{"id":1801,"date":"2017-11-01T23:01:12","date_gmt":"2017-11-02T03:01:12","guid":{"rendered":"https:\/\/patents.harnessip.com\/?p=1801"},"modified":"2017-11-06T09:08:54","modified_gmt":"2017-11-06T14:08:54","slug":"expert-testimony-on-lack-of-motivation-won-the-battle-but-lost-the-war","status":"publish","type":"post","link":"https:\/\/patents.harnessip.com\/?p=1801","title":{"rendered":"Expert Testimony on Lack of Motivation Won the Battle, but Lost the War"},"content":{"rendered":"

In BayerPharma AG v. Watson Laboratories, Inc.<\/a>, [2016-2169] (November 1, 2017), the Federal Circuit reversed the district court’s holding that claims 9 and 11 of\u00a0U.S. Patent No. 8,613,950 would not have been obvious.<\/p>\n

The district court\u00a0rejected each of Watson\u2019s arguments. It found a person of\u00a0ordinary skill in the art would not have been motivated to
\ncreate an ODT formulation of vardenafil and would not\u00a0have used mannitol and sorbitol as excipients. It found\u00a0the prior art taught away from formulating vardenafil\u00a0ODT as immediate-release. The district court also addressed\u00a0Bayer\u2019s objective evidence of nonobviousness and
\nfound it supported its conclusion that Watson failed to\u00a0prove by clear and convincing evidence that claims 9 and\u00a011 would have been obvious.<\/p>\n

The district court determined that Watson failed to\u00a0meet its burden of proving by clear and convincing evidence\u00a0that there would have been a motivation to formulate\u00a0vardenafil as an ODT formulation\u00a0largely on the court\u2019s finding the\u00a0testimony of Bayer\u2019s expert, Dr. Wicks, more persuasive\u00a0than the testimony of Watson\u2019s expert, Dr. Jacobs.\u00a0 The Federal Circuit said that the clear error in the district court fact finding that\u00a0there was no motivation to formulate ED drugs in ODTs,\u00a0is that it concluded that the record did not contain an\u00a0indication that ED drugs would be good candidates for\u00a0ODT formulations.\u00a0 The Federal Circuit noted that the district court’s opinion did not discuss any of the references that Watson cited to show that\u00a0ED drugs would be good candidates for\u00a0ODT formulations.<\/p>\n

It is well within the district court\u2019s discretion to credit\u00a0one expert\u2019s competing testimony over another. The Federal Circuit said it must\u00a0give due regard to the trial court\u2019s opportunity to judge\u00a0the witnesses\u2019 credibility.\u00a0 However,\u00a0a district\u00a0court cannot, through a credibility determination, ignore\u00a0the wealth of evidence, especially as in this case where\u00a0the expert did not even address it.<\/p>\n

The Federal Circuit also faulted the district court’s focus on the fact that\u00a0\u00a0no ODT ED drug had gained\u00a0FDA approval as of \u2019950 patent\u2019s priority date.\u00a0 The Federal Circuit said that\u00a0 the\u00a0motivation to combine inquiry is not limited to what\u00a0products are forthcoming or currently available on the\u00a0market.\u00a0 The Federal Circuit said that\u00a0any\u00a0motivation, \u201cwhether articulated in the references themselves\u00a0or supported by evidence of the knowledge of a\u00a0skilled artisan, is sufficient.<\/p>\n

The Federal Circuit was left with the definite and firm\u00a0conviction that the district court clearly erred when it\u00a0found there would not have been a motivation to formulate\u00a0vardenafil ODT.<\/p>\n

The\u00a0district court also found a person of ordinary skill in\u00a0the art would not have been motivated to use mannitol\u00a0and sorbitol in an ODT formulation, again finding Dr. Wicks\u2019\u00a0testimony on this limitation more credible than\u00a0Dr. Jacobs\u2019.\u00a0 The Federal Circuit did not question the district court\u2019s credibility determinations.\u00a0However, the district court\u2019s analysis for\u00a0the sorbitol and mannitol limitation focused on the\u00a0 commercial availability of products while failing to address\u00a0relevant prior art. Upon consideration of the entire\u00a0record and under a proper analysis, we conclude that the\u00a0district court clearly erred in finding a person of ordinary\u00a0skill in the art would not have been motivated to formulate\u00a0an\u00a0 ODT with sorbitol and mannitol.<\/p>\n

Finally, the Federal Circuit rejected the district court’s determination that vardenafil\u2019s expected bitter taste taught away from an oral formulation.\u00a0 The Federal Circuit noted that a\u00a0reference teaches\u00a0away when it suggests that the line of development\u00a0flowing from the reference\u2019s disclosure is unlikely to be\u00a0productive of the result sought by the applicant.\u00a0\u00a0The Federal Circuit said that the district court did not find that a person of ordinary\u00a0skill in the art would have believed vardenafil\u2019s expected\u00a0bitter taste and increased bioavailability would have
\nlikely rendered an immediate-release formulation unproductive, but instead focused on whether a person of ordinary skill in the art would have pursued other alternatives.\u00a0 The Federal Circuit said that\u00a0the teaching\u00a0away inquiry does not focus on whether a person of ordinary
\nskill in the art would have merely favored one disclosed\u00a0option over another disclosed option.\u00a0\u00a0In assessing\u00a0whether prior art teaches away, that better alternatives\u00a0exist in the prior art does not mean that an inferior\u00a0combination is inapt for obviousness purposes.<\/p>\n

Weighing all four Graham factors, the Federal Circuit concluded that
\nclaims 9 and 11 of the \u2019950 patent would have been obvious.\u00a0The repeated suggestion in the prior art to make an\u00a0ODT formulation of an ED drug and the suggestion to use\u00a0the combination of sorbitol and mannitol as excipients were strong evidence of a motivation to make the claimed\u00a0combination.<\/p>\n","protected":false},"excerpt":{"rendered":"

In BayerPharma AG v. Watson Laboratories, Inc., [2016-2169] (November 1, 2017), the Federal Circuit reversed the district court’s holding that claims 9 and 11 of\u00a0U.S. Patent No. 8,613,950 would not have been obvious. The district court\u00a0rejected each of Watson\u2019s arguments. … 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":[54,12],"tags":[],"class_list":["post-1801","post","type-post","status-publish","format-standard","hentry","category-motivation-to-combine","category-obviousness"],"post_mailing_queue_ids":[],"_links":{"self":[{"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=\/wp\/v2\/posts\/1801","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=1801"}],"version-history":[{"count":1,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=\/wp\/v2\/posts\/1801\/revisions"}],"predecessor-version":[{"id":1802,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=\/wp\/v2\/posts\/1801\/revisions\/1802"}],"wp:attachment":[{"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=1801"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=1801"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=1801"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}