Bill Would Protect Production Processes
No doubt about it, biotechnology companies--especially those making drugs--have a patent problem. Biotech patents, particularly those covering production processes but even, in many cases, the final product, are difficult to get and often highly contested.
The problem, to a large measure, stems from the essence of the work: What biotechnology makes really isn’t all that new. And in patents, the emphasis is on new.
The products that are expected to be biotech’s blockbusters, such as growth hormones, insulin, interferons and erythropoietin, are, simply put, reproductions of what already exists in nature--in our own bodies, in fact. What’s new in biotech is the ability to identify and isolate the genetic coding for these substances and then produce vast quantities of them in their purified forms.
In biotech, the production, or manufacturing techniques--which process patents are designed to cover--are also part of nature. Biotech companies use cells as miniature factories; as the cell reproduces itself, it also reproduces the desired genetic material that has been inserted into it. Such techniques are as “obvious” to a biologist as, say, the production method for making an everyday pudding--mixing the ingredients and stirring them over heat--is to an average cook.
Now, just as a cook or even a maker of packaged pudding mix can’t patent the stir-and-heat process, so is it nearly impossible for a biotech company to patent the obvious manufacturing techniques it uses.
The Biotechnology Patent Protection Act proposed by Rep. Frederick C. Boucher (D-Va.) would change all that, however.
The Boucher bill would extend patent protection to even obvious or common processes as long as novel starting materials were used. In the pudding example, if the pudding maker had “invented” a new starting ingredient--perhaps a no-cholesterol egg--she could, under the provisions of the bill, patent the stir-and-heat process that used the new egg in puddings.
Why would she want to? Well, perhaps she couldn’t get a patent on her low-cholesterol pudding (which would be the case if other pudding makers before her had made, perhaps even patented, low-cholesterol pudding using different ingredients). And even if she had a patent on her egg, under existing U.S. trade laws, foreign cooks could use her egg, make the pudding overseas and import it without infringing on her patent.
That, in very simple terms, is what is happening in biotech. Often, researchers at universities or even at other companies have identified the final product long before a company succeeds in figuring out how to make it in large enough quantities to be useful; so it can’t obtain a product patent.
The company may be able to patent its discovery of the DNA sequences (genetic coding), and even the kind of cells that will be able to serve a factory for the desired substance. However, those patents do not really protect the companies from foreign competition.
The Boucher bill would also amend trade laws so that foreign-made products that infringed upon these new process patents, and even on the starting materials patents, would be stopped from coming into the country.
Patent experts--even those from companies supporting the bill--don’t see the proposed legislation as a balm for all their patent troubles. The potential for many different patents incorporating the same process could be troublesome, and license arrangements could become more complicated. (For example, would someone who had license rights to the no-cholesterol egg have to pay additional license fees to use the egg in the stir-and-heat process?)
Undoubtedly, said John E. Kittle, director of the U.S. Patent Office’s biotechnology examination group, there will be “a lot of judicial interpretation of where the property line is drawn.”
