Court Opinion

ID: 9496502
Source: CourtListenerOpinion
Date Created: 2023-08-05 16:28:11.018788+00
Date Added: 2024-06-11T17:57:36.919001
License: Public Domain

MAYER, Chief Judge,
dissenting.
I agree with the court to the extent that it upholds the validity of '077 patent; however, because I believe that the district court erred in its claim construction by concluding that the term “acid” as used in the claim should be construed to encompass both acids and salts, I dissent. Such construction does not accord with a plain reading of the claim or the claim in light of the specification.
In a few instances in the specification of the '077 patent, alendronic acid is named when actually referring to the salt. But in the vast majority of instances, the specification distinguishes between the two. For example: the specification lists as the preferred embodiments, inter alia, 4-amino-l-hydroxybutane-l,l-biphosphonic acid and its sodium, aniline, and lysine salts, '077 patent, col. 3, ll. 20-26; in the “Toxicology Study” section of the specification, tests were conducted for the acid and the salt, listing them as separate compounds, id. at col. 6, ll. 48-49; and in a discussion of the bone reabsorption and in vivo calcification experiments, the acid is juxtaposed with the name of another compound that is characterized as the sodium salt, id. at col. 9, ll. 45-51. These examples, and there are others, evidence that the acid and the salt are distinct compounds and that the patentee is able to distinguish between the two when he so chooses.
Further support for the proposition that the two are distinct compounds can be found in the testimony of the parties’ expert witnesses. Three expert witnesses, two provided by Merck, one by Teva, all possessing ordinary skill in the art of chemistry and pharmacology, testified that acid — as that word is ordinarily and customarily used in the relevant art — is distinct in its chemical composition from salt. The term “acid,” then, as it is used here, cannot be read to mean “acid and its salts”; the literal scope of the claim can extend only to the acid itself. Because Teva’s proposed products are not acids, there can be no literal infringement of the '077 patent.
Nor can there be infringement under the doctrine of equivalents. “[W]hen a patent drafter discloses but declines to claim subject matter ... this action dedicates that unclaimed subject matter to the public.” Johnson & Johnston Assocs. v. R.E. Serv. Co., 285 F.3d 1046, 1054 (Fed.Cir.2002). Here, the patentee disclosed alendronic acid “and [its] sodium, aniline and lysine salts” but failed to explicitly claim the salts. '077 patent, col. 3, ll. 24-26; id. at col. 16, ll. 43-47. It is a “fundamental principle that claims define the scope of patent protection.” Johnson & Johnston, 285 F.3d at 1052. Because the '077 patent does not capture sodium, aniline and lysine salts within the language of the claim, they are dedicated to the public. Therefore, such salts are not equivalent to the alendronic acid literally claimed.
I also disagree with the court’s conclusion that the patent is entitled to a term extension. A patent term extension under 35 U.S.C. § 156 extends the life of a patent that claims a method of using a product that has been the subject of regulatory review. The product that was subject to regulatory review here was 4-amino-l-hydroxybutane-l,l-biphosphonic acid mo-nosodium salt trihydrate whereas the patent, as I see it, claims only 4-amino-l-hydroxybutane-l,l-biphosphonic acid. *1375Because the patent does not claim a product that was subject to regulatory review, the patent term extension that was granted for the '077 patent is invalid.