Merck 'Evergreens' Off-Patent Lipitor By Creating Combination Drug With No Additional Benefit

Big pharma often gets a rather rough ride here on Techdirt, what with its attempts to stop governments granting licenses for life-saving and low-cost generics in emerging countries, engaging in legal action to prevent drug safety information being released, and paying kickbacks to doctors. But sometimes you get the impression that drug companies really go out of their way to be disliked, as this great post by Josh Bloom on the Medical Progress Today site, pointed out to us by John Wilbanks, demonstrates

On Techdirt.

Open Science, Closed Source

One of the things that disappoints me is the lack of understanding of what's at stake with open source among some of the other open communities. For example, some in the world of open science seem to think it's OK to work with Microsoft, provided it furthers their own specific agenda. Here's a case in point:

John Wilbanks, VP of Science for Creative Commons, gave O'Reilly Media an exclusive sneak preview of a joint announcement that they will be making with Microsoft later today at the O'Reilly Emerging Technology Conference.

According to John, who talked to us shortly after getting off a plane from Brazil, Microsoft will be releasing, under an open source license, Word plugins that will allow scientists to mark up their papers with scientific entities directly.

"The scientific culture is not one, traditionally, where you have hyperlinks," Wilbanks told us. "You have citations. And you don't want to do cross-references of hyperlinks between papers, you want to do links directly to the gene sequences in the database."

Wilbanks says that Science Commons has been working for several years to build up a library of these scientific entities. "What Microsoft has done is to build plugins that work essentially the same way you'd use spell check, they can check for the words in their paper that have hyperlinks in our open knowledge base, and then mark them up."

That might sound fine - after all, the plugins are open source, right? But no. Here's the problem:

Wilbanks said that Word is, in his experience, the dominant publishing system used in the life sciences, although tools like LaTex are popular in disciplines such as chemistry or physics. And even then, he says it's probably the place that most people prepare drafts. "almost everything I see when I have to peer review is in a .doc format."

In other words, he doesn't see any problem with perpetuating Microsoft's stranglehold on word processing. But it has consistently abused that monopoly by using its proprietary data formats to lock out commercial rivals or free alternatives, and push through pseudo-standards like OOXML that aren't truly open, and which have essentially destroyed ISO as a legitimate forum for open standards.

Working with Microsoft on open source plugins might seem innocent enough, but it's really just entrenching Microsoft's power yet further in the scientific community, weakening openness in general - which means, ultimately, undermining all the other excellent work of the Science Commons.

It would have been far better to work with OpenOffice.org to produce similar plugins, making the free office suite even more attractive, and thus giving scientists yet another reason to go truly open, with all the attendant benefits, rather than making do with a hobbled, faux-openness, as here.

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In Praise of the Public Domain

I write a lot about licensing here. Indeed, licensing arguably lies at the heart of free software. But there's another important way of looking at things, which is essentially licence-less, as John Wilbanks reminds us:

It is a damn shame that we no longer think of the public domain as an option that is attractive. It’s a sign of the victory of the content holders that the free licensing movements work against that something without a license – something that is truly free, not just just free “as in” – is somehow thought to be worse. We’ve bought into their games if we allow the public domain to be defined as the BSD. The idea of the public domain has been subjected to continuous erosion thanks to both the big content companies and our own movements, to the point where we think freedom only comes in a contract.

The public domain is not contractually constructed. It just is. It cannot be made more free, only less free. And if we start a culture of licensing and enclosing the public domain (stuff that is actually already free, like the human genome) in the name of “freedom” we’re playing a dangerous game.

How true. Which means that those of us in the free software world must be careful that we don't play into the hands of those who want *everything* to be licensed.

John Wilbanks on the Knowledge Web

Here's a nice meditation from Science Commons' John Wilbanks on openness, access and innovation, which includes the following thoughts on the "knowledge web":

Just to be clear, here’s what I mean by a knowledge web: it’s when today’s web has enough power to work as well for science as it currently works for culture. That means databases are integrated as easily as web documents, and it means that powerful search engines let scientists ask complex research questions and have some comfort that they’re seeing all the relevant public information in the answers. A knowledge web is when journal articles have hyperlinks inside them, not just citations, letting systems like Google do their job properly.

A knowledge web is predicated on access, and not control, of knowledge. There will never be a competition to provide the best single-point query to the full-text of journals without access- unless the journals all merge down into one company. That’s the only way a controlled system covers the whole world, through monopoly. There will never be a knowledge web where the entire backfile is hyperlinked to databases for relevance based indexing without access. Scientists won’t get to use the newest and best technologies until those companies that control knowledge decide to adopt those technologies. Control is the enemy of testing the newest technologies, of building one’s own system to suit one’s own needs. We have to have access to build a knowledge web, at least if we hope to replicate the success of the regular Web and the Internet.

The Real Big Switch

An eloquent statement by John Wilbanks about the commons, sharing and solving complex problems:

One of the reasons I believe so deeply in the commons approach (by which i mean: contractually constructed regimes that tilt the field towards sharing and reuse, technological enablements that make public knowledge easy to find and use, and default policy rules that create incentives to share and reuse) is that I think it is one of the only non-miraculous ways to defeat complexity. If we can get more people working on individual issues – which are each alone not so complex – and the outputs of research snap together, and smart people can work on the compiled output as well – then it stands to reason that the odds of meaningful discoveries increase in spite of overall systemic complexity.

He concludes:

It is not easy. But it is, in a way, a very simple change. It just requires the flipping of a switch, from a default rule of “sharing doesn’t matter” to one of “sharing matters enormously”.

That's what it's all about, people.

Open Access Data - A Question of Protocol

Something calling itself a “Protocol for Implementing Open Access Data” sounds about as exciting as a list of ingredients for paint. But this memo from the Science Commons is one of the most important documents in this field to date. Its scope is explained in the opening paragraph:

This memo provides information for the Internet community interested in distributing data or databases under an “open access” structure. There are several definitions of “open” and “open access” on the Internet, including the Open Knowledge Definition and the Budapest Declaration on Open Access; the protocol laid out herein is intended to conform to the Open Knowledge Definition and extend the ideas of the Budapest Declaration to data and databases.

Again, that may not sound very exciting, but trying to come up with definitions of “open data” or “open access data” have proved extraordinarily hard, and in the course of the memo we learn why:

3. Principles of open access data
Legal tools for an open access data sharing protocol must be developed with three key principles in mind:
3.1 The protocol must promote legal predictability and certainty.
3.2 The protocol must be easy to use and understand.
3.3 The protocol must impose the lowest possible transaction costs on users.

These principles are motivated by Science Commons’ experience in distributing a database licensing Frequently Asked Questions (FAQ) file. Scientists are uncomfortable applying the FAQ because they find it hard to apply the distinction between what is copyrightable and what is not copyrightable, among other elements. A lack of simplicity restricts usage and as such restricts the open access flow of data. Thus any usage system must both be legally accurate while simultaneously very simple for scientists, reducing or eliminating the need to make the distinction between copyrightable and non-copyrightable elements.

The terms also need to satisfy the norms and expectations of the disciplines providing the database. This makes a single license approach difficult – archaeology data norms for citation will differ from those in physics, and yet again from those in biology, and yet again from those in the cultural or educational spaces. But those norms must be attached in a form that imposes the lowest possible costs on users (now and in the future).

The solution is at once obvious and radical:

4. Implementing the Science Commons Database Protocol for open access data
4.1 Converge on the public domain by waiving all rights based on intellectual property

The conflict between simplicity and legal certainty can be best resolved by a twofold measure: 1) a reconstruction of the public domain and 2) the use of scientific norms to express the wishes of the data provider.

Reconstructing the public domain can be achieved through the use of a legal tool (waiving the relevant rights on data and asserting that the provider makes no claims on the data).

Requesting behavior, such as citation, through norms and terms of use rather than as a legal requirement based on copyright or contracts, allows for different scientific disciplines to develop different norms for citation. This allows for legal certainty without constraining one community to the norms of another.

Thus, to facilitate data integration and open access data sharing, any implementation of this protocol MUST waive all rights necessary for data extraction and re-use (including copyright, sui generis database rights, claims of unfair competition, implied contracts, and other legal rights), and MUST NOT apply any obligations on the user of the data or database such as “copyleft” or “share alike”, or even the legal requirement to provide attribution. Any implementation SHOULD define a non-legally binding set of citation norms in clear, lay-readable language.

The solution is obvious because the public domain is the zero state of copyright (in fact, the new Creative Commons public domain licence is called simply CCZero.) It is radical because previous attempts have tried to build on the evident success of the GNU GPL by taking a kind of copyleft approach: using copyright to limit copyright. But the new protocol explicitly negates the use of both GPL's copyleft and the Creative Commons Sharealike licences because, minimal as they are, they are still too restrictive – even though they are both predicated on maximising sharing.

One knock-on consequence of this is that attribution requirements are out. This is not just a matter of belief or principle, but of practicality:

In a world of database integration and federation, attribution can easily cascade into a burden for scientists if a category error is made. Would a scientist need to attribute 40,000 data depositors in the event of a query across 40,000 data sets? How does this relate to the evolved norms of citation within a discipline, and does the attribution requirement indeed conflict with accepted norms in some disciplines? Indeed, failing to give attribution to all 40,000 sources could be the basis for a copyright infringement suit at worst, and at best, imposes a significant transaction cost on the scientist using the data.

It is this pragmatism, rooted in how science actually works, that makes the current protocol particularly important: it might actually be useful. It's also significant that it plugs in to previously existing work in related fields. For example, as the accompanying blog post explains:

We are also pleased to announce that the Open Knowledge Foundation has certified the Protocol as conforming to the Open Knowledge Definition. We think it’s important to avoid legal fragmentation at the early stages, and that one way to avoid that fragmentation is to work with the existing thought leaders like the OKF.

Moreover, the protocol has already been applied in drawing up another important text, the Open Data Commons Public Domain Dedication & Licence:

The Open Data Commons Public Domain Dedication & Licence is a document intended to allow you to freely share, modify, and use this work for any purpose and without any restrictions. This licence is intended for use on databases or their contents (”data”), either together or individually.

Many databases are covered by copyright. Some jurisdictions, mainly in Europe, have specific special rights that cover databases called the “sui generis” database right. Both of these sets of rights, as well as other legal rights used to protect databases and data, can create uncertainty or practical difficulty for those wishing to share databases and their underlying data but retain a limited amount of rights under a “some rights reserved” approach to licensing. As a result, this waiver and licence tries to the fullest extent possible to eliminate or fully license any rights that cover this database and data.

Again, however dry and legalistic this stuff may seem it's not: we're talking about the rigorous foundations of new kinds of sharing - and we all know how important and powerful that can be.

Update: John Wilbanks has pointed me to his post about the winnowing process that led to this protocol - fascinating stuff.