Latest Intellectual Property Chapter Of TPP Agreement Leaked: Would Be A Disaster For Public Health

from the transparency-needed dept

Large brand-name drug firms want to use the TPP to impose rules throughout Asia that will raise prices on medicine purchases for consumers and governments, and be in effect for the next several decades. With billions at stake, Big Pharma wants the TPP to be a road map for rules that will govern Pacific Rim economies for the next several decades.



A U.S. proposal in the text – to provide long automatic monopolies for biotech drugs or biologics, which includes most new treatments for cancer – contradicts the policies included in recent White House budgets and if adopted would undermine key cost savings touted by the administration. The past budgets have included a specific pledge to shorten the same monopoly periods so as to reduce cost burdens on Medicare and Medicaid.



If the TPP is ratified with this U.S.-proposed provision included, Congress would be unable to reduce monopoly periods without risking significant penalties and investor-state arbitration.

Also new in the May 2014 text is a "drug company-friendly" version of the TRIPS agreement for compulsory licensing of vital drugs patents. This is a diminished version of the TRIPS agreement that was present in the 2013 text. In theory, by issuing a compulsory licence, a government can authorise cost-cutting generic competition with patented drugs, in exchange for royalty payments to the patent holder. It is a key tool to promote affordable access to medicines. The new exceptions are set out here and here, having deleted the option for "Other Use Without Authorisation of the Right Holder" in the August 2013 text. The current global norms for justifying exceptions to patents are set out in the TRIPS agreement under either Article 30 or 31. Article 30 is a 3-step test that is restrictive in what it grants exceptions for, and is open to interpretation with regards to procedures for doing these tests. Article 31 (referred to in the August 2013 text and now gone) is the one generally used on all compulsory licensing for HIV and cancer drugs. Whilst it is more restrictive, it is limited to cases where patent holders are paid, so as long as a drug qualifies (as most HIV and cancer drugs do) it is possible to get an exception to the patent held by big pharmaceutical companies, breaking big pharma's monopoly on life-saving drugs.



However, the new version of the text of the TPP IP Chapter has deleted the option to use this assessment procedure, requiring many judgement calls on aspects such as how this might "prejudice" the patent holder. This will mean that the procedure is more restrictive and open to interpretation, and therefore lobbying and manipulation. In short, the TPP will greatly reduce the ability for creating more affordable drugs to save more lives, and increase the pharmaceutical industry's ability to retain monopolies.

For greater certainty, a Party may not deny a patent solely on the basis that the product did not result in an enhanced efficacy of the known product when the applicant has set forth distinguishing features establishing that the invention is new, involves an inventive step, and is capable of industrial application.

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For years, we've discussed the ridiculous and unnecessary secrecy concerning trade agreements negotiated by the USTR. The text of the negotiating documents and even the US's general position is kept secret until the very end, at which point concerns from the public and innovators no longer matter. Instead, the USTR relies on legacy industry "advisors" who are mostly interested in protecting what they have from disruption, change and innovation. For all the talk of how these agreements are "free trade" agreements, they tend to be anything but. They are focused on protecting a few industries against competition, disruption and innovation. The former US Trade Rep Ron Kirk was unusually honest a few years ago in admitting that these agreements would never get adopted if the public actually knew what was in them. A year ago, Wikileaks helped leak the "Intellectual Property" chapter of the Trans Pacific Partnership (TPP) agreement, and now it's done so again with a more recent version of the chapter. Public Citizen has put together a thorough analysis , highlighting a key change: the US pushing toaccess to affordable treatments for cancer and other diseases, in direct contrast to the pledges of the Obama administration.Thankfully, other countries appear to be pushing back on this proposal, but the US is always the 800-pound gorilla in these negotiations. Still, as Wikileaks summarizes , the US is pushing strongly for "drug-company friendly" language that undermines existing agreements under TRIPS. In particular, TRIPS has long allowed countries to authorize the production of cheaper generic drugs to deal with significant health problems. Big Pharma -- showing how it really feels about public health -- has been angry about this for years, and appears to be using TPP as a vehicle to try to undermine it. Of course, they know better than to kill off this provision entirely, but rather, are looking to undermine it. Wikileaks explains:Elsewhere in the document, we see that the US and Japan (who appear to be aligned a lot against everyone else) are pushing for the following:Consider this to be the "Eli Lilly clause." As you may recall, Eli Lilly is currently demanding $500 million from Canada under a corporate sovereignty ("investor state dispute settlement" or ISDS) tribunal, because Canada rejected some of its patents for not being any more effective than existing offerings. For most of us, it seems like a perfectly reasonable reason to reject a patent: your patented drug doesn't do anything to make it more useful than existing products. Canadian law agrees. But big pharma, like Eli Lilly flips out, because they want to produce new drugs that they can patent as old patents run out, hoping to trick people into wanting the new, much more expensive "new new thing" rather than the old, generic, cheaper offering that is just as (if not more) effective.A bunch of countries are pushing for the right to cancel a patent if it "is used in a manner determined to be anti-competitive," but of course, the US and Japan are completely against such a thing. Instead, the US and Japan say it should only be cancelled on grounds that would have been justified for refusing to grant the patent in the first place. In other words, most of the countries recognize that patents can be abused in anti-competitive ways and want to protect against that. The US and Japan, on the other hand, appear to bewith enabling anti-competitive abuses with patents. That says something.In the copyright section, it appears that US goes beyond existing US law in asking that "making available" be considered one of the exclusive rights protected under copyright law. Some US courts consider "making available" to be considered part of the "distribution" right, but others have disagreed (saying that the distribution right only covers works that have actually been, you know,). While the legacy entertainment industry likes to pretend this is settled law and merely making available equals distribution, that's not entirely clear. No matter, in the agreement, the US (and Japan) push to require everyone to include "making available" as an exclusive right for copyright holders.There was great fanfare a few years ago when the USTR announced that, for the first time ever, it would include some language about fair use to appease those who were concerned about how these agreements only ratcheted up the enforcement side of copyright, and not the public's rights. Except, when the details finally leaked, we realized the proposed language was actually about limiting fair use by putting a much stricter definition on it. That language is still in the agreement. There still appears to be debate about copyright term length, with at least some pushing to extend the copyright term, because, hey, copyright termsexpand. This comes despite even the head of the Copyright Office agreeing that copyright terms should be reduced.The US is also looking to definitively kill off any chance of an Aereo-like solution (even if Congress were to pass a law in response to the Supreme Court), by saying that such a service shall not be allowed without authorization of the copyright holder. The agreement would also extend broken anti-circumvention rules that block non-infringing and perfectly reasonable uses. The US is (of course) pushing for morecopyright efforts (Vietnam and Malaysia are pushing back). The US, against pretty much everyone else, is also pushing for statutory damages to be aoption for civil copyright cases, despite the massive problems we've seen with statutory damages in the US and how it enables shady practices like copyright trolling.There's a lot of debate about whether or not recording a movie in a theater should be a criminal act. The US, of course, is pushing for what appears to be an extreme definition where any recording should absolutely be seen as criminal. Other countries would like it to be more flexible, leaving it up to the countries to decide if they want to make it criminal. Singapore says the taping should be, and Mexico says it should only apply to apart of the film. The US doesn't care. If you accidentally record a bit of a movie? Go to jail.There's a lot more in there, but, once again you can clearly seethe US remains so against any transparency at all in these negotiations. Having to actually answer for why they're only concerned with protecting the rights of the legacy copyright industry and pharmaceutical industries, while paying little to no attention to the impact on public health, knowledge and innovation, would apparently put a damper on their future job prospects

Filed Under: copyright, criminal copyright, exceptions, fair use, japan, patents, public health, tpp, us, ustr