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SIGMA-TAU INDUS. FARMA. RIUNITE v. LONZA

February 22, 1999

SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE, S.P.A. AND BIOSINT, S.P.A., PLAINTIFF,
v.
LONZA, LTD., DEFENDANT.



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

I. Background

The Patent

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.

Drs. Kohl and Scholl discovered that the hygroscopicity of L-carnitine is essentially eliminated when it is combined with the substance known as L-tartrate. See id. Thus, by combining the two substances, Drs. Kohl and Scholl discovered a use for L-carnitine that "is preferably suitable in particular for producing tablets or capsules" that do not need special air tight seals and can be taken orally. 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.

The Plaintiffs

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 ...


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