{"id":2139,"date":"2018-07-13T21:03:43","date_gmt":"2018-07-14T01:03:43","guid":{"rendered":"https:\/\/patents.harnessip.com\/?p=2139"},"modified":"2018-07-29T22:22:25","modified_gmt":"2018-07-30T02:22:25","slug":"federal-circuit-finds-no-error-in-district-court-determination-the-claimed-invention-was-not-obvious","status":"publish","type":"post","link":"https:\/\/patents.harnessip.com\/?p=2139","title":{"rendered":"Federal Circuit Finds No Error in District Court Determination the Claimed Invention was not Obvious"},"content":{"rendered":"

In Endo Pharmaceutical Solutions, Inc. v. Custopharm Inc.<\/a>, [2017-1719] (July 13, 2018), the Federal Circuit affirmed the determination that the claims of U.S. Patent Nos. 7,718,640 and\u00a08,338,395 on a long-acting injectable testosterone replacement\u00a0therapy were not invalid for obviousness.<\/p>\n

the district court found that the prior art did not disclose\u00a0the 750 mg TU injection dosage, and that Custopharm\u00a0had not shown, by clear and convincing evidence, that a\u00a0skilled artisan would have been motivated to lower the\u00a0dosage of TU from 1000 mg to 750 mg.\u00a0 The district court
\nfound that articles about studies do not inherently disclose the particular co-solvent or the particular ratio of solvent\u00a0to co-solvent claimed by the patents-in-suit simply because\u00a0this formulation was what had been used in the\u00a0studies forming the basis of the articles.<\/p>\n

The claims required a\u00a0750 mg dosage, which the parties agreed was not disclosed by the prior art.\u00a0 However, Custompharm argued the district court erred in finding no motivation for a\u00a0skilled artisan to lower the dose of TU from the 1000 mg disclosed in the prior art to\u00a0750 mg.\u00a0 \u00a0After discussing the evidence, the Federal Circuit\u00a0said the district court
\nreasonably rejected Custopharm\u2019s argument that a skilled\u00a0artisan would consider 1000 mg of TU to be an overdose\u00a0and would have been motivated to lower the dosage to the\u00a0patented 750 mg.<\/p>\n

Custopharm also\u00a0argued that the district court erred in finding that the
\nclaimed formulation was not inherently described by prior art articles Articles.\u00a0 Although the formulation was not disclosed is the articles,\u00a0 Custopharm argues that the vehicle formulation\u00a0was \u201cnecessarily present\u201d in the articles because it was\u00a0later revealed to be the actual formulation the authors of\u00a0the Articles used in their reported clinical studies, but the Federal Circuit disagreed.\u00a0 The Federal Circuit noted that\u00a0Custopharm has not demonstrated that a\u00a0skilled artisan could extrapolate the vehicle formulation\u00a0used in the Articles from pharmacokinetic performance\u00a0data.\u00a0 It was Custopharm\u2019s\u00a0burden to present clear and convincing evidence that the\u00a0Articles necessarily disclosed the vehicle formulation to\u00a0one of skill in the art, and\u00a0 Custopharm\u2019s expert\u2019s testimony and briefing fall short of\u00a0meeting this burden.\u00a0 The Federal Circuit said that\u00a0under the circumstances
\nof this case, the incomplete description of the injection composition elements denied skilled artisans\u00a0from having access to that composition, thereby precluding\u00a0use of the inherency doctrine to fill in disclosure about\u00a0the product missing from the articles.<\/p>\n

Regarding the motivation to combine, the Federal Circuit said that the district court thus did not err in considering the\u00a0obviousness inquiry from the perspective of a skilled\u00a0artisan \u201cconfronted with the same problems as the inventor,\u201d\u00a0which in the present case is developing a commercially
\nviable long-acting testosterone therapy.\u00a0 Doing so, the district\u00a0court properly found that Custopharm failed to meet\u00a0its burden of showing that a skilled artisan would combine\u00a0the lowered dose with the injection schedule in the\u00a0manner claimed.<\/p>\n","protected":false},"excerpt":{"rendered":"

In Endo Pharmaceutical Solutions, Inc. v. Custopharm Inc., [2017-1719] (July 13, 2018), the Federal Circuit affirmed the determination that the claims of U.S. Patent Nos. 7,718,640 and\u00a08,338,395 on a long-acting injectable testosterone replacement\u00a0therapy were not invalid for obviousness. the district … 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":[12],"tags":[],"class_list":["post-2139","post","type-post","status-publish","format-standard","hentry","category-obviousness"],"post_mailing_queue_ids":[],"_links":{"self":[{"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=\/wp\/v2\/posts\/2139","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=2139"}],"version-history":[{"count":1,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=\/wp\/v2\/posts\/2139\/revisions"}],"predecessor-version":[{"id":2140,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=\/wp\/v2\/posts\/2139\/revisions\/2140"}],"wp:attachment":[{"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=2139"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=2139"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=2139"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}