The opinion of the court was delivered by: Joyce Hens Green, District Judge.
MEMORANDUM OPINION AND ORDER
Plaintiffs, Sigma-Tau Industrie Farmaceutiche Riunite, S.p.A.
("Sigma-Tau") and its subsidiary Biosint, S.p.A. ("Biosint"),
commenced this action against defendant, Lonza, Ltd., for a
declaratory judgment of non-infringement and invalidity of
United States Patent No. 5,073,376 (" '376 patent"). Currently
pending before this Court is Lonza's renewed motion to dismiss
for lack of subject matter jurisdiction.*fn1 Upon
consideration of the entire record in this matter, and for the
reasons discussed below, the motion will be denied.*fn2
On December 17, 1991 the United States Patent and Trademark
Office granted the '376 patent to Willibald Kohl and Thomas
Scholl. The defendant, Lonza, Ltd., is the named assignee. The
following facts are undisputed. The '376 patent involves a
preparation for enteral (oral) application of a compound known
as L-carnitine L-tartrate ("LCLT"). Both L-carnitine and
L-tartrate are common substances. L-carnitine supplies the
muscles with energy in order to increase endurance and stress
tolerance. See Ren. Mot. to Dismiss Exh. M. It is generally
used as a food supplement by athletes and as therapeutic
medicine for treatment of metabolic diseases. See id.
L-carnitine, by itself, is highly hygroscopic*fn3 and, as
such, will liquefy in a short period of time. See id. For this
reason, L-carnitine is sold in liquid form for use
parenterally*fn4 or in tablets that are packaged individually
in air-tight seals. See id.
The '376 patent has ten claims involving the preparation of
LCLT for oral use. Claim 1 states
A preparation for enteral [oral] application
comprising at least one tablet composed of the
sale of L-carnitine with L-tartaric acid
[L-tartrate] in the molar ratio of 2:1, powder
composed of the salt of L-carnitine with
L-tartaric acid in the molar ratio of 2:1 or at
least one capsule containing the sale of
L-carnitine with L-tartaric acid in the molar
ratio of 2:1.
Id. Claim 2 involves the use of adjuvants (additives) such as
amino acids and binding agents to make tablets, capsules and
powder suitable for oral administration. See id. Claims 3 and 4
involve combining sugar additives to LCLT to form a tablet. See
id. Claims 5 and 6 involve a preparation for LCLT in powder
form and capsule form. See id. Claims 7 through 9 involve a
preparation for oral administration of LCLT. See id. Claim 10
involves the oral consumption of LCLT by a human. See id.
Sigma-Tau is an Italian pharmaceutical company that,
according to plaintiff, is the "world's largest manufacturer of
L-carnitine, its salts and derivatives, such as L-carnitine
tartrate." See Opp. to Orig. Mot. to Dismiss at 4. Biosint,
S.p.A. was founded in the early 1980's as a subsidiary of
Sigma-Tau "specifically to produce L-carnitine, including
L-carnitine tartrate, both for sale and for use by Sigma-Tau."
Id. Biosint produces and sells LCLT as a raw material, not a
finished product, in both the European and American markets.
See id. at 5; Ren. Mot. to Dismiss at 18. This raw material can
be converted by its purchasers into a finished product that is
either a solid or a liquid. See Ren. Mot. to Dismiss at 29.
Biosint's Sales of LCLT to Seltzer Chemicals
Biosint, S.p.A. imported LCLT into the United States and sold
it to an American Company, Seltzer Chemicals, Inc. ("Seltzer"),
at unspecified dates in 1991 and 1992. See Ren. Mot. to Dismiss
at 26. The parties do not address whether Biosint and/or
Sigma-Tau were aware of Seltzer's intent with respect to the
raw material LCLT. However, it is apparent that Seltzer sold
the product for oral use because on April 1, 1992 Lonza sent a
letter to Seltzer advising that Seltzer was infringing the '376
patent by "selling [LCLT] to others for making certain
preparations for oral administration." Orig. Mot. to Dismiss
Exh. DX C. Seltzer responded by forwarding a letter to
Sigma-Tau advising that "[a]s a direct result of [Lonza's]
letter, out of a desire to avoid becoming involved in
litigation, Seltzer Chemicals has ceased sales of ...