at 58:23-25. Dettwiler was unable to say whether fluidized bed
spray drying influenced the particle size of LCLT. See id. at
Kohl states that all dryers tested, including the paddle dryer
and the fluidized bed spray dryer, produced LCLT suitable for the
patent's purpose, see Kohl Decl. at ¶ 10. Assuming Kohl knew of
Dettwiler's conclusions concerning the milling effect of the
paddle dryer and the clumping effect of the fluidized bed sprayer
dryer, there remains a factual dispute as to whether these
particular dryers were unsuitable for practicing the patent in
Dettwiler stated only that the LCLT material becomes lumpy
after drying in a fluidized bed spray dryer when it is stored in
the drums for a "long time." Dettwiler does not say what drums he
is referring to, how long a storage time is at issue, and whether
or not the use of this type of dryer is an impediment to carrying
out the claimed invention. Kohl, in both his deposition testimony
and in his declaration, states that at the time he filed the
patent application, the patent's objective could be obtained with
a fluidized bed spray dryer. See Kohl Decl. at ¶ 8; Kohl Dep.
2. Willibald Kohl
Lonza relies in great part on the fact that Kohl stated in his
deposition there were plenty of dryers on the market and he
needed a "careful dryer" that "would not break down the crystals
too much." Kohl Dep. at 66:7-11; 66:23-25. Kohl further stated in
his deposition he was aware dryers such as shelf dryers and
rotating dryers did not cause crystal breakdown. See id. at
67:9-11. However, he explains in his declaration that because
these dryers were not used by Lonza he could not have
contemplated them to be the best mode of drying the product.
See Kohl Decl. at ¶ 11.
Kohl further acknowledged in his deposition that at the time he
filed his application he was aware that some types of dryers
might break down crystals, but he did not indicate which dryers
did so. See Kohl Dep. at 67:12-22. In his declaration, Kohl
explains he was just stating a proposition that is well known in
his field. See Kohl Decl. at ¶ 12. If it is indeed well known
in the industry that some dryers create a milling effect and
impede flowability, then the fact that there are some dryers on
the market that cause this problem does not necessarily mean that
Kohl considered all of them and selected the best one as a
preferred method, or even that he had to disclose the existence
of these dryers. As the Federal Circuit has noted, "[a] patent
need not teach, and preferably omits, what is well known in the
art." Spectra-Physics, Inc. v. Coherent, Inc., 827 F.2d 1524,
1534 (Fed.Cir. 1987).
3. Deposition of Christopher Rhodes
Although unclear from the briefs and exhibits submitted, the
Court presumes Christopher Rhodes ("Rhodes") was retained by
Sigma-Tau as an expert in this case. Rhodes testified in his
deposition that by failing to specify any particular dryer or
drying method, Lonza omitted "essential, practical detail which
would allow one skilled in the art to apply the invention without
difficulty." Rhodes Dep. at 93:2-5.
Rhodes does not say, however, whether he tested various methods
for drying, or whether he knows of a particular method
that will best enable one to practice the '376 patent. He
indicates that if he were practicing the '376 patent, he might
attempt to use, or at least think about using, a tray dryer, a
rotary dryer, or a spray dryer.*fn18 See id. at 117:3-9. There
is nothing to indicate these dryers would or would not enable one
skilled in the art to practice the '376 patent. Rhodes speculates
that if he sat down and looked at all the variables, he might
find that a "significant number of [dryers] would work" and that
"an even more significant number would not work." See id. at
170:9-16-17. Rhodes' testimony leaves open many factual questions
as to whether one skilled in the art can practice the '376 patent
without the disclosure of a specific drying method.
4. Declaration and Deposition of Arthur H. Goldberg
Arthur H. Goldberg ("Goldberg") was retained as an expert by
Lonza. See Goldberg Decl. at ¶ 2. He disputes Rhodes'
conclusions. Goldberg claims that any standard dryer could dry
the LCLT to a sufficient degree and that drying LCLT "does not
present any unusual problems." Id. at ¶ 43. In fact, according
to Goldberg, "[n]o matter how the [LCLT] is processed for
commercial quantities, if the teaching of the '376 patent is
followed, it will always result in [LCLT] with a hygroscopicity
sufficiently low to permit processing into solid dosage forms."
Id. at ¶ 44. Goldberg states the type of dryer used "most
frequently  does not" have an impact on the particle size of
the product. See Goldberg Dep. at 131:1-5. He noted that
nonstatic dryers, such as spray dryers and fluidized bed dryers,
would have "no effect or very little effect on particle size."
Id. at 131:14-132:10. Static dryers, such as "tray dryers,
paddle dryers, drum dryers, cone dryers, and double-cone dryers,"
"may have an effect on particle size." Id. at 131:14-121:2
After considering all of this evidence, as well as other
evidence submitted by the parties, the Court concludes there
remains a genuine issue of material fact as to whether there is a
best mode for drying LCLT and whether Kohl contemplated this best
mode at the time he filed his patent application.
Whether There Was Sufficient Disclosure
The Court need not reach the second part of the best mode test
if she concludes there remains a factual dispute as to whether
Kohl contemplated a best mode for drying the LCLT. See Transco,
38 F.3d at 560. However, even if the Court established that Kohl
contemplated a specific type of dryer as the best mode, a factual
dispute would remain as to whether the drying process in this
context is so routine as to preclude the disclosure requirement.
See Young Dental Mfg. Co., 112 F.3d at 1144. This dispute is
evidenced by the opposite positions taken by Rhodes and Goldberg
regarding whether the drying process has been disclosed in
"sufficient detail to allow a skilled artisan to practice it
without undue experimentation." Nobelpharma AB v. Implant
Innovations, Inc., 141 F.3d 1059, 1064 (Fed.Cir. 1998).
Rhodes claims that without specifics on the drying process,
practicing the patent may be a "horrendous task" that could take
a very long time. See id. at 118:6-7; 120:8-14. Goldberg
states, to the contrary, that "[to] the extent that any methods
or specific processing parameters are not disclosed in the '376
patent, it would be clear to one skilled in the art how to arrive
at such methods and parameters without undue experimentation."
Goldberg Decl. at ¶ 41. Thus, even if the Court deemed summary
judgment appropriate on the issue of contemplation, there would
remain a factual dispute on the issue of disclosure.
Summary judgment on the best mode issue is denied.
IV. Consolidated Motion To Declare '376 Patent Invalid Under 35
U.S.C. § 102
Sigma-Tau has filed a consolidated motion for summary judgment
alleging that the '376 patent is invalid under 35 U.S.C. § 102(e)
because the invention claimed in the '376 patent was described
and anticipated in United States patent number 4,968,517
("Gergely U.S. patent") and United States patent number 5,030,657
("Georgia patent") before Lonza filed its patent application.
Sigma-Tau also asserts that the '376 patent is invalid under
35 U.S.C. § 102(b) because its invention was described and
anticipated in German patent number DE 36 35 864 A1 ("Gergely
German patent") more than one year prior to the date of Lonza's
patent application. Lonza claims that neither the Gergely patents
nor the Georgia patent could have described or anticipated the
'376 patent because neither Gergely nor Georgia teach that the
salt of L-carnitine can be combined with L-tartrate in the 2:1
molar ratio to produce a non-hygroscopic form of tablets,
capsules or powder for oral application. In addition, Lonza
claims that it is entitled to priority over the Georgia patent
because the '376 patent was reduced to practice in the United
States prior to the filing of the Georgia patent. For the reasons
discussed below, Sigma-Tau's motion is denied.
All patents are presumed valid. See 35 U.S.C. § 282; Intel
Corp. v. U.S. Int'l Trade Com'n, 946 F.2d 821, 834 (Fed. Cir.
1991); Orthokinetics v. Safety Travel Chairs, Inc.,
806 F.2d 1565, 1570 (Fed.Cir. 1986). This statutory presumption can be
overcome only by clear and convincing evidence that the patent is
invalid. See Price v. Symsek, 988 F.2d 1187, 1194 (Fed.Cir.
1993); Intel, 946 F.2d at 834. "To be clear and convincing, the
evidence must produce a firm belief or conviction that the matter
sought to be established is highly probable and free from serious
doubt. The validity of a patent may be upheld solely on the
failure of the challenger's evidence to convincingly establish
the contrary." Maxwell v. K Mart Corp., 880 F. Supp. 1323, 1329
(D.Minn. 1995) (citing Orthokinetics, 806 F.2d at 1570).
One way to assert invalidity of a patent is to claim the
invention was anticipated or described in prior art. A person is
not entitled to a patent if
the invention was patented or described in a printed
publication in this or a foreign country or in public
use or on sale in this country, more than one year
prior to the date of the application for patent in
the United States, or . . .
the invention was described in a patent granted on an
application for patent by another filed in the United
States before the invention thereof by the applicant
for patent. . . .
35 U.S.C. § 102(b) and 102(e), respectively.
A party asserting under 35 U.S.C. § 102 that a patented
invention was anticipated must show identity of invention.
"Identity of invention is a question of fact, and one who seeks
such a finding must show that each element of the claim in issue
is found, either expressly, or under principles of inherency, in
a single prior art reference, or that the claimed invention was
previously known or embodied in a single prior art device or
practice." Minnesota Mining and Mfg. Co. v. Johnson & Johnson
Orthopaedics, Inc., 976 F.2d 1559, 1565 (Fed.Cir. 1992). Thus,
in order to have the '376 patent declared invalid as having been
anticipated by either the Gergely or Georgia patents, Sigma-Tau
must show by clear and convincing evidence that each and every
element of the '376 patent was disclosed either expressly or
under principles of inherency in either the Gergely or the
See Ferag AG v. Grapha-Holding AG, 905 F. Supp. 1, 4 (D.D.C.
1995); see also SSIH Equip. S.A. v. United States Intern. Trade
Com'n, 718 F.2d 365, 377 (Fed.Cir. 1983); RCA Corp. v. Applied
Digital Data Sys., Inc., 730 F.2d 1440, 1444 (Fed.Cir. 1984).
Under principles of inherency, prior art can be deemed
anticipatory if, as a matter of scientific fact, an unstated
element contained in the anticipating reference flows naturally
from the elements expressly disclosed. See Hughes Aircraft Co.
v. U.S., 8 U.S.P.Q.2d 1580, 1583, 15 Cl.Ct. 267 (1988). In other
words, if the Gergely patent inherently discloses the invention
of the '376 patent, one skilled in the art could produce the
results claimed in the '376 patent simply by practicing the
Gergely patent, i.e., the result flows naturally from the
express disclosures of the Gergely patent whether or not others
are aware of it Id.; see also Verdegaal Bros. v. Union Oil,
814 F.2d 628, 633 (Fed.Cir. 1987).
Reduction to Practice
A patent will not be declared invalid on the basis of an
anticipation if the anticipating art does not have priority of
invention. A person is entitled to a patent unless
before the applicant's invention thereof the
invention was made in this country by another who had
not abandoned, suppressed, or concealed it. In
determining priority of invention, there shall be
considered not only the respective dates of
conception and reduction to practice of the
invention, but also the reasonable diligence of one
who was first to conceive and last to reduce to
practice, from a time prior to conception by the
35 U.S.C. § 102(g).