{"id":2239,"date":"2018-10-12T16:29:59","date_gmt":"2018-10-12T20:29:59","guid":{"rendered":"https:\/\/patents.harnessip.com\/?p=2239"},"modified":"2018-10-14T19:56:45","modified_gmt":"2018-10-14T23:56:45","slug":"district-court-did-not-rely-on-flawed-obvious-to-try-rational","status":"publish","type":"post","link":"https:\/\/patents.harnessip.com\/?p=2239","title":{"rendered":"District Court Did Not Rely on Flawed Obvious to Try Rational"},"content":{"rendered":"

In Teva Pharmaceuticals USA, Inc., v. Sandoz Inc.<\/a>, [2017-1575] (October 12, 2018), the Federal Circuit affirmed the district court decision invalidating for obviousness all asserted\u00a0claims of patents directed to COPAXONE\u00ae 40mg\/mL, a\u00a0product marketed for treatment of patients with relapsing\u00a0forms of multiple sclerosis.<\/p>\n

On appeal, Teva argued the district court improperly discounted the “sufficiency” terms in its claims,\u00a0construing these terms to be nonlimiting\u00a0statements of intended effect.\u00a0 The Federal Circuit\u00a0said that \u201cthe\u00a0regimen being sufficient to reduce the frequency of relapses\u00a0in the patient\u201d does not change the express dosing\u00a0amount or method already disclosed in the claims, or\u00a0otherwise result in a manipulative difference in the steps
\nof the claims.” The Federal Circuit further found that Teva’s argument that the\u00a0 sufficiency terms were added\u00a0during prosecution to overcome rejections\u00a0overstated the intrinsic record. Accordingly the Federal Circuit found no error in the district court’s construction.<\/p>\n

As to obviousness, Teva argued for the patentability of its claimed dosing regimen,\u00a0\u00a0the improved tolerability,\u00a0reduced frequency of adverse effects, and the reduced severity of\u00a0injection site reactions.<\/p>\n

The Federal Circuit rejected Teva’s argument that the district court engaged in an improper obvious to try analysis.\u00a0 An \u201cobvious to try\u201d analysis is improper if it\u00a0suggests varying all parameters or try every available option until one\u00a0succeeds, where the prior art gave no indication of critical\u00a0parameters and no direction as to which of many possibilities is likely to be successful.\u00a0\u00a0 An \u201cobvious to try\u201d analysis is involves a new\u00a0technology or general approach in a seemingly promising\u00a0field of experimentation, but the prior art gives only\u00a0general guidance as to the particular form or method of
\nachieving the claimed invention. The Federal Circuit said that neither of these was what the district court did — the prior art focused on two critical\u00a0variables, dose size and injection frequency, and provided\u00a0clear direction as to choices likely to be successful in
\nreducing adverse side effects and increasing patient\u00a0adherence.<\/p>\n

Teva contends that the\u00a0unpredictable nature of the compound categorically precludes the\u00a0obvious-to-try analysis employed by the district court.\u00a0 Again the Federal Circuit disagreed, noting\u00a0obviousness was proven through human clinical studies\u00a0establishing the safety, efficacy, and tolerability at\u00a0doses and dose frequencies similar to the claimed regimen.<\/p>\n

Regarding\u00a0improved tolerability and reduced frequency,\u00a0Teva argued that the prior art did not lead POSITAs\u00a0to expect improved tolerability and reduced frequency of
\ninjection reactions from the claimed regimen compared to\u00a0the prior art, but the Federal Circuit disagreed.\u00a0 Teva found\u00a0fault with the district court\u2019s reference to\u00a0\u201ccommon sense\u201d in its reliance on expert testimony, and argued that the expert testimony was conclusory and unsupported by the prior art.\u00a0 The Federal Circuit found no error in what\u00a0is essentially a credibility determination.<\/p>\n

On reduced severity, the Federal Circuit again agreed with the district court that the evidence provided a reasonable expectation to those skilled in the\u00a0art that reducing the number of injections per week may\u00a0also reduce the severity of injection site reactions.<\/p>\n

 <\/p>\n

 <\/p>\n

 <\/p>\n

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

In Teva Pharmaceuticals USA, Inc., v. Sandoz Inc., [2017-1575] (October 12, 2018), the Federal Circuit affirmed the district court decision invalidating for obviousness all asserted\u00a0claims of patents directed to COPAXONE\u00ae 40mg\/mL, a\u00a0product marketed for treatment of patients with relapsing\u00a0forms of … 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-2239","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\/2239","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=2239"}],"version-history":[{"count":1,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=\/wp\/v2\/posts\/2239\/revisions"}],"predecessor-version":[{"id":2240,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=\/wp\/v2\/posts\/2239\/revisions\/2240"}],"wp:attachment":[{"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=2239"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=2239"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=2239"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}