Should the duration of pharmaceutical patents be extended?

Some Kats never grow up.
Merpel will do anything for
the strawberry flavoured one ...

This Kat was intrigued about a debate this week in the Wall Street Journal concerning the duration of protection for pharmaceutical patents: "Should Patents on Pharmaceuticals Be Extended to Encourage Innovation?" At its simplest, the WSJ explained the issue as follows:

'The drug makers say those profits fund the research that produces breakthrough treatments. They warn that with patents expiring on several big-money drugs, their ability to develop new drugs will be severely hampered. Longer-lasting patents, they say, would protect the profits that they need to keep innovative products moving through the pipeline.

Critics question that assumption. There's no proof, they say, of a link between patent life and innovation. In their view, drug companies focus on developing the most marketable drugs instead of the most urgently needed medications. So extending patents would serve mainly to boost drug companies' profits, not to encourage the innovation needed to address the world's unmet medical needs'.

For pharmaceutical patent extension


Writing in favour of an increase in patent protection was Dr Josh Bloom (right), director of Chemical and Pharmaceutical Sciences athet American Council on Science. He describes the 'problem' as follows:

'A confluence of events in recent years has made drug discovery more difficult, expensive and time consuming. Most important, it has become less profitable, largely because longer development times mean companies have less time left under patents to exclusively market their discoveries. Now, the industry faces a financial crisis because of the recent or imminent expiration of the patents on many of its most profitable drugs'.

In the course of his argument, Dr Bloom provides some striking statistics (or 'Ugly Numbers' as he calls them). For instance, bringing one new drug to market takes roughly 14 years and at a cost of roughly US $1.3 billion (£835 million or so). For every medicine which makes it on to the market, more than 50 research programmes fail. Further, owing to increased development times, pharmaceutical companies usually only have 11 years of market exclusivity for their medicines. Dr Bloom concedes that 'of course longer patents would mean that important drugs would remain relatively expensive for a longer time'. However, this is quickly followed by the (expected) ominous warning: 'but the expense of new drugs is preferable to not having them at all'.  Taking a compromise positoin, Dr Bloom concludes:

'... a well-planned extension of patent protection, especially for innovative drugs [as opposed to the 'so-called line extensions-where companies simply tweak existing patents enough to earn a new patent'] is both reasonable and necessary to keep what is left of the American pharmaceutical industry healthy enough to continue its crucial work'.

Against pharmaceutical patent extension


Writing against an increase in patent protection was Dr Els Torreele (right), director of the Access to Essential Medicines Initiative of the Open Society Foundation's Public Health Program. For Dr Torreele, the 'problem' is that:

'... drug companies are more focused on developing the drugs with the greatest market potential than they are on developing truly innovative treatments that address critical health needs. And the patent system encourages that approach. The previously stringent criteria ensuring that patents applied only to real innovations have gradually been eased. Nowadays, companies can secure a 20-year monopoly by either making minor changes to an existing drug or inventing a totally new drug—so why take the risk of failure associated with the latter?'

In response to the suggestion that the patent system could be modified so that 'innovative drugs' received longer protection, Dr Torreele stated that this:

'perpetuates the fallacy of a link between patents and therapeutic innovation—and that distracts us from thinking about alternative policy tools to promote real health innovation. It's perfectly possible to achieve a major medical breakthrough with a product that isn't patented, while the fact of obtaining a patent doesn't say anything about a compound's actual medical value. Moreover, the patent office [ie the United States Patent and Trademark Office] isn't equipped to judge therapeutic benefit'.

Instead, Dr Torreele proposes a more stringent approach so that new medicines had to demonstrate 'a therapeutic benefit over existing treatments before giving market approval—a judgment the agency [the Food and Drug Administration in the United States] is perfectly capable of making, but somehow doesn't now'. She continues with the (expected) ominous warning that 'without such a prerequisite, companies will continue to focus on pharmaceuticals with the highest market potential, rather than innovating to address medical need'.

As an alternative to patent extension, Dr Torreele believes that the answer is:

'institut[ing] a regulatory environment that prioritizes health innovation instead of market opportunities, by making approval of new drugs contingent on therapeutic advances that address unmet health needs. In parallel, we should mobilize public and private resources to finance research and development independently of patents, so that we can stop relying on pharmaceutical sales as the primary source of funding for research'.

You've heard both sides -- so the IPKat and Merpel throw the topic open for discussion: should the duration of pharmaceutical patents be long or short, and should they be driven by patent protection or pushed by funding in a regulatory environment?  Do tell us!