Thursday, October 28, 2010

Liberal Law Professor Files at UN Formal Allegations Against US Government's 'Special 301Program' Claiming US Laws Protecting IP Violate 'International Human Right' to Access to Medicines

[On July 20, 2010, Professor Sean Flynn of the Program on Information Justice and Intellectual Property (PIJIP) at American University School of Law, Washington, DC, representing various liberal clients including US and foreign nongovernmental organizations (NGOs) and two US law professors from Howard University, Washington, DC,  filed a formal complaint against the U.S. government with the United Nations Special Rapporteur on the situation of Human Rights Defenders, Anand Grover, 'housed' within the Office of the United Nations High Commissioner for Human Rights. 

See IN THE MATTER OF USE OF THE “SPECIAL 301” PROGRAM, SECTION 182 OF THE TRADE ACT OF 1974, TO LIMIT ACCESS TO MEDICINES IN VIOLATION OF THE INTERNATIONAL RIGHT TO HEALTH, accessible online at: .  The complaint assumed the form of an "Allegation Letter" which the Special Rapporteur typically uses to make contact with the State (country) alleged to have committed human rights violations. See Special Rapporteur on the situation of Human Rights Defenders - Submitting Allegations, Office of the United Nations High Commissioner for Human Rights website accessible online at:
The Allegation Letter claims that the following US government practices violate the international human rights of the world's poor which foreign governments are responsible for protecting via exploitation of the WTO TRIPS flexibilities - (e.g., compulsory licensing, patent exclusions, exceptions and limitations to the patent right more generally, etc.):

"The United States has a long history of using Special 301, other trade negotiations, the Generalized System of Preferences, foreign aid, technical assistance and diplomatic pressure to promote intellectual property and pharmaceutical regulations that restrict access to affordable medications in developing countries. These policies are continuing in the present administration, and cause grave and needless suffering around the world. UN Human Rights officials have frequently affirmed that promoting access to medicines in poor countries is a human rights duty of all countries, including of donors and trade partners, and have reviewed country compliance with these mandates in human rights review proceedings."

In support of their creative argument that international human rights laws trump the United States Constitution and the protections that it guarantees to American citizens, including legal persons, pursuant to Article I, Section 8, Clause 8, of the U.S. Constitution (the 'inventor's clause') and the Fifth Amendment of the US Bill of Rights to the US Constitution (the 'takings clause'), namely, the protection of their exclusive private property rights, including patents and trade secrets, as against the arbitrary and capricious actions taken by foreign governments abroad (e.g., the threat to issue or the actual issuance of compulsory licenses for public interest purposes without payment of full, adequate and complete FMV),  the complainants make the following claims:

"12. UN human rights officials and bodies have repeatedly found that the globalization of intellectual property rights can only be squared with human rights if countries are permitted and encouraged to utilize the full scope of intellectual property exceptions and limitations provided for in the TRIPS agreement to promote access to medicines and that even then the international intellectual property regime is ill-equipped to provide competitive and low-cost access to medicines to incentivize medical research on so-called neglected diseases primarily affecting poor people in developing countries."

"13. As described by the Special Rapporteur on the Right to Health, to promote access to medicines and the right to health while complying with the minimum standards of the TRIPS agreement, developing countries 'should incorporate the flexibility to: (a) Make full use of the transition periods; (b) Define the criteria of patentability; (c)  Issue compulsory licences and provide for government use; (d) Adopt the international exhaustion principle, to facilitate parallel importation; (e) Create limited exceptions to patent rights; (f) Allow for opposition and revocation procedures. In addition, countries need to have strong pro-competitive measures to limit abuse of the patent system.'"

"14. Examining the human rights duties of states to take advantage of TRIPS flexibilities to promote access to medicines has been a frequent subject of human rights treaty monitoring bodies. Such reviews have included analysis of the duties of wealthy countries to promote the use of TRIPS flexibilities in poor countries."

"15. This body of human rights law was summarized by Special Rapporteur Paul Hunt as meaning that 'that no rich State should encourage a developing country to accept intellectual property standards that do not take into account the safeguards and flexibilities included under the TRIPS Agreement. In other words, developed States should not encourage a developing country to accept  'TRIPS-plus' standards.'” (boldfaced italics emphasis added).

Professor Flynn's UNHRC Allegation Letter sought the following 'relief':
26. The Special Rapporteur for the Right to Health should call on the U.S. halt its use of the Special 301 program and other elements of its foreign policy to encourage and coerce developing counties to adopt intellectual property norms that restrict access to medicines, including access to antiretroviral medicines for people living with HIV/AIDS. The Special Rapporteur should encourage the U.S. to use its trade and foreign assistance programs to promote full use of TRIPS flexibilities and to otherwise revise its foreign policies to promote access to medicines. The Special Rapporteur should call on the U.S. to provide a procedure for the appeal of human rights issues within the Special 301 report, to reverse its unlawful unilateral threats of trade sanctions via Special 301, and to reconsider and reverse the many decisions it has made that violate the right to health of poor people around the world.

The Allegation Letter followed Professor Flynn's previous submission of a formal complaint to the Office of the US Trade Representative (UTSR) prepared on behalf of other US and foreign NGOs this past February 2010. See IN THE MATTER OF 2010 SPECIAL 301 REVIEW: IDENTIFICATION OF COUNTRIES UNDER SECTION 182 OF THE TRADE ACT OF 1974 (Feb. 16, 2010), accessible online at: .  This complaint essentially argues that as the result of  fulfilling its US constitutional responsibility, as determined by US Supreme Court caselaw, to protect  in international and multilateral venues the exclusive private property rights of US citizens, the USTR has violated international trade and human rights law:

"1.   Using Special 301 to Promote Restrictions on Public Health Flexibilities in TRIPS Violates the Doha Declaration;"


"2.   The 2009 Special 301 Report Violates International Commitments of the US and Fails to Adhere to Basic Administrative Justice Norms." Id

[Unfortunately, Professor Flynn's Allegation Letter, however, ignores the following:

1.  Property rights are natural, individual-based human rights, within the meaning of the 1948 Declaration, the 1948 American Declaration on the Rights and Duties of Man, the 1976 International Covenant on Economic, Social and Cultural Rights, and ultimately, the United States Constitution (1787) and its accompanying Bill of Rights (1791).  Consequently,  governments mustpay heed to the strict substantive and procedural conditions imposed on unauthorized governmental ‘takings’ of private IP rights set forth within TRIPS Article 31(a), (d), (h), (i), (j) and (k); 44.2; and 62.44.

2.  Although the TRIPS Agreement may have grandfathered the highly disputed Paris Convention grounds for issuing compulsory licenses (incorporated by reference within TRIPS Article 2 and the Preamble to TRIPS Article 31 (‘the broad mouth of the funnel’), these bases remain tightly circumscribed by the substantive and procedural conditions imposed by the subsections to TRIPS Article 31. These provisions were arguably intended to ensure protection of patentees’ affirmative right to substantive and procedural due process of law against wanton governmental seizures of exclusive private property (human) rights within the meaning of theFifth Amendment of the U.S. Bill of Rights and other U.S. constitutional provisions (‘the narrow neck of the funnel’). See ITSSD Comments on ‘Desk Review of the Intergovernmental Working Group on Public Health, Innovation and Intellectual Property from a Right to Development Perspective’
(April 6, 2009) at:

3. This means that when a government (e.g., Brazil, Thailand, Canada, France, India, etc.) or an intergovernmental organization such as the WHO, etc. wishes to ‘take’ patented private medicine or medical technology products for a ‘public use’ (i.e., on the basis of an identified and declared ‘public interest’), that government or intergovernmental organization must pay itself, or cause a selected third party licensee to pay, full, complete and adequate fair market value compensation for such patents. After all, this is consistent with established U.S. Supreme Court jurisprudence and with the understanding of the parties to the WTO TRIPS and WIPO Agreements. And, fair market value (FMV) means ‘arms-length’ pricing agreed to between a willing buyer and a willing seller; not some unilaterally predetermined price deemed to be ‘fair’ by a national or regional government or intergovernmental body. See ITSSD Comments Concerning Document (SCP/13/3) Patent Exclusions, Exceptions & Limitations, Institute for Trade, Standards and Sustainable Development (March 27, 2009), at: .

4.  The Special 301 statute requires USTR to address in its review foreign country practices that "deny fair and equitable market access to U.S. persons that rely upon intellectual property protection.” A country cannot be said to adequately and effectively protect intellectual property rights within the meaning of the trade statutes if that country puts in place regulations that effectively nullify the value of the patent rights granted. A patent gives the patent holder the exclusive right to sell his invention in a market, but that right can be undermined by government polices which work to push the price down toward the marginal cost of production. The Special 301 statute calls upon USTR to designate a trading partner as a priority foreign country ('PFC') even if there were no apparent clear-cut violations of the country’s TRIPS Agreement obligations in the operation or enforcement of its intellectual property rights laws. Section182(b)(4) of the Trade Act of 1974, as amended, requires USTR, in making a PFC designation, to take into account whether a country is providing “adequate and effective protection...of intellectual property rights.” A country that maintains IPR laws on the books but eviscerates the value of patented inventions through other regulations cannot be said to provide “adequate and effective protection.” This is further reinforced in section 301(d)(3)(F)(ii) of the Trade Act of 1974, as amended, which “includes restrictions on market access related to the use, exploitation, or enjoyment of commercial benefits derived from exercising intellectual property rights...”

5.  The U.S. Supreme Court has held that the U.S. Government cannot act against, and must affirmatively protect, outside of the territory of the United States, any and all of the constitutional rights guaranteed to U.S. citizens by the U.S. Constitution and the Bill of Rights within the United States. The Fifth Amendment right against the taking of private property for public use without just compensation falls within this obligation. This has remained the law of the land for over 150 years. In the case of  Reid v. Covert, 354 U.S. 1 (1957), the US Supreme Court explained its reasoning as follows: “[R]eject[ing] the idea that when the United States acts against citizens abroad it can do so free of the Bill of Rights. The United States is entirely a creature of the Constitution...When the Government reaches out to punish a citizen who is abroad, the shield which the Bill of Rights and other parts of the Constitution provide to protect his life and liberty should not be stripped away just because he happens to be in another land...The language of Art[icle] III, [Section] 2 manifests that constitutional protections for the individual were designed to restrict the United States Government when it acts outside of this country, as well as here at home...This Court and other federal courts have held or asserted that various constitutional limitations apply to the Government when it acts outside the continental United States. While it has been suggested that only those constitutional rights which are ‘fundamental’ protect Americans abroad, we can find no warrant, in logic or otherwise, for picking and choosing among the remarkable collection of ‘Thou shalt nots’ which were explicitly fastened on all departments and agencies of the Federal Government by the Constitution and its Amendments.”). Id., at , 5-9; See also Mitchell v. Harmony, 54 U.S. 115, 135 (1851).

6. The obligation of the federal government to protect the private property rights held by U.S. citizens outside of U.S. borders against unlawful appropriation also extends to takings effectuated pursuant to treaties. The U.S. Supreme Court recognized this hierarchy almost fifty years ago, in the case of While treaties and federal statutes constitute the “supreme law of the United States,” and are effective equal to one another in status, they are both inferior to the U.S. Constitution and the Bill of Rights. Reid v. Covert. Thus, according to the Court, it is arguable that the President cannot execute and that Congress can neither ratify nor enact legislation implementing a treaty with another nation that effectively violates any of the Constitutional protections afforded U.S. citizens. Furthermore, “the records of the Virginia Ratifying Convention contain specific discussions of thescope of the treaty power. These discussions confirm that the Framers did in fact envision [constitutional] limitations on the treaty power.”Consequently, the President, in the exercise of his Article II powers, and the Congress, in the exercise of its Article I powers,would therefore be constitutionally precluded from executing and implementing a treaty the provisions of which did not adequately protect U.S. citizens against non- or poorly compensable takings oftheir intellectual property by a foreign treaty party’s government. Reid v. Covert at p. 18 (“The prohibitions of the Constitution were designed to apply toall branches of the National Government and they cannot be nullified by the Executive or by the Executive and the Senate combined ...This Court has regularly and uniformly recognized the supremacy of the Constitution over a treaty.” (footnoteomitted)). See Lawrence A. Kogan, Brazil's IP Opportunism Threatens U.S. Private Property Rights, Inter-American Law Review, 38 (Fall 2006): 1–139, 114-116, accessible online at:

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