Abbott Laboratories v. TorPharm, Inc.

309 F. Supp. 2d 1043, 2004 U.S. Dist. LEXIS 4147, 2004 WL 513654
CourtDistrict Court, N.D. Illinois
DecidedMarch 15, 2004
Docket97-C-7515
StatusPublished
Cited by5 cases

This text of 309 F. Supp. 2d 1043 (Abbott Laboratories v. TorPharm, Inc.) is published on Counsel Stack Legal Research, covering District Court, N.D. Illinois primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Abbott Laboratories v. TorPharm, Inc., 309 F. Supp. 2d 1043, 2004 U.S. Dist. LEXIS 4147, 2004 WL 513654 (N.D. Ill. 2004).

Opinion

OPINION

Posner, Circuit Judge.

Abbott Laboratories filed suit for patent infringement in 1997 against TorPharm, a manufacturer of generic pharmaceutical drugs, and affiliates of TorPharm unnecessary to discuss separately. 35 U.S.C. § 271(e)(2)(A). The district court granted summary judgment in favor of Abbott on both validity and infringement. 156 F.Supp.2d 738 (N.D.Ill.2001). The Federal Circuit affirmed the validity of Abbott’s patent but remanded for a trial on infringement. 300 F.3d 1367 (Fed.Cir.2002). I was designated to conduct the trial pursuant to 28 U.S.C. § 291(b)—a bench trial, because Abbott is seeking only equitable relief. Indeed, it could not seek damages, because TorPharm has not yet begun to market its generic substitute for Abbott’s product. The trial was conducted between February 23 and February 27 of this year, and I now set forth my findings of fact and conclusions of law.

The patent (actually two patents, U.S. Patent Nos. 4,988,731 and 5,212,326, but they differ in only one material respect, discussed later, so in most of the opinion I shall treat them as one) is on a chemical called divalproex sodium, which Abbott sells under the trade name Depakote for the treatment of epilepsy and other ailments. The chemical formula is (C16H31 Na04)n, with the “n” signifying that the chemical unit is repeated n times. Dival-proex sodium, the unit, is a combination, of a type commonly called a “complex,” of two molecules, one of sodium valproate and the other of valproic acid. Each molecule contains valproate, an organic compound composed of carbon, oxygen, and hydrogen atoms, and it is the valproate that is responsible for the therapeutic properties of the drug. The other constituents of the complex — a sodium ion in the sodium valproate molecule and an extra hydrogen atom in the valproic acid molecule — do no therapeutic work. The chart at the end of this opinion (“Atwood 1” — a demonstrative exhibit used by Abbott’s expert witness at the trial) contains a diagram of divalproex sodium and its constituent molecules (with the valproate itself *1045 designated “V”) together with some of the other data referred to in this opinion.

Although either sodium valproate or val-proic acid would have all the therapeutic properties of divalproex sodium, neither is as easy to manufacture into pills — valproic acid because it is a liquid and sodium valproate because it is hygroscopic, that is, attracts moisture from the atmosphere, which makes it semi-liquid unless costly efforts are undertaken to remove the moisture from the atmosphere of the manufacturing plant. When sodium valproate and valproic acid combine to form divalproex sodium, however, the result is a nonhygro-scopic, crystalline solid (powder or flakes) better suited for manufacturing into pills than either of its constituents.

What holds the sodium valproate molecule to the valproic acid molecule? A normal atom has a neutral charge because it has the same number of protons and electrons and because the other atomic particle, the neutron, has no charge. An ion is an atom that has a different number of protons and electrons and therefore carries a positive charge (if it has more of the former) or a negative charge (if it has more of the latter). The sodium atom in the sodium valproate molecule is a positively charged ion, because the oxygen in the valproate “steals” an electron from that atom. The ion is attracted to the (negatively charged) electrons in the oxygen atoms of the valproic acid molecule (see Atwood 1), bonding the two molecules.

For reasons that have never been adequately explained, the patent examiner before whom Abbott prosecuted its patent application insisted that the patent claims include a specification of the chemical structure of divalproex sodium beyond what I have just described. Abbott obliged by claiming that divalproex sodium is an oligomer consisting of about 4 to 6 units of the divalproex sodium. In one of the patents, the number of units is not specified, but the parties make nothing of this; in effect they have agreed that if TorPharm’s product contains no fewer than 4 and no more than 6 or 7 units, it infringes both patents.

Just as the' two molecules combine to form the divalproex sodium complex, ‘ so two or more of these complexes might join together to form a larger structure, such as a crystal, which might consist of millions or billions of identical units, whether atoms, molecules, or looser complexes. A polymer, usually a “soft” structure (many proteins are polymers) compared to a crystal, and usually classified as a molecule— although a very loosely bound polymer might instead be described as a “coordination polymer” — is an assemblage of a large number of smaller molecules. It is like a crystal (indeed sodium valproate, which is a crystal, was also described by one of the expert witnesses as a coordination polymer), but it needn’t be solid and it will usually not be as extensive, although some proteins consist of thousands of lesser molecules.

At the opposite extreme is a monomer. If the divalproex sodium complex — this bound pair of valproate molecules — does not have any discernible linkage with neighboring divalproex sodium complexes, so that a batch of divalproex sodium would be a loose mixture, like the grains of sugar in a teaspoonful of sugar (which is a mixture of sugar crystals — the mixture itself having no structure, whether crystalline or otherwise), then divalproex sodium is a monomer.

An oligomer, as the name implies, is an assemblage of several rather than, as in the case of .a polymer, many identical units, in this case divalproex sodium complexes. In other words, it is a small polymer. TorPharm’s product must be an oli-gomer of about 4 to 6 units to infringe Abbott’s product. Divalproex sodium in *1046 the solid state is a crystal, and a crystal is a structure of many repeating units, but it could be composed of oligomers loosely connected to each other to form the crystal. Alternatively, it could be composed of monomers, as I have already noted, or it could be a polymer; in either event it would not be infringing.

TorPharm insists that to count as an oligomer the units constituting the aggregate in question must be connected “end to end” in the special sense of forming a row, rather than a circle or sphere or any other shape other than simple horizontality. There is no basis in the scientific literature, the patent itself, the proceedings before the patent office, or the Federal Circuit’s opinion for so restrictive a definition.

Although the exact structure of the divalproex sodium complex is, as I’ll explain, unknown, the expert testimony indicates that each of the two molecules composing it has a “head” and a “tail.” The tail is a chain of carbon and hydrogen atoms constituting part of the valproate; in the diagram at the end of this opinion, the tail is shown as the top layer of the upper molecule, the sodium valproate molecule, and the lower layer of the lower molecule, the valproic acid molecule.

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Related

Abbott Laboratories v. TorPharm, Inc.
503 F.3d 1372 (Federal Circuit, 2007)
Abbott Laboratories v. Apotex, Inc.
455 F. Supp. 2d 831 (N.D. Illinois, 2006)
United States v. Nikita Hampton
464 F.3d 687 (Seventh Circuit, 2006)

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Bluebook (online)
309 F. Supp. 2d 1043, 2004 U.S. Dist. LEXIS 4147, 2004 WL 513654, Counsel Stack Legal Research, https://law.counselstack.com/opinion/abbott-laboratories-v-torpharm-inc-ilnd-2004.