{"id":2241,"date":"2018-10-12T19:56:59","date_gmt":"2018-10-12T23:56:59","guid":{"rendered":"https:\/\/patents.harnessip.com\/?p=2241"},"modified":"2018-10-14T21:17:03","modified_gmt":"2018-10-15T01:17:03","slug":"the-board-may-consider-non-prior-art-evidence-in-considering-the-knowledge-motivations-and-expectations-of-a-phosita-regarding-the-prior-art","status":"publish","type":"post","link":"https:\/\/patents.harnessip.com\/?p=2241","title":{"rendered":"The Board\u00a0May Consider Non-Prior Art Evidence in Considering the Knowledge, Motivations, and Expectations of a PHOSITA Regarding the Prior Art."},"content":{"rendered":"

In Yeda Research and Development Co., Ltd. v. Mylan Pharmaceuticals Inc.<\/a>, [2017-1594, 2017-1595, 2017-1596] (October 12, 2018) the Federal Circuit affirmed the Board’s determination that\u00a0U.S. Patent Nos. 8,232,250,\u00a08,399,413, and 8,969,302 unpatentable as obvious.<\/p>\n

Yeda contends that its due process rights and the\u00a0APA were violated because it did not have notice of,\u00a0and an opportunity to respond to, Khan 2009. The Board relied on Khan 2009\u00a0in deciding whether a\u00a0POSITA would have had a reasonable expectation of\u00a0 success of a thrice-weekly regimen.\u00a0 Yeda received notice of Khan 2009 in Petitioners’ expert reply declaration, attached to Petitioners\u2019\u00a0reply. Yeda deposed Dr. Green after receiving his\u00a0reply declaration; he discussed Khan 2009 in that\u00a0deposition and was questioned about it.\u00a0\u00a0Yeda also moved to exclude Khan 2009\u00a0as irrelevant, which the Board denied.\u00a0Yeda could have,\u00a0but did not, address Khan 2009 at the oral hearing or
\nseek leave to file a surreply to substantively respond\u00a0to Khan 2009.<\/p>\n

Based on this record, the Federal Circuit received proper notice\u00a0of and an opportunity to respond to Khan 2009\u2014an\u00a0opportunity Yeda took advantage of when it moved to\u00a0 exclude the study. But Yeda contends that it had no\u00a0notice that the Board \u201cmight rely extensively\u201d on\u00a0Khan 2009 and make it \u201can essential part of its\u00a0obviousness analysis.\u201d The Federal Circuit said that although Yeda framed its argument as being\u00a0about due process, it really only challenges the\u00a0Board\u2019s use of Khan 2009.\u00a0 The Board acknowledged\u00a0that Khan 2009 does not qualify as statutory\u00a0prior art, but because the study began two years\u00a0before the priority date of the patents, the\u00a0Board concluded that Khan 2009 is \u201cprobative of the\u00a0fact that those skilled in the art were motivated to
\ninvestigate dosing regimens of GA with fewer injections\u00a0to improve patient compliance.\u201d<\/p>\n

The real question before the Federal Circuit was whether the Board\u00a0may consider non-prior art evidence, such as Khan\u00a02009, in considering the knowledge, motivations, and
\nexpectations of a POSITA regarding the prior art.\u00a0 The Federal Circuit noted that the statute\u00a0permits IPR petitioners to rely on evidence beyond\u00a0the asserted prior art. Section 312(a)(3) of Title 35\u00a0specifies that a petition should include both \u201ccopies of
\npatents and printed publications that the petitioner\u00a0relies upon,\u201d and \u201caffidavits or declarations of supporting\u00a0evidence and opinions.\u201d As do the regulations.\u00a0\u00a0See 37 C.F.R. \u00a7 42.104(b).<\/p>\n

The Federal Circuit said that the Board has recognized that non-prior art\u00a0evidence of what was known \u201ccannot be applied,\u00a0independently, as teachings separately combinable\u201d\u00a0with other prior art, but \u201ccan be relied on for their\u00a0proper supporting roles, e.g., indicating the level of\u00a0ordinary skill in the art, what certain terms would\u00a0mean to one with ordinary skill in the art, and how\u00a0one with ordinary skill in the art would have understood\u00a0a prior art disclosure.\u201d The Federal Circuit said that the expert’s reliance\u00a0on Khan 2009\u00a0is permissible, as it supports and explains his position\u00a0that a POSITA would have thought less frequent\u00a0dosing worthy of investigation as of the priority date. The Federal Circuit found the reliance proper, but to\u00a0the extent that this reliance was error,
\nit concluded that it was harmless error,\u00a0because substantial evidence otherwise
\nsupports the Board\u2019s conclusion.<\/p>\n

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

In Yeda Research and Development Co., Ltd. v. Mylan Pharmaceuticals Inc., [2017-1594, 2017-1595, 2017-1596] (October 12, 2018) the Federal Circuit affirmed the Board’s determination that\u00a0U.S. Patent Nos. 8,232,250,\u00a08,399,413, and 8,969,302 unpatentable as obvious. Yeda contends that its due process rights … 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-2241","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\/2241","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=2241"}],"version-history":[{"count":1,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=\/wp\/v2\/posts\/2241\/revisions"}],"predecessor-version":[{"id":2242,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=\/wp\/v2\/posts\/2241\/revisions\/2242"}],"wp:attachment":[{"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=2241"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=2241"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=2241"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}