Health Activists Out to Destroy US Patent System & Give Away US Drug Technologies to the UN: Candidate Hillary Clinton Approves

http://www.huffingtonpost.com/james-love/access-to-medicine-in-dev_b_89151.html




Access to medicine in developing countries -- hoping for 'change'


Posted February 29, 2008 09:53 AM (EST)


For his first seven years, Bill Clinton pursued an aggressive policy of imposing tough intellectual property rules for developing countries, most importantly in the area of new medicines, which were seen as an important U.S. export. In 1994, I began a long effort to address the flaws in this policy, working first with (Huffpo blogger) Rob Weissman, Ralph Nader, and soon a few global public health groups, like Health Action International and MSF, and local public health groups in Thailand and South Africa. In 1998, through 1999, a global campaign advocating the use of compulsory licenses on medicines was launched. By June of 1999, a small but very motivated and informed group of U.S. AIDS activists began a campaign to disrupt the Gore campaign for President, to protest Gore's direct involvement in bullying South Africa over proposed changes in its patent laws.


With very few exceptions,* the U.S. new media had largely ignored this issue, until it became an unexpected but real problem for Al Gore. For the first time, the U.S. public had some information about why the U.S. is resented around the world, on this topic. The United States Trade Representative and the U.S. Department of State, directed by President Clinton and Vice President Gore, were forcing developing countries to impose tough and costly monopolies on medicines, and directly reducing access to medicines needed to prevent death and suffering. As an aside, it was through this issue that I met Arianna Huffington. Although she was then known mostly as a right wing allay of Newt Gingrich, she began writing about the dispute over drug patents in Africa, and more generally about the nature of corporate power, and her columns on this topic helped change U.S. trade policy.


Both Gore and Clinton responded to the pressure from AIDS activists (people like Paul Davis, Asia Russell, Mark Milano, Eric Sawyer, Bob Lederer and many other brave and selfless persons whose names I am ungratefully neglecting) and groups like ours, and by 1999, U.S. trade policy was significantly modified, most dramatically in a well received speech delivered by Bill Clinton on December 1, 1999, on world AIDS day, at a chaotic WTO meeting in Seattle. Gore flipped too, and made peace with the AIDS activists, who then supported his run against George W. Bush.


The changes in Trade policy announced by Bill Clinton in December 1, 1999 began a moderation of a very bad trade policy, but only partly. For example, in January 2001, in his last ten days in office, Bill Clinton authorized a WTO case against Brazil, in order to stop Brazil from issuing compulsory licenses on patents for the AIDS drug efavirenz, an action dubbed "the Merck case" by USTR.


George W. Bush's election was initially not a disaster on the access to medicines issue. Bob Zoellick, then the head of USTR, initially retained the Clinton changes in trade policy, and to make a very long story short, in November 2001, agreed to the Doha Declaration on TRIPS and Public Health, which called for implementing patent laws in manner to promote "access to medicine for all." Unfortunately, drug company CEOs then began meeting directly with Karl Rove, and a much reigned in USTR began a long pro-big-pharma drift that now features regular bullying of developing countries on the drug patent issue.


Looking back, on his worst days, George W. Bush has had a better trade policy on medicine patents than Bill Clinton did on his worst days. But looking forward, it is quite important that the next president make some big 'changes', and allow countries like India, Brazil, Thailand and others to issue compulsory licenses on drug patents.





[ARE THESE THIS THE TYPE OF 'CHANGE' PROMOTED BY THE 'GREAT OBAMA' - GIVING AWAY FUTURE AMERICAN INGENUITY??]





More important, we need to create a new global trade policy based upon public health needs, looking to treaties on research and development, rather than the ever tougher intellectual property rules. Resolutions that would support these changes included Senate Resolution 241, and House Resolution 525.






[SENATE RES. 241 - SPONSORED BY DEMOCRATIC SENATOR SHERROD BROWN (OH): A resolution expressing the sense of the Senate that the United States should reaffirm the commitments of the United States to the 2001 Doha Declaration on the TRIPS Agreement and Public Health and to pursuing trade policies that promote access to affordable medicines. See: http://www.govtrack.us/congress/bill.xpd?bill=sr110-241]







[HOUSE RES. 525 - SPONSORED BY DEMOCRATIC CONGRESSMAN THOMAS ALLEN (ME): Expressing the sense of the House of Representatives that the United States should reaffirm the commitments of the United States to the 2001 Doha Declaration on the TRIPS Agreement and Public Health and to pursuing trade policies that promote access to affordable medicines. See: http://www.govtrack.us/congress/bill.xpd?bill=hr110-525 .]







[***THIS IS ACTUALLY A POLICY OF GIVING AWAY AMERICA'S FUTURE TECHNOLOGICAL INNOVATION & ECONOMIC GROWTH TO THIRD COUNTRIES WHICH WILL HOBBLE U.S. LIFE SCIENCES COMPANIES AND RESULT IN ADDITIONAL LOSS OF AMERICAN JOBS AND LOWER STANDARDS OF LIVING***]




We now have three leading candidates for President, and none of them have agreed to co-sponsor Senate Resolution 241. But we have "hope" for good things.






[THIS IS MOST LIKELY BECAUSE THEY DON'T WISH TO BE CRITICIZED, ONE WAY OR THE OTHER, DUE TO ACTIVIST CAMPAIGNS LAUNCHED BY BOTH THE 'EXTREME' DEMOCRATS & THE 'EXTREME' REPUBLICANS].



Hillary has clearly been influenced by a combination of her own sensitivities to the health issue, and the increasingly deep commitment of Bill Clinton, as an ex-president, to address concerns about access to medicine in developing countries. Like many liberal Congressional Democrats, Bill Clinton has often embraced a policy of AIDS exceptionalism on these issues, which focuses on the needs to AIDS patients, but does not necessarily extend this concern to other health problems, such as the need for developing countries to have access to new treatments for cancer or heart diseases.


But many activists believe that Hillary will be very good on this issue if she becomes president. My own 16 year old son actually talked directly to Hillary about this topic, during a February 7 visit she made at an Arlington High School. Senator Clinton took a moment to personally express her support for poor patients having access to new medicines, and she endorsed the use of compulsory licensing of patents to make this possible.




[***BY FAVORING THE ISSUANCE OF COMPULSORY LICENSES AS OFFICIAL U.S. POLICY, FOR THE BENEFIT OF NON-U.S. CITIZENS ABROAD, MRS. CLINTON IS NOW ON RECORD FOR PROMOTING THE DEMISE OF U.S. CONSTITUTIONALLY PROTECTED PRIVATE PROPERTY RIGHTS IN INDIVIDUAL DISCOVERIES & INVENTIONS QUALIFYING FOR CIVIL RIGHT PROTECTION UNDER THE U.S. PATENT LAWS, AS AMENDED, SINCE THE FOUNDING OF OUR NATION. IN OTHER WORDS, SHE HAS DECLARED, CONTRARY TO U.S. HISTORY & SUPREME COURT JURISPRUDENCE, THAT PATENTS ARE NOT PROTECTABLE PRIVATE PROPERTY UNDER THE 'TAKINGS' CLAUSE OF THE 5TH AMENDMENT TO THE U.S. CONSTITUTION.***]



AIDS activists have had some luck in getting Obama to offer some encouraging words on this topic, as it relates at least to AIDS, and his very bright Senate staff has given meetings on the topic, and seem sympathetic.


For both Hillary and Obama, I should emphasize that huge efforts have so far have failed to get either candidate to co-sponsor Senate Resolution 241. This is not entirely encouraging. But we have hope.


John McCain has shown a lot of independence from big pharma on domestic issues, like parallel trade in medicines (importing cheaper brand name drugs from Canada or Europe to benefit U.S. consumers). But he has yet to directly address the trade issue in a constructive way, and the best that can be said is that his unhelpful statements reflect a lack of understanding. But, we hope that if he becomes president, he will do the right thing.


This is a very important issue. Thailand is today being pressured by the U.S. Department of State and the USTR to abandon compulsory licenses it had earlier issued on patents on drugs for AIDS, heart disease and cancer. Brazil is being pressured to not issue a compulsory license for the Gilead drug tenofovir. Chile has been pressured over it's efforts to import generic versions of an expensive leukemia drug. The USTR is pressuring dozens of Latin American countries to abandon a pro-public health position in a far ranging negotiation on public health, innovation and intellectual property at the World Health Organization. The U.S. government is trying to stop the World Health Organization from offering useful technical assistance on patent issues to poor countries, and opposes many measures that would promote greater access to safe generic medicines.


These issues don't directly concern U.S. voters, but they are extremely important. We are creating new global norms that will last several decades, and impact billions of persons throughout the world. For people who don't follow this issue very closely, this is what is at stake. People who live in developing countries typically have average incomes of anywhere from 1 to 20 percent of the US. And, within developing countries, unskilled workers are far below the average. With monopolies, drug companies typically choose prices that are only affordable for the richest 1 to 20 percent of the populations. With generic competition prices fall a lot (More than 95 percent for many important drugs), and access is much better.



[NO. WHAT IS AT STAKE IS AMERICA'S FUTURE INNOVATION & COMPETITIVENESS, BECAUSE ACTIVIST GROUPS LIKE THE ONE JAMIE LOVE OPERATES ARE CALLING FOR U.S. LIFE SCIENCES COMPANIES TO GIVE AWAY THEIR NEW DRUG DISCOVERIES & INVENTIONS TO THIRD COUNTRIES AND WILL HAVE INADEQUATE PROFITS TO REINVEST INTO FUTURE DRUG RESEARCH & DEVELOPMENT. ALSO, U.S. TAXPAYERS WILL BE DIRECTLY AFFECTED, BECAUSE THESE COMPANIES WILL BE FORCED TO RAISE THE COSTS OF THEIR NEW DRUGS IN THE U.S. TO COMPENSATE FOR THE LOSS OF THEIR PRIVATE PROPERTY ABROAD. IN OTHER WORDS, AMERICANS WILL BE CALLED TO SUBSIDIZE THE ENTIRE WORLD'S HEALTH NEEDS BASED ON GENERAL COMMUNITARIAN PRINCIPLES OF PUBLIC INTEREST. SO MUCH FOR THE QUALITY OF LIFE AMERICANS WILL NEED TO SACRIFICE UNDER SUCH PROPOSALS...]


In the global battle over access to medicines, what side are these candidates on? And what changes will they made if elected?


[APPARENTLY, ACTIVISTS, HILLARY CLINTON & BARACK OBAMA ARE AGAINST THE INTERESTS OF AMERICA'S SMALL AS WELL AS LARGE INVENTORS]

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Journalists who wrote about US trade disputes before the 1999 Gore Zaps February 29th, 2008 James Love
-------------

In a blog posted today on the Huffington Post, I could have, should have, elaborated a bit on the few U.S. journalists who had written about the trade disputes involving patents on medicines, before AIDS activists began their zaps of Gore's presidential campaign in June of 1999.

I can recall (help me if I am forgetting someone) four journalists who were ahead of the curve. Each had to sell their institutions on the news value of the stories, and have continued excellent reporting on these issues.

* March 29, 1998, Donald McNeil, for the New York Times, "South Africa=E2=80=99s Bitter Pill for World's Drug Makers." A long (more than 2,= 900
words) and informative article about the dispute over parallel trade, written more than one year before others wrote about the dispute.

* April 11, 1999, Lisa Richwine for Reuters, "Groups say U.S. Hurts World Access to AIDS Drugs." The first U.S. wire service article on the trade dispute, Lisa addressed a wide range of technical issues and topics, including even Donna Shalala's refusal to allow Thailand to use the NIH owned patent on ddI.

* April 28, 1999, Merrill Goozner in the Chicago Tribune, "Third World Battles for AIDS Drugs." This long article ran on page one above the fold, with a photo, and was the winner of a Washington Monthly journalism award. The Goozner article was reportedly read by President Clinton on Airforce One, causing him to use the White House staff to immediately track down Sandy Thurman (who was taking a bath in a Hotel) to talk about the issue. Interesting fact: It was in this article that Goozners mentioned the TRIPS provision on national emergencies, leading to thousands of subsequent news stories which implied incorrectly that compulsory licensing could only be done in cases of national emergencies.

* May 24, 1999, Sabin Russell, in the San Francisco Chronicle, "New Crusade to Lower AIDS Drug Costs: Africa's needs at odds with firms' profit motive." A front page story by a knowledgeable reporter on AIDS and other health issues.

KEI Activists Try to Promote Anti-Patent Populism to Prod Politically-Motivated Patent Reforms Reminiscent of Prior Poor Policy Proposals

The following 1886 New York Times Op-Ed was disseminated by James Love of the George Soros-Funded Activist Organization, Knowledge Ecology International (KEI), in an Effort to Persuade US Policymakers & Congressional Representatives How the US Patent System is Broken and Needs to Be Replaced. Sadly, This Effort is Not Only Misguided But also Dangerous to Future U.S. Global Economic & Technological Competitiveness.


The article below is actually demonstrative of the historical ebbs and flows of U.S. patent policy during the late 19th and 20th centuries, as is reflected in additional information provided by the ITSSD following this article.


In the 19th Century, the New York Times on a number of occasions reported and editorialized on various proposals at radical reform of patent laws, including this automatic licensing [COMPULSORY LICENSING] proposal in 1886.


"PATENT LAW AMENDMENTS." The New York Times, February 11, 1886.


Representative Dunn, of Arkansas, introduced in the House on Monday a bill to prevent the establishment of monopolies under the patent laws of the United States. Section 4,884 of the Revised Statutes gives the inventor a complete monopoly of his invention. It provides that, in addition to a description of the invention, every patent shall contain "a grant to the patentee, his heirs or assigns, for the term of seventeen years, of the exclusive right to make, use and vend the invention or discovery throughout the United States and the Territories thereof." Mr. Dunn's bill amends this section by declaring that the grant to the inventor shall be, as now, for seventeen years, but instead of an exclusive and entire property in the invention, it shall cover "a royalty of 10 per centum of all gross sales of the right to make, use, and vend the same throughout the United States." Any person, it is further provided, shall have the right to make, use, and vend the patented article upon payment of the 10 per cent royalty to the patentee or his heirs or assigns.


The principle of Mr. Dunn's bill is sound and its purpose is commendable. It is obvious that some amendment of the bill would be necessary, for patented inventions vary so widely in respect to their cost of construction, the extent of the public demand for them, and the expense of putting them on the market, that a 10 per cent royalty would in many cases be a very insufficient return to the patentee for his expenditures of time, labor, money, and brains. The effect of such a law would be to discourage invention, and that would be a worse evil than the tendency to monopoly which the bill aims to check. The problem is too complicated to be solved in that simple way, but there is not the slightest doubt that a just and workable amendment to the patent laws can be drawn up which would prevent the use of the grants of the Patent Office as a foundation for greedy and oppressive monopolies.


It is high time that the interests of the people as against those of patentees received some consideration and protection. The spirit of the time is hostile to monopolies, and justly so. It is hard enough for the public to bear the exactions of corporate monopolies which have no other warrant than a charter granted under State laws and no protection save that accorded them by bribed legislators and lenient Judges. But that the great seal of the United States should be allowed to confer a license for unlimited extortion is a monstrous wrong. The doctrine that a corporation may demand "what the traffic will bear" is held to be outrageous and wicked. Yet letters patent of the United States at present grant to patentees an absolutely unrestricted right to apply this doctrine to the sale and use of their inventions. Surely there is somewhere a just limit to the profit which a patentee may be permitted to exact from the public under his grant from the Government, a limit which would yield him the due reward of his genius and insure him a full and generous return for his toil and outlay, and yet would protect the people to whom his devices were a necessity from that boundless avarice which experience has shown is often fostered in the favoring and secure shelter of a patent. Such a restriction would not discourage inventors, and it would have the salutary effect of making useful inventions more widely available.


There is one form of extortion under the patent laws, and it is the most common one which ought to be made impossible. The best example of this kind of legalized pillage is furnished by the Bell Telephone Company. That company, protected by a patent whose validity is strenuously disputed, exacts and annual rent of $14 from the local companies for telephone instruments which cost $3.42. That is the whole case in a nutshell of robbery by royalty. As a consequence of this 350 per cent profit and of its great revenues from the local companies, whose stock it holds to the face value of $22,000,000, the capital stock of the Bell Company, according to the statement of Boston newspapers, has been "watered" to seven times its original amount, and still the dividends are 17 per cent upon the enormously inflated capital. No such monopoly as that ought to exist by the sanction of the Government.


There should be most assuredly a well defined limit to extortion in the form of rent or royalty upon patented machines and devices. And the privilege of exacting royalties is one which should never be accorded save with reasonable safeguards. It ought not to be possible for a patentee to exact his own price with no alternative to the user. The latter should have the option of purchase outright in lieu of royalty or rent paid at stated periods; and the permissible royalty or rent would naturally become the basis of the purchase price. A patentee ought to be content to sell his machine or device at a fair price, and the user ought to have the right of absolute ownership in it if he chooses to remunerate the patentee in that way.


James Love, Knowledge Ecology International (KEI)


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It is no surprise that U.S. government treatment of patents, copyrights & trade secrets has long been influenced by concerns and fears about economic downturns.


“A Brief History of the Patent Law of the United States”


According to at least legal commentator,


“[D]ifferent attitudes...have prevailed at [] different times and...have had...effects on...the...development of [] patent law...In the last two decades of the nineteenth century there was a period of economic depression and increasing concern about the power of "big business" leading to the passage of the Sherman Antitrust Act in 1890. This climate was reflected in the patent field by an increasing tendency of the courts to hold patents invalid. By the late 1890's the depression had run its course and patents came back into favor with the reviving economy. In general the twentieth century has seen a dynamic interrelationship between the patent system and the application of antitrust laws. Although the first antitrust law, the Sherman Act, was enacted in 1890, the courts did not start to give it teeth until Theodore Roosevelt’s administration (1901-1909). It was not until the 1930's that the patent system started to come under attack, being viewed as assisting in the maintenance of monopolies that were seen as being at least a contributing factor to the economic misery of the thirties. This skepticism about the patent system survived World War II and blossomed again in the depressed economic conditions of the 1970's, a period of strong anti-trust enforcement...In the early 1980's, the thinking of the Chicago School of economists came to the fore and with the election of President Reagan enthusiasm for antitrust enforcement went out of fashion.” (Ladas & Perry, LLP – 2003)



Source: Rediscovering the Value of Intellectual Property Rights, Presented at The 20th Liberty Forum Of Instituto de Estudos Empresariais - iee “Property Rights and Development”, ‘IP in the 21st Century: Challenges & Concerns’, in Porto Alegre, Brazil
April 17, 2007, accessible at: http://www.itssd.org/ppt/IPinthe21stCentury.ppt .

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.

Former ITSSD Intern Reveals How American & European Activists and Politicians Attack U.S. Intellectual Property Rights

The New War on Drugs:
Activists and Politicians Attack Intellectual Property Rights

Capital Research Center - Organizational Trends

January 2008

http://www.capitalresearch.org/pubs/pdf/v1199294989.pdf

America’s pharmaceutical industry is the envy of the world and the savior of millions of sick people. But activist groups, many of them founded by Ralph Nader and funded by liberal foundations, are campaigning to limit the industry’s incentives to produce new life-saving drugs. Their strategy focuses on undermining the intellectual property rights that protect pharmaceutical innovation.

By Karl Crow


Karl Crow is a 3rd Year student at Temple University's Beasley School of Law. In 2007 he was an intern at the Institute for Trade, Standards, and Sustainable Development (ITSSD) in
Princeton, New Jersey.