{"id":2027,"date":"2018-04-16T22:03:53","date_gmt":"2018-04-17T02:03:53","guid":{"rendered":"https:\/\/patents.harnessip.com\/?p=2027"},"modified":"2018-04-26T00:40:38","modified_gmt":"2018-04-26T04:40:38","slug":"hold-the-mayo-specific-method-of-treatment-for-specific-patients-using-a-specific-compound-at-specific-doses-to-achieve-a-specific-outcome-is-patent-eligible-subject-matter","status":"publish","type":"post","link":"https:\/\/patents.harnessip.com\/?p=2027","title":{"rendered":"Hold the Mayo: Specific\u00a0Method of Treatment for Specific Patients using a Specific\u00a0Compound at Specific Doses to Achieve a Specific Outcome Is Patent-Eligible Subject matter"},"content":{"rendered":"

In Vanda Pharmaceuticals Inc. v. West-ward Pharmaceuticals International Limited<\/a>, [2016-2707, 2016-2708] (April 16. 2018), the Federal Circuit affirmed the district court;s determination that\u00a0claims 1\u20139, 11\u201313, and 16 of U.S. Patent 8,586,610 (infringed and not invalid.<\/p>\n

The Federal Circuit noted that\u00a0inducement can be found where\u00a0there is evidence of active steps taken to encourage\u00a0direct infringement, which can in turn be found in advertising\u00a0an infringing use or instructing how to engage in an\u00a0infringing use.\u00a0 Thus ican be found where\u00a0there is evidence of active steps taken to encourage
\ndirect infringement, which can in turn be found in advertising\u00a0an infringing use or instructing how to engage in an\u00a0infringing use.\u00a0 The Federal Circuit rejected West-ward’s argument that the proposed label was insufficient to find inducement, without an underlying direct infringer, because in an ANDA case infringement is statutorily defined as filing or amending the application, not by selling a product.<\/p>\n

The Federal Circuit also found that\u00a0the district court did not clearly\u00a0err in finding that the proposed label recommends performance\u00a0of all the claimed steps, finding that potential noninfringing uses do not preclude a finding of\u00a0specific intent to induce infringement.<\/p>\n

Regarding subject matter eligibility, the Federal Circuit rejected West-ward’s argument that the claims were similar to the the claims found patent ineligible in Mayo<\/em>.\u00a0\u00a0First, the claims in\u00a0Mayo were not directed to a novel method of treating a\u00a0disease. Instead, the claims were directed to a diagnostic\u00a0method based on the relationships between concentrations\u00a0of certain metabolites in the blood and the likelihood\u00a0that a dosage of a thiopurine drug will prove ineffective or\u00a0cause harm.\u00a0\u00a0This relation was a consequence of the\u00a0ways in which thiopurine compounds are metabolized by\u00a0the body\u2014entirely natural processes. And so a patent\u00a0that simply describes that relation sets forth a natural\u00a0law.\u00a0 in contrast, the Federal Circuit found the instant claims were directed to \u201ca new way of using an existing drug\u201d that is safer for\u00a0patients.<\/p>\n

Second,\u00a0the Federal Circuit found that unlike the claim in Mayo<\/em>, the present\u00a0claims do not tie\u00a0up the doctor\u2019s subsequent treatment decision.\u00a0\u00a0The claim in Mayo<\/em> did not go beyond recognizing\u00a0 a\u00a0need to increase or decrease a dose — it could be infringed even if the doctor did not actually change the treatment.\u00a0 In other words, the claim in Mayo did not involve using the natural relationship. In contrast, the claims in suit\u00a0recite the steps of carrying\u00a0out a dosage regimen based on the results of genetic\u00a0testing.\u00a0 Thus the claims do not broadly tie up the doctor’s subsequent treatment decisions.<\/p>\n

The Federal Circuit analogized the case to CellzDirect<\/em>, where the claims were not directed to an observation or detection, but to a method of preserving cells.\u00a0There, the natural ability of the subject matter to undergo the process\u00a0did not make the claim “directed to” that natural\u00a0ability. The Federal Circuit also distinguished Myriad<\/em>, where the court noted that\u00a0method claims and patents on new applications\u00a0of knowledge about particular\u00a0 genes were not\u00a0implicated by its decision, noting the claims fall squarely\u00a0 within categories of claims\u00a0not implicated by its decision.<\/p>\n

The Federal Circuit concluded that the claims were directed to a specific<\/em>\u00a0method of treatment for specific<\/em> patients using a specific<\/em>\u00a0compound at specific<\/em> doses to achieve a specific<\/em> outcome.\u00a0They are different from Mayo because they recite more than the
\na natural relationship; instead, they\u00a0recite a method of treating patients based on this relationship.<\/p>\n

The Federal Circuit affirmed that the\u00a0district court clearly erred in finding that the\u00a0 patent sufficiently discloses the claimed invention.<\/p>\n

Finally, the Federal Circuit agreed that\u00a035 U.S.C. \u00a7 271(e)(4) supports\u00a0the injunctive relief granted by the district court.<\/p>\n

 <\/p>\n

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

In Vanda Pharmaceuticals Inc. v. West-ward Pharmaceuticals International Limited, [2016-2707, 2016-2708] (April 16. 2018), the Federal Circuit affirmed the district court;s determination that\u00a0claims 1\u20139, 11\u201313, and 16 of U.S. Patent 8,586,610 (infringed and not invalid. The Federal Circuit noted that\u00a0inducement … 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":[15],"tags":[],"class_list":["post-2027","post","type-post","status-publish","format-standard","hentry","category-15"],"post_mailing_queue_ids":[],"_links":{"self":[{"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=\/wp\/v2\/posts\/2027","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=2027"}],"version-history":[{"count":1,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=\/wp\/v2\/posts\/2027\/revisions"}],"predecessor-version":[{"id":2028,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=\/wp\/v2\/posts\/2027\/revisions\/2028"}],"wp:attachment":[{"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=2027"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=2027"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=2027"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}