WHEN Jonas Salk was asked who held the patent for his newly created polio vaccine back in the 1950s, he famously replied: 鈥淭here is no patent. Could you patent the Sun?鈥�
Well no, but it often appears as though today鈥檚 biotechnologists are trying to patent everything under it (see 鈥淔ooting the bill鈥�). Worries about companies owning the essential building blocks of human life are nothing new. Journalists, campaigners and scientists have been voicing them for years, and when celebrating the culmination of the race to sequence the genome, Bill Clinton felt it necessary to calm fears with warm and fuzzy noises about the 鈥渂ook of life鈥� being owned by 鈥渁ll of humanity鈥�.
Despite this, the commercial stampede to patent DNA sequences, proteins and cells rages on. In theory Europe takes a stricter line than the US on what can and can鈥檛 be patented, but on both sides of the Atlantic patent examiners are drowning in biotech applications. Human genes are being grabbed as rapidly as they are discovered. Legal battles rage over stem cells and over exactly who owns the techniques involved in Dolly-style cloning. Patent lawyers are laughing all the way to the bank鈥攁nd multiplying faster than streptococci (see Graph).
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There is nothing wrong with companies expecting a return on their investments but ultimately what we want from biomedical research isn鈥檛 more lawyers but useful new medicines and clinical tools developed efficiently and cheaply. You don鈥檛 need to be morally opposed to capitalism or patents to recognise that the present system rewards luck and greed as much as enterprise and ingenuity. It urgently needs reforming.
Consider the latest controversy. Across the world researchers limber up for the mammoth job of turning the raw data of the human genome into useful genetic tests and drugs. Then out of the blue comes a Melbourne-based company claiming to own the techniques they鈥檒l be using and asking for fees and patent royalties. What the company appears to have patented is not an actual molecule or product, but a set of ideas that underpin a whole range of what are now regarded as standard common-sense genetic techniques. It is rather like an engineer popping up on the eve of the Apollo 11 launch claiming to own the basic idea of using the Moon鈥檚 gravity to get there.
Obtaining these patents involved some clever forward thinking and the company says it will not charge excessively. No matter. The sheer abundance of biotech patents means biomedical researchers are already overburdened with legal red tape. If claims like these are allowed to stand, there鈥檒l be more effort wasted on negotiating yet more licenses, and the already costly business of developing new medicines will get even slower and more expensive.
The underlying problem with this and many other biotech patent claims is they are unfairly broad and speculative. Patents are supposed to be for novel inventions of clear utility. Many applications simply report a gene, scrap of DNA or protein and then list every imaginable way it might be used. The US patent office has supposedly tightened up the rules to prevent such blatant land grabbing. But the utility threshold is still set way too low.
Pushing the bar up will help. Yet it won鈥檛 solve every problem. Obtain a gene patent in the US and you really do own the gene and all its future commercial uses. And while gene patents in Europe are supposed to be limited to specific applications, enforcing this rule requires resources the European patent office does not have. The consequences are not pretty. Already patents are making it harder and more expensive for patients to get genetic tests, as patent holders demand hefty licence fees and royalties from clinics. And without firm action stem cells could soon go the same way.
Europe鈥檚 leading biotech think-tank rightly says companies should be allowed to patent only specific applications of human stem cells and the procedures used to create them (see 鈥淪ay no to stem cell patents鈥�). The cells themselves should be off-limits. The same should be true of genetic information. By all means let companies patent specific genetic test kits or drugs derived from genes, but not the DNA code itself. It is too fundamental and versatile to allow individual companies to monopolise it.
Some say we should let the courts sort out what is and isn鈥檛 patentable, and strike down the scores of bad biotech patents being issued. But that鈥檚 not good enough. In such a rapidly evolving area of science, the delay and expense of legal challenges puts too much of a brake on progress.
We cannot and should not scrap biotech patents. But we do need firmer rules, and we need them fast. It鈥檚 time for political leaders to drop the warm and fuzzy sentiments and take a lead.