{"id":2653,"date":"2020-01-07T16:04:00","date_gmt":"2020-01-07T21:04:00","guid":{"rendered":"https:\/\/patents.harnessip.com\/?p=2653"},"modified":"2020-01-26T19:08:43","modified_gmt":"2020-01-27T00:08:43","slug":"markush-groups-open-to-additional-elements","status":"publish","type":"post","link":"https:\/\/patents.harnessip.com\/?p=2653","title":{"rendered":"Markush Groups Open to Additional Elements"},"content":{"rendered":"\n

Amgen, Inc. v. Amneal Pharmaceuticals LLC<\/a>, [2018-2414, 2019-1086] (January 7, 2020), the Federal Circuit vacated and remand the district court\u2019s judgment that Amneal did not infringe U.S. Patent 9,375,405, and affirmed that Piramal did not infringe and that Zydus did infringe the \u2018405 patent.<\/p>\n\n\n\n

On appeal Amgen challenged\nthe district court\u2019s construction of a Markush group of binders:<\/p>\n\n\n\n

from about 1% to about 5% by weight of at least one binder selected from the group consisting of povidone, hydroxypropyl methylcellulose, hydroxypropyl cellulose, sodium carboxymethylcellulose, and mix-tures thereof<\/p><\/blockquote>\n\n\n\n

and a Markush group of\ndisintegrants:<\/p>\n\n\n\n

from about 1% to 10% by weight of at least one disintegrant selected from the group consisting of crospovid[o]ne, sodium starch glycolate, croscarmellose sodium, and mixtures thereof<\/p><\/blockquote>\n\n\n\n

The district court held both\nof these Markush groups were closed, such that additional binder and\ndisintegrant substances in addition to the ones specified in the Markush ground\navoided infringement.<\/p>\n\n\n\n

The\nFederal Circuit said that Multilayer <\/em>and\nShire <\/em>did not hold broadly that, whenever \u201cconsisting of\u201d Markush group\nlanguage is present in a particular claim limitation, even when the limitation\nfollows a general claim transition phrase of \u201ccomprising,\u201d all components of an\naccused product that perform the general function of the particular limitation\nmust meet the requirements of that limitation, thus precluding components\noutside the Markush group.  The Federal\nCircuit explained that those decisions do not apply in this case, where the\nquestion is whether the \u201cbinder\u201d or \u201cdisintegrant\u201d claim limitations are\nwritten to preclude other binders and disintegrants in the claimed composition.\nThe Federal Circuit concluded that they are not.<\/p>\n\n\n\n

In Multilayer<\/em>, the\nMarkush group was closed because the language of the claim was closed,\nrequiring \u201ceach layer being selected from the group consisting of . . . \u201c.  In Multilayer<\/em>\nthe Federal Circuit further held that dependent claim 10, which added a\nrequirement that \u201cat least one said inner layer\u201d contain a resin not listed in the\nelement, was invalid because it was inconsistent with the independent claim.  In particular, the Federal Circuit said, it had\nno occasion to, and did not, consider the effect of the transition phrase \u201ccomprising\u201d.<\/p>\n\n\n\n

In construing the (a) and (b)\nMarkush groups in Shire<\/em>, the Federal\nCircuit explained that the \u201cconsisting of\u201d language defined the groups and\ncreated a \u201cvery strong presumption\u201d that the Markush groups were closed to\nadditional elements not specified in the claim. \nThe Federal Circuit pointed out that this was also decided without\nreference to the comprising transition. \nThe claim specified that  the outer\nmatrix of the claimed composition \u201cconsists of\u201d the compounds in the Markush\ngroup. The outer matrix, by the terms of the element, had to \u201cconsist of\u201d of\nthose compounds to meet that limitation.<\/p>\n\n\n\n

The Federal Circuit found\nthat the decisive issue in the current case is critically different from any\nissue decided in Multilayer <\/em>or Shire<\/em>. The issue is whether all\nbinders or disintegrants in the claimed formulation are subject to the specific\nbinder or disintegrant limitations. The Federal Circuit concluded that they\nwere not.  First, the Federal Circuit\nnoted that there is no language in Amgen\u2019s claim indicating that every binder\nor disintegrant in the claimed formulation must be within the Markush groups.  The Federal Circuit said that the limitations\nmerely require that those particular binders or disintegrants meet the\nspecified weight-percentage requirements, which is not inconsistent with the\noverall composition containing other binders or disintegrants.<\/p>\n\n\n\n

The Federal Circuit said that\nthe plain language of the claim requires \u201cat least one\u201d of the Markush members\nand certainly does not indicate that the only binders and disintegrants in the\nclaimed formulation are those listed in the groups. The Federal Circuit did not\nsee a sufficient basis for a different conclusion in the specification or in\nthe prosecution history.  The Federal\nCircuit also noted the transition \u201ccomprising,\u201d which makes clear that the\nclaim does not preclude the presence of components or steps that are in\naddition to, though not inconsistent with, those recited in the limitations\nthat follow.  The Federal Circuit said\nthat the use of the \u201ccomprising\u201d transition phrase reinforces the conclusion\nthat the language of those limitations is best construed not to foreclose such\nadditional binders and disintegrants.\n\nThe Federal Circuit vacated the district court\u2019s\ndecision as to the Amneal product. \nHowever, the Federal Circuit agree that prosecution history estoppel\nprevented Amgen from asserting that Piramal\u2019s product infringed under the doctrine\nof equivalents.\n\n\n\n<\/p>\n","protected":false},"excerpt":{"rendered":"

Amgen, Inc. v. Amneal Pharmaceuticals LLC, [2018-2414, 2019-1086] (January 7, 2020), the Federal Circuit vacated and remand the district court\u2019s judgment that Amneal did not infringe U.S. Patent 9,375,405, and affirmed that Piramal did not infringe and that Zydus did … 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-2653","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\/2653","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=2653"}],"version-history":[{"count":1,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=\/wp\/v2\/posts\/2653\/revisions"}],"predecessor-version":[{"id":2654,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=\/wp\/v2\/posts\/2653\/revisions\/2654"}],"wp:attachment":[{"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=2653"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=2653"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=2653"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}