Why Opening Up Clinical Trials Data Is Good For Pharma Companies Too

Earlier this year we wrote about how AbbVie, the pharma company spun out of Abbott Laboratories, had gone to court to stop the European Medicines Agency (EMA) from releasing clinical trials information about one of its drugs. Despite what AbbVie claimed, this was not commercially sensitive in any way, but simply basic data about safety and efficacy. 

On Techdirt.

India's Approach To Pharma Patents Under US Attack, But Other BRICS Nations Likely To Adopt It

Techdirt has been reporting for a while on India's growing success in providing its population with access to low-cost generic drugs, making use of the permissions to do so granted by TRIPS. That has naturally earned it the ire of Western pharma companies, which now seem to be striking back, as this post on Infojustice.org explains: 

On Techdirt.

The Joy Of Monopolies: Orphan Drug Price Increasing By Nearly 40% Each Year

A couple of years ago, Techdirt carried an article by Andy Kessler about the difference between entrepreneurs who create value, and those who lock it up. The former tend to drive prices down constantly, innovating all the while in order to make a profit; the latter, by contrast, typically enjoy monopolies that allow them to push up prices without offering anything more in return. 

On Techdirt.

Using Patents To Needlessly Drive Up Healthcare Costs: The Economic Impact Of Evergreening Drugs

One technique in the world of pharma that has started appearing here on Techdirt is "evergreening" -- making small changes to a drug, often about to come off patent, in order to gain a new patent that extends its manufacturer's control over it. The advantages for pharma companies are evident, but what about the public? What economic impact does evergreening have? That's what a fascinating new paper in the open access journal PLoS Medicine seeks to establish: 

On Techdirt.

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.

How Investor-State Dispute Resolution Threatens Access To Medicines, And Much Else

A couple of weeks ago, we wrote about the growing importance of investor-state dispute resolution in so-called free trade agreements (FTAs). One of the most troubling aspects is how potentially it can be used to undo the hard-won gains for important areas like access to medicines. The US law professor Brook K. Baker, whose work we discussed last year, has written an excellent exploration of this under-appreciated risk. After an introduction running through the recent wins in the field of access to medicines -- a topic that we've covered extensively here on Techdirt -- he explains how big pharma could employ investor-state dispute resolution to thwart these and similar moves to protect health: 

On Techdirt.

OxyContin And The Art Of 'Evergreening'

A few weeks back, we wrote about the Indian Supreme Court's rejection of Novartis's attempt to use "evergreening" to prolong its patent on Gleevec, sold as Glivec in India. That term refers to the trick of making small changes to a drug, usually one about to come off patent, in order to gain a new monopoly that extends its manufacturer's control over a medicine. But how does that work in practice? 

On Techdirt.

'Pay For Delay' Drug Deals Under Scrutiny In US, EU And UK

The last time Techdirt wrote about "pay for delay" deals, whereby a big pharma company essentially buys off manufacturers of generics so that the former can continue to enjoy monopoly pricing long after its patents have expired, things didn't look too good. Back in 2010, the Second Circuit had refused to re-hear a case on the issue after dismissing a lawsuit arguing these deals were anti-competitive. But now things seem very different, and not just in the US. 

On Techdirt.

Indian Supreme Court Rejects Trivial 'Evergreening' Of Pharma Patents

Back in October last year, in the context of India showing itself increasingly sceptical about pharma patents that drive up drug prices beyond the reach of its citizens, we wrote about an important court battle over Novartis's drug Gleevec, sold as Glivec in India. The definitive judgement from India's Supreme Court was announced today, reported here by The Guardian:

On Techdirt.

Giant Pharma Company Claims Releasing Data On Drug Safety Is Illegal As It's Confidential And 'Commercially Sensitive'

One of the initiatives gaining momentum around the world is open data -- the idea that, for example, non-personal data affecting the public should be made freely available. That's partly to improve transparency, so that citizens are more informed about what is happening, and partly to stimulate new kinds of business that build products and services based on that data. 

On Open Enterprise blog.

Canada Denies Patent For Drug, So US Pharma Company Demands $100 Million As Compensation For 'Expropriation'

An increasingly problematic aspect of free trade agreements (FTAs) is the inclusion of investor-state provisions that essentially allow companies -- typically huge multinationals -- to challenge the policies of signatory governments directly. The initial impulse behind these was to offer some protection against the arbitrary expropriation of foreign investments by less-than-democratic governments. But now corporations have realised that they can use the investor-state dispute mechanism to challenge all kinds of legitimate but inconvenient decisions in any signatory nation. Here's a good example of how this provision is being invoked to contest a refusal by Canadian courts to grant a patent on a drug, as explained on the Public Citizen site: 

On Techdirt.

Pharma Companies Try 'DRM' For Drugs As A Ploy To Stymie Generics

One of the striking features of the drug world is how pharma companies become noticeably more inventive immediately before their patents are due to run out and their drugs are about to enter the public domain. That's because they need to find a way to differentiate themselves from the generic manufacturers that are then able to offer the same medicines for often vastly lower prices. 

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.

Emerging Countries Take Note: Big Pharma's Losing Patent Battles In India

Techdirt has been following the important story of the kidney and liver cancer drug marketed under the name Nexavar since March, when India granted a compulsory license for the first time since re-instating patents on pharmaceuticals. Naturally, the patent holder, Bayer, fought back, and appealed against that decision. Now we learn from Intellectual Property Watch that Bayer has lost: 

On Techdirt.

India Moves Even More Of Its Healthcare Away From Western Pharma

A few years back, Techdirt noted that India had 16,000 licensed drug manufacturers in the 1990s, and became a net exporter of pharmaceutical products. Things changed somewhat when India joined the WTO, which forced it to recognize pharmaceutical patents, but more recently it has started moving back towards generics, notably with the compulsory licensing of a kidney and liver cancer drug that was being sold by Bayer in the country for around $70,000 a year. 

On Techdirt.

Johnson & Johnson Refuses To License Three HIV Drugs To Medicines Patent Pool; Invites Patent Override

By their very nature, drug patents can create monopolies that allow prices to be kept artificially high. In other domains that may be simply an annoyance or inconvenience, but in the world of medicines, it can be a matter of life or death for those unable to afford those inflated prices. 

On Techdirt.