> -----Original Message----- > From: [EMAIL PROTECTED] [mailto:[EMAIL PROTECTED] On > Behalf Of Deborah Harrell > Sent: Wednesday, May 10, 2006 5:08 PM > To: [email protected] > Subject: Drug patents > > Dan asked me a ways back about who held the most > patents on new drugs: here is why I do not believe > that drug companies are the primary source of > innovation. > > There is an article in the WSJ today about a lawsuit > between Eli Lilly vs 2 former NIH researchers; I do > not have it on-line, and the site below has to do with > an earlier lawsuit involving the same drug.
I read through your examples, and I see a rather different pattern than you do. I think we have different understandings of the nature of purpose of patents and the way they have been used as a means to foster private innovation. For an invention to be patented, it has to include a novelty. This novelty can be dependant on earlier novelties. For example, my patented techniques for density logging with scintillation detectors require that the technique for high temperature scintillation detectors already be established. One buys the detectors from a company that holds patents on them, and goes on. The fact that a new design is dependant on what has already been done does not preclude patentability. This is true even if it is dependant on work that has been patented. The rules are that all known prior art must be given in the patent application. If there is novelty shown, then that novelty can be patented. For example, let's say a new technique for developing solar panels has been patented. The technique is promising, but expensive. Another company sees this work, and develops a technique for cutting costs 75%. It can patent that technique. If both techniques are required for inexpensive production, as I am assuming, than anyone who manufactures these panels inexpensively must make arrangement with both patent holders. The first company can make panels on its own, without coming to an agreement with the second company...but these panels cannot use the technique that cuts costs. The second company cannot manufacture panels without dealing with the first company. Further, if a third company comes up with a different technique for making the panels inexpensively, then it can ignore the second company's patent, but not the first. Broad patents that are hard to work around are very important to companies. There are certain limits that are already set on what can be claimed as intellectual property. For example, the techniques I developed and patented while I worked at my previous company are owned by them....that's part of a standard employment agreement. I cannot use those techniques at a new company without some agreement in place between my new company and my former company. However, what I learned during the time I worked for the previous company is my own. My previous company cannot own the knowledge of physics, engineering, technique, etc. that I have in my head. Even if I was taught that by an expert in the field, the knowledge I have is owned by me. If I come up with a new technique that is clearly based on the knowledge I had acquired earlier, if that technique is considered novel, when compared to the literature, then I can still patent it. If this were not true, then both productivity and employability would suffer. A company could ensure that no employee could take a job offer elsewhere. Even if they fired the employee, they could ensure that she'd have to switch fields in order to work again....because they owned what was in her head. They can, however, own specific techniques, even if they have not patented them. These are referred to as "trade secrets." The dividing line is not a clear bright line, and is very much open to interpretation. Since there can be _a lot_ of money on the line, it can be quite contentious with lotsa lawyers on each side. Unfortunately, the people who decide usually do not possess "ordinary skill in the art", so mistakes are often made in this process. So, having said all that, let's go back to your examples. I see them as fights over just how broadly one must interpret prior art. The first example is a fight over whether the patented technique was dependant on specific techniques developed 10 years earlier or if it was only dependant on knowledge obtained then. Another discussed what happens when virtually equivalent patents are filed and accepted, based on separate work and different techniques. I want to spend a bit of time on the article on a patent dispute from your San Diego source. Let me quote a couple of bits: <quote> The question the Supreme Court is wrestling with is when it is permissible for drug researchers to use a breakthrough that has been patented by someone else. If the court recognizes a fairly broad right to do so under federal law, patents developed by biotech companies could lose value and significantly crimp the $26 billion research industry, legal experts said. A ruling strictly protecting the patents could discourage research into new drugs or halt it in some cases, pharmaceutical companies argue. "The fallout is going to be highly dependent on exactly what the court does," said John Van Amsterdam, an attorney in Boston who specializes in biotechnology and pharmaceutical patents and is not involved in the case. <end quote> To me, this illustrates just how much can be riding on the breadth of existing patents. If the court goes hard one way or the other, it will either lower the value of present and future patents, discouraging research; or it will make it much harder to come up with novelty (limiting research). There is an out suggested at the bottom of the article: <quote> "In terms of a life or death thing, it's definitely bigger for the small biotechs," he said. "Some of them may find some significant difficulties if the case goes the wrong way. Whereas for big (pharmaceutical companies), they'd have to pay a little more for using a particular patented discovery. "If you compare the amount of money that it would cost them to fair and square pay for the use of certain things, it's probably a very, very small amount compared to the rest of the drug development process." <end quote> Some form of license for using earlier broad techniques seems fairly reasonable here. It would reward research into broad new fields, without prohibiting people from coming up with innovations that are not so broad. Let me give an example of this. I will use hypotheticals that may not be realistic, but I think you will get the idea. Let's say that researches have found a certain reaction in the body that is associated with MS. That's promising, but it isn't anywhere near a cure. It does, however, point to a potential area of future research. Researchers at company A use this information in their work, and develop a drug that delays the progress of MS significantly. Unfortunately, the drug causes stomach ulcers in a number of patients. Still, for some people, the ulcers are a reasonable tradeoff and they take the drug. Researchers at company B see the drug and its potential from the patent, and note its side effects. They work a few years and come up with a variation that reduces both the severity and frequency of ulcers significantly. My argument is that the government should be funding basic research, and that a good set of patent laws would reward both Company A and Company B for their efforts. Finding that line can be hard. But, it is defiantly worthwhile. One final point: In my example, both Company A and Company B were engaged in drug discovery as well as drug development. The fact that a new innovation is based on knowledge of an older one does not stop it from being an innovation. Dan M. _______________________________________________ http://www.mccmedia.com/mailman/listinfo/brin-l
