{"id":3559,"date":"2023-11-06T21:23:00","date_gmt":"2023-11-07T03:23:00","guid":{"rendered":"https:\/\/patents.harnessip.com\/?p=3559"},"modified":"2023-12-12T15:30:55","modified_gmt":"2023-12-12T21:30:55","slug":"extrinsic-evidence-needed-to-construe-numerical-limitation-in-the-claims","status":"publish","type":"post","link":"https:\/\/patents.harnessip.com\/?p=3559","title":{"rendered":"Extrinsic Evidence Needed to Construe Numerical Limitation in the Claims"},"content":{"rendered":"\n

Actelion Pharmaceuticals Ltd, v. Mylan Pharmaceuticals Inc.<\/em>, [2022-1889]<\/a> (November 6, 2023), the Federal Circuit vacated the district court\u2019s claim construction order with respect to the term \u201ca pH of 13 or higher\u201d in U.S. Patent Nos. 8,318,802 and 8,598,227 and the judgment of infringement, and remand for the district court to consider the extrinsic evidence and its impact on claim construction.\u00a0 The patents in suit were directed to improved epoprostenol formulations.<\/p>\n\n\n\n

The claim required \u201cthe bulk solution has a pH of 13 or higher.\u201d<\/em>\u00a0 Both parties proposed the plain and ordinary meaning of the term but disagreed on what that means.\u00a0 Actelion argued that \u201ca pH of 13\u201d in the context of the asserted claims is \u201ca value of acidity that is given as an order of magnitude that is subject to rounding.\u201d\u00a0 More specifically, Actelion\u2019s proposal would allow a pH of 12.5, which rounds to 13, to read on the claim limitation of \u201ca pH of 13 or higher.\u201d By contrast, Mylan argued that the proper construction cannot cover any pH values less than 13.<\/p>\n\n\n\n

The Federal Circuit said that there was no blanket rule that ranges, or specifically open-ended ranges, must foreclose rounding.\u00a0 Unlike other claim terms, the disputed claim term lacks approximation language like \u201cabout.\u201d\u00a0 Mylan argued, \u201c13\u201d and \u201cabout 13\u201d would both imply rounding, making the approximation language superfluous.\u00a0 Actelion argued that rounding is required because approximation language like \u201cabout\u201d signals different variations than those of rounding. Actelion also argued that \u201cit is not practically possible to measure exact pH values\u201d because to get an \u201cexact\u201d measurement \u201cone would have to count every hydrogen ion in solution, which is not scientifically possible.\u201d\u00a0 Ultimately, the Federal Circuit did not find the absence of approximation language dispositive here, and rejected any invitation to create a bright-line rule.<\/p>\n\n\n\n

The specification revealed that the inventor inconsistently described the level of specificity for a pH of 13.\u00a0 The specification explains that \u201c[t]he pH of the bulk solution is preferably adjusted to about 12.5-13.5, most preferably 13.\u201d\u00a0 Mylan argues that this shows that the inventor (1) knew how to use approximation language when it wanted (\u201cabout 12.5-13.5\u201d) and chose not to for a pH of 13; (2) distinguished a pH value of \u201c12.5\u201d from that of \u201c13\u201d; and (3) distinguished a range (\u201c12.5-13.5\u201d) from a definite value (\u201c13\u201d).\u00a0 Actelion countered that \u201c13\u201d should allow rounding or else a preferred embodiment of the invention, meaning a pH of about 12.5 to 13.5, would be excluded from the claim scope.<\/p>\n\n\n\n

The specification seems to equate a pH of \u201c13.0\u201d to that of \u201c13.\u201d Example 4 describes screening several \u201cformulations with the pH of bulk solution . . . adjusted between 10.5 and 13.0.\u201d \u2019802 patent col. 10 ll. 63\u201364. Tables 8 and 9 show the resulting stability data and display a bulk solution pH as \u201c13\u201d with no decimal point. Mylan argues that this shows that the inventor equated a pH of \u201c13\u201d with \u201c13.0.\u201d\u00a0 The Federal Circuit noted that the specification uses both \u201c13\u201d and \u201c13.0\u201d\u2014and various degrees of precision for pH values generally\u2014throughout. In other words, the specification supplies the same clarity as to the desired level of precision as muddied water.<\/p>\n\n\n\n

Turning to the prosecution history, the Federal Circuit note that the inventor amended the claim language at issue several times, and that the Examiner said that the inventor had demonstrated that for a pH of 13 \u201cthere is a significant difference.\u201d<\/p>\n\n\n\n

The Federal Circuit said that this case was one where the proper claim construction cannot be reached without the aid of extrinsic evidence, and that the district court should have considered, at minimum, the textbook excerpts offered and addressed by the parties. The Supreme Court has made clear that there are cases where the district court must \u201clook beyond the patent\u2019s intrinsic evidence and . . . consult extrinsic evidence in order to understand, for example, the background science or the meaning of a term in the relevant art during the relevant time period.\u201d The Federal Circuit vacated the district court\u2019s judgment of infringement, and remand for the district court to consider the extrinsic evidence and its impact on claim construction.<\/p>\n","protected":false},"excerpt":{"rendered":"

Actelion Pharmaceuticals Ltd, v. Mylan Pharmaceuticals Inc., [2022-1889] (November 6, 2023), the Federal Circuit vacated the district court\u2019s claim construction order with respect to the term \u201ca pH of 13 or higher\u201d in U.S. Patent Nos. 8,318,802 and 8,598,227 and … Continue reading →<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[7],"tags":[],"class_list":["post-3559","post","type-post","status-publish","format-standard","hentry","category-claim-constructino"],"post_mailing_queue_ids":[],"_links":{"self":[{"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=\/wp\/v2\/posts\/3559","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=3559"}],"version-history":[{"count":1,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=\/wp\/v2\/posts\/3559\/revisions"}],"predecessor-version":[{"id":3560,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=\/wp\/v2\/posts\/3559\/revisions\/3560"}],"wp:attachment":[{"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=3559"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=3559"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=3559"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}