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	<title>RegSmart</title>
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		<title>RegSmart</title>
		<link>http://regsmart.wordpress.com</link>
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		<title>Court Rules That Watson Does Not Infringe Patent Related to Generic Version of Concerta(R) and Declares Patent Invalid</title>
		<link>http://regsmart.wordpress.com/2009/03/31/court-rules-that-watson-does-not-infringe-patent-related-to-generic-version-of-concertar-and-declares-patent-invalid/</link>
		<comments>http://regsmart.wordpress.com/2009/03/31/court-rules-that-watson-does-not-infringe-patent-related-to-generic-version-of-concertar-and-declares-patent-invalid/#comments</comments>
		<pubDate>Tue, 31 Mar 2009 21:46:47 +0000</pubDate>
		<dc:creator>regsmart</dc:creator>
				<category><![CDATA[Patent Challenge]]></category>

		<guid isPermaLink="false">http://regsmart.wordpress.com/?p=71</guid>
		<description><![CDATA[Watson Pharmaceuticals, Inc. (NYSE: WPI), a leading specialty pharmaceutical company, announced today that the United States District Court for the District of Delaware has ruled that Watson&#8217;s generic version of Concerta (methylphenidate hydrochloride extended-release tablets) does not infringe United States Patent No. 6,919,373 (the &#8217;373 Patent) and that the &#8217;373 Patent is invalid.  The opinion, [...]<img alt="" border="0" src="http://stats.wordpress.com/b.gif?host=regsmart.wordpress.com&amp;blog=7009920&amp;post=71&amp;subd=regsmart&amp;ref=&amp;feed=1" width="1" height="1" />]]></description>
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		<title>New Senate Bill Takes Shortcuts on Path to Biosimilars</title>
		<link>http://regsmart.wordpress.com/2009/03/28/new-senate-bill-takes-shortcuts-on-path-to-biosimilars/</link>
		<comments>http://regsmart.wordpress.com/2009/03/28/new-senate-bill-takes-shortcuts-on-path-to-biosimilars/#comments</comments>
		<pubDate>Sat, 28 Mar 2009 03:40:57 +0000</pubDate>
		<dc:creator>regsmart</dc:creator>
				<category><![CDATA[Biosimilar/Biogeneric]]></category>

		<guid isPermaLink="false">http://regsmart.wordpress.com/?p=69</guid>
		<description><![CDATA[March 26, 2009, WASHINGTON&#8211;(BUSINESS WIRE)&#8211;The following statement was issued by Biotechnology Industry Organization President and CEO Jim Greenwood regarding legislation introduced today by Senators Charles Schumer (D-NY), Sherrod Brown (D-OH), Susan Collins (R-ME) and Mel Martinez (R-FL) to establish a pathway for the approval of biosimilars: “While well-intentioned, the bill introduced today by Senators Schumer, [...]<img alt="" border="0" src="http://stats.wordpress.com/b.gif?host=regsmart.wordpress.com&amp;blog=7009920&amp;post=69&amp;subd=regsmart&amp;ref=&amp;feed=1" width="1" height="1" />]]></description>
		<wfw:commentRss>http://regsmart.wordpress.com/2009/03/28/new-senate-bill-takes-shortcuts-on-path-to-biosimilars/feed/</wfw:commentRss>
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		<title>Senators announced bipartisan legislation for generic versions of biologic drugs</title>
		<link>http://regsmart.wordpress.com/2009/03/28/senators-announced-bipartisan-legislation-for-generic-versions-of-biologic-drugs/</link>
		<comments>http://regsmart.wordpress.com/2009/03/28/senators-announced-bipartisan-legislation-for-generic-versions-of-biologic-drugs/#comments</comments>
		<pubDate>Sat, 28 Mar 2009 03:38:25 +0000</pubDate>
		<dc:creator>regsmart</dc:creator>
				<category><![CDATA[Biosimilar/Biogeneric]]></category>

		<guid isPermaLink="false">http://regsmart.wordpress.com/?p=67</guid>
		<description><![CDATA[March 26, 2009, Washington DC: U.S. Senators Charles E. Schumer (D-NY), Susan Collins (R-ME), Sherrod Brown (D-OH), Mel Martinez (R-FL), Debbie Stabenow (D-MI) and David Vitter (R-LA) announcedThursday thatthey have reached agreement on bipartisan legislation to create an approval pathway for generic versions of biologic drugs. The measure, which was endorsed in President Obama’s budget [...]<img alt="" border="0" src="http://stats.wordpress.com/b.gif?host=regsmart.wordpress.com&amp;blog=7009920&amp;post=67&amp;subd=regsmart&amp;ref=&amp;feed=1" width="1" height="1" />]]></description>
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		<title>Mylan Confirms Four First-to-File Challenges</title>
		<link>http://regsmart.wordpress.com/2009/03/28/mylan-confirms-four-first-to-file-challenges/</link>
		<comments>http://regsmart.wordpress.com/2009/03/28/mylan-confirms-four-first-to-file-challenges/#comments</comments>
		<pubDate>Sat, 28 Mar 2009 03:25:12 +0000</pubDate>
		<dc:creator>regsmart</dc:creator>
				<category><![CDATA[Patent Challenge]]></category>

		<guid isPermaLink="false">http://regsmart.wordpress.com/?p=65</guid>
		<description><![CDATA[Mylan Inc.  yesterday announced that it and/or a subsidiary have been sued in connection with four separate &#8220;first-to-file&#8221; Abbreviated New Drug Applications filed with the U.S. Food and Drug Administration.  Mylan and Alphapharm Pty. Ltd were sued by Sepracor Inc. in the U.S. District Court of New Jersey in connection with the ANDA filing for [...]<img alt="" border="0" src="http://stats.wordpress.com/b.gif?host=regsmart.wordpress.com&amp;blog=7009920&amp;post=65&amp;subd=regsmart&amp;ref=&amp;feed=1" width="1" height="1" />]]></description>
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		<title>Teva Announces FDA Response to Citizen Petition</title>
		<link>http://regsmart.wordpress.com/2009/03/28/teva-announces-fda-response-to-citizen-petition/</link>
		<comments>http://regsmart.wordpress.com/2009/03/28/teva-announces-fda-response-to-citizen-petition/#comments</comments>
		<pubDate>Sat, 28 Mar 2009 03:14:14 +0000</pubDate>
		<dc:creator>regsmart</dc:creator>
				<category><![CDATA[Citizen Petitions]]></category>
		<category><![CDATA[FDA Updates]]></category>

		<guid isPermaLink="false">http://regsmart.wordpress.com/?p=62</guid>
		<description><![CDATA[Teva Pharmaceutical Industries Ltd.  announced on March 25, 2009, that the Food and Drug Administration has responded to their Citizen Petition (CP: 32.14, -0.61, -1.86%) regarding COPAXONE(R: 28.26, -1.5492, -5.2%) (glatiramer acetate injection). The FDA declined to review the CP &#8220;without comment on the approvability of any Abbreviated New Drug Application (ANDA: undefined, undefined, undefined%) [...]<img alt="" border="0" src="http://stats.wordpress.com/b.gif?host=regsmart.wordpress.com&amp;blog=7009920&amp;post=62&amp;subd=regsmart&amp;ref=&amp;feed=1" width="1" height="1" />]]></description>
		<wfw:commentRss>http://regsmart.wordpress.com/2009/03/28/teva-announces-fda-response-to-citizen-petition/feed/</wfw:commentRss>
		<slash:comments>0</slash:comments>
	
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		<title>Cubist Files Patent Infringement Lawsuit Against Teva</title>
		<link>http://regsmart.wordpress.com/2009/03/24/cubist-files-patent-infringement-lawsuit-against-teva/</link>
		<comments>http://regsmart.wordpress.com/2009/03/24/cubist-files-patent-infringement-lawsuit-against-teva/#comments</comments>
		<pubDate>Tue, 24 Mar 2009 20:21:26 +0000</pubDate>
		<dc:creator>regsmart</dc:creator>
				<category><![CDATA[Patent Challenge]]></category>

		<guid isPermaLink="false">http://regsmart.wordpress.com/?p=59</guid>
		<description><![CDATA[Cubist Pharmaceuticals, Inc. confirmed today that it has filed a patent infringement lawsuit against Teva Parenteral Medicines, Inc. (TPM), Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries Ltd. The complaint, which was filed in the U.S. District Court for the District of Delaware, alleges infringement of US Patent Nos. 6,468,967 and 6,852,689, which expire on [...]<img alt="" border="0" src="http://stats.wordpress.com/b.gif?host=regsmart.wordpress.com&amp;blog=7009920&amp;post=59&amp;subd=regsmart&amp;ref=&amp;feed=1" width="1" height="1" />]]></description>
		<wfw:commentRss>http://regsmart.wordpress.com/2009/03/24/cubist-files-patent-infringement-lawsuit-against-teva/feed/</wfw:commentRss>
		<slash:comments>0</slash:comments>
	
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		<title>CHI Joins California Companies to Urge Caution on Patent Reform</title>
		<link>http://regsmart.wordpress.com/2009/03/20/chi-joins-california-companies-to-urge-caution-on-patent-reform/</link>
		<comments>http://regsmart.wordpress.com/2009/03/20/chi-joins-california-companies-to-urge-caution-on-patent-reform/#comments</comments>
		<pubDate>Fri, 20 Mar 2009 20:40:40 +0000</pubDate>
		<dc:creator>regsmart</dc:creator>
				<category><![CDATA[Patent  Reform]]></category>

		<guid isPermaLink="false">http://regsmart.wordpress.com/?p=54</guid>
		<description><![CDATA[Today, CHI joined with more than 100 California-based companies and organizations in submitting a letter to Senator Dianne Feinstein, expressing important concerns about recently reintroduced patent reform legislation. CHI represents more than 250 life sciences companies and academic research organizations whose inventions are the basis of California’s global leadership in the life sciences industry, representing [...]<img alt="" border="0" src="http://stats.wordpress.com/b.gif?host=regsmart.wordpress.com&amp;blog=7009920&amp;post=54&amp;subd=regsmart&amp;ref=&amp;feed=1" width="1" height="1" />]]></description>
		<wfw:commentRss>http://regsmart.wordpress.com/2009/03/20/chi-joins-california-companies-to-urge-caution-on-patent-reform/feed/</wfw:commentRss>
		<slash:comments>0</slash:comments>
	
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		<title>Impax confirms that Warner Chilcott and Mayne Pharma filed suit for patent infringement in connection with Doryx®</title>
		<link>http://regsmart.wordpress.com/2009/03/20/impax-confirms-that-warner-chilcott-and-mayne-pharma-filed-suit-for-patent-infringement-in-connection-with-doryx%c2%ae/</link>
		<comments>http://regsmart.wordpress.com/2009/03/20/impax-confirms-that-warner-chilcott-and-mayne-pharma-filed-suit-for-patent-infringement-in-connection-with-doryx%c2%ae/#comments</comments>
		<pubDate>Fri, 20 Mar 2009 20:16:51 +0000</pubDate>
		<dc:creator>regsmart</dc:creator>
				<category><![CDATA[Patent Challenge]]></category>

		<guid isPermaLink="false">http://regsmart.wordpress.com/?p=49</guid>
		<description><![CDATA[Impax Laboratories, Inc. today confirms that Warner Chilcott Laboratories Ireland Limited, Warner Chilcott Company, Inc., Warner Chilcott (US), LLC, and Mayne Pharma International Pty. Ltd. filed suit for patent infringement against Impax in the United States District Court for the District of New Jersey in response to Impax’s challenge of the patent listed in connection [...]<img alt="" border="0" src="http://stats.wordpress.com/b.gif?host=regsmart.wordpress.com&amp;blog=7009920&amp;post=49&amp;subd=regsmart&amp;ref=&amp;feed=1" width="1" height="1" />]]></description>
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		<slash:comments>0</slash:comments>
	
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		<title>Norway&#8217;s Pronova to defend Lovaza patent</title>
		<link>http://regsmart.wordpress.com/2009/03/20/norways-pronova-to-defend-lovaza-patent/</link>
		<comments>http://regsmart.wordpress.com/2009/03/20/norways-pronova-to-defend-lovaza-patent/#comments</comments>
		<pubDate>Fri, 20 Mar 2009 16:43:16 +0000</pubDate>
		<dc:creator>regsmart</dc:creator>
				<category><![CDATA[Patent Challenge]]></category>

		<guid isPermaLink="false">http://regsmart.wordpress.com/?p=47</guid>
		<description><![CDATA[Pronova BioPharma, which makes diet supplements from fish oil, said U.S. drug group Par Pharmaceutical aimed to launch a generic version of Pronova&#8217;s prescription drug Lovaza, sending its shares down. &#8216;Pronova has full confidence in its intellectual property portfolio protecting Lovaza and will vigorously defend and enforce its patents,&#8217; the Norwegian company said in a [...]<img alt="" border="0" src="http://stats.wordpress.com/b.gif?host=regsmart.wordpress.com&amp;blog=7009920&amp;post=47&amp;subd=regsmart&amp;ref=&amp;feed=1" width="1" height="1" />]]></description>
		<wfw:commentRss>http://regsmart.wordpress.com/2009/03/20/norways-pronova-to-defend-lovaza-patent/feed/</wfw:commentRss>
		<slash:comments>0</slash:comments>
	
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		<title>OSI Pharmaceuticals Files Patent Infringement Lawsuits Against Teva and Mylan</title>
		<link>http://regsmart.wordpress.com/2009/03/20/osi-pharmaceuticals-files-patent-infringement-lawsuits-against-teva-and-mylan/</link>
		<comments>http://regsmart.wordpress.com/2009/03/20/osi-pharmaceuticals-files-patent-infringement-lawsuits-against-teva-and-mylan/#comments</comments>
		<pubDate>Fri, 20 Mar 2009 13:51:57 +0000</pubDate>
		<dc:creator>regsmart</dc:creator>
				<category><![CDATA[Patent Challenge]]></category>

		<guid isPermaLink="false">http://regsmart.wordpress.com/?p=41</guid>
		<description><![CDATA[OSI Pharmaceuticals, Inc. announced yesterday that the Company has filed two lawsuits in U.S. District Court in Delaware against Teva Pharmaceuticals USA, Inc. (“Teva”) and Mylan Pharmaceuticals, Inc. (“Mylan”) for infringement of US Patent No. 5,747,498, US Patent No. 6,900,221 and US Patent No. 7,087,613. All three patents are associated with Tarceva® (erlotinib). The lawsuits are based [...]<img alt="" border="0" src="http://stats.wordpress.com/b.gif?host=regsmart.wordpress.com&amp;blog=7009920&amp;post=41&amp;subd=regsmart&amp;ref=&amp;feed=1" width="1" height="1" />]]></description>
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