http://www.patentbaristas.com/archives/2009/07/14/senate-committee-12-years-of-data-exclusivity-is-cool/?utm_source=rss&utm_medium=rss&utm_campaign=senate-committee-12-years-of-data-exclusivity-is-cool Freshly Brewed Bio/Pharma Chat. Served Up Daily. Tue, 07 Feb 2012 11:57:58 +0000 hourly 1 http://wordpress.org/?v=3.3.1 http://www.patentbaristas.com/archives/2009/07/14/senate-committee-12-years-of-data-exclusivity-is-cool/comment-page-1/#comment-69695 Fact vs. Fiction: The Truth on Biologics and Biosimilars | IPWatchdog.com | Patents & Patent Law Sun, 06 Dec 2009 16:54:13 +0000 http://www.patentbaristas.com/?p=1847#comment-69695 [...] This kind of copy-cat competition, which allows a competitor to “use” (i.e., steal) the innovator’s research, does not exist in virtually any other industry outside of drugs. In fact, such copy-cat competition does not even exist today for biologics at all, which is why in order to authorize such a short-cut, non-innovative path to market Congress must enact legislation to authorize the FDA to use an abbreviated approval process for biosimilars. Despite the misrepresentations made by many, the innovator biotechnology industry has never argued that short-cut competition should exist, but has advocated for a fair and reasonable length of exclusive protection before such short-cut competition is allowed to exist. So the question is not whether this kind of competition should be possible, but rather how long an innovators’ data should be protected before they can be used by non-innovators who will piggyback on the large R&D investment made by the innovator to gain approval of a competitive product. This period of time is referred to as data exclusivity. The innovator biotech community has urged Congress for 12 to 14 years of data exclusivity, the Federal Trade Commission has concluded in a lengthy report that zero years of data exclusivity is appropriate, President Obama has suggested that 7 years of data exclusivity is appropriate and Congress has so far agreed with the biotech industry and supported 12 years of data exlusivity. [...] [...] This kind of copy-cat competition, which allows a competitor to “use” (i.e., steal) the innovator’s research, does not exist in virtually any other industry outside of drugs. In fact, such copy-cat competition does not even exist today for biologics at all, which is why in order to authorize such a short-cut, non-innovative path to market Congress must enact legislation to authorize the FDA to use an abbreviated approval process for biosimilars. Despite the misrepresentations made by many, the innovator biotechnology industry has never argued that short-cut competition should exist, but has advocated for a fair and reasonable length of exclusive protection before such short-cut competition is allowed to exist. So the question is not whether this kind of competition should be possible, but rather how long an innovators’ data should be protected before they can be used by non-innovators who will piggyback on the large R&D investment made by the innovator to gain approval of a competitive product. This period of time is referred to as data exclusivity. The innovator biotech community has urged Congress for 12 to 14 years of data exclusivity, the Federal Trade Commission has concluded in a lengthy report that zero years of data exclusivity is appropriate, President Obama has suggested that 7 years of data exclusivity is appropriate and Congress has so far agreed with the biotech industry and supported 12 years of data exlusivity. [...]

]]> http://www.patentbaristas.com/archives/2009/07/14/senate-committee-12-years-of-data-exclusivity-is-cool/comment-page-1/#comment-69300 Patent Baristas » House Bill OK’s 12-Year Data Exclusivity for Biotech Drugs Mon, 03 Aug 2009 17:17:35 +0000 http://www.patentbaristas.com/?p=1847#comment-69300 [...] in favor of allowing 12 years of data exclusivity for biotech drugs. The change on data exclusivity follows the similar amendments by the Senate Health, Education, Labor and Pensions [...] [...] in favor of allowing 12 years of data exclusivity for biotech drugs. The change on data exclusivity follows the similar amendments by the Senate Health, Education, Labor and Pensions [...]

]]> http://www.patentbaristas.com/archives/2009/07/14/senate-committee-12-years-of-data-exclusivity-is-cool/comment-page-1/#comment-69207 Posts about Orrin Hatch as of July 15, 2009 | MelaniedeJonge.com Wed, 15 Jul 2009 15:46:56 +0000 http://www.patentbaristas.com/?p=1847#comment-69207 [...] for Congress Matters. Click here for the morning session and here for the afternoon session . Senate Committee: 12 Years of Data Exclusivity is Cool – patentbaristas.com 07/15/2009 “To amend the public health service act to establish a [...] [...] for Congress Matters. Click here for the morning session and here for the afternoon session . Senate Committee: 12 Years of Data Exclusivity is Cool – patentbaristas.com 07/15/2009 “To amend the public health service act to establish a [...]

]]> http://www.patentbaristas.com/archives/2009/07/14/senate-committee-12-years-of-data-exclusivity-is-cool/comment-page-1/#comment-69206 Senate panel gives 12-year exclusivity to…. Patent Baristas » Senate Committee: …. | Total Info Wed, 15 Jul 2009 02:33:35 +0000 http://www.patentbaristas.com/?p=1847#comment-69206 [...] The U.S. Senate Health, Education, Labor, and Pensions (HELP) Committee voted Monday in favor of a proposal by Sens. Kay Hagan (D-NC), Michael Enzi (R-WY), and Orrin Hatch (R-UT) to create a follow-on biologics (FOB) pathway that provides 12 years of data exclusivity for brand-name biologic drugs.</pRead more at http://www.patentbaristas.com/archives/2009/07/14/senate-committee-12-years-of-data-exclusivity-is-c... [...] [...] The U.S. Senate Health, Education, Labor, and Pensions (HELP) Committee voted Monday in favor of a proposal by Sens. Kay Hagan (D-NC), Michael Enzi (R-WY), and Orrin Hatch (R-UT) to create a follow-on biologics (FOB) pathway that provides 12 years of data exclusivity for brand-name biologic drugs.</pRead more at http://www.patentbaristas.com/archives/2009/07/14/senate-committee-12-years-of-data-exclusivity-is-c... [...]

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