{"id":2655,"date":"2019-12-27T16:09:20","date_gmt":"2019-12-27T21:09:20","guid":{"rendered":"https:\/\/patents.harnessip.com\/?p=2655"},"modified":"2020-01-26T19:14:35","modified_gmt":"2020-01-27T00:14:35","slug":"inherency-supplied-missing-claim-limitation-in-obviousness-analysis","status":"publish","type":"post","link":"https:\/\/patents.harnessip.com\/?p=2655","title":{"rendered":"Inherency Supplied Missing Claim Limitation in Obviousness Analysis"},"content":{"rendered":"\n

In Persion Pharmaceuticals LLC v. Alvogen Malta Operations LTD<\/a>., [2018-2361] (December 27, 2019) the Federal Circuit affirmed the district court\u2019s determination that the asserted claims of U.S. Patent No. 9,265,760 and 9,339,499 entitled \u201cTreating Pain in Patients with Hepatic Impairment\u201d were obvious.<\/p>\n\n\n\n

Persion raised four primary\nchallenges to the district court\u2019s obviousness conclusion. First, Persion\ncontended that the district court improperly relied on inherency to conclude\nthat the prior art discloses the pharmacokinetic limitations of the asserted\nclaims.  It is long settled that in the\ncontext of obviousness, the mere recitation of a newly discovered function or\nproperty, inherently possessed by things in the prior art, does not distinguish\na claim drawn to those things from the prior art.  The Federal Circuit noted that the Supreme Court\nexplained long ago that it is not invention to perceive that the product which\nothers had discovered had qualities they failed to detect.<\/p>\n\n\n\n

However, inherency is a high standard, that is carefully circumscribed in the context of obviousness.\u00a0 Inherency may not be established by probabilities or possibilities, and the mere fact that a certain thing may result from a given set of circumstances is not sufficient.\u00a0 Inherency renders a claimed limitation obvious only if the limitation is \u201cnecessarily present,\u201d or is \u201cthe natural result of the combination of elements explicitly disclosed by the prior art.\u201d\u00a0 The Federal Circuit said \u201cinherency may supply a missing claim limitation in an obviousness analysis\u201d where the limitation at issue is \u201cthe natural result of the combination of prior art elements,\u201d and found that was the case here.<\/p>\n\n\n\n

Second, Persion argued that the district court improperly relied on pharmacokinetic profiles from drugs other than extended-release single-active-ingredient hydrocodone formulations and from patients other than those with hepatic impairment in reaching its obviousness conclusion.\u00a0 The Federal Circuit found that the district court provided several reasons for its conclusion that a person of ordinary skill in the art would have considered other types of drug products in developing a hydrocodone-only extended-release formulation.\u00a0 In light of the record as a whole, we find no clear error in the district court\u2019s findings on the relevance of combination product data to a person of ordinary skill considering the administration of a hydrocodone-only product.<\/p>\n\n\n\n

Third, Persion contended that the district court erred by finding the asserted claims obvious before considering the objective indicia factors.\u00a0 The Federal Circuit found that the district court considered Persion\u2019s evidence of objective indicia together with the other evidence presented at trial on the issue of obviousness.\u00a0 While the district court\u2019s discussion of objective indicia followed its discussion of the asserted prior art, the Federal Circuit found that the substance of the court\u2019s analysis makes clear that it properly considered the totality of the obviousness evidence in reaching its conclusion and did not treat the objective indicia as a mere \u201cafterthought\u201d relegated to rebutting a prima facie case.\u00a0 Overall, the Federal Circuit found no clear error with the district court\u2019s assessment of the objective indicia evidence. Fourth, Persion argued that the district court\u2019s factual findings concerning obviousness are inconsistent with its findings concerning the lack of written description support.\u00a0 The Federal Circuit found no such inconsistency, noting that Persion\u2019s entire argument with respect to this issue is based on incomplete quotations from the district court\u2019s opinion. <\/p>\n","protected":false},"excerpt":{"rendered":"

In Persion Pharmaceuticals LLC v. Alvogen Malta Operations LTD., [2018-2361] (December 27, 2019) the Federal Circuit affirmed the district court\u2019s determination that the asserted claims of U.S. Patent No. 9,265,760 and 9,339,499 entitled \u201cTreating Pain in Patients with Hepatic Impairment\u201d … 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-2655","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\/2655","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=2655"}],"version-history":[{"count":1,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=\/wp\/v2\/posts\/2655\/revisions"}],"predecessor-version":[{"id":2656,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=\/wp\/v2\/posts\/2655\/revisions\/2656"}],"wp:attachment":[{"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=2655"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=2655"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=2655"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}