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Leak of May 11 TPP Draft Chapter on ‘Intellectual Property’ Shows TPP Intent To Deprive Nations of Generic Drugs and Biologics

July 1, 2015 (EIRNS)—Politico’s "Agenda" today runs an explosive summary of the leaked "Intellectual Property" chapter of the May 11 TPP draft. Author Michael Grunwald’s report shows that the TPP will deprive U.S. and worldwide populations of life-saving generic drugs and biologics (the next big breakthrough in the pharmaceutical world) for as long as any drug company can make arguments that they are linked to existing patents.

Rohit Malpani, Policy Director of Doctors Without Borders, the heroes who risked death to stop the Ebola epidemic in Africa, told Grunwald, "There’s very little distance between what Pharma wants and what the U.S. is demanding." Malpani said that the U.S. negotiators have basically functioned as drug company lobbyists. The TPP countries have 40 percent of global economic output, and Malpani believes the TPP could set a precedent that crushes the generic drug industry under a mountain of regulation and litigation: “We consider this [TPP] the worst-ever agreement in terms of access to medicine,. It would create higher drug prices around the world—and in the U.S., too. In the U.S., generics now comprise more than five-sixths (83 percent) of all prescription drugs.

The "intellectual property" chapter of the TPP as of May 11, prepared for the Guam round of negotiations, involves the rights of drug companies. The text reveals arguments between the U.S.— often with the support of Japan—Grunwald reports, and its TPP partners of what patents can cover; when and how long they can be extended; how long pharmaceutical companies can keep their clinical data private, and more. On every issue, Grunwald reports, the U.S. sides with the drug companies.

The fight is centered on provisions involving "patent linkage," which would prevent regulators in TPP nations from approving generic drugs whenever there are any unresolved patent issues. The May TPP draft would make this linkage mandatory, which would allow drug companies to block generics by claiming patent infringement.

Grunwald notes that, while Obama describes TPP as the most progressive trade deal in history, its "mandatory linkage" provision "seems to be a departure from the [so-called "May 10 Agreement of 2007] framework. In an April 15 letter to U.S. Trade Negotiator Michael Froman, Heather Bresch, the CEO of the generic drug company Mylan, warned that mandatory patent-linkage would be "a recipe for indefinite evergreening [continuation] of pharmaceutical monopolies," leading to the automatic rejection of generic applications: "With all due respect [Froman] has cherry-picked the single provision designed to block generic entry to the market." Generics are thriving in the U.S. despite linkage, saving Americans an estimated $239 billion on drugs in 2013. But the U.S. is the world’s largest market, and generic drug manufacturers may not take on the risk of litigation if TPP creates obstacles in smaller markets. Genetic drug manufacturer Hospira, according to Grunwald, testified at a TPP forum in Melbourne, Australia, that it would not launch generics outside U.S. markets with linkage.

Another big worry is the TPP’s effect on the U.S. market, because the May 11 language extends mandatory patent-linkage to biologics, the next big advance in the pharmaceutical world. Biologics can cost six-figure sums for patients with rheumatoid arthritis, hepatitis B, and cancer, and the first "knock-offs" have not yet reached pharmacies. Drug companies are already pushing for TPP to guarantee them 12 years of exclusive possession of their data on biologics.

Extending linkage to biologics, which can have hundreds of patents—would insulate drug companies from competition forever. Drug company spokesmen continue to argue for their exclusive rights, Grunwald shows, but the TPP negotiators instead are now soft-peddling the genocidal intent of TPP which this leak makes clear.

http://www.politico.com/agenda/story/2015/06/tpp-deal-leaked-pharma-000126