Chart
“FIG. 1 illustrates the estradiol flux (μg/cm2/hr) over time (0-81 hours) from transdermal delivery systems according to the invention (▴ & ●), as compared to Vivelle-Dot® (♦).”

On July 5, Chief Judge Stark of the Delaware District issued a claim construction opinion in the pharmaceutical patent case of Noven v. Actavis.  The patent at issue is US Patent No. 8,231,906, “Transdermal estrogen device and delivery.”

Like many US pharmaceutical patent cases, this one arises under the Hatch-Waxman framework, in which a generic manufacturer submits an Abbreviated New Drug Application to the FDA and thereby creates a constructive infringement that allows the parties to litigate whether the patent is valid and infringed, before the generic manufacturer commits extensive resources to developing and marketing their potentially-infringing product.

Claim construction opinions often touch on dozens of terms spread across multiple patents. But Judge Stark’s opinion is mercifully compact: it addresses only a single term. That term is:

coat weight selected from the group consisting of 12.5 mg/cm2 and 15 mg/cm2.

The question before the court was the number of significant figures to assign to these numbers.

Should the court follow the defendant’s expert and construe “15” to mean “15.0” (three significant figures, i.e. approximately from 14.95 to 15.05), thus matching the number of significant figures in “12.5”?

Or should it assume that since “15” has two significant figures, it can be any number from approximately 14.5 to 15.5?

The defendant brought in an expert who contended that a person of skill in the art would read “15” in this context as “15.0” (three significant figures). But Judge Stark concluded that the expert’s opinion was unpersuasive against the plain meaning of the text.

Further, because the patent itself frequently varied the number of significant figures, there was no basis for the court to conclude that a person of skill in the art would read this particular number as being intended to have three significant figures rather than two.

This case provides an unusually simple and crisp view of the moves in the Markman dance for pharmaceutical patents. In contrast to some other frequently-litigated fields such as software, the patentability of the subject matter is seldom at issue in the pharmaceutical field. Thus the defendant seeks to push the court to the narrowest possible reading of the claims (and the plaintiff tries to pull the court toward the broadest possible reading).

The translatorial angle

Legal translation is closely aligned with comparative law, and patent translation is a kind of applied comparative patent law. From that perspective, it’s interesting that the Korean application based on this patent (10-2011-7002884) was rejected by the Korea Intellectual Property Office. (This appears to be the only national-phase filing that did not proceed to grant; the EPO and JPO both issued patents based on the US patent, although the European patent is currently in opposition proceedings.)

Somewhat ironically, at this writing the administrative history of the Korean patent is more easily viewed via the USPTO’s Global Dossier service than via KIPRIS.

One of the grounds for rejection cited by the KIPO examiner is closely related to the matter at issue in Judge Stark’s claim construction order: the specificity of ranges.

3-1. 청구항 제1항, 제3항, 제7항, 제9항, 제11항 내지 제14항, 제17항 내지 제22항 중 “약”이란 표현은 그 상한과 하한을 정할 수 없어 그 의미가 불분명하므로 이는 보호받고자 하는 발명이 명확하게 기재된 것으로 볼 수 없습니다. 3-2. 청구항 제2항, 제4항 내지제6항, 제8항, 제15항은 기재불비를 포함하고 있는 청구항을 인용하고 있으므로 상기 3-1에 기재된 내용과 동일한 이유로 보호받고자 하는 발명이 명확하게 기재된 것으로 볼 수 없습니다. 3-3. 청구항 제8항 중 “이상”이란 표현과, 청구항 제11항 중 “초과”라는 표현은 그 상한을 정할 수 없어 그 의미가 불분명하므로 이는 보호받고자 하는 발명이 명확하게 기재된 것으로 볼 수 없습니다.

(My translation:)

3-1. In Claims 1, 3, 7, 9, 11 through 14, and 17 through 22, because the expression “approximately” does not specify an upper or lower bound, the meaning thereof is unclear; thus, the invention for which protection is sought has not been described clearly thereby.

3-2. Claims 2, 4 through 6, 8, and 15 refer to claims that are deficiently described; thus, the invention for which protection is sought has not been described clearly, for the same reasons set forth in 3-1 above.

3-3. Because the expressions “at least” in Claim 8 and “greater than” in Claim 11 do not specify an upper bound, the meaning thereof is unclear; thus, the invention for which protection is sought has not been described clearly thereby.

(Although frequently not the case, here the claim numbers appear to be identical to those in the US patent.)

This rejection certainly shows the remarkably keen scrutiny to which patents are subjected in the Korean system, at least by some examiners.

And for a translator, it also highlights the importance of paying close attention to terminology related to numeric ranges, to ensure that the translation is neither more nor less specific than the source text.