{"id":2143,"date":"2018-07-13T12:09:04","date_gmt":"2018-07-13T16:09:04","guid":{"rendered":"https:\/\/patents.harnessip.com\/?p=2143"},"modified":"2018-07-30T09:08:04","modified_gmt":"2018-07-30T13:08:04","slug":"materials-available-at-internet-identified-in-federal-register-before-the-critical-date-were-printed-publications","status":"publish","type":"post","link":"https:\/\/patents.harnessip.com\/?p=2143","title":{"rendered":"Materials Available at Internet Identified in Federal Register Before the Critical Date Were Printed Publications"},"content":{"rendered":"

In Jazz Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, LLC<\/a>, [2017-1671, 2017-1673, 2017-1674, 2017-1675, 2017-1676,\u00a02017-1677, 2017-2075] (July 13, 2018), affirmed the PTAB decision that claims of\u00a0U.S. Patent Nos. 7,668,730,\u00a07,765,106, 7,765,107, 7,895,059, 8,589,182,\u00a08,457,988, and 8,731,963 on a drug distribution system for
\ntracking prescriptions of a \u201csensitive drug\u201d were invalid for obviousness.<\/p>\n

The Board’s obviousness determination relied upon certain materials from the regulatory review process, and primary the issue on appeal is whether these materials were sufficiently accessible to the public to
\nconstitute prior art.\u00a0 The\u00a0Board determined that the materials were publicly\u00a0accessible on an FDA website over two months prior to the critical\u00a0date.\u00a0 The Board found that a person of ordinary skill in the art\u00a0\u00a0that a\u00a0person of ordinary skill \u201cwould have been familiar with
\nthe Federal Register and motivated to look for notices\u00a0related to drug distribution, safety, or abuse prevention,\u201d\u00a0and that a skilled artisan would have known that Xyrem\u00ae\u00a0contained a “sensitive drug,” providing a\u00a0person of ordinary skill with \u201csufficient motivation to\u00a0have located the Federal Register Notice and FDA web-site.\u00a0 Such a person would have been capable of finding the Notice and following the links to the materials in the Notice.<\/p>\n

The Federal Circuit said that a\u00a0reference\u00a0is considered publicly accessible upon a satisfactory\u00a0showing that such document has been disseminated or\u00a0otherwise made available to the extent that persons
\ninterested and ordinarily skilled in the subject matter or\u00a0art, exercising reasonable diligence, can locate it.\u00a0\u00a0If accessibility is proved, there is no
\nrequirement to show that particular members of the\u00a0public actually received the information.<\/p>\n

The Federal Circuit\u00a0agreed with Amneal that substantial evidence supports\u00a0the Board\u2019s finding that the materials were\u00a0publicly accessible.\u00a0 The Federal Circuit examined the public notices, and observed that\u00a0this is not the first time it has considered whether
\nmaterials disclosed in association with meetings or conferences
\nwere \u201cprinted publications,\u201d citing MIT,<\/em> Klopfenstein, <\/em>Cordis, <\/em>and Medtronic.<\/em><\/p>\n

\u00a0\"\"<\/a><\/p>\n

Comparing the facts of the present case to those in MIT<\/em>,
\nKlopfenstein<\/em>, and Medtronic<\/em> confirmed that the materials\u00a0were disseminated more broadly and for a longer\u00a0duration to persons of ordinary skill than the materials\u00a0disclosed at individual meetings in those cases. In addition,\u00a0unlike in Cordis<\/em>, disclosure through public domain\u00a0sources such as the Federal Register and a public federal
\nagency website plainly indicates that there was no reasonable
\nexpectation that the materials would remain\u00a0confidential.<\/p>\n

The Federal Circuit found that:<\/p>\n