{"id":1547,"date":"2017-05-19T11:10:46","date_gmt":"2017-05-19T15:10:46","guid":{"rendered":"https:\/\/patents.harnessip.com\/?p=1547"},"modified":"2017-05-21T11:58:25","modified_gmt":"2017-05-21T15:58:25","slug":"functionwayresult-test-causes-headaches-in-chemical-cases-substitute-insubstantial-differences-test","status":"publish","type":"post","link":"https:\/\/patents.harnessip.com\/?p=1547","title":{"rendered":"Function\/Way\/Result Test Causes Headaches in Chemical Cases; Substitute Insubstantial Differences Test"},"content":{"rendered":"

In Mylan Institutional LLC v. Aurpbindo Pharma Ltd.<\/em><\/a>, [2017-1645] (May 19, 2017), the Federal Circuit affirmed the grant of a preliminary injunction against the infringement of\u00a0U.S.\u00a0Patent 9,353,050 on a triarylmethane dye used to map lymph nodes.<\/p>\n

The district court found that Aurobindo did not raise\u00a0a substantial question of validity of the \u2019050 patent based\u00a0on its arguments that the process patent is invalid:\u00a0under \u00a7112,\u00a0\u00a7102, and\u00a0\u00a7103. \u00a0Regarding the\u00a0\u00a7112 challenge, the Federal CIrcuit agreed that\u00a0\u201cby HPLC\u201d was a
\ncommon and well-understood way of designating or determining\u00a0purity, as seen in \u201cnumerous sources,\u201d including\u00a0other patents and the scientific literature. \u00a0Regarding the\u00a0\u00a7103 challenge, the Federal Circuit agreed that it did not raise a\u00a0substantial question regarding motivation to combine the
\nreferences or a reasonable expectation of success. Regarding the\u00a0\u00a7102 \u00a0challenge, the Federal Circuit agreed that the conflicting evidence did not raise a substantial question as to the patent’s validity.<\/p>\n

On the likelihood of success, the Federal Circuit noted the unusual nature of a preliminary injunction issuing in the case of infringement under the doctrine of equivalents. \u00a0The Federal Circuit said that the law on the doctrine of\u00a0equivalents as applied to chemical materials is not clear,
\nand its misapplication can lead to unsound results. \u00a0In particular the Federal Circuit noted that while the function\/way\/result tset may be suitable for analyzing mechanical\u00a0devices, it often provides a poor framework for\u00a0analyzing other products or processes — particular in the chemical arts.<\/p>\n

In reviewing the district court’s equivalence analysis, the Federal Circuit found that either the did not address the “way” prong of the function\/way\/result test, or it did so incorrectly. \u00a0While the district court correctly found that manganese dioxide and silver oxide performed the same function, there is room for sufficient doubt\u00a0as to whether silver oxide and manganese dioxide oxidize\u00a0isoleuco acid in the same way so as to satisfy the \u201cway\u201d\u00a0prong of the function\/was\/result test.<\/p>\n

The Federal Circuit explained the headaches that can be caused using the function\/way\/result test (as opposed to insubstantial differences test) in chemical cases:<\/p>\n

consider the well-known compounds aspirin\u00a0and ibuprofen, which chemists would not usually\u00a0consider to be structural equivalents under the insubstantial\u00a0differences test. Chemical compounds are characterized
\nby their structures, and these two compounds differ\u00a0substantially in structure (see appendix). However, the\u00a0two compounds would seem to be substantial equivalents\u00a0under the FWR test. They each provide analgesia and\u00a0anti-inflammatory activity (\u201cfunction\u201d) by inhibiting
\nprostaglandin synthesis (\u201cway\u201d) in order to alleviate pain,\u00a0reduce fevers, and lessen inflammation (\u201cresult\u201d).<\/p>\n

The Federal Circuit observed that\u00a0a compound may appear to be equivalent under the function\/way\/result, but not under the substantiality of the differences\u00a0test, and concluded that the substantial differences test may be\u00a0more suitable than function\/way\/result for determining equivalence in\u00a0the chemical arts.<\/p>\n

Thus the Federal Circuit modified the preliminary injunction to eliminate the process patents as the basis for the preliminary injunction, but left the injunction intact as to the ‘050 product patent. \u00a0The Federal Circuit found no error in the district court’s courts conclusion that there was no substantial question about the validity of the patent, and agreed with the district court’s finding of irreparable harm.<\/p>\n

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

In Mylan Institutional LLC v. Aurpbindo Pharma Ltd., [2017-1645] (May 19, 2017), the Federal Circuit affirmed the grant of a preliminary injunction against the infringement of\u00a0U.S.\u00a0Patent 9,353,050 on a triarylmethane dye used to map lymph nodes. The district court found … 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":[40],"tags":[],"class_list":["post-1547","post","type-post","status-publish","format-standard","hentry","category-doctrine-of-equivalents"],"post_mailing_queue_ids":[],"_links":{"self":[{"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=\/wp\/v2\/posts\/1547","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=1547"}],"version-history":[{"count":2,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=\/wp\/v2\/posts\/1547\/revisions"}],"predecessor-version":[{"id":1549,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=\/wp\/v2\/posts\/1547\/revisions\/1549"}],"wp:attachment":[{"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=1547"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=1547"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=1547"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}