive change to the standard for disclosure and that, in
fact, the application of both the old and new rule should result
in the same conclusion. Tr. at 5.91. Mr. Manbeck explained that
the old rule defined materiality as a "substantial likelihood
that a reasonable examiner would consider the reference important
in deciding whether or not to issue claims in patent cases." Tr.
at 5.92. The new rule, promulgated in 1992, defines materiality
in terms of whether a reference "if by itself or taken together
with other references, would create a prima facie case of
unpatentability." Tr. at 5.93. In addition, the inquiry is
whether the "reference would be inconsistent with an argument
being made for patentability by the applicant or would be
inconsistent with the position he was taking in opposition to the
examiner's position." Tr. at 5.93.
Mr. Manbeck opined that after the parties were before this
Court in the '778 litigation, Boehringer was required to tell the
examiner all material information from those proceedings. Tr. at
5.96. He also explained that all examiners attend a Patent
Academy and learn the applicable law and regulations and are all
very experienced. Tr. at 5.95. Mr. Manbeck further explained that
MPEP section 2001.06(c) provides that "[w]here the subject matter
for which a patent is being sought or has been involved in
litigation, the existence of such litigation and any other
material information arising there from must be brought to the
attention of the Patent and Trademark Office." Examples of such
material information include evidence of possible prior public
uses or sales, questions of inventorship, prior art, allegations
of `fraud,' `inequitable conduct,' and `violation of duty of
disclosure.' Tr. at 5.97-5.98. Mr. Manbeck provided another
example of such material as any assertion made during the
litigation which is "contradictory to assertions made to the
examiner. Such information might arise during litigation in, for
example, pleadings, admissions, discovery including
interrogatories, depositions and other documents and testimony."
Tr. at 5.98. Mr. Manbeck qualified this testimony with the fact
that this is not a statutory obligation but rather advice from
the Patent Office to attorneys. Tr. at 5.99. He also said that a
failure to disclose such information without intent ...