Category Archives: IP etc

Another impressive declaration but will it help increase access?

On June 27th, over 30 international parliamentarians attended the Global Fund
Partnership Forum
in São Paulo, Brazil. At the conclusion of the Forum, attendees adopted a statement titled, São Paulo Parliamentary Declaration On Access To Medicines And Other Pharmaceutical Products. It aims to achieve many things, including a commitment to: 

Oppose, and refrain from pursuing or adopting, provisions in bilateral and regional trade and investment agreements, that would undermine access to medicines and other pharmaceutical products, including provisions that would further limit the use of policy options such as compulsory licensing and parallel importing; data exclusivity restrictions; linkage between patent status and registration of generics; patent term extension; and enforcement measures and investment provisions that include intellectual property rights.

While stated commitments serve to send a clear political message, how well do they translate into action?

The most significant public health amendment to the TRIPs Agreement–known as the Doha Declaration–has yet to result in equitable access. Although 60 countries have utilized TRIPs flexibilities in order to gain access to lower cost drugs, the global intellectual property (IP) system continues to flex its muscle and effectively block affordable access. While there have been tremendous gains in the global scale up of essential medicine, particularly for HIV drugs, equitable access still remains precarious at best. There are many reasons for this, one of which is the movement toward greater IP protection, known as “TRIPS plus”, which essentially looks like the TRIPs agreement on steroids.

While the São Paulo Declaration gives me hope that smart people with political leverage are going to bat for a great cause, I wonder how much impact it will have on access. Is this (and other stated declarations) a necessary first step toward equitable access, or better yet, global IP reform? Or will it become just another optimistic statement that will crumble in the face of stringent IP rules that have systematically failed to meet the health needs of the global poor?

I tip my hat to the parliamentarians who helped draft this document. My only hope is that it translates into tangible health improvements for people who require medicine but can’t afford it.


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Roche Wins as High Court Limits University Patent Rights

The United States Supreme Court recently announced their decision on a landmark case revolving around university patent rights on life-saving medical technologies. The technology in question, quantitative polymerase chain reaction (real-time PCR), is a highly effective tool in diagnosing infectious diseases and detecting new and emerging threats.

Originally developed by Stanford scientist Mark Holodniy, advancements in real-time PCR were claimed to be owned by the university, under the conditions of the 1980 Bayh-Dole Act that outlines universities’ legal rights for research funded by the federal government. Holodniy later signed agreements that transferred ownership of his PCR work to Cetus Corp, now owned by Roche Pharmaceuticals. Stanford argued that the Bayh-Dole Act superseded any agreement made afterwards by Holodniy and Cetus.

However, in the ruling led by Chief Justice John Roberts, it’s said that the 1980 law doesn’t displace the historical principle that inventors are allowed to have first claim on their work. This decision will certainly affect future cases of patent ownership and potentially all technologies that were jointly developed through federal funding, university research and industry collaboration.

The patent for real-time PCR will be held by Roche until 2021.

For more coverage on this case, the full article by Bloomberg News is available here.

A press release by Roche on the court’s ruling can be read here.

Access 101: Introduction to Compulsory Licensing

If you’re new to the issue of access to medicines, you’ll see us talk often of intellectual property and how these laws and rules affect people’s ability to obtain life-saving medicines. Today I’ll discuss compulsory licensing but before I do, I need to talk a bit about intellectual property.

What is intellectual property? Well, intellectual property is a branch of law that deals with the rights and ownership of ideas–properties of the mind, so to speak. It’s grounded in the belief that individuals should be able to protect their ideas and profit off of them and in turn, the financial returns will also drive economic development. We usually see intellectual property in the form of:

  • Copyright (the expression of ideas say in a textbook or journal article)
  • Trademarks (think of Microsoft’s floating window logo and McDonald’s golden arches) or
  • Patents (which applies to inventions like cameras or chemical compounds)

So this is all very well and good we might say–if I come up with some original work, I ought to be able to take ownership and make money to recoup the time and resources I spent coming up with that valuable idea. For the most part I would agree with that. But what about when this idea means the difference between life or death, sickness and health? What happens when people don’t have the means to afford the prices someone else sets? That’s where compulsory licenses (CL) come into light. CL’s are a legal means to force a patent-holder to grant use of a patent to the government or another party. Historically, CL’s are used in extraordinary situations to protect health and human safety, situations like:

  • World War II, where the allies needed to manufacture a large number of specific engines in airplanes for minimum cost.
  • 2001, where the Anthrax bacteria scare in the U.S. led their government to issue a compulsory license to maximize production of the antibiotic ciprofloxacin.
  • The HIV/AIDS pandemic, where the cost to treat one patient for one year in the early 1990’s was well over $10,000.

So we see that there are very good reasons to use compulsory licensing when human safety is threatened and there is a clear precedent of its use and value. When faced with the rising problem of access to medicines in the developing world, the World Trade Organization incorporated means to address these imbalances by implementing mechanisms to use CL in the international trade agreement, TRIPS. Critics of the WTO have argued however that these measures are insufficient and do not allow CL to be effectively used by populations in need (read more in the links below).

Initially TRIPS only allowed a country to obtain a compulsory license for domestic markets, that meant if you’re a country like Rwanda that has no pharmaceutical industry, you will need someone industrialized (like Canada) to export medicine to you. TRIPS was updated to reflect this gap in something called the ‘August 30th Decision’–it allowed member countries to develop a legal mechanism for manufacturers to obtain a CL so they could export a life-saving medicine to developing countries. Canada was the first to do so by creating Canada’s Access to Medicines Regime; however, this is far from a functional solution which Dave Ng writes more about here.

Compulsory licensing is but one solution for a variety of problems that constitute the challenging in providing medicines for the 1-in-3 people around the world who still lack access. We have much to talk about the limitations of compulsory licensing, other mechanisms for improving access in terms of IP management and other logistical problems that prevent medicines reaching points of care from points of manufacturing.

For more readings on compulsory licensing in general and in practice, visit:

Comments are always welcome below.

A Primer on the Subject of Access to Medicines

Here’s a piece I wrote for online reading at Scientific American. It basically tries to cover the main ideas and main challenges in Access to Medicines issues. Not a bad place to start to get into the swing of things. Also, If you’re a reader from Canada, don’t forget to check out aidsaction.ca. Here, you can look up your candidates and send off an email to support the Call to Action to reform Canada’s Access to Medicines Regime and help save lives!

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30 minutes, 70 fates.

You don’t know it, but as I write this piece, there is some serious procrastination going on. My attention span is weak and sidetracked constantly by a variety of diversions, and if you must know, it’s taken me close to half an hour to write these first two sentences. Still, one could argue that none of us are strangers to procrastination, and 30 minutes is relatively short – only a minor instance of time in the grand scheme of things.

But a lot can happen in thirty minutes. Earlier, I had been looking over some 2009 UNAIDS statistics, and noting the numbers issued in the report. They are all very big, big enough certainly to require the pressing of buttons on calculators. More to the point, I learn that during my thirty minutes, approximately 70 people died from HIV/AIDS in Sub-Sahara Africa. That’s 1.3 million victims each year – in Sub-Sahara Africa alone. Many of these were parents leaving orphans, and many were young children just leaving. Most troubling, however, is the fact that all of them suffered their fate with a loss of dignity.

Why do I say this? I say this because people shouldn’t have to die from HIV/AIDS. There are good medicines out there, and they can control the disease. In fact, for those in the developed world, HIV/AIDS is now considered a chronic disorder, not a death sentence. If you are diagnosed, you are no longer forced to take a shortcut to demise. You can still have a long life, you can still be productive, and you can still live with dignity.

Unfortunately, this wasn’t an option for those who passed away. For them, the medicines were out of reach. They were simply too expensive. And from this, you come to realize a cold hard fact in this narrative: that the fate of a person living or dying from HIV/AIDS is determined by their income. This statement is fairly straightforward, with no mincing of words, or confused rhetoric. But for most, it feels fundamentally wrong, and yet, it is a simple reality of how the world works today. Why it works in this way, however, is complicated.
Continue reading

Sneaky: European Free Trade Talks can also affect prices of drugs in Canada

Yup. Apparently, our previous post on data exclusivity and the like, will also effect prices in places like Canada as well.

Specifically:

Provisions in a new trade deal being negotiated between Canada and the European Union could add about $2.8-billion a year in costs to Canadian drug plans if implemented, a new report warns.

The estimate includes $1.3-billion more for public drug plans and $1.5-billion for private drug plans.

This is because the EU is asking for a number of things, including lengthening the terms of data exclusivity. Given that in Canada, “Generics account for 54 per cent of prescription drugs and brand-name drugs 46 per cent,” moves such as this will obviously prevent or at least greatly delay the existence of generics in the market. Crucially, and what is a bit dodgy about this whole thing, is that such moves will do these things even if a patent has already expired. It’s just another sneaky way for the pharmaceutical industry to keep control.

Anyway, read the whole Globe and Mail article at the link below.

LINK; EU trade deal could cost Canadian drug plans billions

Why do Data Exclusivity and Investment Rules suck?

O.K. First the tough part: bringing yourself to want to read about “Data Exclusivity” and “Investment Rules.” Granted, not the most common buzz words you hear about in media, but it’s actually very interesting. More so, if you have even a peripheral interest in what all the fuss is with regards to the EU-India Free Trade Agreement talks.

Anyway, there’s a great piece from MSF that does a pretty good job of outlining the problems with granting Data Exclusivity and tweaking Investment Rules when it comes to generic drug production.

Here’s the part on Data Exclusivity, if you’re more keen to just get on with reading it than clicking through to the whole article:

Data exclusivity (DE) is a backdoor way for multinational pharmaceutical companies to get a monopoly and charge high drug prices, even when their drug has been found to not deserve a patent, or the patent has expired – DE would apply to all drugs.

If India accepts DE, the agency in charge of approving medicines for use in the country would not be allowed to register a generic version of a medicine for a period of time – usually 5 to 10 years. To register a generic, producers rely on the clinical trial data provided by the originator company to show the drug is safe and effective. All the generic has to prove is that it is identical to the originator product. But if DE were in place, the originator company’s clinical trial data would be protected by ‘exclusivity’ and generic producers would therefore have to submit their own safety & efficacy data to register the generic medicines. This would oblige them to repeat clinical trials—something that would take years and be incredibly expensive, not to mention unethical, as it would involve withholding a drug that has already proven to be effective from some of the participants in the trial.

LINK: Briefing Note: Data Exclusivity & Investment Rules in EU-India FTA

What is a patent pool? And more importantly, are Speedos strictly forbidden?

The answer the first question can be seen by checking out this video:

Also:

Consider signing this petition by the Stop AIDS Campaign – inviting Johnson and Johnson to join the MSF “Patent Pool Party” by sharing their rights to Darunavir (an important antiretroviral!)

More information here: http://www.stopaidscampaign.org.uk/

Sign here: http://stopaidscampaign.org/poolparty/

For the second question, I’ll have to get back to you, but man… I sincerely hope so.