Whatever the principle at stake, one practical effect of Judge Sweet’s ruling, if it isn’t reversed, will be to eliminate part of the legal structure upon which the biotechnology industry was founded. The US might leave the company of Japan, Canada, Australia, and the European Union to become the biggest industrialized nation to consider a gene that’s been discovered, characterized, and isolated through scientific inquiry as categorically non-patentable.
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There is still, of course, the very legitimate, and clearly urgent, question of whether gene patents serve the larger goal of advancing medical research and promoting the creation of therapies. But the best answer to this question is unlikely to arrive through a patent challenge. Determining the benefit to society of gene patents involves much more than just the narrow legal consideration of whether DNA isolated through the process of scientific discovery fits the definition of an invention under the US Patent Act.
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Perhaps the best policy would be to simply do away with these patents. But the issue is of such magnitude that it would be best addressed outside the court system, by an act of Congress.
It is good to see that at least some in the mainstream media are waking up to the reality of what is at stake in the ACLU's challenge to gene patents.
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3 comments:
What is the nature of law? Does size matter? If something can be seen with the naked eye, that is patented, does it deserve a different standard of law over something that can not be seen with the naked eye, such as the microscopic nature of genes? If someone reduces and isolates the necessary mechanical parts of a car, mainly a vehicle with wheels, power plant, and chassis, can this person patent it, the simplified and isolated vehicle? Granted, cars do not naturally exist in nature, but genes do naturally exist in nature.
A person who splices genes together is not creating life, merely manipulating it, such as a gardener who isolates a gene by selectively breeding plants to express the desired gene.
The common public is largely unaware how genes code for proteins, and more specifically, that these proteins are the necessary "tools" used to conduct further research into the chromosome to understand genes, in addition to exploring how a protein might work within the cell. Without the right "tools" molecular work con not happen in the lab. A specific protein might be the only protein that can access the secrets of the parts of the cell that are a mystery, so a patent can obstruct research by allowing the patent holder to grant, or not to grant, the authority for another individual to use the patent; hence, a researcher who is trying to study a patented protein, a protein that is fundamentally unique, will be disappointed to learn that there is no manner or method to invent around this patent and their research to market something useful will stop until the patent expires.
If it is decided that genes can be patented, I argue that these patents must follow the same rules for the macroscopic (things that can be seen with the naked eye). If three car manufactures can patent various parts of a car, without compromising the patents of other car manufactures, yet each vehicle has the same function and general parts (wheels, chassis, power plant, maybe even similar components such as metal and glass for various items), so to a gene patent must also abide to this interpretation of the law, as size should not matter in the domain of law; In other words, if some arbitrary gene has 50 components and the desired phenotype trait does require nothing other than rendering the gene dysfunctional, there will be thousands of ways to geometrically alter the gene, and each permutation will look physically different, much like the schematics of two different car engines. If a patent is given to a gene, it must be for that specific association of chemicals in a fixed schematic, and any insertion of any other chemical into the patented gene will require its own patent because the schematic has changed. Patents do not protect concepts, and if a patent did, a person could patent the concept of a car based upon its down stream function and use.
Law should be applied universally and fairly, even if it is a flawed law. If gene patents are allowed, I would like to see that a company will have to file individual patents for every possible permutation of their targeted gene, an expense that may make it too expensive to even bother with it. If a company has a patent for transcriptase, isolated in its natural form, another company should be able to merely add or tack away a chemical, so as to alter its chemical schematic, to qualify for a new patent, even if the protein has the very same down stream effect in the real world.
If the so called conservative congress is so very concerned about excessive regulation of business than they ought to revamp the entire patent and tradmark system to make it harder for the holders of these patents and trademarke to sue for violations. Everybody pays for the legation one way or another. Many businesses are seriously harmed by having to defend themselves against lawsuits brought by all the holders of these unreasonable patents and trademarks. Consumers are forced to pay much higher prices for the patented and trademarked services and products than would otherwise be the case. Reform is needed now.
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