<html><head><meta http-equiv="Content-Type" content="text/html charset=utf-8"></head><body style="word-wrap: break-word; -webkit-nbsp-mode: space; -webkit-line-break: after-white-space;" class=""><i class="">Two articles below...</i><br class=""><div class=""><br class=""></div><div class=""><div style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;" class=""><b class=""><span style="font-size: 24pt; font-family: 'Times New Roman', serif;" class="">U.S. Official Says Hatch's Specific Proposals For TPP Fixes Nearly Ready<o:p class=""></o:p></span></b></div><div style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;" class=""><span style="font-size: 12pt; font-family: 'Times New Roman', serif;" class="">February 09, 2016<o:p class=""></o:p></span></div><div style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;" class=""><span style="font-size: 12pt; font-family: 'Times New Roman', serif;" class=""><br class=""></span></div><div style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;" class=""><span style="font-size: 12pt; font-family: 'Times New Roman', serif;" class="">Staff for Senate Finance Committee Chairman Orrin Hatch (R-UT) are close to completing work on a set of specific proposals for addressing the senator's complaints about the Trans-Pacific Partnership (TPP), according to an administration official.<o:p class=""></o:p></span></div><div style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;" class=""><span style="font-size: 12pt; font-family: 'Times New Roman', serif;" class=""><br class=""></span></div><div style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;" class=""><span style="font-size: 12pt; font-family: 'Times New Roman', serif;" class="">The official, who spoke on the condition of anonymity, stressed that the administration was still awaiting specific proposals from Hatch's staff in an apparent effort to deflect the senator's criticism earlier in the day that the administration was not engaging meaningfully with him on his complaints about TPP.<o:p class=""></o:p></span></div><div style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;" class=""><span style="font-size: 12pt; font-family: 'Times New Roman', serif;" class=""><br class=""></span></div><div style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;" class=""><span style="font-size: 12pt; font-family: 'Times New Roman', serif;" class="">“We understand the Hatch staff is close to having a comprehensive set of proposals to share. We're eager to work closely with them on their ideas,” the official said. A spokeswoman for Hatch did not immediately respond to a request for comment.<o:p class=""></o:p></span></div><div style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;" class=""><span style="font-size: 12pt; font-family: 'Times New Roman', serif;" class=""><br class=""></span></div><div style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;" class=""><span style="font-size: 12pt; font-family: 'Times New Roman', serif;" class="">The official said the administration has had “productive early conversations” with Hatch's staff. “We look forward to continuing that engagement, including hearing the specifics of their proposals,” he said.<o:p class=""></o:p></span></div><div style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;" class=""><span style="font-size: 12pt; font-family: 'Times New Roman', serif;" class=""><br class=""></span></div><div style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;" class=""><span style="font-size: 12pt; font-family: 'Times New Roman', serif;" class="">Informed sources said in late January that Hatch's staff was developing specific requests for TPP implementation on such issues as market exclusivity for biologic drugs.<o:p class=""></o:p></span></div><div style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;" class=""><span style="font-size: 12pt; font-family: 'Times New Roman', serif;" class=""><br class=""></span></div><div style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;" class=""><span style="font-size: 12pt; font-family: 'Times New Roman', serif;" class="">The official's comments came after Hatch told reporters Tuesday afternoon that the administration's engagement on TPP thus far was “pretty much lip service.” Hatch, who spoke to reporters at the Capitol after the Senate's weekly caucus lunches, was responding to a question on whether the administration's engagement on TPP had been meaningful or just lip service.<o:p class=""></o:p></span></div><div style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;" class=""><span style="font-size: 12pt; font-family: 'Times New Roman', serif;" class=""><br class=""></span></div><div style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;" class=""><span style="font-size: 12pt; font-family: 'Times New Roman', serif;" class="">Hatch said he and his staff have come up with “definite proposals” for addressing his TPP objections that have been discussed “multiple times with multiple people in the administration.” When pressed for details on his proposals, Hatch said his position remains that the TPP should have required countries to provide 12 years of market exclusivity for biologic drugs.<o:p class=""></o:p></span></div><div style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;" class=""><span style="font-size: 12pt; font-family: 'Times New Roman', serif;" class=""><br class=""></span></div><div style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;" class=""><span style="font-size: 12pt; font-family: 'Times New Roman', serif;" class="">He said he prefers to fix this through renegotiation of TPP but that this issue could also be addressed through side agreements or other tools. Hatch said the administration has not responded to his proposals but has claimed “they're working on it.”<o:p class=""></o:p></span></div><div style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;" class=""><span style="font-size: 12pt; font-family: 'Times New Roman', serif;" class=""><br class=""></span></div><div style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;" class=""><span style="font-size: 12pt; font-family: 'Times New Roman', serif;" class="">“I think they should have stuck with the 12 years, and they haven't made any proposals back, and I have to say that … that's going to be one of the biggest problems they're going to have” when it comes to passing TPP, he said.<o:p class=""></o:p></span></div><div style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;" class=""><span style="font-size: 12pt; font-family: 'Times New Roman', serif;" class=""><br class=""></span></div><div style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;" class=""><span style="font-size: 12pt; font-family: 'Times New Roman', serif;" class="">Hatch underlined that he is “very upset” about the way the TPP's intellectual property provisions ended up, and said that the administration has been unwilling to make any changes.<o:p class=""></o:p></span></div><div style="margin: 0in 0in 0.0001pt;" class=""><font face="Times New Roman, serif" size="3" class=""><br class=""></font></div><div style="margin: 0in 0in 0.0001pt;" class=""><font face="Times New Roman, serif" size="3" class=""> “They have messed up the intellectual property matters in that [TPP agreement], and they don't seem willing to make any changes. And they're going to have to make them, or it’s </font><span style="font-family: 'Times New Roman', serif; font-size: 12pt;" class="">going to be very difficult to pass this,” he said.</span></div><div style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;" class=""><span style="font-size: 12pt; font-family: 'Times New Roman', serif;" class=""><br class=""></span></div><div style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;" class=""><span style="font-size: 12pt; font-family: 'Times New Roman', serif;" class="">Hatch said he interprets TPP as requiring a minimum of five years of market exclusivity for biologics, although he noted that the Obama administration claims it is eight.<o:p class=""></o:p></span></div><div style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;" class=""><span style="font-size: 12pt; font-family: 'Times New Roman', serif;" class="">TPP Article 18.51 requires countries to either provide eight years of market exclusivity for biologics, or to provide five years plus “other measures” to deliver a comparable outcome in the market.<o:p class=""></o:p></span></div><div style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;" class=""><span style="font-size: 12pt; font-family: 'Times New Roman', serif;" class=""><br class=""></span></div><div style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;" class=""><span style="font-size: 12pt; font-family: 'Times New Roman', serif;" class="">The Utah senator said this wording amounted to a win for Australia. That country currently provides five years of data exclusivity for biologics, but argues that additional regulatory requirements in its system effectively extend that period for several additional years.<o:p class=""></o:p></span></div><div style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;" class=""><span style="font-size: 12pt; font-family: 'Times New Roman', serif;" class=""><br class=""></span></div><div style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;" class=""><span style="font-size: 12pt; font-family: 'Times New Roman', serif;" class="">“Australia has the advantage because they got away with exactly what they wanted, even though I made it abundantly clear over and over and over that five years wasn't good enough,” Hatch said.<o:p class=""></o:p></span></div><div style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;" class=""><span style="font-size: 12pt; font-family: 'Times New Roman', serif;" class=""><br class=""></span></div><div style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;" class=""><span style="font-size: 12pt; font-family: 'Times New Roman', serif;" class="">He said he has met with U.S. Trade Representative Michael Froman to discuss his complaints, but not since Froman returned to Washington after traveling to New Zealand for the TPP signing on Feb. 3.<o:p class=""></o:p></span></div><div style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;" class=""><span style="font-size: 12pt; font-family: 'Times New Roman', serif;" class=""><br class=""></span></div><div style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;" class=""><span style="font-size: 12pt; font-family: 'Times New Roman', serif;" class="">While strongly reiterating his complaints to the TPP deal, Hatch said he did not have any problem with U.S. business groups lobbying in favor of the deal on Capitol Hill. But that position does not appear to be universally shared among members of Congress and their staff who want changes to the deal.</span></div></div><div style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;" class=""><span style="font-size: 12pt; font-family: 'Times New Roman', serif;" class=""><br class=""></span></div><div style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;" class=""><h1 style="margin-right: 0in; margin-left: 0in; font-size: 24pt; font-family: 'Times New Roman', serif;" class="">President's Budget Repeats Call For Seven Years Of Biologics Exclusivity<o:p class=""></o:p></h1><div style="margin: 0in 0in 0.0001pt; font-size: 11pt;" class="">February 09, 2016 <o:p class=""></o:p></div><p style="margin-right: 0in; margin-left: 0in; font-size: 12pt; font-family: 'Times New Roman', serif;" class="">The fiscal year 2017 budget proposal submitted by the Obama administration on Tuesday (Feb. 9) reiterated its proposal from previous years to roll back the term of market exclusivity for biologics under U.S. law to seven years from the current 12 years, which would be one year less than what the administration claims is required under the Trans-Pacific Partnership (TPP).<o:p class=""></o:p></p><p style="margin-right: 0in; margin-left: 0in; font-size: 12pt; font-family: 'Times New Roman', serif;" class="">The <a href="http://insidetrade.com/sites/insidetrade.com/files/documents/feb2016/wto2016_0392_06.pdf" style="color: purple;" class="">proposal to reduce the term to seven years</a> is one of three previously proposed reforms in the budget “designed to increase access to generic drugs and biologics.” These reforms would do so by “stopping companies from entering into anti-competitive deals intended to block consumer access to safe and effective generics, by awarding brand biologic manufacturers seven years of exclusivity, rather than 12 years under current law, and by prohibiting additional periods of exclusivity for brand biologics due to minor changes in product formulations,” according to the budget.<o:p class=""></o:p></p><p style="margin-right: 0in; margin-left: 0in; font-size: 12pt; font-family: 'Times New Roman', serif;" class="">Senate Finance Committee Chairman Orrin Hatch (R-UT) and other congressional Republicans have criticized TPP for failing to require 12 years of biologics exclusivity and have called for this aspect of the deal to be changed. TPP requires countries to either provide eight years of market exclusivity for biologics, or to provide five years plus “other measures” that deliver a comparable outcome.<o:p class=""></o:p></p><p style="margin-right: 0in; margin-left: 0in; font-size: 12pt; font-family: 'Times New Roman', serif;" class="">The president's budget proposal carries no legal weight, as Congress is tasked with setting the spending levels for the government for the next fiscal year. But it is typically used by the administration to outline its funding priorities and propose reforms.<o:p class=""></o:p></p><p style="margin-right: 0in; margin-left: 0in; font-size: 12pt; font-family: 'Times New Roman', serif;" class="">The administration included the proposal to roll back the exclusivity period for biologics to seven years in its previous three budgets.</p></div><div class=""><br class=""></div></body></html>