{"id":1654,"date":"2017-07-18T10:21:41","date_gmt":"2017-07-18T14:21:41","guid":{"rendered":"https:\/\/patents.harnessip.com\/?p=1654"},"modified":"2017-07-18T10:22:29","modified_gmt":"2017-07-18T14:22:29","slug":"unexpected-results-of-an-obvious-process-are-non-obvious","status":"publish","type":"post","link":"https:\/\/patents.harnessip.com\/?p=1654","title":{"rendered":"Unexpected Results of an Obvious Process are Non-obvious"},"content":{"rendered":"

In Millennium Pharmaceuticals, Inc., v. Sandoz Inc.<\/em><\/a>, [2015-2066, 2016-1008, 2016-1009, 2016-1010, 2016-1109,\u00a02016-1110, 2016-1283, 2016-1762] (July 17, 2017), the Federal Circuit reversed the district court, finding that invalidity was not established.<\/p>\n

\u00a0At issue was the validity of U.S. Patent No. 6,713,446 for treatment
\nof oncology disease, sold under the name Velcade\u00ae. \u00a0 \u00a0The district court held that the claims were obvious\u00a0because they were the inherent result of an allegedly\u00a0obvious process, namely lyophilizing bortezomib in the presence\u00a0of the bulking agent mannitol, even though nothing the prior art
\ntaught or suggested that the claimed new compound\u00a0would be formed, or taught or suggested making the\u00a0claimed new compound by any method, or taught or\u00a0suggested that this new compound would have the properties of stability, solubility, and dissociability that it\u00a0exhibited.<\/p>\n

The Federal Circuit framed the issue as “whether a person of ordinary skill,\u00a0seeking to remedy the known instability and insolubility
\nand to produce an efficacious formulation of bortezomib,
\nwould obviously produce the D-mannitol ester of bortezomib,
\na previously unknown compound.” \u00a0Finding that\u00a0the prior art contains no teaching or suggestion of\u00a0this new compound, or that it would form during lyophilization, the Federal Circuit concluded that the invention was not obvious.<\/p>\n

While conceding the truth of Sandoz’ argument that (1) lyophilization was generally\u00a0known in formulating pharmaceutical products; (2)\u00a0bulking agents were known for use in lyophilization; and (3) that\u00a0mannitol was a known bulking agent, the Federal Circuit nonetheless found that the prior art does not teach or suggest that\u00a0lyophilization of bortezomib in the presence of mannitol \u00a0would produce a chemical reaction and form a new chemical\u00a0compound, or provide a reason to make this specific
\nnew chemical compound, or that this new compound\u00a0would solve the previously intractable problems of bortezomib\u00a0formulation.<\/p>\n

In the end, this is a triumph of “unexpected results” over what it technically obvious, or at least what is the inherent result of what is technically obvious. \u00a0The Federal Circuit suggested otherwise, noting that “[a]\u00a0result is obvious when it is ‘the\u00a0natural result flowing from the operation as taught,’ or a ‘property that is necessarily present’ when applying a\u00a0process disclosed in the prior art,” and finding that Sandoz “failed to show that it was obvious to use mannitol to make\u00a0an ester during lyophilization, or that the ester would\u00a0solve the problems experienced with bortezomib. \u00a0The Federal Circuit’s analysis seems to put more weight on the obviousness of the unexpected results, than the obviousness of the process that resulted in unexpected results.<\/p>\n

While it seems right to reward someone who solves a “previously intractable problem,” \u00a0it throws a kink into the obvious analysis to evaluate the obviousness of the unexpected results of an obvious process (which by definition are not obvious), rather than the obviousness of the process itself.<\/p>\n

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

In Millennium Pharmaceuticals, Inc., v. Sandoz Inc., [2015-2066, 2016-1008, 2016-1009, 2016-1010, 2016-1109,\u00a02016-1110, 2016-1283, 2016-1762] (July 17, 2017), the Federal Circuit reversed the district court, finding that invalidity was not established. \u00a0At issue was the validity of U.S. Patent No. 6,713,446 … 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-1654","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\/1654","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=1654"}],"version-history":[{"count":2,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=\/wp\/v2\/posts\/1654\/revisions"}],"predecessor-version":[{"id":1656,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=\/wp\/v2\/posts\/1654\/revisions\/1656"}],"wp:attachment":[{"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=1654"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=1654"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=1654"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}