<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=""><a href="http://www.wsj.com/articles/u-s-australia-agree-on-complicated-compromise-on-biologic-drugs-1443988019" style="color: purple; font-family: Calibri, sans-serif; font-size: 15px;" class="">http://www.wsj.com/articles/u-s-australia-agree-on-complicated-compromise-on-biologic-drugs-1443988019</a><div class=""><br class=""><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., Australia Agree on Complicated Compromise on Biologic Drugs<o:p class=""></o:p></span></b></div><div style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;" class=""><b class=""><span style="font-size: 18pt; font-family: 'Times New Roman', serif;" class="">Sources say Trans-Pacific Partnership deal will give biologic drugs up to 8 years of exclusivity<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="">By<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="">William Mauldin<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="">Updated Oct. 4, 2015 3:51 p.m. ET<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="">ATLANTA—The U.S. and Australia are in agreement on an elaborate compromise within <a href="http://www.wsj.com/articles/countries-inch-toward-trans-pacific-partnership-trade-deal-1443974873" target="_self" style="color: purple;" class="">the Trans-Pacific Partnership</a> to protect the intellectual property of complex drugs known as biologics, according to industry officials and an organization following the talks.<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="">Under the bilateral deal, whose exact language is believed to be incomplete, countries in the trade bloc would have an alternative of either providing eight years of exclusivity to biologic drugs, or providing five years of so-called data exclusivity plus up to three more years under a regulatory framework in the TPP, the people 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="">The outline of the U.S.-Australia deal agrees with a document a government official showed The Wall Street Journal at talks in Atlanta and was confirmed by a source briefed overnight on the latest language.<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="">It wasn’t immediately clear whether the other 10 countries had signed onto the deal or whether it could change before the entire <a href="http://www.wsj.com/articles/u-s-pacific-partners-seek-to-conclude-trade-pact-in-atlanta-1443117418" target="_self" style="color: purple;" class="">TPP trade agreement is completed</a>.<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="">Asked about the language, a major pharmaceutical company executive, business group official and leading opponent of prolonged exclusivity for such drugs each said it was unclear whether the deal would essentially give biologic drug producers a full eight years of exclusivity or whether some countries could effectively offer just 5 years of data exclusivity in the 12-nation trade bloc, with the option of additional time under a regulatory framework.<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 U.S. has 12 years of exclusivity for biologics, a period that limits the introduction of generic imitations called biosimilars, but Australia, Chile, Peru and other countries are hesitant to back more than five years because of concerns it would add to the cost of medicine. The compromise will help both sides to claim a measure of victory in the bitter medicine dispute, according to people following the talks.<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="">Trade ministers scheduled a news conference for 6 p.m. eastern time in Atlanta to discuss the overall outcome of their efforts to agree on the TPP. Business leaders and officials said the ministers are close to a deal, but some people following the talks said sensitive language may have to be worked out over time.<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="">Major U.S. drug companies are backing <a href="http://www.wsj.com/articles/rift-over-drug-protections-complicates-trans-pacific-partnership-trade-talks-1443691801" target="_self" style="color: purple;" class="">12 years of exclusivity</a> for biologics to boost revenue and allow for the development of major new drugs. Their position on the U.S.-Australia compromise is unclear and may depend on the final language, the people 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="">Other groups—including Doctors Without Borders—are pressing for less protection to boost the affordability of medicine in poorer countries. <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="">Developing countries in the TPP may have more time to adopt the measures on intellectual property for pharmaceuticals, officials have 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=""><b class=""><span style="font-size: 12pt; font-family: 'Times New Roman', serif;" class="">Write to </span></b><span style="font-size: 12pt; font-family: 'Times New Roman', serif;" class="">William Mauldin at <a href="mailto:william.mauldin@wsj.com" target="_blank" style="color: purple;" class="">william.mauldin@wsj.com</a><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="color: rgb(31, 73, 125);" class=""> </span></div></div></div></body></html>