2.2.0.7 false Litigation 0218 - Disclosure - Litigation true false false false 1 USD false false USD Standard http://www.xbrl.org/2003/iso4217 USD iso4217 0 Shares Standard http://www.xbrl.org/2003/instance shares xbrli 0 Pure Standard http://www.xbrl.org/2003/instance pure xbrli 0 USDEPS Divide http://www.xbrl.org/2003/iso4217 USD iso4217 http://www.xbrl.org/2003/instance shares xbrli 0 $ 2 0 biib_LitigationAbstract biib false na duration Litigation. false false false false false true false false false false false false 1 false false false false 0 0 false false false xbrli:stringItemType string Litigation. false 3 1 biib_LitigationTextBlock biib false na duration Litigation. false false false false false false false false false false false verboselabel false 1 false false false false 0 0 <!--DOCTYPE html PUBLIC "-//W3C//DTD XHTML 1.0 Transitional//EN" "http://www.w3.org/TR/xhtml1/DTD/xhtml1-transitional.dtd" --> <!-- Begin Block Tagged Note 18 - biib:LitigationTextBlock--> <div style="margin-left: 0%"> <div style="margin-top: 12pt; font-size: 1pt">&#160; </div> <table width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt; font-family: Arial, Helvetica; color: #000000; background: transparent; text-align: left"> <tr> <td width="5%"></td> <td width="95%"></td> </tr> <tr valign="top"> <td> <b><font style="font-family: 'Times New Roman', Times">18.&#160;&#160;</font></b> </td> <td> <b><font style="font-family: 'Times New Roman', Times">Litigation</font></b> </td> </tr> </table> <div style="margin-top: 6pt; font-size: 1pt">&#160; </div> <div align="left" style="margin-left: 0%; margin-right: 0%; text-indent: 4%; font-size: 10pt; font-family: 'Times New Roman', Times; color: #000000; background: transparent"> Along with several other major pharmaceutical and biotechnology companies, Biogen, Inc. (now BIMA) or, in some cases, Biogen Idec Inc. was named as a defendant in lawsuits filed by the City of New York and numerous Counties of the State of New York. All of the cases&#160;&#8212; except for cases filed by the County of Erie, County of Oswego and County of Schenectady (Three County Actions)&#160;&#8212; are the subject of a Consolidated Complaint, first filed on September&#160;15, 2005 in the U.S.&#160;District Court for the District of Massachusetts in Multi-District Litigation No.&#160;1456 (MDL proceedings). The complaints allege that the defendants (i)&#160;fraudulently reported (or caused others to report incorrectly) the Average Wholesale Price for certain drugs for which Medicaid provides reimbursement (Covered Drugs); (ii)&#160;marketed and promoted the sale of Covered Drugs to providers based on the providers&#8217; ability to collect inflated payments from the government and Medicaid beneficiaries that exceeded payments possible for competing drugs; (iii)&#160;provided financing incentives to providers to over-prescribe Covered Drugs or to prescribe Covered Drugs in place of competing drugs; and (iv)&#160;overcharged Medicaid for illegally inflated Covered Drugs reimbursements. Among other things, the complaints allege violations of New York state law and advance common law claims for unfair trade practices, fraud, and unjust enrichment. In addition, the amended Consolidated Complaint alleges that the defendants failed to accurately report the &#8220;best price&#8221; on the Covered Drugs to the Secretary of Health and Human Services pursuant to rebate agreements, and excluded from their reporting certain discounts and other rebates that would have reduced the &#8220;best price.&#8221; With respect to the MDL proceedings, some of the plaintiffs&#8217; claims were dismissed, and the parties, including Biogen Idec, began a mediation of the outstanding claims on July&#160;1, 2008. On October&#160;21, 2010, we reached a non-material out-of-court resolution of all outstanding claims against us, and the plaintiffs have agreed to dismiss the complaints as to us. </div> <div style="margin-top: 6pt; font-size: 1pt">&#160; </div> <div align="left" style="margin-left: 0%; margin-right: 0%; text-indent: 4%; font-size: 10pt; font-family: 'Times New Roman', Times; color: #000000; background: transparent"> In 2006, the Massachusetts Department of Revenue (DOR) issued a Notice of Assessment against BIMA for $38.9&#160;million of corporate excise tax for 2002, which includes associated interest and penalties. The assessment asserts that the portion of sales attributable to Massachusetts, the computation of BIMA&#8217;s research and development credits and the availability of certain claimed deductions were not appropriate, resulting in unpaid taxes for 2002. On December&#160;6, 2006, we filed an abatement application with the DOR seeking abatements for 2001, 2002 and 2003. The abatement application was denied on July&#160;24, 2007. On July&#160;25, 2007, we filed a petition with the Massachusetts Appellate Tax Board seeking, among other items, abatements of corporate excise tax for 2001, 2002 and 2003 and adjustments in certain credits and credit carry forwards for 2001, 2002 and 2003. Issues before the Board include the computation of BIMA&#8217;s sales factor for 2001, 2002 and 2003, computation of BIMA&#8217;s research credits for those same years, and the availability of deductions for certain expenses and partnership flow-through items. We anticipate that the hearing on our petition will take place in the second quarter of 2011. </div> <div style="margin-top: 6pt; font-size: 1pt">&#160; </div> <div align="left" style="margin-left: 0%; margin-right: 0%; text-indent: 4%; font-size: 10pt; font-family: 'Times New Roman', Times; color: #000000; background: transparent"> On June&#160;8, 2010, we received Notices of Assessment from the DOR against BIMA for $103.5&#160;million of corporate excise tax, including associated interest and penalties, related to our 2004, 2005 and 2006 tax filings. The asserted basis for these assessments is consistent with that for 2002. For all periods under dispute, we believe that positions taken in our tax filings are valid and believe that we have meritorious defenses in these disputes. We intend to contest these matters vigorously. </div> <div style="margin-top: 6pt; font-size: 1pt">&#160; </div> <div align="left" style="margin-left: 0%; margin-right: 0%; text-indent: 4%; font-size: 10pt; font-family: 'Times New Roman', Times; color: #000000; background: transparent"> On October&#160;27, 2008, Sanofi-Aventis Deutschland GmbH (Sanofi) filed suit against Genentech and Biogen Idec in federal court in Texas (E.D. Tex.) (Texas Action) claiming that RITUXAN and certain other Genentech products infringe U.S.&#160;Patents 5,849,522 (&#8217;522 patent) and 6,218,140 (&#8217;140 patent). Sanofi seeks preliminary and permanent injunctions, compensatory and exemplary damages, and other relief. The same day Genentech and Biogen Idec filed a complaint against Sanofi, Sanofi-Aventis U.S.&#160;LLC, and Sanofi-Aventis U.S., Inc. in federal court in California (N.D. Cal.) (California Action) seeking a declaratory judgment that RITUXAN and other Genentech products do not infringe the &#8217;522 patent or the &#8217;140 patent and a declaratory judgment that those patents are invalid. (Sanofi-Aventis U.S.&#160;LLC and Sanofi-Aventis U.S., Inc. were later dismissed voluntarily.) The Texas Action was ordered transferred to the federal court in the Northern District of California and consolidated with the California Action and we refer to the two actions together as the Consolidated Actions. We have not formed an opinion that an unfavorable outcome in the Consolidated Actions is either &#8220;probable&#8221; or &#8220;remote,&#8221; and do not express an opinion at this time as to the likely outcome of the matters or as to the magnitude or range of any potential loss. We believe that we have good and valid defenses and are vigorously defending against the allegations. </div> <!-- XBRL Pagebreak Begin --> </div> <!-- END PAGE WIDTH --> <!-- PAGEBREAK --> <div style="margin-left: 0%"> <!-- BEGIN PAGE WIDTH --> <div align="center" style="margin-left: 0%; margin-right: 0%; font-size: 10pt; font-family: Arial, Helvetica; color: #000000; background: transparent"> <b> <font style="font-family: 'Times New Roman', Times"> </font> </b> </div> <div style="margin-top: 0pt; font-size: 1pt"> </div> <div align="center" style="margin-left: 0%; margin-right: 0%; font-size: 10pt; font-family: Arial, Helvetica; color: #000000; background: transparent"> <b> <font style="font-family: 'Times New Roman', Times"> </font> </b> </div> <div align="center" style="margin-left: 0%; margin-right: 0%; font-size: 10pt; font-family: Arial, Helvetica; color: #000000; background: transparent"> <b> <i> <font style="font-family: 'Times New Roman', Times"> </font> </i> </b> </div> <!-- XBRL Pagebreak End --> <div style="margin-top: 6pt; font-size: 1pt">&#160; </div> <div align="left" style="margin-left: 0%; margin-right: 0%; text-indent: 4%; font-size: 10pt; font-family: 'Times New Roman', Times; color: #000000; background: transparent"> On October&#160;24, 2008, Hoechst GmbH filed with the ICC International Court of Arbitration (Paris) a request for arbitration against Genentech, relating to a terminated license agreement between Hoechst&#8217;s predecessor and Genentech that pertained to the above-referenced patents and related patents outside the U.S.&#160;The license was entered as of January&#160;1, 1991 and was terminated by Genentech on October&#160;27, 2008. We understand that Hoechst seeks payment of royalties on sales of Genentech products, including RITUXAN, damages for breach of contract, and other relief. We estimate, based solely on our understanding of Hoechst&#8217;s claims and not on any evaluation of the merits of the claims, that royalties and interest, if awarded in connection with RITUXAN, could total $100&#160;million based on the 0.5% royalty rate set forth in the agreement and historical RITUXAN net sales. Although we are not a party to the arbitration, any damages awarded to Hoechst based on sales of RITUXAN may be a cost charged to our collaboration with Genentech. </div> <div style="margin-top: 6pt; font-size: 1pt">&#160; </div> <div align="left" style="margin-left: 0%; margin-right: 0%; text-indent: 4%; font-size: 10pt; font-family: 'Times New Roman', Times; color: #000000; background: transparent"> On September&#160;15, 2009, we were issued U.S.&#160;patent No.&#160;7,588,755 (&#8217;755 Patent), which claims the use of beta interferon for immunomodulation or treating a viral condition, viral disease, cancers or tumors. This patent, which expires in September 2026, covers, among other things, the treatment of MS with our product AVONEX. On May&#160;27, 2010, Bayer Healthcare Pharmaceuticals Inc. (Bayer) filed a lawsuit against us in federal court in the District of New Jersey seeking a declaratory judgment of patent invalidity and noninfringement and seeking monetary relief in the form of attorneys&#8217; fees, costs and expenses. On May&#160;28, 2010, BIMA filed a lawsuit in federal court in the District of New Jersey alleging infringement of the &#8217;755 Patent by EMD Serono, Inc. (manufacturer, marketer and seller of REBIF), Pfizer, Inc. (co-marketer of REBIF), Bayer (manufacturer, marketer and seller of BETASERON and manufacturer of EXTAVIA), and Novartis Pharmaceuticals Corp. (marketer and seller of EXTAVIA) and seeking monetary damages, including lost profits and royalties. The court has consolidated the two lawsuits. On August&#160;16, 2010, BIMA amended its complaint to add Ares Trading S.A. (Ares), an affiliate of EMD Serono, as a defendant, and to seek a declaratory judgment that a purported &#8220;nonsuit and option agreement&#8221; between Ares and BIMA dated October&#160;12, 2000, that purports to provide that Ares will have an option to obtain a license to the &#8217;755 Patent, is not a valid and enforceable agreement or, alternatively, has been revoked <font style="white-space: nowrap">and/or</font> terminated by the actions of Ares or its affiliates. Ares has answered the amended complaint and has moved to compel arbitration of the claims against it and its motion is pending. Bayer, Pfizer, Novartis and EMD Serono have all filed counterclaims seeking declaratory judgments of patent invalidity and noninfringement, and seeking monetary relief in the form of costs and attorneys&#8217; fees. </div> <div style="margin-top: 6pt; font-size: 1pt">&#160; </div> <div align="left" style="margin-left: 0%; margin-right: 0%; text-indent: 4%; font-size: 10pt; font-family: 'Times New Roman', Times; color: #000000; background: transparent"> On March&#160;23, 2010, we and Genentech were issued U.S.&#160;Patent No.&#160;7,682,612 (&#8217;612 patent) relating to a method of treating CLL using an anti-CD20 antibody. The patent which expires in November 2019 covers, among other things, the treatment of CLL with RITUXAN. On March&#160;23, 2010, we filed a lawsuit in federal court in the Southern District of California against Glaxo Group Limited and GlaxoSmithKline LLC (collectively, GSK) alleging infringement of that patent based upon GSK&#8217;s manufacture, marketing and sale of ARZERRA. We seek damages, including a royalty and lost profits, and injunctive relief. GSK has filed a counterclaim seeking a declaratory judgment of patent invalidity, noninfringement, and inequitable conduct, and seeking monetary relief in the form of costs and attorneys&#8217; fees. </div> <div style="margin-top: 6pt; font-size: 1pt">&#160; </div> <div align="left" style="margin-left: 0%; margin-right: 0%; text-indent: 4%; font-size: 10pt; font-family: 'Times New Roman', Times; color: #000000; background: transparent"> We are also involved in product liability claims and other legal proceedings generally incidental to our normal business activities. While the outcome of any of these proceedings cannot be accurately predicted, we do not believe the ultimate resolution of any of these existing matters would have a material adverse effect on our business or financial conditions. </div> <!-- XBRL Pagebreak Begin --> </div> <!-- END PAGE WIDTH --> <!-- PAGEBREAK --> <div style="margin-left: 0%"> <!-- BEGIN PAGE WIDTH --> <div align="center" style="margin-left: 0%; margin-right: 0%; font-size: 10pt; font-family: Arial, Helvetica; color: #000000; background: transparent"> <b> <font style="font-family: 'Times New Roman', Times"> </font> </b> </div> <div style="margin-top: 0pt; font-size: 1pt"> </div> <div align="center" style="margin-left: 0%; margin-right: 0%; font-size: 10pt; font-family: Arial, Helvetica; color: #000000; background: transparent"> <b> <font style="font-family: 'Times New Roman', Times"> </font> </b> </div> <div align="center" style="margin-left: 0%; margin-right: 0%; font-size: 10pt; font-family: Arial, Helvetica; color: #000000; background: transparent"> <b> <i> <font style="font-family: 'Times New Roman', Times"> </font> </i> </b> </div> <div style="margin-top: 0pt; font-size: 1pt"> </div> <!-- XBRL Pagebreak End --> </div> <!--DOCTYPE html PUBLIC "-//W3C//DTD XHTML 1.0 Transitional//EN" "http://www.w3.org/TR/xhtml1/DTD/xhtml1-transitional.dtd" --> <!-- Begin Block Tagged Note false false false us-types:textBlockItemType textblock Litigation. 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