Another Boost For Generics: Brazilian Judge Annuls Patent On Key AIDS Drug

from the keep-taking-the-medicine dept

Last week Techdirt reported on an important decision in India to allow the production of a generic version of a kidney and liver cancer drug, with huge savings for the Indian health system, and major effects in terms of lives likely to be saved. Now Intellectual Property Watch has news of a court case in Brazil that could have equally important consequences for the local use of generics:

Word is spreading of a recent decision by a Brazilian judge to annul a patent on a key AIDS drug, effectively allowing less expensive generic versions into the country, and calling into question other such patents.

Here's why the case is setting a precedent:

A leading feature of the case is that the patent was granted under the "pipeline" process, which allowed "revalidation" of patents granted in other countries while Brazil was modifying its patent law for certain new areas including pharmaceuticals.

The judge in this case ruled that the pipeline process was unconstitutional, according to sources.

The "pipeline" process refers to a mechanism for granting patents in technological fields that had earlier been excluded under Brazilian law, using the date of the first filing for patents elsewhere. This allowed companies to extend the reach of patent monopolies already obtained outside Brazil without needing to go through that country's patent application process.

Lack of constitutionality had been raised back in 2008 because of the way that pipeline patents diminished the public domain:

"The concession of pipeline patents also violates the acquired right of the collectivity by removing from the public domain knowledge belonging to everyone, which once again goes against society’s interest," said Renata Reis, an attorney at the non-governmental Brazilian Interdisciplinary AIDS Organization.

Among the drugs that were removed from the public domain by the pipeline process is the ritonavir/lopinavir combination, the subject of the judge's order annulling Abbott Laboratories' patent. Not surprisingly, the company has said that it will appeal the decision. But if the ruling is upheld it may lead to other patents granted to drugs through the pipeline process being invalidated too.

Taken together with the Indian decision, this latest ruling emphasizes the increasingly important role of generics in global healthcare. That's another reason why both ACTA and the Trans-Pacific Partnership agreement are problematic.

ACTA, for example, allows generics to be seized in transit on the basis of complaints about names that are "confusingly similar" to a brand-name drug. TPP, meanwhile, would bring in a range of measures to make it substantially harder for companies to produce generic versions of patented drugs in signatory nations. The divergence between what the BRICS countries are doing in this area, and what plurilateral treaties like ACTA and TPP seek to mandate, is another reason why it is unlikely the former will ever sign up to the latter.

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Filed Under: access to medicines, aids, brazil, generics, healthcare, patents, pipeline
Companies: abbott labs

Obama Administration Trying To Move Away From Allowing Countries To Ignore Patents To Save Lives

from the sickening dept

Well here's another depressing one. For about a decade, there's been something known as the Doha Declaration, under the World Trade Organization (WTO), which effectively said that since public health and "access to medicines for all" was important, countries could have some "flexibility" in dealing with patented medication. In practice, this has meant that in order to deal with health issues, countries can ignore patents when necessary to make sure there is more medicine and that the medicine is reasonably priced. This is good for public health.

Of course, the pharmaceutical companies hate it.

KEI is tracking how the Obama Administration has been quietly backing away from the Doha Declaration and limiting the types of diseases that can be covered under Doha. Even though Doha is pretty clear that it can cover any kind of medicine in the interest of public health, a recent draft text for new agreements clearly (but quietly) tries to make sure that "Non-Communicable Diseases" (NCDs) are not considered to be covered by Doha. In other words, if you're talking about cancer, diabetes or heart disease... countries won't be able to use Doha to provide cheap and necessary drugs to people.

There's apparently a negotiation going on about an agreement on NCDs which, not surprisingly, has been driven by people representing the pharmaceutical industry. In one particularly egregious situation, according to the KEI report, a group representing the pharma industry was "grouped as civil society" at one of the meetings. Yes, for the purposes of one of the meetings, pharma lobbyists were labeled as a consumer interest group.

The end result is that, as it stands right now, the draft text around NCDs does not mention the Doha Declaration any more. This may not seem like a big deal, in that it still mentions "flexibilities," but trying to carve out what is and what is not covered by Doha clearly appears to be a means of ratcheting back the ability of countries to do the right thing in protecting public health:

By seeking to eliminate any references to the Doha Declaration, the U.S. appears to be asserting that the "access to medicine for all" provisions in the Doha Declaration do not apply to drugs for cancer and other non-communicable diseases.

[....]

Why is this controversy important? The US has conceded that compulsory licenses can be used for NCDs, an issue of no controversy legally, but politically sensitive. However, by removing the reference to the Doha Declaration, and maintaining the political position that the Doha Declaration does not apply to NCDs, the White House seeks to eliminate the "access to medicine for all" standard, and to raise doubts about the application of other elements of the Doha Declaration, including paragraphs 5, 6 and 7 to NCDs, if not legally, at least politically.

It's tough not to be cynical about this kind of stuff. But I'm having trouble seeing this as anything other than doing a favor for the pharma industry.

There was some hope that the administration might clarify its position and answer some questions related to this in a USTR paper that was recently released, but the actual release turned out to be nearly totally devoid of substance, angering plenty of consumer groups concerned about access to medicine. Even worse, the paper appears to suggest that greater patent protection may make more sense. The summary from Tido von Schoen-Angerer makes all this clear:

The leaked papers reveal a number of U.S. objectives: to make it impossible to challenge a patent before it is granted; to lower the bar required to get a patent (so that even drugs that are merely new forms of existing medicines, and don't show a therapeutic improvement, can be protected by monopolies); and to push for new forms of intellectual property enforcement that give customs officials excessive powers to impound generic medicines suspected of breaching IP.

And there's more.

The U.S. will also reportedly introduce measures to make it harder and more expensive for generic drugs to get regulatory approval, and to lengthen patent monopolies for pharmaceutical firms so that they keep generics out and prop up drug prices for longer. All of these measures are known to hit the availability of affordable medicines in developing countries hard.

The really amazing thing is how incredibly short-sighted this is. Even if you wanted to argue that it's somehow "good for the economy" to artificially prop up pharma companies with longer and stronger patents, if it comes at the expense of public health, that's not going to help the economy at all. A healthy population is a consuming population. Letting people die around the world is not good for the economy.

Filed Under: access to medicines, healthcare, patents