is a powder produced by plaintiffs, constitutes a preparation
for oral application covered by the '376 patent.
The plaintiffs claim they are directly producing an
infringing product because the patent covers "any quantity of
[LCLT] which can be taken orally, without restrictions as to
amount, package form or dose." Opp. to Ren. Mot. to Dismiss at
7. Plaintiffs claim that a person can open a drum of LCLT
produced by Biosint and consume the powder directly with a
spoon. See id. at 8. Thus, plaintiffs argue that they are
directly infringing the patent by producing LCLT because "the
'376 patent cover[s] a composition for oral application
comprising LCLT powder alone, in any amount, which is exactly
what plaintiffs have imported, offered for sale, sold and
advertised in the United States and are prepared to sell if the
'376 patent is found to be invalid and/or unenforceable." See
Opp. Mot. to Dismiss at 9.
The defendant argues that "the invention was not the creation
of the powder itself but the ability to provide a form of
powder that was ready for oral ingestion." Ren. Mot. to Dismiss
at 10. It claims that the term "preparation for enteral
application" in the '376 patents refers to an oral dosage form
and not the bulk raw material produced by the plaintiffs. For
example, the defendant states that "the bulk [LCLT] raw
material would have to undergo a further processing step (such
as, for example, filling the powder is [sic, in] small sachets
. . .) to be made into dosage form." Id. at 19.
In the order dismissing the original motion to dismiss, the
Court initially thought that the second prong of the test for
determining if an actual controversy exists "will turn upon the
complex matter of interpretation of the '376 patent's claims."
Sigma-Tau v. Lonza, Civ No. 97-0562 (D.D.C. June 2, 1998) at 3.
Upon further review of this matter and the supplemental
documentation and exhibits provided by the parties, however,
the Court is of the opinion that the defendant's motion to
dismiss can be decided without construing the patent claims.
Based on the present record, the plaintiffs have potentially
infringed the patent in a manner sufficient to establish an
actual controversy if they sell LCLT with the knowledge or
intent that their customers will use the product for oral
application. This applies if the plaintiffs are directly
responsible by selling LCLT to customers who intend to consume
it in spoonfuls, or if plaintiffs are indirectly responsible by
inducing their customers to take the further step of putting
the LCLT capsules, tablets or some type of specific dosage
form. Thus, the issue at this juncture is whether or not the
plaintiffs are prepared to produce LCLT and sell it to their
customers for any oral use.
Preparation to Produce Potentially Infringing Product
It is well established that a mere interest in producing a
superior patented product is insufficient to create a
justiciable controversy. See e.g., BP Chems., 4 F.3d at 980.
Instead, any potentially infringing activity must be "real and
immediate" and not "prospective and uncertain of occurrence."
Super Sack Mfg. Corp. v. Chase Packaging Corp., 57 F.3d 1054,
1058 (Fed. Cir. 1995).
Plaintiffs claim they have a real and immediate intent to
sell LCLT in the United States for oral ingestion. Several
factors support this conclusion. Plaintiffs have a previous
history of selling LCLT to customers for oral application.
Biosint sold LCLT to Seltzer in 1991 and 1992 and to another
customer during the years 1994 through 1996. See Interdynamics,
Inc. v. Firma Wolf, 698 F.2d 157, 172 (3d Cir. 1982) (quoting
Super Prod. Corp. v. DP Way Corp., 546 F.2d 748, 753 (7th Cir.
1976) (noting as persuasive in establishing subject matter
jurisdiction the fact that plaintiff has a previously
established "business enterprise specifically directed to the
manufacture and sale of a potentially infringing product")).
It was only after plaintiffs became fearful of a lawsuit for
infringement that they ceased selling LCLT in the United States
for oral consumption. The defendant argues that plaintiffs'
cessation of activity, coupled with their statement that it
would not sell LCLT for customers to use orally unless the
Court declares the patent invalid or unenforceable, suggests
that plaintiffs have no
immediate intention of marketing the potentially infringing
product. There is no indication, however, that plaintiffs
digressed from their original intention, dating back to 1991,
to sell LCLT for oral consumption. The fact that plaintiffs
opted to await the Court's decision on the declaratory judgment
action before they resumed selling their product does not
defeat jurisdiction. Cf. Super Prod. Corp., 546 F.2d at 748
(party faced with choice of "either incurring potential
liability for infringement of the defendant's patent or
abandoning existing business enterprise" can instead opt to
file a declaratory judgment action and await the Court's
decision); Electro Med. Sys. v. Cooper Lasersonics, 617 F. Supp. 1036,
1038 (N.D.Ill. 1985) (jurisdiction appropriate where
foreign distributor awaited outcome of patent infringement
action before commencing distribution of product in the United
Plaintiffs are currently ready and able to provide LCLT to
customers who intend to use it for oral consumption. This is
evidenced by the establishment and delivery of LCLT to Biosint,
U.S.A. for warehousing, the samples provided to customers, the
marketing and advertising of the product, the sales of LCLT in
Europe, and the prior sales in the United States. In addition,
without commenting on the merits of the contract filed under
seal and dated four months after the complaint in this action
was filed, Sigma-Tau indicates that it has agreed "to offer to
supply GNC with LCLT once plaintiffs are legally free to do
so." Opp. to Ren. Mot. to Dismiss at 13. "Although it is the
situation at the time suit was filed that establishes the
existence vel non of the actual controversy, subsequent events
can reinforce the correctness of the conclusion." BP Chems., 4
F.3d at 980 (citations omitted). Thus, Sigma-Tau's agreement
with GNC can be considered as part of the "totality of the
circumstances" that indicate plaintiffs' present ability and
intent to produce the potentially infringing product. See id.
(citing C.R. Bard, Inc. v. Schwartz, 716 F.2d 874, 881 (Fed.
Plaintiffs have established that they have both a reasonable
apprehension of suit and a present intent to produce a
potentially infringing product. As a result, an actual
controversy exists and this Court exercises its jurisdiction
over this declaratory judgment action. It is therefore
ORDERED that defendant's renewed motion to dismiss for lack
of jurisdiction is hereby denied.
IT IS SO ORDERED.