On Monday, Judge Robinson issued a thorough, lengthy opinion resulting from a patent infringement bench trial where Judge Robinson found in favor of plaintiff Alcon, despite several claim construction and validity arguments by defendant Teva. Alcon, Inc. v. Teva Pharmaceuticals USA, Inc., Civ. No. 06-234-SLR (Oct. 19, 2009). Teva had filed an Abbreviated New Drug Application (“ANDA”) “to market a generic version of the antibacterial drug VIGAMOX® proprietary to plaintiffs.” Id. at 1. VIGAMOX is an antibiotic, and its active ingredient, moxifloxacin hydrochloride, is protected by Patent No. 6,716,830, according to Alcon. Teva’s submission of an ANDA is an act of infringement, id. at 14, so the two issues in this case were (1) claim construction (whether the Teva’s generic is covered by the Alcon’s patent) and (2) validity.
Claim construction turned solely on the definition of “moxifloxacin” as used in claim 1 of Alcon’s ‘830 patent. Id. at 14-15. Both Teva’s generic and Alcon’s patent include “moxifloxacin” as the active ingredient, but Teva argued that Alcon’s patent had redefined “moxifloxacin” to mean something narrower than the ordinary industry understanding of that term. According to Teva, “because the specification . . . provides an alternate meaning for the claim term ‘moxifloxacin’ in the form of the depiction of a structurally different compound, the ordinary meaning of moxifloxacin has been displaced.” Id. at 18. Teva further argued that the specification referred to a “new class of antibiotics,” and that quinolones, the class to which moxifloxacin belongs, “were not a new class of antibiotics; therefore, the subject matter of the ‘830 patent must be directed to a different family of compounds.” Id. The court rejected each of these arguments, because “[t]he record before the court is replete with instances in which Teva’s proposed construction is at odds with the specification of the ‘830 patent so as to cause an absence of the . . . clarity, deliberateness and precision” required for a patentee to “act as his own lexicographer.” Id. at 18-19.
The validity analysis started with anticipation, which focused on a prior patent. Id. at 21-26. The prior patent disclosed a similar moxifloxacin composition, but at a different concentration range. Id. at 24-25. The ‘830 patent claimed a concentration range of “0.1 to 1.0 wt%,” while the prior patent’s range was “0.5 to 99.5 wt%.” Id. The court held that the prior patent did not anticipate the ‘830 patent, based on a genus/species analysis of the “range disparity” between the claimed and disclosed concentration numbers. Id. at 25. The court also rejected Teva’s argument that the prior patent had an “inherent range” that extended below the explicitly disclosed range. Id. at 26.
The court then addressed obviousness. Teva argued “that a motivation to combine exists inasmuch as moxifloxacin would have been ‘obvious to try’ in a topical ophthalmic composition, due to both market pressure and the existence of ‘a finite number of identified, predictable solutions’ to treat ophthalmic infections,’” and further that a person of ordinary skill in the art would have expected the combination to have desirable properties. Id. at 28. The court rejected each of these arguments, holding that “the record indicates anything but a finite number of identified, predictable solutions,” and that even if the result of substitution was predictable, that “provides little insight” into the “crucial” question of “whether the prior art motivated a person of ordinary skill to even select moxifloxacin for use in a . . . composition.” Id. at 30. In particular, the court focused on the fact that “the prior art consistently taught away from the use of moxifloxacin” in such compounds, due to its toxicity, poor performance, and ineffectiveness against certain “key” pathogens. Id. at 36, 30-33. Secondary considerations also supported non-obviousness, including initial skepticism by other experts in the field, the long felt need for a compound like this, the commercial success of VIGAMOX(r) (which achieved hundreds of millions of dollars in sales), and some unexpected properties of the invention. Id. at 35-36.
Finally, the court addressed the form requirements for validity, including best mode, written description, and enablement. Teva argued that the inventor had known, but failed to disclose, that the salt form of moxifloxacin was more effective, thus failing the best mode requirement; the court held that the inventor was not subjectively aware of the increased effectiveness of the salt form, and even if he had been, the salt form provides no material improvement anyway. Id. at 39-41. Regarding the written description requirement, Teva claimed that the specification called for a preservative, but the composition claimed did not include one; the court held that the specification encompassed embodiments that did not include a preservative, and thus met the requirement. Id. at 41-44. Finally, as to enablement, Teva asserted that the claim required undue experimentation, based on a lack of process steps in the specification; the court held that a person of ordinary skill in the art could determine appropriate steps and practice the invention.