{"id":2779,"date":"2020-04-21T17:38:17","date_gmt":"2020-04-21T22:38:17","guid":{"rendered":"https:\/\/patents.harnessip.com\/?p=2779"},"modified":"2020-04-26T13:10:39","modified_gmt":"2020-04-26T18:10:39","slug":"the-scope-of-patent-term-extension-under-35-usc-%c2%a7156-only-includes-the-active-ingredient-of-an-approved-product","status":"publish","type":"post","link":"https:\/\/patents.harnessip.com\/?p=2779","title":{"rendered":"The Scope of Patent Term Extension under 35 USC \u00a7156 Only Includes the Active Ingredient of an Approved Product"},"content":{"rendered":"\n

In Biogen International GmbH v. Banner Live Sciences, LLC, [2020-1373]<\/a> (April 21, 2020), the Federal Circuit affirmed the district court’s determination that Banner does not infringe the extended portion of U.S. Patent No. 7,691,001.<\/p>\n\n\n\n

The ‘001 patent covers the administration of dimethyl fumarate, methyl hydrogen fumarate, or combinations thereof , and cover both the dimethyl ester and monomethyl ester forms are covered by this claim. <\/p>\n\n\n\n

Biogen asserted the \u2019001 patent in an infringement action against Banner in the District of Delaware. Banner immediately moved for a judgment of
noninfringement, arguing that \u00a7 156(b)(2) limits the scope of the \u2019001 patent\u2019s extension to methods of using the approved product as defined in \u00a7 156(f)\u2014in this case, DMF, its salts, or its esters\u2014and that MMF is none of those. Biogen responded that \u00a7 156(b)(2) does not limit extension of a method of treatment patent to uses of the approved product, but instead only to uses of any product within the original scope of the claims. Biogen further argued that, in any event, \u201cproduct\u201d in \u00a7 156 has a broader meaning encompassing any compound that shares with the approved product an \u201cactive moiety.\u201d<\/p>\n\n\n\n


<\/p>\n\n\n\n

The district court agreed with Banner\u2019s interpretation of \u00a7 156 in both respects and rendered a judgment of noninfringement. It rejected Biogen\u2019s argument that extension of a method of treatment patent under \u00a7 156(b)(2) is not limited to uses of the approved product.<\/p>\n\n\n\n

The Federal Circuit explained that under \u00a7 156, an NDA holder is entitled to extend the term of only one patent for the corresponding approved product. Subsection (a) places several conditions on term extension for an NDA holder, including that the applicant\u2019s approved NDA must be \u201cthe first permitted commercial marketing or use of the product. Subsection (b) limits the scope of the patent extension to \u201cany use approved for the product,\u201d and further, for method of treatment patents, to uses also \u201cclaimed by the patent.\u201d The Federal Circuit said that citically, for the purposes of the appeal, subsection (f) defines \u201cproduct\u201d as \u201cthe active
ingredient of . . . a new drug . . . including any salt or ester
of the active ingredient.\u201d \u00a7 156(f)(2)(A).<\/p>\n\n\n\n

The Federal circuit said that \u201cActive ingredient\u201d is a term of art, defined by the FDA as \u201cany component that is intended to furnish pharmacological activity or other direct effect,\u201d 21 C.F.R. \u00a7 210.3(b)(7), and it \u201cmust be present in the drug product when administered.\u201d The active ingredient
of a given drug product is defined by what is approved and is specified on the drug\u2019s label. The Federal Circuit noted that MMF is not the approved product, nor is it specified as the active ingredient on the Tecfidera\u00ae label. Esters are included in the statutory definition of what can be extended, but MMF is the de-esterified form of DMF, not an ester of DMF. Thus, it is
not the same product under \u00a7 156(f) and does not fall within the scope of the \u2019001 patent\u2019s term extension under \u00a7 156(b)(2).<\/p>\n\n\n\n

<\/p>\n\n\n\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

In Biogen International GmbH v. Banner Live Sciences, LLC, [2020-1373] (April 21, 2020), the Federal Circuit affirmed the district court’s determination that Banner does not infringe the extended portion of U.S. Patent No. 7,691,001. The ‘001 patent covers the administration … 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":[79],"tags":[],"class_list":["post-2779","post","type-post","status-publish","format-standard","hentry","category-anda"],"post_mailing_queue_ids":[],"_links":{"self":[{"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=\/wp\/v2\/posts\/2779","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=2779"}],"version-history":[{"count":1,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=\/wp\/v2\/posts\/2779\/revisions"}],"predecessor-version":[{"id":2780,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=\/wp\/v2\/posts\/2779\/revisions\/2780"}],"wp:attachment":[{"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=2779"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=2779"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=2779"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}