Intellectual Property

16 Democrat Members of the House of Representatives, 14 March 2014, “Congress has a central role to play in setting policies that assure affordable access to essential medicines and we are deeply disturbed that significant changes from TRIPS and the May 10 agreement would be made in a trade negotiation process that is not open for sufficient Congressional review and oversight…”

5 Democrat Members of the House of Representatives, 17 January 2014, “Our trade agreements should not impede our partners in the developing world from access to these medicines… we look forward to working with you to preserve key medicine-related aspects of the May 10 agreement, necessary for developing countries.” (Rep Sander Levin (Ranking Member, Committee on Ways and Means), Rep Henry Waxman (Ranking Member, Committee on Energy and Commerce), Rep John Conyers (Ranking Member, Committee on the Judiciary), Rep Charles Rankel (Ranking Member, Subcommittee on Trade, Committee on Ways and Means), Rep Jim McDermott (Ranking Member, Subcommittee on Health, Committee on Ways and Means, and Co-chair, Congressional HIV-AIDs caucus).

2 Bipartisan Members of the House of Representatives, 12 December, 2013, “In particular, we are concerned that the TPP Intellectual Property Rights chapter leaked in November 2013 would place undue restrictions on our copyright laws, harming our innovation, our economy, and an open and free Internet.”

6 Democrat Members of the House of Representatives, 9 December 2013, “…we want to express our strong opposition to actions that would create new barriers to generic competition or remove pricing and formulary options that would allow the United States and other countries to lower the price of medicines.”

1 House Democrat, 6 December 2013, “The United States must ensure that the TPP does not result in generic medicines becoming available in TPP developing countries later than in the United States… In addition, the patent flexibilities available to developing nations in the Doha Declaration on Public Health should not be denied or weakened in the agreement.” (Rep Henry Waxman, Ranking Member, Committee on Energy and Commerce)

1 Republican Senator, 2 December 2013, “I would be particularly concerned if some of our negotiating partners are not willing to undertake rules that provide for high levels of intellectual property rights protection, including twelve years of regulatory data protection for biologics and the elimination of restrictions on cross-border data flows.” (Sen Orrin Hatch, Ranking Member, Senate Committee on Finance)

35 Republican Members of the House of Representatives, 27 June 2013, “These negotiations provide an opportunity to include strong, ambitious, and enforceable provisions that would eliminate tariff and non-tariff barriers for U.S. exports of goods, services and agricultural products, as well as ensure strong intellectual property (IP) protections.” (House Republican Freshmen)

2 Bipartisan Members of the Senate, 22 March 2013, “We urge you to seek commitments from our trading partners that reflect the level of protection under U.S. law, for example 12 years of regulatory data protection for biologic pharmaceuticals and strong remedies, including civil and criminal penalties, for trade secret theft.” (Sen. Baucus, Chairman of the Senate Committee on Finance, and Sen. Hatch, Ranking Member of the Senate Committee on Finance)

8 U.S. Governors, 10 August 2012, “Given the substantial complexities of bringing biologics to market and the significant investment required to establish, and sustain development, it is critical that the TPP include 12 years of biologics data protection as found in U.S. law.”

1 Senate Democrat, 6 August 2012, “Specifically, the negotiations should sustain the high standards on intellectual property rights that are a hallmark of U.S. law. In the emerging field of biological medical products, it is especially important that the negotiations protect the 12 years of exclusivity that U.S. law now provides, as memorialized in the Affordable Care Act just a few years ago.”

8 Democrat Members of the House of Representatives, 13 July 2012, “As you continue the next round of negotiations towards the Trans-Pacific Partnership (TPP) free trade agreement, we hope you will propose a high standard of intellectual property rights for biologics, which is consistent with the 12 years of exclusivity under U.S. law.”

2 Democrat Members of the Senate, 12 July 2012, “It is our belief that the TPP negotiations must ensure consistency with U.S. law, which provides for 12 years of data protection for biologics. The current protections for biologic drugs have been thoroughly debated and the established 12 years of protection received strong bipartisan support in both the House and the Senate.”

1 Senate Democrat, 11 May 2012, “… it is vitally important that U.S. negotiators propose and seek to secure robust intellectual property rights for biologics, including 12 years of data protection as found in U.S. law.” (Sen Menendez, Member of Senate Committee on Finance and Committee on Foreign Relations)

2 Republican Members of the Senate, 4 May 2012, “… we want to stress the importance of proposing intellectual property protection for biologic drugs that reflects the 12 years of exclusivity. … We hope you would agree that it would be troubling were the TPP to become perceived as a side-door around domestic intellectual property protections and urge you to ensure that the U.S. negotiators will support current law in their negotiations.”

2 Democrat Members of the Senate, 3 May 2012, “…we urge you to ensure high intellectual property (IP) standards are included in any TPP agreement. These standards should include robust intellectual property rights for biologics, including the 12-year data protection found in U.S. law.”

1 Senate Independent, 1 December 2011, “I join other members of Congress in calling for improvement of the USTR’s position in this negotiation, including the incorporation of the May 10 Agreement provisions to achieve more flexible test data protections and the elimination of proposed mandatory patent term extensions.”

4 Democrat Members of the House, 19 October 2011, “… we are writing to underscore the importance of upholding the U.S. commitment to advancing an agreement that safeguards access to medicines in the developing world.”

2 Democrat Members of the Senate, 12 September 2011, “… we want to stress the importance of proposing a high standard of intellectual property rights for biologics, which is consistent with the 12 years of exclusivity under U.S. law.”

37 Bipartisan Members of the Senate, 12 September 2011, “As you are aware, U.S. law provides for a 12-year term of regulatory data protection for biologics and we believe that should serve as the baseline for the administration’s objectives for this aspect of the negotiation. This 12-year term was the result of careful deliberations in which the U.S. Congress arrived at a bipartisan consensus taking into account and weighing many factors. It is our view that the agreed upon term of protection best supports the Congress’ goals of maintaining the nation’s competitiveness as the leading innovator of biologics products, increasing the number of high-value jobs, and improving access to safe and affordable medicines by creating a clear pathway for the regulatory approval of biosimilar drugs. Because intellectual property rights are a cornerstone for job creation and American competitiveness, we urge you to ensure that the U.S. negotiators are given clear instructions to attain this negotiating objective.” (Sen Orrin Hatch (R), Sen John Kerry (D), and others)

5 Democrat Members of the House of Representatives, 8 September 2011, “The terms agreed by Congress and President Bush on May 10, 2007 should be considered a non-negotiable starting point for the TPP negotiations.”

7 Democrat Members of the House of Representatives, 4 August 2011, “As the United States prepares to propose text on intellectual property rights concerning pharmaceuticals in the negotiations of the Trans-Pacific Partnership (TPP), we strongly recommend that the United States refrain from negotiating any provisions related to exclusivity for biosimilar medicines … Proposing 12 years of exclusivity in the context of TPP negotiations would also conflict with stated Administration policy, as reflected in the FY 2012 budget proposal, recommending that the exclusivity period for biologics be reduced to 7 years. According to the Administration’s budget, a term of 7 years of exclusivity instead of 12 years would achieve an estimated $2.34 billion in savings over the decade.”

10 Democrat Members of the House of Representatives, 2 August 2011, “We are concerned about reports that the balance is once again shifting away from… access to affordable medicines and towards the greater protection of intellectual property rights for brand-name pharmaceutical companies in the developing world, a move that would jeopardize treatment goals and millions of lives… TRIPS-plus provisions in FTAs have been demonstrated to dramatically increase the cost of medicines in developing countries, pricing medicines out of reach of the poor and straining public health budgets.”

40 Bipartisan Members of the House of Representatives, 27 July 2011, “…we urge you to support current U.S. law on biologics, which provides for 12 years of protection. The U.S. – led biopharmaceutical industry would be disadvantaged if the U.S. does not ensure consistency with U.S. law as part of the TPP, because foreign countries do not provide the same type of protection rules.”

14 Democrat Members of the House of Representatives, 26 July 2011, “The consensus that was reached between Congress and the Bush Administration on May 10, 2007 was an historic first step in that direction, laying out key obligations to help raise living standards at home Congressional Actions on TPP and abroad. We urge you to incorporate and defend the May 10 Agreement as you develop the U.S. position in the TPP negotiations.” (Ways and Means Committee Democrats)

22 Bipartisan Members of the House of Representatives, 13 July 2011, “We believe the TPP IP provisions should build upon the high standards for IP protection contained in the most recently concluded U.S. free trade agreement – the U.S.-Korea Free Trade Agreement (“KORUS”) – and U.S. law. We urge your administration to use KORUS as a baseline for negotiation with our TPP partners, and to table text at the next round of TPP negotiations in September based upon the high IP Standards embodied in KORUS.”

7 U.S. Governors, 27 May 2011, “Among your priorities for these negotiations, we ask that you include very strong intellectual property rights provisions, consistent with U.S. law, for protecting the investments of our innovative, intellectual property-intensive sectors, such as biopharmaceuticals.”

28 Bipartisan Members of the Senate, 17 May 2011, “We urge you to continue to seek the highest IP standards as your administration finalizes its proposals in this area and during the course of the TPP negotiations. We urge you to reject efforts by other TPP participants to seek a weakening of intellectual property protection standards as compared with high-standard agreements such as the KORUS FTA.”

18 Bipartisan Members of the House of Representatives, 14 February 2011, “we write to urge your administration to pursue the highest levels of protection for American intellectual property (IP) rights.” (Members of the House Judiciary Committee)