Silly Apologist-Analyst Recommends That America Give Away its Future IP-Based Economy to the World

http://www.brookings.edu/opinions/2006/0825trade_klemens.aspx


U.S. Patent Imperialism Hurts American Interests


August 25, 2006 —


The Patent Reform Act of 2006 (S.3818), introduced to the Senate floor on August 8, will entirely fail to reform patents. The bill makes important modifications to rules on filing and review of paperwork, but the Senate has chosen to overlook many serious problems with patents that cost consumers billions of dollars and embarrass the U.S. internationally.


Much of this excess cost and embarrassment comes as a result of a double standard between imports and domestic goods. All patent disputes may be tried in U.S. District Courts, but disputes over imports may also be tried at the International Trade Commission (ITC), a branch of the Department of Commerce. The ITC uses a broader definition of patent infringement than the district courts, meaning that an import may be found to infringe on a patent that it would not infringe upon if it were produced in the U.S. Such a double standard affects U.S. taxpayers and consumers, who have fewer choices and more monopolies with which to contend.


[THIS COMMENTATOR IS OBVIOUSLY REFERRING TO SECTION 337 OF THE TARIFF ACT OF 1930, WHICH PERMITS THE U.S. INTERNATIONAL TRADE COMMISSION (ITC) TO INVESTIGATE COMPLAINTS BROUGHT BY PARTIES IN ORDER TO DETERMINE WHETHER ALLEGEDLY 'PIRATED' IMPORTED ARTICLES SHOULD BE BARRED FROM ENTERING THE U.S. UNDER SECTION 337 THE ITC POSSESSES THE AUTHORITY TO EXCLUDE IMPORTS BECAUSE OF 'UNFAIR ACTS', 'UNFAIR METHODS OF COMPETITION' OR 'ACTS OF INTELLECTUAL PROPERTY INFRINGEMENT' COMMITTED IN CONNECTION WITH IMPORTATION. AS CONCERNS THE PROCEDURAL LIGITATION METHODS REFERENCED, THE COMMENTATOR IS OBVIOUSLY REFERRING TO A 1989 GENERAL AGREEMENT ON TARIFFS AND TRADE (GATT) PANEL DECISION WHICH FOUND THAT CERTAIN ASPECTS OF SECTION 337 HAD VIOLATED THE NATIONAL TREATMENT PROVISIONS OF THE GATT INTERNATIONAL TRADE LAW. THE URUGUAY ROUND OF TRADE NEGOTIATIONS PURSUANT TO WHICH THE WORLD TRADE ORGANIZATION WAS CREATED, ADDRESSED THESE VIOLATIONS. AS A RESULT, FOLLOWING U.S. ACCESSION TO THE WTO AGREEMENTS, CONGRESS IN 1995 ENACTED IMPLEMENTING LEGISLATION TO AMEND SECTION 337, CONSISTENT WITH THE NEW WTO REQUIREMENTS].


[THIS COMMENTATOR'S ARGUMENT APPEARS TO OBJECT TO SECTION 337 AS AMENDED, MUCH AS THE EUROPEAN UNION DID DURING 2000. SEE: UNITED STATES SECTION 337 OF THE TARIFF ACT OF 1930 AND AMENDMENTS THERETO Request for Consultations by the European Communities and their member States, WT/DS186/1 IP/D/21 18 (January 2000) AT: http://trade.ec.europa.eu/doclib/docs/2004/january/tradoc_114327.pdf ].


Over the past decade, there have been abundant examples of how patent law has been stretched too far to the detriment of U.S. consumers and manufacturers. The reader may recall the problems faced by the makers of the Blackberry, who faced a lengthy patent battle in domestic courts over software on its Canadian email servers. In hearing that case, the Court of Appeals for the Federal Circuit (CAFC) declared that if "control and beneficial use" of a device is in the U.S., then it is beholden to U.S. patent law. With this simple declaration, millions of web sites all around the world suddenly had liability exposure in U.S. courts.


In another example, Creative, Inc., claims that the iPod violates its patent on organizing songs by artist, album, and genre (U.S. patent #6,928,433). Since the iPod is made abroad, Creative sued Apple in domestic courts and petitioned the ITC to block their U.S. sale. On Wednesday, with the threat of an iPod ban looming, Apple paid Creative $100 million to withdraw its complaints.


And the dueling standards collide at a cost to the government, too. For example, Amgen, Inc., has a patent on Epogen, a drug that treats anemia in patients who are on dialysis for end-stage renal disease. Thanks to its patent, Amgen is the monopolist vendor of a life-saving drug—and it sets its price accordingly. Every year, Medicare pays over $1 billion for this drug alone.


[THIS COMMENTATOR TAKES THE IDEOLOGICAL POSITION THAT ALL INTELLECTUAL PROPERTY RIGHTS, ESPECIALLY PATENTS ON HEALTH CARE PRODUCTS AND DEVICES AND INFORMATION TECHNOLOGIES, CONSTITUTE ILLEGAL MONOPOLIES. THIS POSITION IS AKIN TO THAT ADVANCED BY SOME EMERGING ECONOMIES SUCH AS BRAZIL AND BY DEVELOPING COUNTRIES SUCH AS THAILAND.]


A Swiss pharmaceutical company, Roche, has a drug that would compete head-to-head with Epogen, and thus force down Epogen's price and possibly improve patient outcomes—except the drug is produced abroad. Roche's product is likely to be found to be a valid, non-infringing competitor to Amgen's patents and products in U.S. District Courts, but will have a harder time getting past the ITC's broader definition of patent infringement. As a result, Amgen may continue to bill Medicare at the full monopoly price.


Maintaining a separate definition of patentability for imports directly violates WTO treaties mandating non-discrimination. Other court-invented innovations in patent law also create a growing rift between the U.S. and the rest of the world that will be a liability for the U.S. in negotiations over trade and tariffs.


[THE U.S. CONGRESS AMENDED SECTION 337 TO COMPLY WITH THE WTO AGREEMENTS].


All of the rulings that have shaped patent law in the last few decades have come from the CAFC, a court founded in the early 1980s to resolve patent and trade disputes. It is heavily stocked with former prominent patent attorneys, so it no surprise that the CAFC has actively expanded the powers of patents well beyond pre-1980 limits.


[THIS COMMENTATOR TAKES ISSUE WITH THE FACT THAT A UNIQUE COURT (THE FEDERAL CIRCUIT COURT OF APPEALS WAS ESTABLISHED TO IMPROVE JUDICIAL EFFICIENCY AND ADJUDICATION OF PATENT DISPUTES) POSSESSING SPECIALIZED KNOWLEDGE IN INTELLECTUAL PROPERTY. OTHER IMPORTANT PIECES OF FEDERAL LEGISLATION AFFECTING PATENT RIGHTS WAS ENACTED TO IMPROVE, AND REMARKABLY IMPROVED, U.S. GLOBAL COMPETITIVENESS - NAMELY THE BAYH-DOLE ACT. ALSO THE HATCH-WAXMAN ACT WAS ENACTED DURING SUCH TIME. IT IMPROVED CONSUMER ACCESS TO GENERIC DRUGS].


Rather than striving to maximize innovation and economic benefits, the CAFC tends to rule via tortuously close readings of statute. Its ruling that established the separate ITC standard for patent infringement is based almost entirely upon a reading of the boilerplate phrase "for purposes of this title." Its statement regarding "control and beneficial use" is nowhere to be found in statute, but did build upon a prior CAFC divination—that the Congress of 1952 intended that software would one day be patentable.


Patent law has been expanded and forcefully exported by a single court, without oversight by Congress. Internationally, the courts' favoring of domestic producers over importers, and the CAFC's self-declaration that it has jurisdiction over any Internet-enabled computer in the world, has put U.S. trade negotiators in a weaker position and will hurt Americans in the long run. Domestically, it has created the usual problems associated with unfettered monopolies: prices rise, choices diminish, and consumers suffer.


Congress needs to take real action to explicitly establish a single standard for patent infringement regardless of the manufacturer's address, and to restore the scope of patents to where it was before the CAFC's unilateral expansions. The Patent Reform Act of 2006 is not enough.

KEI Anti-Patent Activist Praises Thailand For Planning to Issue 4 Cancer Drug Compulsory Licenses

http://www.bangkokpost.com/News/25Jan2008_news15.php


[Thai] Government approves four cancer drugs: Compulsory licensing a must, says Mongkol


January 25, 2008


Bangkok Post


APIRADEE TREERUTKUARKUL


The outgoing military-appointed government will go ahead with the implementation of compulsory licensing (CL) for four cancer drugs, Public Health Minister Mongkol Na Songkhla said yesterday. The minister did not disclose the names of the drugs listed for compulsory licensing, simply saying the decision had been made on Jan 4 following a proposal submitted by the sub-panel chaired by Government Pharmaceutical Organisation (GPO) board chairman Vichai Chokewiwat.


The Vichai [VICHY] panel has advised the public health minister to issue compulsory licences for the breast cancer drug Letrozole and the leukaemia drug Imatinib, both produced by Novartis, the breast and lung cancer drug Docetaxel, produced by Sanofi-Aventis, and lung cancer drug Erlotinib, made by Roche.


The objective is to seek cheaper generic forms of the drugs for treating patients under the universal healthcare scheme, thereby saving the government huge sums of money.


Dr Mongkol said he had thoroughly considered the pros and cons of applying CL to such cancer drugs.


''We would not do it if it's not necessary. But we don't have time for more negotiation. We did the best we can,'' he said, adding that health officials had met patent owners for at least 13 rounds of negotiations over prices without making any significant progress.


The minister said he was certain that generic versions of cancer drugs would be of high quality and that patients under the universal healthcare scheme would receive the best benefits from the state policy on CL.


Letters stating the necessity to bypass patents of cancer drugs would be sent to all sectors involved _ the GPO, the Department of Intellectual Property and pharmaceutical companies owning the patents to the drugs by next week as he would soon finish his term, he said.


''I have faced pressure from several sides by making such a decision, but I am happy that poor patients will not go bankrupt due to the cost of cancer treatment,'' he said.


Cancer ranks as the number one cause of death in Thailand. The male population suffers mostly from lung cancer, whereas breast cancer is the major cause of death among women.


Meanwhile, pharmaceutical giant Sanofi-Aventis has threatened legal action against an India-based generic drug maker chosen to supply Thailand with a generic version of the heart drug Plavix.


Withit Artavatkun, managing director of the GPO board, said the threat was the latest in a series of attempts by the patent owner of Plavix to interrupt the country's CL policy.


Plavix, a blood thinner, is used to treat coronary artery, peripheral vascular and cerebrovascular diseases.


''Sanofi-Aventis' threat will not affect the procurement agreement as the first batch of two million heart drug tablets will be arriving by next week,'' said Dr Withit.


The India-based Zydus Cadila firm was chosen ahead of the other potential supplier Emcure Pharmaceuticals, also based in India, because Emcure had not yet provided bioequivalent documents essential for a registration grant from the Food and Drug Administration.


However, Dr Withit believed a threat from the patent owner was one of the main reasons that delayed Emcure's decision to supply a copycat version of the heart drug to Thailand.


The company last year also sent a letter to Emcure, claiming that selling generic versions of the medicine to Thailand was illegal as the country had not made public its decision to override the patent.


However, the GPO managing director said the ministry had officially declared its policy on the compulsory licensing of Plavix for over a year.

Brazil’s ‘Open and Universal Access’ Agenda Undermines its Own Technological Future

Brazil’s ‘Open and Universal Access’ Agenda Undermines its Own Technological Future


The following article was authored by Pat Choate, PhD, Director, Manufacturing Policy Project.


The article was prepared to support the manuscript entitled,


Rediscovering the Value of Intellectual Property Rights: How Brazil's Recognition and Protection of Foreign IPRs Can Stimulate Innovation and Generate Economic Growth, International Journal of Economic Development, Vol. 8, Nos. 1-2 (Sept. 2006), at pp. 1-4, at:


http://www.spaef.com/IJED_PUB/v8n1-2.html


http://www.itssd.org/White%20Papers/ijed-8-1-2-choate.pdf


Brazil’s ‘Open and Universal Access’ Agenda Undermines its Own Technological Future


The great riddle of 19th and early 20th Century economics was the role that technology exerted in economic progress versus the contributions of labor and capital. By the beginning of the 21st Century, most economists agreed that technological innovation was the motor of development and that its continuity and accumulated creations, what the Institutional Economists called “tools,” furthered a progress that persistently reduced squalor and improved the life of nations.


Lawrence A. Kogan’s article is in that tradition. His thesis is Brazil is undermining its national innovation efforts by policies and practices whose ultimate effect is to discourage the creativity of the Brazilian people and divert meaningful levels of direct foreign investment.


Kogan buttresses his argument with a detailed description of how the Government of Brazil has sent forth its diplomats to diffuse the concept of intellectual property rights in various international forums. First at the World Trade Organization (WTO), then the World Health Organization (WHO, and then at the World Intellectual Property Organization (WIPO), among others, he describes and analyses how Brazil has advanced an agenda of “open and universal access” which translates into a “taking” by the state of the creations of others and then making them publicly available without proper compensation, or often even acknowledgement. As a strategy, Brazil, he notes, is forum shopping, changing one provision here, and another there, all the while creating ever more holes in an already cheesy-like regime of global protections.


Unfortunately, Brazil and other developing countries are succeeding. As a condition for entering the Doha Round of WTO talks, Brazil led efforts to change the intellectual property protections for pharmaceuticals, allowing developing nations to force compulsory licensing and then produce patented medicines under terms largely decided by the government. Appropriately, Kogan points out that all except four or five of the more than 400 medicines now on the WHO critical medical list are generic, freely available for production by anyone in the world.


The principal problem is not that a handful of pharmaceutical companies are keeping medicines from peoples in Africa or other developing places, but that those governments do not enforce the integrity of pharmaceutical production inside their countries, nor do they ensure the integrity of the pharmaceutical distribution systems. So, the generic medicines available to billions of people cannot be assumed to be safe.


Brazil’s agenda is an ideological one, backed by a stubborn and confused post-communist politics of state “takings.” Brazil’s leadership in the open and universal access movement is not new. For almost a half century, it led efforts that sought to transfer intellectual properties developed by innovators from the developed nations to the societies of the underdeveloped countries. While justifying its actions on moral grounds, those efforts were and remain tainted by a corrupt political system where well-connected corporations have used the power of the state to advance a privatized and highly rewarding commercial piracy.


Kogan persuasively argues that Brazil would prosper under a strong regime of intellectual property protections. He points out that it has one of the world’s greatest collections of plant and life forms, which could under gird the creation of a world-class pharmaceutical industry, plus the development of biotech, biotechnology, environmental biotech, agro biotech, and chemical sectors, among many others.


But, to seize these opportunities, Brazil needs to acquire and develop technologies on a massive scale.


Fortunately, Brazil has the resources and people required for development on such magnitudes.


China is an example of a nation that has well managed this acquisition/development process. Chinese leaders have exchanged market access and incentives with the corporations from the developing nations for technologies and know how. The bargain is simple: foreign companies get the benefits if they bring their best technologies to China and share patent ownership for any technological improvement made in China. With that exchange China is modernizing its economy rapidly and simultaneously it is making the necessary investments in its human capital to become a world-class research and development center from which future innovations will flow. Even as China blatantly violates its WTO commitments to protect foreign intellectual properties, it is creating a domestic structure of intellectual property protections that is increasingly being used by the Chinese to protect their new creations.


In contrast, to China’s pragmatism, Brazil seems more interested in advancing the ideology of open and universal access. Yet, as Kogan notes, Brazil has treaty obligations with the other WTO members to honor and protect the intellectual properties of foreign owners. In this exchange, the United States has given Brazilian exports largely unimpeded access to the American market. Brazil seems to want the benefits of that deal even as it tries to wiggle out of its corresponding obligations.


It is a risky political approach. Specifically, the companies whose technologies Brazil is trying to take are unlikely to invest heavily there, an opportunity cost of great consequence to that nation. Equally important, Brazil risks reopening the piracy and counterfeiting wars of the 1970s and 1980s with the United States.


But most of all, Kogan argues that Brazil is diminishing its own future by not creating a legal, political, and developmental environment in which Brazilians and foreigners are inspired and rewarded for innovating.


This piece is lucid and written strikingly well. A full set of endnotes with sources, elaborations, and aside comments that merit attention backs the analysis. The audience should be Brazilian intellectuals, politicians, media and business people. The Brazilian government’s ideological pursuit of an open and universal system is undermining its national technological future.


International Journal of Economic Development Volume Eight, Numbers 1-2, pp. 1-4 2006