Teva Pharmaceuticals USA, Inc. v. Sandoz Inc.
810 F. Supp. 2d 578
S.D.N.Y.2011Background
- Teva sued Sandoz and Mylan for patent infringement and declaratory judgment; actions consolidated.
- Nine patents-in-suit share a common specification and priority chain from 1994 applications related to Copaxone and copolymer-1.
- Dispute centers on claim construction of terms covering copolymer-1, its weight characteristics, manufacturing methods, and MS treatment utilities.
- Defendants argue indefiniteness due to alleged failure to specify molecular weight type and determination standards; Teva argues AMW is Mp with SEC-derived measurements.
- The court undertook claim construction under Phillips v. AWH Corp. and Markman standards, concluding AMW is amenable to construction and viable with the specified context.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Construction of copolymer-1 | Teva: copolymer-1 means specific composition with non-uniform MW and sequence, synthesized from protected amino acids. | Sandoz: copolymer-1 must start from 23,000 Da and may be random in composition. | Copolymer-1 construed as mixture of polypeptides 6:2:5:1, non-uniform by MW and sequence, synthesized from protected amino acid carboxyanhydrides. |
| Meaning of ‘polypeptides composed of’ and ‘copolymers of’ | Teva: open phrases allow broader coverage; includes constituents beyond explicitly listed residues. | Sandoz/Mylan: these terms exclude unlisted elements and should be limited. | Constructions should be ‘consisting essentially of’ for both phrases, allowing impurities that do not alter core properties. |
| Copolymer-1 fraction | Teva: term covers two making methods; should not be limited to the second method only. | Mylan: limit to the second method described in the specification. | Copolymer-1 fraction means a portion with a narrower MW distribution than the starting protected mixture. |
| Average molecular weight (AMW) interpretation | Mp read from SEC chromatogram; Mp is AMW; test data and intrinsic/extrinsic evidence support this. | AMW is vague without standard conditions and instrumentation details; need precise method. | AMW means peak molecular weight detected by SEC on an appropriately calibrated gel filtration column; AMW is not indefinable. |
| Predetermined and predetermined by a test reaction | Teva: ordinary meaning; test reaction defined as a small-scale, preparatory test not necessarily on same batch. | Sandoz: requires a test reaction on the same batch and a specific relationship to large-scale reaction. | Predetermined = determined beforehand; predetermined by test reaction = determined beforehand by a test reaction (can be on a separate batch). |
Key Cases Cited
- Markman v. Westview Instruments, Inc., 517 F.3d 390 (U.S. 1995) (claim construction is a matter of law)
- Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (claim terms to be given ordinary meaning with intrinsic/extrinsic sources)
- Exxon Research & Eng’g Co. v. United States, 265 F.3d 1371 (Fed. Cir. 2001) (some experimentation to determine scope does not render claims indefinite)
- Honeywell Int’l, Inc. v. Intl. Trade Comm’n, 341 F.3d 1332 (Fed. Cir. 2003) (indefiniteness analysis depends on claim, description, and prosecution history)
- Intervet Am., Inc. v. Kee-Vet Labs., Inc., 887 F.2d 1050 (Fed. Cir. 1989) (specification not to be read as claim limitation)