Wednesday, June 24, 2009

It's the novelty...

So, what it comes down to is this: those who argue that the gene patents they so dearly protect are valid and justifiable must argue two things:

1) that "isolation and purification" as it is being conducted are sufficiently inventive to warrant patent protection, and that what is created in the process is something somehow new, and

2) that we must somehow provide the incentive of patents for gene sequences in order to realize beneficial products from new knowledge about our genes.

Of course, I dispute both claims.

"Isolation and purification"" of genes from a naturally-occurring genome is not inventive, and doesn't create anything new. The science argues in my favor, as does logic. The body "isolates and purifies" genes to the same extent as researchers simply by using mRNA to do the work of the gene. mRNA only reads the exons, skips the introns, and makes a protein, determining by the logic of our natural processes where to begin, and what codons to read to create the final protein. Now let's reason once again by analogy. Imagine creating an artificial heart (which has been done a few times). Clearly, the artificial heart itself is patentable as something new, useful, and non-obvious. But is the process of pumping blood patentable? In the case of gene sequences, the sequence is the process, whereas the final protein is the product. In the body, the processes and products are naturally-occurring, and thus any attempt to replicate them, or realize them synthetically, might result in a new, patentable process, but the genes themselves will not be new, nor will the products that result by patentable if they are naturally-occurring. This conflicts with the current interpretation of what is patentable since things like Epogen are patentable products even though they are analogues of naturally-occurring proteins. My argument hinges upon realizing that this is an over-broad application of the patent law, as are patents on gene sequences.

Let's look again at an analogy. Gravity may be used in perhaps infinite mechanisms that might be used to lift or lower things. Cranes, elevators, etc., all might be designed in nearly limitless ways (even if certain designs are most practical). The device as a whole, which utilizes the force of gravity, is patentable even though gravity is not because it lacks the novelty requirement. Similarly, the process of creating a naturally-occurring product, or part of nature, may be new even though the product has long existed. My example of a water-synthesis machine is on-point. There might be many hundreds of devices we could build that could synthesize water out of hydrogen and oxygen, each of which should be patentable if it meets the criteria for patentability, but the molecule H2O could never be patentable. Neither should the product "Epogen" nor any patent claim on existing human genes. They have long-existed, have been doing exactly what they do that makes them useful to us for many eons, are not the result of our inventive behaviors, and should not be patentable. Isolating them is less complex and less arbitrary than, say, drawing lines on a map simply due to the fact that nature has figured out how to isolate them itself, devising mechanisms for beginning transcription and ending transcription at the natural start and end of the genes. Purification? That too is being done as the mRNA reads only the exons. So where's the inventive step? Why reward anyone for finding these natural things? Better we should reward those who discover new means to create new, useful products like therapies and drugs. If stem cells are successfully used to grow new organs, would anyone seriously argue that the final organs are patentable products rather than just the process by which they are grown?

Take again the example of gravity: if patents were granted on gravity itself, rather than its application in new devices for lifting and lowering things, then the range of inventions available for inventors to produce during the patent term shrinks significantly.

So why the clamor to save these claims on gene sequences? Perhaps it's as Venter said in the article I posted last: because it made patent lawyers rich.


Tim Vos said...

A very interesting point of view. Moreover, I totally agree on the concept that isolation and purification of genes does not create something new. However, there are companies that can synthetize short pieces of DNA (oligonucleotides) bottom up, and ligate these to create artificial genes. Since these genes are not obtained by purification but are artificially created from "scratch", does it make them patentable? Furthermore, scientists are working on implementing non-standard basepairs (other than the common T, A, G, C) to give DNA strands certain "new" characteristics. This changes the genetic code drastically, and can have many applications. Who would own such a gene? Or is that even still a gene? And what if (in the distant future) it's implemented in a human being? Science is giving ethics a hard time I'm afraid. More reason to dive into these difficult topics. I am looking forward reading your book.

drkoepsell said...

If the creation were not simply a duplication of something extant in nature, then it is inventive, and novel, and thus arguably patentable in my opinion.