Addressing non-infringement on a summary judgment motion, the US District Court for the Eastern District of Texas ruled that Mylan and Teva's accused generic products did not infringe as a matter of law because water is not a "gelling agent" as required by the asserted claims. Allergan Sales, LLC v. Teva Pharmaceuticals USA, Inc., Case No. 2017 WL 4800734 (E.D. Tex., Sept. 28, 2017) (Payne, J); adopted by Allergan Sales, LLC v. Teva Pharmaceuticals USA, Inc., Case No. 2017 WL 4792543 (ED Tex., Oct. 24, 2017) (Gilstrap, J).
The infringement action arose from abbreviated new drug applications (ANDAs) filed by Teva and Mylan to market a generic version of Allergan's ulcerative colitis drug sold under the brand name Delzicol. The dispute did not concern Delzicol itself, but rather the capsule that holds the drug and the patent covering that capsule (US Patent No. 6,649,180).
Mylan and Teva moved for summary judgment of non-infringement, each contending that their proposed generic products would not include at least one element of the asserted claims, because the accused capsules were not formed from a film composition comprising a "gelling agent" as the asserted claims required.
The '180 patent claimed a hard capsule formed of a film composition comprising a hydroxypropyl methyl cellulose (HPMC) base, a gelling agent, a gelling aid and optional additives. The gelling agents described in the specification were all hydrocolloid compounds.
The capsules used by Mylan and Teva's generic products did not use a hydrocolloid-like gelling agent such as those described by the '180 patent. Instead, the accused capsules were manufactured using a thermogelation process that takes advantage of the intrinsic gelling properties of HPMC. When the aqueous solution of HPMC is heated, the water structure breaks down and the HPMC precipitates out of the water, forming a gel.
Parties disputed the construction of the term "gelling agent" and whether the water used in making their generic capsule would qualify as the "gelling agent" by itself. The court determined that the plain and ordinary meaning of "gelling agent" was a "substance that gels the film composition." The court found that while the specification mentioned water 21 times, it was never mentioned in the context of being a gelling agent. Water was mentioned in the specification only in two contexts: (1) in terms of residual "water content" present in the capsule, and (2) as a solvent used to dissolve the HPMC, gelling agent, gelling aid and other optional additives during the capsule forming process.
Thus, the fact that the inventors contemplated the presence of water in the process but failed to call water out as a "gelling agent" indicated that water was not intended to be a gelling agent. The court held that under this clarifying construction, Mylan and Teva's accused products could not, as a matter of law, be encompassed by the claims of the '180 patent because there is no dispute that the products do not contain any substance other than water that could be considered a "gelling agent."
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