In case you didn't hear, Human Genome Sciences was awarded a patent to a receptor possible crucial to the treatment of HIV. Here is the news article:http://biz.yahoo.com/rf/000216/bf5.htmlAre you back? Well, good. With all the hoopla today on the new patent, I decided to take a gander. The patent number is 6,025,154 and can be found on the US Patent and Trademark Office web site:www.uspto.govLets start with a little primer. A U.S. Patent gives the holder a right to exclude others from making, using or selling what is “claimed” in the patent. What is “claimed” is defined precisely by a set of consecutively numbered sentences that appear at the end of the patent. Appropriately enough, these sentences are called “claims.” Like a deed to land, the claims describe the “metes and bounds” of the patent owner's right to exclude. If all the elements (or subparts) of a claim describe something that is made, used or sold, that thing is infringing on the patent holder's rights.Gene patents have been allowed since a landmark case in 1979 called Diamond v. Chakrabarty. Against the protest of many religious and other groups, the Supreme Court deemed genes to be patentable as long as they are “made by man.” In other words, one cannot patent a naturally occurring gene.Gene patents are still hotly disputed, however, due to the fact that people are uncomfortable with the idea that the blueprint of living things can be patented. Recently, the President has publicly expressed concern that recent high volume patenting of human genes may be overly broad. The concern about overly broad protection pertains to patents that include claims to genes as a composition of matter. Once a claim to a gene as a composition of matter is awarded, anyone who makes, uses or sells that gene is an infringer. Contrast this to claims to the gene in a method, such as a method of treating cancer. A claim to the method of using a gene to treat cancer would only be infringed if someone were to make, use or sell the method using the gene to treat cancer. However, ALL methods of using the gene as a treatment (cancer, heart disease, ischemia, etc.) will infringe the gene as a composition of matter.How can a human gene, which is natural, be patentable if it has to be “made by man?” Well, the USPTO currently considers a gene to be made by man if it has been purified. Purified is defined as separated from its natural surroundings. The rationale is that it doesn't exist in nature in this purified state and it got there through the hand of a person and is therefore “made by man.”Where does all this lead? Well, much of HGSI's (and many othe biotech companys) value is tied up in gene patents. The pressure from the President and others to narrow claims to genes as a composition of matter can adversely affect these patents. It appears that there are two safety valves for controlling the recent mass patenting of genes. One way to cut down on the number and breadth of the patents is to mandate (legislatively or through the courts) that purification is insufficient to meet the “made by man” standard. Another, is to limit the patents to genes based on a showing of utility.To meet the utility standard an invention must be useful. It can be useful in any way shape or form. Only one utility needs to be proved. For instance, in a patent directed to a chair one might assert that the use is as a place to sit. Someone who comes along and makes the chair, but uses it to stand on, will still be infringing. The utility standard is not too hard to meet, by the way. Usually, only throw-away or junk utilities are considered insufficient. For instance, an invention claiming a tube with a few magnets on the outside was found to lack utility despite an assertion that the taste of liquids were improved when passing through the tube. The inventor needed more solid scientific support for this utility. They didn't have it and the court declared the patent invalid, making it useless.Apparently, many recent gene patents are submitted so quickly after finding the gene that the applicants have not carefully determined a use for the gene. Many of the applications rely on homology, or similarity, to known genes as evidence of utility. Others speculated on the future use of the gene based on this homology. Basically, it appears that not much biological experimentation is done to determine what treatments or other uses to which the gene could be applied. The Patent office is now insisting that an applicant assert a utility and that that utility must be CREDIBLE. This means that speculative utilities must be supported with more documentation and/or testing to justify patentability.So lets summarize. Gene patents claiming the gene as a composition of matter are threatened by recent political and public reaction. These types of claims may well be ruled invalid on a wide scale. Also, the asserted utility of these inventions is being scrutinized more closely. We can estimate the possible damage to a patent by understanding 1) how many of the claims are directed to a gene as a composition of matter and 2) how detailed the support is for the asserted utility.HGSI's patent is entitled “Polynucleotides encoding human G-protein chemokine receptor HDGNR10.” Wow, that's a mouthful. The thing to note is that it says nothing about HIV or AIDS in the title. Guess what? It says nothing about HIV or AIDS in the ENTIRE APPLICATION. Is that good or bad? Well, its tough to say. It would be better if they did disclose a possible use in the treatment of HIV because that would definitely be a utility. On the other hand, if you recall, we only need one utility and the standard is pretty low. The application does discloses the uses of other G-proteins. Apparently there are a bunch of G proteins and they do a bunch of things. This is the homology approach to asserting a utility. They are saying “We don't know exactly what its good for, but these others that are similar do this and this and this...” Other asserted utilities include use of the gene for the detection of underexpression and overexpression of the G-protein. Still another asserted utility is in the detection of mutation in the G-protein.It appears that the above cited utilities are not as solid as citing a cure or treatment for HIV. Evidently, though, the utilities that were cited were enough to make it past the examiner at the patent office. That the cited utilities are possibly a bit flimsy is something to consider before running out and buying the stock based on a single patent. I wonder how many of the Wise bothered to read it before throwing hard earned dollars at the company?The patent also seems to be strongly dependent on the viability of claims to genes as a composition of matter. Of 19 claims, 15 of them are directed to the gene as a composition of matter. So the risk is definitely there that this patent could be worthless after a legislative or judicial mandate declaring composition of matter patents invalid. So what does this all lead to? Investing in HGSI is risky. Big surprise. Do some research, make sure you are comfortable with the above issues before investing. Just a little disclaimer. I am not a lawyer and this is certainly not legal advice. It is just a generalized discussion of a single patent and kicks around some issues regarding the patentability of genes. It is not really a complete analysis. If the issue really concerns you, hire an attorney. Also, I own stock in HGSI.
Great post, Greg. I now understand the distiction between composition of matter claim and a method/utility claim. The implication of possible legislation against composition of matter claims on genes is huge. This is a perfect example.One question I have: Why on earth would they have not made an HIV claim on CCR5? It certainly would have been accepted as being reasonable. Doesn't it make sense to make as many utility claims as possible since any ban on composition of matter claims would leave all unclaimed utilities up for grabs? The only thing I can come up with is that I heard pharma companies would bury their utility claims on compounds for which matter claims have expired by giving them obscure titles. But they would still make all the appropriate method claims! Doesn't this sound like they are placing an awful big bet on the government keeping their hands off the compostion of matter laws?Of course, this is only one of HGSI's patents, so my evaluation of their future remains unchanged. Thanks for the analysis.I wonder how many of the Wise bothered to read it before throwing hard earned dollars at the company?Nary a one, I'd bet. There are a lot of folks out there who throw cash at news to see what sticks. If they are smart enough to stay with HGSI, they'll get lucky on this one.-S
One possibility that may be missed here. It may be the purpose of thse patents to dissuade or slow down efforts by competitors, even though the company knows that such patents are perhaps largely untenable. This could help to ensure HGSI and its partners an advantage in being first-to-market with a product.
One question I have: Why on earth would they have not made an HIV claim on CCR5? Well, they probably didn't know it was an HIV receptor at the time. When you get your filing date for submitting your material at the USPTO you CANNOT add new material later on. No matter how good it is. So, think back about 2 years. Did they know this was an HIV receptor then? Probably not. And they sure as hell didn't want to file a new patent and lose that early date.What they probably did do, however, was file a continuation in part (CIP) in the meantime. The CIP can have new matter and old matter. The new matter, however, gets a later filing date, i.e., that of the CIP and not the original patent.Sound reasonable?Greg
Nice post Greg.Could you elaborate on the following?"Gene patents claiming the gene as a composition of matter are threatened by recent political and public reaction. These types of claims may well be ruled invalid on a wide scale. Also, the asserted utility of these inventions is being scrutinized more closely. We can estimate the possible damage to a patent by understanding 1) how many of the claims are directed to a gene as a composition of matter and 2) how detailed the support is for the asserted utility."I would have thought it unlikely that any future changes in the patent law would affect patents that had already issued (like HGSI's CCR5 patent)?Also, I think this patent illustrates an interesting situation that can arise. As you mentioned, the reason HGSI doesn't claim HIV uses is because CCR5 hadn't been shown to be the coreceptor for HIV when HGSI first cloned it. It was merely an orphan GPCR receptor in their eyes. However, it is very likely that the group that later identified CCR5 as a HIV coreceptor also filed a patent claiming both the composition of matter and utility for treating HIV. Obviously HGSI beat them to the composition of matter. However, this might lead to HGSI owning the gene itself but someone else owning uses for that gene to treat HIV (depending on the exact nature of the therapy)! If that were to be the case, the two parties would have to come to some sort of a cross licensing agreement (which may have already happened given the collaborations involving HGSI and other companies mentioned in the Yahoo! article).Fushi
One question I have: Why on earth would they have not made an HIV claim on CCR5? Well, they probably didn't know it was an HIV receptor at the time.Another possibility is that they want it to be as general as possible, like all patents. If you've ever read one all the way through, you quickly get bogged down in the "...said means and said method enabling said transformation...". They try to be as general as possible, while still pinning down what it is they're trying to patent. I think if they'd mentioned HIV or AIDS, that would have restricted the patent to those areas (not exactly small potatoes), and if somebody else came up with an application of their method to cure degenerative macrophbia, they'd have to allow it. As it is, anybody does anything with their gene, owes them a nickel. Maybe more. I think Elric's right, there's the possibility of trouble afoot with these patents. (I just had another thought about that: anybody who actually has the gene (or whatever) in question, surely ought to get part of that nickel. Because, if I had it from the beginning, and you want to patent it now, I ought to get a cut.) One way or another, this is going to keep lawyers occupied for many years to come.
I would have thought it unlikely that any future changes in the patent law would affect patents that had already issued (like HGSI's CCR5 patent)?The USPTO gives the go ahead to a patent, but it must bow to the courts and the legislature. The government has always held that a patent is granted by them like a favor and they can take all or part away any time they please. For any reason. Of course the Constitution says otherwise...but as many law professor has said. "If you are arguing Constitutional Law, you have already lost."However, it is very likely that the group that later identified CCR5 as a HIV coreceptor also filed a patent claiming both the composition of matter and utility for treating HIV. Cross licensing would not be necessary unless both groups wanted to make/use/sell the treatment. Keep in mind that a patent grants the power to exclude, not the right to use. Most likely, the inventor of the method of treating using the gene would just pay a license to HGSI. Also note that the use of the gene patented by HGSI in ANYTHING ELSE, be it drug or otherwise, will have to have HGSI's approval.gregReiterating my earlier disclaimer; I am not a patent attorney and this isn't legal advice.
Another possibility is that they want it to be as general as possible, like all patents. This is partially correct, the claims are in layers, each depending claim getting more specific. This is just in case the broader ones are held invalid. I believe it to be highly unlikely that they would not put in a claim to HIV treatment if they knew about it.Also, the specification itself (the part of the patent that is not the claims) is always best written with as much detail as possible.GregAnother disclaimer <sigh>, not an attorney, this isn't legal advice, blah blah
ElricSeven,You are truely an asset to this community. When I think of what one is able to learn from others at this site (TMF) I am moved.....emotionally.What you and a lot of others have contributed to these bio boards is priceless. What the Gardner's have built that allows this to take place is simply amazing. Words do not do justice.Tom
Lets start with a little primer.Thank you for this primer. It has certainly helped me in my efforts to better understand the issue of patents as they apply to genes.How can a human gene, which is natural, be patentable if it has to be “made by man?” Well, the USPTO currently considers a gene to be made by man if it has been purified. Purified is defined as separated from its natural surroundings. The rationale is that it doesn't exist in nature in this purified state and it got there through the hand of a person and is therefore “made by man.”Is this logic equating purification with "made by man" applied to any other substance?TIA.Doug
Is this logic equating purification with "made by man" applied to any other substance?Yes, its applied to chemical patents all of the time. Was done with patents on synthetic rubber. There was a big hullaboo about those being too broad when it happened, but they were upheld.
I'm still a bit puzzled about what is meant by patenting a gene. It seems to be more than just the process, which is common to all.It sounds as if someone could have patented something like fluorine. There is no F just sitting around because it is so reactive. Someone had to find a process to extract it from a compound where it was bound. Are the gene patents simply equivalent to a patent on the extraction process, or is it more? Is the patent on ANY future use of F?
Elric great post.One additional question...is it possible to have a CIP (continuation in progress) patent that would include claims to AIDS as a means to extend the patent life or does the original date stand on a CIP?Yo.PS more questions to come...still chewing on this one.
Sorry,Should have read the entire thread before posting...However, I am still unsure of the priority date on a CIP?Yo.
Quick question.Can you add updated claims once the patent application has been filed? Is this what YoHo00 means by "CIP"? I guess the answer is no.And how does the provisional patent filing fit in? They date they have listed on the patent is June 5, 1995: Is this the provisional or full patent filing date? The reason I ask is the first paper linking CCR5 and HIV just over a year later (June 20, 1996). Not to sound like an X-Files conspiricy theorist, but could the authors have waited until the patent was filed (full) to avoid having HIV being included in the utility claims? Timing just looks funny.-S
This post on the HGSI board should answer many of your questions about CIP's:http://boards.fool.com/Message.asp?id=1130088000104003&sort=idAs a general rule, you can only claim what was disclosed on the date you filed that material. You've got lots of chances to continuously update that material during prosecution, with CIPs, etc. However, if the matter is not supported by the previous filing in sufficient detail to equip one in the art to make/use/sell the invention then it is *new matter*. New matter must settle for the later filing date when it is properly disclosed.Note, however, that this does not prohibit a broad claim from encompassing later inventions. I can claim an invention of A + B and then someone can later make use or sell A + B + C. If it has A + B, then it infringes the original filing.Even if the later inventor patents A + B + C (which he can because C is novel), he still has to pay the owner of the original patent. He only has a right to exclude others from using A + B + C, not to use it himself.If a third party wanted to use A + B + C he would have to pay both inventors.
And how does the provisional patent filing fit in? They date they have listed on the patent is June 5, 1995: Is this the provisional or full patent filing date? The reason I ask is the first paper linking CCR5 and HIV just over a year later (June 20, 1996). Not to sound like an X-Files conspiricy theorist, but could the authors have waited until the patent was filed (full) to avoid having HIV being included in the utility claims? Timing just looks funny.That date could have been held by either a provisional or full application. I see no reference in the first paragraph of the spec to the provisional application, so it probably was a full application.The inventors would have no motivation to avoid having HIV included. You don't include it, then you get nothing for it. Someone else could come along and patent it in the meantime. Also, failure to disclose the "best mode" (best way of doing things) can result in a court holding the patent invalid.hope that helps,Gregdisclaimer; you know the routine, not an attorney, this is not legal advice, I own HGSI and am damn glad after today and yesterday
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