By Leith van Onselen who has previously worked at the Australian Treasury, Victorian Treasury and Goldman Sachs. You can follow him on Twitter at twitter.com/leithvo. Originally published at MacroBusiness
Wikileaks leaked the final draft of the Intellectual Property chapter of the Trans-Pacific Partnership (TPP) over the weekend, which has been panned by various “experts”.
Most notable of these is La Trobe Universtity lecturer in Public Health, Dr Deborah Gleeson, who has analysed the chapter and concluded that it “represents nothing less than a disaster for global health”:
Many harmful provisions still remain in the final chapter, bearing out the concerns of public health advocates. These include:
- Patents for new uses and new methods of using existing products (Article QQ.E.1.2, p. 17);
- A low inventiveness threshold – potentially preventing countries from tightening the criteria for granting patents (Footnote 33, p. 17);
- Patent term extensions to compensate for delays in granting patents (Article QQ.E.12, p. 20) and delays in marketing approval (Article QQ.E.14, p. 22);
- Data protection for small molecule drugs – at least 5 years for new pharmaceutical products plus 3 years for new indications, formulations or methods of administration (Article QQ.E.16, p. 23-24);
- Patent linkage provisions likely to result in delays in marketing approval for generic drugs (Article QQ.E.17); and
- Market exclusivity for biologics, provided through one of two options: at least 8 years of data protection, or at least 5 years of data protection and other measures to “deliver a comparable outcome in the market” (Article QQ.E.20, p. 25-26).
This is the first time a provision for market exclusivity for biologic products has ever appeared in a trade agreement – and this is a new obligation for many TPP countries.
The outcome of this suite of obligations will be delayed competition from follow-on generics and biosimilars – which means delayed access to affordable medicines, placing them out of reach altogether for many people in developing countries. Even countries like Australia, the TPP obligations will lock in current intellectual property standards, making it difficult or impossible to reform our system to improve access to affordable medicines in future…
If the TPP countries ratify the deal, Big Pharma will have succeeded in cementing intellectual property standards that will stymie access to medicines for up to 800 million people in the short term, and more if additional countries sign up in future. Furthermore, the TPP’s intellectual property chapter sets a new norm that is likely to become the template for future trade agreements: its implications are global as well as regional.
The governments of TPP countries have been complicit in a global health disaster of unimaginable proportions – a deal that will prevent untold numbers of people from obtaining medicines that those in many developed countries take for granted…
The Australian Government’s brief about the TPP outcomes for biologics says:
“In the TPP, Australia has negotiated protections that are consistent with Australian law and practice. Australia is not required to change any part of its current law, including data protection for biologics, or our patent regime. There will be no adverse impact on the Pharmaceutical Benefits Scheme and no price increase for medicines. But the final text of the TPP’s IP chapter contains some problematic language and troubling ambiguities”.
Article QQ.E.20.1 (p. 25-26) outlines two options that countries can implement to protect new biologics:
1) At least 8 years’ protection of clinical trial data (QQ.E.20.1(a)); or
2) At least 5 years’ protection of clinical trial data along with other measures to “provide effective market protection” and “deliver a comparable outcome in the market”.
Whatever the understanding reached between parties in the negotiating room, according to the agreed legal text, it appears that the TPP parties are obliged to ensure the same market exclusivity outcomes regardless of which option they choose.
The legal language provides room for the United States to continue to pressure the other TPP countries to ensure that they keep biosimilars (more affordable follow-on products) off the market for eight years, in order to provide equivalent “effective market protection” and a “comparable outcome” to eight years of data protection…
Conclusions…
The provisions relating to biologics are problematic and ambiguous. They appear to commit countries to providing either eight years of clinical trial data protection, or five years of clinical trial data protection along with other measures to deliver comparable outcomes. While the Australian Government has said that the regime for biologics in Australia will not change, the language leaves room for continued pressure by the United States to ensure that TPP countries prevent biosimilars from entering the market for eight years. The definition of biologics is very broad and likely to limit countries’ flexibility in determining the scope of the obligation. A review by the TPP Commission of both the length and scope of protection after ten years provides a further mechanism for US pressure to expand and extend monopolies on expensive biologics.
Dr Gleeson’s full critique is well worth reading and can be viewed here.
Meanwhile, the Electronic Frontier Foundation (EFF), the leading nonprofit organisation defending civil liberties in the digital world, has criticised the final TPP text for extending copyright protections.
In addition to extending copyright terms to creator’s life plus 70 years, the TPP would ban the circumvention of Digital Rights Management (DRM), as well as permit disproportionate penalties on users that are deemed to have breached copyright:
The provisions in QQ.G.10 that prohibit the circumvention of DRM or the supply of devices for doing so are little changed from earlier drafts…
The odd effect of this is that someone tinkering with a file or device that contains a copyrighted work can be made liable (criminally so, if wilfullness and a commercial motive can be shown), for doing so even when no copyright infringement is committed. Although the TPP text does allow countries to pass exceptions that allow DRM circumvention for non-infringing uses, such exceptions are not mandatory, as they ought to be.
The parties’ flexibility to allow DRM circumvention also requires them to consider whether rightsholders have already taken measures to allow those non-infringing uses to be made…
Alongside the prohibition on circumvention of DRM is a similar prohibition (QQ.G.13) on the removal of rights management information, with equivalent civil and criminal penalties. Since this offense is, once again, independent of the infringement of copyright, it could implicate a user who crops out an identifying watermark from an image, even if they are using that image for fair use purposes and even if they otherwise provide attribution of the original author by some other means…
On damages, the text (QQ.H.4) remains as bad as ever: rightsholders can submit “any legitimate measure of value” to a judicial authority for determination of damages, including the suggested retail price of infringing goods. Additionally, judges must have the power to order pre-established damages (at the rightsholder’s election), or additional damages, each of which may go beyond compensating the rightsholder for its actual loss, and thereby create a disproportionate chilling effect for users and innovators…
One of the scariest parts of the TPP is that not only can you be made liable to fines and criminal penalties, but that any materials and implements used in the creation of infringing copies can also be destroyed (QQ.H.4(12)). The same applies to devices and products used for circumventing DRM or removing rights management information (QQ.H.4(17)). Because multi-use devices such as computers are used for a diverse range of purposes, this is once again a disproportionate penalty. This could lead to a family’s home computer becoming seized simply because of its use in sharing files online, or for ripping Blu-Ray movies to a media center.
The Intellectual Property Chapter also requires signatories to hand over details of people that are alleged to have breached copyright:
Without prejudice to its law governing privilege, the protection of confidentiality of information sources, or the processing of personal data, each Party shall provide that, in civil judicial proceedings concerning the enforcement of intellectual property rights, its judicial authorities have the authority, upon a justified request of the right holder, to order the infringer or, in the alternative, the alleged infringer, to provide to the right holder or to the judicial authorities, at least for the purpose of collecting evidence, relevant information as provided for in its applicable laws and regulations that the infringer or alleged infringer possesses or controls. Such information may include information regarding any person involved in any aspect of the infringement or alleged infringement and regarding the means of production or the channels of distribution of the infringing or allegedly infringing goods or services, including the identification of third persons alleged to be involved in the production and distribution of such goods or services and of their channels of distribution.
Overall, there’s no joy in Intellectual Property chapter of the TPP, which shifts power away from users/consumers towards the owners of IP, most of whom reside in the US.
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Yah, “the Ownership Society.” Lest we forget what that was sold as from the got-go, the shrubbeb version: https://en.m.wikipedia.org/wiki/Ownership_society
And lest we forget who first read the new testament of privilege and enormous concentration of all wealth to the rest of us, http://georgewbush-whitehouse.archives.gov/. Earlier chapters having been scrivened by other charter members of the Bush League, like this former CIA director and all around nice-guy penner of bread-and-butter notes, ofhttp://www.sweetliberty.org/issues/war/bushsr.htm c
Son of this piece of work, https://en.m.wikipedia.org/wiki/Prescott_Bush.
Why us ordinary people can never have nice things… Not that the aspiration for same is not a root cause of global economic and ecological creative destruction (TM)…
The Ownership Society sounds like a more formalized version of what was going on in Victorian England. Where a gentleman was expected to “retire with competence”.
Meaning that savings and other assets were expected to allow someone to quit working and live of rents and interests, while spending his days playing cards and such at the club.
That Victorian (and earlier) notion of course depended on mercantilism, “trade” as in Empire, enclosing the Commons, all that jazz, and a closed club. The Pwnership Society is a lot more malicious and malignant — it’s a Great Big Version of what Henry Potter probably ended up doing to Bedford Falls, despite the valiant efforts of George Bailey and the Little People there — my bet is on Bedford Falls becoming Potterville, corrupt and mean and debased… http://www.nationalreview.com/article/377771/where-have-you-gone-george-bailey-lee-habeeb-and-mike-leven And the Owners will rent back all the stuff we mopes used to own, and lend us the money to pay the rent, and siphon up all the value of our lives and labor on the way to burning the planet… TPP/TTIP/TISA/All “FTAs” are the shackles and nails in the coffin…
I USUALLY don’t strip away DRM on “stuff” but, as a rule, I DO strip DRM from ALL my ebooks. I will not have some corporation limit the way I can read MY books after I’ve bought them. They’re MINE. I use Calibre on linux with plugins that strip away DRM from ebooks. I will continue to do so and, in fact, if TPP passes I will expand my DRM stripping activities beyond MY books. The beauty is this agreement cannot prevent linux/open source software tools from being created/used/shared at will.
Good for you, EVEN IF limited I.P. could have a useful purpose in a decent society run for the common good, at this point it is to empower snakes.
The beauty is this agreement cannot prevent linux/open source software tools from being created/used/shared at will.
You Think? I wouldn’t be so sure of that. First, “judicial authority” doesn’t sound like it’s an actual court to me, second, it could probably be argued (and it will be) that first that Linux is amongst “devices and products used for circumventing DRM”, then the same argument can be made for each component of Linux until everyone developing Linux are bankrupted by legal fees.
And Sharing? Normally, if one accidentally shares code with IP in it and one is busted for it, the remedy is to remove the offending portion. Now, this is changing to “liability for whatever we think this IP is worth”. Are we *sure* that someone has not patented something inside a huge mass of code, like PostgreSQL or gcc?
As someone who in fact owns some copyrighted material, I am highly skeptical of the rush to criticize copyright as some kind of impediment to intellectual progress. You may want your revenge on Disney, but most owners of copyrights are getting royalties of, oh, maybe, $100 a year.
My first question would be to determine who the copyright owners are that receive that $100 per year. Somewhere out there is a commercial organization that collects the money for the copyright. I suspect that they collect much more that $100, and it would be interesting to know how much of what they do collect is paid to the actual owners.
Nontheless 70 years after the copyright owners death is absurd on the face of it regardless of the monetary amount. It goes beyond IMO the only legitimate purpose of copyright (and patents but they are kind of distinct): to encourage creation.
Lumping patents and copyrights together is convenient for those who believe that information “wants” to be free. Here’s how copyright works in real life. And, yes, the stakes are amazingly low:
http://www.dramatistsguild.com/media/PDFs/WordsPlayers.pdf
Very few writers are inhabiting the world of Martin Shkreli.
Interesting – people who would lose $100 or so in what, annual payments for their ownership of some IP, apparently want to make common cause with Disney, Sony, Big Pharma et al. because they see themselves as being in the same category? Kind of like the mopes who champion Shrunken Government, which mostly equals killing off the so-called safety net, ‘cuz they see themselves as present or potential members of the Have Class, and lookit all them useless Welfare Queens, sucking up the nation’s assets…
And the Big Owners, it becomes increasingly apparent, just laugh at that “rule of law” thing, while inter so much alia, they rip off the little creators of content and music and imagery and stuff. Do little people really expect that the obliquity contained in the TPP and related booolsheet “trade” agreements will in any way constrain the dinosaurs and behemoths from savaging each other in the actually-NO-rules street fight that is the financialized post- and supranational political economy? Or that those “rules,” given how and by whom they are “enforceable,” will somehow protect the puny little incomes of the small-persons with their infinitesimal “presence in the Market”?
“I could pay [or trick] half the working class to kill off the other half of the working class…”
Haha too funny JTMcPhee, those losing $100 in annual payments making common cause with Disney, it really is absurd. They need to decide: which side are you on?
I suggest you bone up on the US view of copyright. We are the ONLY country that allows for copyrights well beyond the life of the creator of the work, and the pending trade deals propose to extend it way beyond that. It’s ridiculous. and I say that as someone who makes my living via creating copyrighted material.
One of the many wonderful flaws and dead ends in The System: People who create the critiques of idiot Rentierism have to rent out their creations to even eat. Share that IP umbrella with me, Mr. Murdoch?…
One hopes that us fellow Lower Order folks will be as generous in sharing our widow’s mite with Yves and Lamdert, come fund raising drive or even right now if the spirit moves, as they are sharing their gifts and time with the rest of us. (I really love the suggestions by (apparently) those reading here who are already “financially secure” — as if that means much any more except for the 0.01% – that a Wise Yves would just erect a paywall, to enrichenate her life…)
My cynicism forces me to point out that the spiritual version of the Golden Rule apparently has about zero chance, despite the crying obvious need, of becoming the Organizing Principle for us grimacig chimps…
I just don’t understand how Pharma can get these patents at all on biologics. They didn’t come up with the idea of the serum or vaccine; they didn’t invent the molecules in question – plants and animals did. Does Pharma attempt to patent vitamins and minerals? I’m sure they would if they could. All they can reasonably patent is a process to manufacture biologics or some invention used in the process. Didn’t the Supremes strike down patent applications claiming rights on sequences of DNA? So it might be fun when China starts manufacturing biologics, sells them cheap to the rest of the world, and we import them from our TPP partners. Because for sure that is going to happen.
“Because they can.”
As Lambert says, “because they can”.
Ian Welsh today on a similar line, “they will take whatever we don’t prevent them from taking”:
http://www.ianwelsh.net/in-france-there-is-a-cost-to-executives-for-laying-off-people/
Right now, the Western Left has bequeathed the NeoLiberals the state’s monopoly on violence and the NeoLibs are taking everything they can until someone develops the spine to stope them.
Well – The Western Left is very busy with creating inalienable rights for religious beliefs. They are not even in the same ball-park as the game that is being played. Total nutters the lot of them, in fact, the European Left is so much out of touch that even the worst of the right-wing nationalists actually sound coherent in comparison.
One wonders what happened. They can’t all have been infected by a brain-eating parasite, can they?
You cannot patent a gene or a particular biological molecule. What you can do is patent a particular use of a biological once you demonstrate it has some particular benefit in some treatment. Of course this is also very tricky and abuse-prone. I have read several patents. In the particular case of US patents it is amazing to find out how a very narrow set of experiments that demonstrate some utility are transformed in claims that usually cover many more products and utilities. The claims start from one particular example (the one the applicant could demonstrate) and following claims become more and more generic so that they end protecting not a result but an idea. And those claims are granted!!! At the end, many patents turn out to be not about some “biological” and its use in diabetes treatment but any molecule that acts similarly and its use in any disease as long as the mode of action it is based on similar principles.
After analysing some many patents in various fields my idea is that their intention is not only to grant a particular monopoly but to discourage any other attempt to develop a competing utility.
The wonders of the US patent system – one can pretty much claim anything in a patent and get it approved. Then it is up to the people sued for infringement to go for a long, expensive, slog through the courts, or, give up and just pay the damn fee for the non-existent IPR (which validates the patent). Once someone pays up, the patent owner can use this “weak money” as a seed fund for suing higher-level targets.
Even bigger than all the EFF’s complaints about the copyright provisions in the TPP — see page 46, where they criminalize copyright infringement, any copyright infringement, as a felony that earns you jail time.