Bayer Fights India's Compulsory Licensing Of Cancer Drug By Claiming It Spent $2.5 Billion Developing It

Back in March last year, the Indian government announced that it was granting its first compulsory license, for the anti-cancer drug marketed as Nexavar, whose $70,000 per year price-tag put it out of reach of practically everyone in India. Nexavar's manufacturer, the German pharmaceutical giant Bayer, naturally appealed against that decision, and the hearing before the India Intellectual Property Appeals Board (IPAB) has now begun. Jamie Love has provided a useful report on the proceedings; here's his summary of what's at stake: 

On Techdirt.

Historic Ruling Against First Modern Drug Patent In India

As Techdirt has reported over the last year, the Indian government is becoming increasingly keen on using cheaper, generic versions of important drugs to treat diseases, rather than paying Western-level prices its people can ill afford. Intellectual Property Watch reports on another instance of the Indian authorities easing the way for low-cost versions by striking down a patent granted to Roche for the treatment of Hepatitis C. As the article explains, it's notable for at least two reasons: 

On Techdirt.

After India, Now Indonesia Introduces Patent Licenses For Generic Versions Of Drugs

As we noted a couple of weeks ago, when we wrote about India's moves to issue compulsory licences for the production of generic versions of expensive, patented drugs, the big fear for Western pharmaceutical companies was that other countries might follow suit. It looks like that's happening in Indonesia, where the country's president has signed a decree authorizing low-cost versions of key HIV drugs: 

On Techdirt.

Making AIDS Drugs Affordable With Prizes, Not Patents

Of all the dysfunctional parts of the patent system, drug patents are arguably the worst, since the exorbitant prices that patent monopolies allow mean that millions of people simply cannot afford medicines that would keep them alive or would improve their quality of life substantially. 

On Techdirt.

Why We Should - and Can - Abolish All Patents

As long-suffering readers will know, I've been warning about the growing problem of patent thickets in the field of software for some time now. Until relatively recently, I and a few others have been voices crying in the wilderness: the general consensus has been that patents are good, and more patents are better. But in the last few weeks, the first hopeful signs have appeared that at least some people are beginning to realise that software patents not only do not promote innovation, they actually throttle it.

On Open Enterprise blog.

The Great Prize: Innovating Without Monopolies

Last week I was in Brussels, talking at the European Parliament - not, I hasten to add, talking to the Parliament. This was a more intimate gathering in one of the smaller (but still quite large) conference halls, discussing a rather interesting matter:

On Open Enterprise blog.

Sharing: Theft or Duty?

I regard Matt Asay as one of the most perceptive commentators on the world of free software and related areas. So I was rather disappointed to read the following in one of his recent columns, which dealt with the BSA's highly dodgy claims about piracy:

I don't mean to diminish the wrong nature of stealing software. Theft is theft and should be punished.

Here's what I wrote to him:

It is very hard to steal software: unless you creep into a computer store and steal the boxes (do they still exist?). As you know, what really happens is that somebody makes a copy of software: that is not theft, of course, that is copyright infringement. If I make a copy of a piece of software, the original still exists, but there is now a copy that I have. I have stolen nothing - I've actually created something - but I *have* infringed on copyright.

But wait, you will say, when you make that perfect copy you are *effectively* stealing the money that you would have paid for a legal copy. Except that you yourself write: "$1 in "lost" licensed revenue would not magically become $1 in proprietary software sales if piracy were reduced. It's very likely that users would elect to spend their money elsewhere." Exactly: couldn't have put it better myself. You can't start talking about that money that wasn't spent as if it were real and concrete: it's not, it's notional.

Of course, it is probably true that some fraction of the people with pirated copies *would* have bought genuine ones had they not made the copy: so that is truly lost revenue. But it also probably true that pirated copies act as marketing samplers and encourage other people to buy legitimate copies that they wouldn't otherwise have bought – to get support, updates etc. (Indeed, in the world of music, there are half a dozen studies that suggest this is the case.) After all, giving away software for free is the basis of many businesses based around open source.

Calling copyright infringement "theft" really plays into the hands of organisations like the BSA that put out these deliberately misleading studies. "Theft" is an emotive word that biases the reader against the people involved. If you call it "copyright infringement", and note that copyright is a time-limited, state-granted *monopoly* - and I think everyone accepts that monopolies are generally bad things - then copyright infringement simply means infringing on a monopoly. That's a rather different emotional bundle, I think, and a better one to place in opposition to the BSA's manipulations.

Since Matt's reply to me was a private email, I won't quote it here, but essentially his answer was that artists can set the terms under which we access their works, whether or not they are reasonable terms, because ultimately it's their creation.

It's a good point, and so I'll try to explain here why I don't think it's correct.

In fact, artists manifestly don't have an absolute right to choose whatever terms they like under which their works are distributed. In many countries, for example, they are limited by the first-sale doctrine. This means they cannot impose the condition that their book or CD, say, once purchased, must never be sold on second-hand, or given away. So already there are limits to what they can demand.

This is accepted, presumably, because there is a broad consensus that this kind of limitation is not reasonable, and that artists should be obliged, by law if necessary, to give up what they might otherwise have seen as a natural “right”.

What this comes down to, then, is a question of what is generally accepted as reasonable. A big problem with digital copies is that we have never lived in a digital world before, so we have not yet established the social norms there that ultimately will allow laws to be framed to capture what is deemed fair.

Not allowing people to make personal copies and share them for non-commercial use is, I believe, exactly like not allowing people to sell their books second-hand, or to give them away (note that I am not extending this to intentional commercial-scale copyright infringement, which is almost by definition criminal because conducted with the specific aim of depriving creators of their sales.)

It is an unreasonable restriction that will, ultimately, I believe, be seen by the majority of society as such. Indeed, the fact that so many young and even not-so-young people share files today already suggests that we are moving to that point fast.

So, why do I think this is unfair? In many ways it is similar to the thinking behind allowing people to give away or sell books second-hand - and note that in the latter case actual money is involved, whereas it almost never is with personal file sharing, so the latter is actually *less* harmful than the situation in the analogue world. But I am more interested in the giving away of books, so I'll concentrate on that.

When we pass on a book to a friend, or just give it away to a charity shop, say, we are really passing on the experience of reading that book, and the knowledge to be gained from it. It is an intensely social act of generosity, a desire to share a pleasure with our fellow human beings. It allows us to manifest our best qualities, and it can also be an opportunity for us to contribute to the general improvement of society – for example, by passing on an educational book, or one that encourages readers to engage in some activity that is beneficial to all (recycling waste, or becoming more tolerant, say.)

So if we were forbidden from sharing our books with friends and strangers, the world would be a poorer place in many ways, since we lose all these opportunities for generosity and contributing, albeit indirectly, to society's progress. Indeed, it's interesting that many people are finding one of the biggest drawbacks of otherwise convenient e-books is that you often *can't* share them in this way: this makes them a far more lonely, and hence rather sadder pleasure.

Of course, there is one important difference between analogue goods like books and digital ones like music or texts. Whereas I can only share an analogue object with one person, digital artefacts can be copied endlessly, allowing me to multiply my generosity and the joy received from it hundreds, thousands or even millions of times.

Not being able to share digital files turns out to be far worse than not being able to share analogue ones like second-hand books in terms of the positive benefits foregone. Moreover, you don't even have to give up your original copy where digital artefacts are concerned, so there is no disincentive for you to share it; some might even say that the social benefits of doing so are so great, that you actually have a duty to share....

Society has already decided that being unable to share second-hand goods is an unreasonable condition for creators to impose. I believe that we will come to the same conclusion for the sharing of digital files, where the case for allowing such non-commercial, personal transfer is even stronger.

After all, this is not some abstract issue. Currently, billions of people in developing countries cannot access huge swathes of transformative, liberating knowledge because of copyright laws, or are denied life-saving medicines because of drug patents. Being able to share is literally a matter of life and death.

Follow me @glynmoody on Twitter or identi.ca.

Patently Outrageous

Drug companies are blocking or delaying the entry of cheaper generic medicines into the EU, pushing up medicine bills, the European Commission has said.

Their actions cost EU healthcare providers 3bn euros ($3.9bn; £2.5bn) in savings between 2000 and 2007, it said.

But how were they doing that?

Drug firms use "perfectly lawful practices - such as patent portfolios, patent litigation and the release of improved medicines," the European Federation of Pharmaceutical Industries and Associations (EFPIA) said.

Ahh, *that's* what patents are for, then....

ACTA of Hypocrisy

I've written several times about the mysterious Anti-Counterfeiting Trade Agreement (ACTA), which is currently being negotiated behind closed doors, with little or no input from proles like you and me. Despite efforts to present us with a fait accompli, it seems that the Very Important People who are working on this are getting slightly rattled by the increasing criticism of both the process and the likely result.

For the fine site Digital Majority has managed to get its mitts on a leaked document put together by the European Commission in a desperate attempt to head off that growing discontent.

You can read the whole thing here, as well as Digital Majority's useful analysis. Basically, it's a case of the lady protesting too much: earnestly assuring us that it doesn't intend to bring in a shopping list of legal nasties - criminalisation of infringement, summary injunctions for those *suspected* of infringing, "three strikes and you're out", etc. - but convincing no one.

But what caught my attention were the closing words of this sad little document:

Fake medicines are reckoned to account for almost 10% of world trade in medicines. Most of these fake drugs are headed for the world’s poorest countries.

Riiiiiiiiiiiight. And why, might one ask, are the world's poorest countries buying all those fake drugs? It couldn't possibly be because of the high prices demanded by the owners of the relevant patents on the "real" thing? And it couldn't possible be the case that much of the counterfeiting this treaty aims to expurgate is caused precisely by those self-same intellectual monopolies?

And yet, strangely, getting rid of monopolies is something that the people working so feverishly on ACTA simply cannot contemplate - despite all the economic evidence that it is the solution to so many of the the problems they claim to be addressing.

Counterfeiting bad, monopolies good.

Beyond a Game

Sixth Floor Labs LLC, a Linux game development company, has launched their business today. Founded by Ethan Glasser-Camp and Carl Li, the company aims to improve Linux's desktop feasibility through the creation of high-quality games. Games are "sold" to the Internet community through the "ransom model" -- for one large payment, the product is released under the GPL and freed forever.

If this reminds you of something, maybe it's this:

The ransom model offered by Sixth Floor Labs follows in the footsteps of the Blender Foundation campaign, which raised 100,000 EUR in seven weeks, and the Free Ryzom ampaign, which raised pledges for 170,000 EUR in twenty-five days.

But this goes far beyond games - or even open source. It's essentially the model that has been proposed for many domains, for example drug development.

Instead of today's creaking system of drugs protected by pharmaceutical patents, one suggestion is to offer a bounty - a big one - for the company that comes up with a solution to a medical problem. Instead of patenting that solution, it is then put into the public domain - rather as Sixth Floor Labs propose doing with their games once the "ransom" has been paid - for anyone to exploit.