[MUSIC] Welcome to this lecture on biotech inventions. In this session, we'll talk about biotech inventions, and how to claim. We'll talk about claim types. We'll talk about genetic sequences. We'll talk about amino acid sequences. We'll talk about how to claim enzymes based on their function. We'll also dive into antibodies, discuss microorganisms and cell lines, how to claim these. And finally we'll talk a bit about the current controversy around stem cells. The suggested reading for this session is chapter six in Peter Ulvskov's book, Patenting in Biotechnology. First of all, it's important to look at the different claim types. And when we talk about biotech product claims, use claims, and methods of production claims, so these three claim types, they're the most important. A product claim is claiming the product itself, no matter how it is produced, and this is really the desirable claim to. Whether you'll be able to have a product claim on, for instance, a genetic sequence, is determined by the prior art. You can also go for use claim, which is claiming the use of a certain sequence, for instance, on method of production, how to produce a certain protein enzymes or whatever. When we talk about biotech inventions, they are really sort of challenging the patent system, and also challenging our way of understanding patentability. If we go back to some of the previous lectures, remember that we discussed novelty as being critical for patentability so that what we have is not identical to what is previously known or what is prior art. We also have to fulfill requirement about inventive step. So that a person skilled in the art, would that be able to do this invention him or herself? And then of course, there's the issue about the same thing, industrial applicable. What I think when we're working with biotech and we're working with ideas in biotech, usually we're considering the possibility of entering into a market, so usually that's not the problem. I think the main problem is really the novelty issue. Because genetic sequences, if we take them as an example, they're usually not novel, but we have many biotech inventions that are relying on genetic sequences or amino acid sequences. So, if you for instance, discover a gene or an enzyme with a special characteristic that could be a benefit for treating a disease or producing some sought of compound, can you then really claim it if it's already existing in nature? The answer is unfortunately both yes and no. If we are dealing with genetic sequences, in patent terms, they're regarded as chemical compounds. So that's pretty clear, how these are regarded in the patenting system. The problem is that you cannot claim a genetic sequence of unknown function. So you cannot claim an open reading frame, for instance, or hypothetical protein. You have to add some more characteristics to this particular sequence. But if you then determine the biological role of the sequence, then, in some regions of the world, it will be regarded as novel. As I mentioned, in some regions, there are regional differences, and especially, there are some different ways of handling these types of sequences in the US and in the EU system. So, in the EU, it's regarded as new when it's made available to the public. So that means, for instance, if we have a gene A that is isolated and functionally annotated, and we show that it can be used, for instance, for diagnostic purposes, so we show the application also, then it can be claimed. So, this about being made available to the public, that is really sort of, also the basis of the patenting system, that we, through the application, are disclosing what we know about, for instance, this sequence, and the function of this particular sequence. And in the EU system, we'll then fulfill novelty when we discuss it in patent terms. Then the issue is about what sort of claim type we can reach with this invention. If we're looking at the same gene A again, and it's claimed for the first time in any species, then we can claim it as a product. Because if I was the first to look into this gene and describe the function of this gene, then I'll have the priority to claim this gene as a product. If an ortholog of this gene has already been claimed with a different function or in a different species, then I'll have to, To decrease my ambition in reaching a claim on this patent, and I'll be sort of lowered to a use claim for this particular gene. So, if we look into possible claims in the EU system, then we could claim disease-related genes. So it could be a gene involved in an inherited disease. It could be a claim on the gene involved in cystic fibrosis for instance, or it could be DNA markers that are closely linked to genes that are involved in diseases or other traits of interest. We can claim this in the EU system, as long as we are the first to describe this and we have the priority. You can also claim antisense, molecules and siRNA molecules for therapy. These are also possible sequences that we can claim. But of course, we have to disclose the function of these, and we have to disclose the sequences. What is a no go in the new system, is anonymous DNA sequences. Sequences where we have not added any functional information. If we go back to the early 1990s, there are lot of sequencing efforts going on. Where CTA sequences and genomic sequences were produced, without inferring any functional annotation on to these, and there were a lot of efforts put into trying to protect these. And this is simply a no-go in the EU system. In the US, there has been quite some controversy about the possibility of patenting genes, and especially with some of the genetics tests that are being made available. For instance, for breast cancer, there's been some disputes, and this has reached the Supreme Court in the US. And they have actually ruled and I should cite this precisely from the court. A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated. So, when we look at the US system after the ruling of this Supreme Court, we actually have an issue compared to the EU system. So, simply the fact that we are isolating this DNA segment will not justify that we can patent it. But there are some loop holes you could say in this ruling. Because if we look at cDNA for instance, then these are, cDNAs, they are created by man. It's not something that would naturally occurring in nature. So you can actually claim cDNA sequences. And there are also some issues around diagnostic methods. So if you're actually using a method to diagnose a certain variant offertine, then there's also still a possibility that you can patent such a discovery. So it's not a total no-go, to try to patent genetic information and use of genetic information. But there are just some issues that you have to be concerned with. So, in summary, claims on genetic sequences in the EU, you can reach product claims on genes. But, we need to disclose the functional annotation of that gene in the application. If there is some prior art around the gene or the sequence that you want to protect i.e., from another species. And also lock from another species, then you might have to reduce your claim to a use claim. Genetic sequences, they can be patented alone or also in combination with promoters or vectors, if you want to use them, for instance, in expression systems. In the US, what you can for surely claim is synthetic sequences, that means sequences that you have synthesized in the lab. There are also some possibilities when we look at genes and cDNAs, that you can protect sequences in that manner. So cDNA sequences, they can actually be protected. If we look into patent applications, then claims on genetic sequences, they use references to sequence identifiers also called SeqID and NOs. And they are referring to annex of the patent application or order patent. What we should consider when we're dealing with genetic sequences is that very often we will have variation. So, if we're looking into the human population for instance, there'll be a lot of variance of a particular gene. And you have to bear that in mind when you're looking or trying to claim the sequence information. Also, if you look across to other species, there might be homologies or sequence identities that you need to try to cover. So an example of a claim could be an isolated, remember that we have to show that we have taken it out from its natural environment. So it's an isolated nucleic acid molecule, which is identical or has at least 90% identity to the sequence set forth in the annex S, SEQ ID NO 1. So and then it the annex, we're providing something similar to a FASTA file or FASTA list of the sequence. So very similar to what you will retrieve in gene bank or other sequencing databases, sequences are listed in patents in a similar way. When we talk about amino acid sequences, they are similar you could say, in the patent system, to genetic sequences. They are also regarded as chemical compounds. But again, if you want to claim an amino acid sequence, a peptide, or whatever, you need to have both the functional annotation, disclosed and also, how you can actually use that in biotech. What is the application of this particular peptide, for instance? And very similar to what we have when we look at the genetic sequences, a claim could look like this, an isolated, again, it has to be isolated. Polypeptide comprising the amino acid sequence that is listed in the annex on the SEQ ID NO 2, that will be a type of a first claim in a patent covering a peptide, for instance. Here again, we need to be aware of. Natural occurring variants or variants that we have created in order to make this invention feasible. It could be an amino acids substitution that we have introduced into our peptide to make the half life of this peptide longer or whatever. And we should also bare in mind the sequence identity like what they are. It consist from other species that could be relevant to try to cover in our patent as well. So this should also be considered when we're dealing with our claims. Enzymes, when we talk about enzymes, and they can be claimed based on their function. And here, bringing an example of a Novozymes claim on a specific type of enzyme called a galactanase. And if you look at this claim that this is trying to cover, both the polypeptide and the activity, then it's showing that we have an isolated polypeptide. Having this specific activity, and then we are actually adding some more. We are adding the sequence of a specific path of this enzyme that is critical for its catalytic activity. And there is some further description about what x is, it's any amino acid and we also have other information about the catalytic side of this polypeptide. In addition to that, and in order to strengthen the patent claim even further, we're also adding Novozymes. They are also adding some characteristics about the activity of the enzymes that they want to cover. It should at least have 30% residual galactanase activity after two hours at the specific temperature at pH 4.5. So they're trying to be very specific in what they are claiming. But the bases that I want to get across here is to this principle to claim enzymes based on their function, and based on which type of conditions that they will be working under. Antibodies is another interesting area when we are dealing with biotech inventions. Antibodies, they can be used both for diagnostic purposes, they can be used for treating disease, cancer, for instance. And they can also be used in other systems for purifying, for instance, proteins from different substances or whatever. If we look at antibody claims granted by the European Patent Office back in 2014. We can see that a lot of the patent granted on antibodies, they were actually product claims. So claims where inventors, they are claiming the antibody as a product. There are also claims on medical use, how can you use this antibody in treating a specific type of disease, for instance, and in ritual use. So this could be for diagnostic purposes, for instance, using it in a LISA test or whatever. And then as mentioned initially, also for producing antibodies and also for purifying these antibodies, there's also been claims on that. So this antibody area in biotech is actually growing and we're seeing more and more activity, and thus, it's very relevant also for this lecture. So how can you actually claim an antibody? An example is given here for both diagnostic and a treatment purpose. So here, we are claiming an antibody that is capable of specifically binding a protein in the West Nile Virus, and is having a neutralizing activity. So it's said in this claim that this antibody will specifically bind to a specific protein in this virus, and it will also neutralize this virus. In order to strengthen the patent, it's also the possibility for the inventor to act information on the particular antibody, on the sequence of this antibody. And you can see it here. I've left at least one sentence, describing one of the CDR regions in this particular antibody that is comprising an amino acid sequence. And this amino acid sequence is disclosed as sequence number 30 in the annex of this particular patent application. So that's a way to more specifically describe your antibody and claiming it in a very specific manner. We're talking about microorganisms, cell lines, and stem cells. We also have some possibility of claiming these. And this goes both for, when these cell lines or microorganisms, they are modified genetically or they are non-GMOs. Microorganisms for specific purposes, they can be claimed. So for instance, if Christian Hanson wants to claim a specific microorganism for producing a certain compound, then they can actually claim the specific organism. But it's actually required due to the Budapest Treaty that they need to deposit this microorganism. In a bank, they simply need to send a sample with this microorganism to a cell bank that will store these microorganisms, in order to be able to file their patent. In the same way, if you want to claim a cell line, you also need to deposit that cell line, or store that cell line in a cell bank, so that other inventors, they can retrieve your cell line, and enable. Enable your invention. So cell lines for instance, can be useful for many different purposes within the human biomedical field. It can be used to test new drugs, it can also be used to develop new methods for diagnosis or whatever. And these cell lines that are relevant for this type of work can of course be claimed but you send in a sample of your particular cell line. Regarding stem cells, then there's quite a bit of controversy because it's considered immoral to do work or at least to create value out of work done on human stem cells. And by value, I mean commercial value. So both in the EU system, and also in the US system, there's a huge controversy on using stem cells and making benefit out of stem cell research. So as you have seen, biotechnological inventions, they are basically patentable in the EU system, but there are some restrictions. So as mentioned with the stem cells, inventions whose commercial exploitation would be contrary to the ordre public or morality. So this is the line that are a challenge that the stem cell work cannot be patented. So it's contrary to morality, and therefore, it cannot be patented. You cannot patent plant or animal varieties. So, whole plants and whole animals, you're not able to claim on these, and you cannot claim on the essential biological processes. So classical breeding for instance, and crossing, and selection of animal and plants, methods for doing that cannot be protected by patents. And then another restriction in the EU system is that methods for treatment cannot be claimed in the EU system. So methods involving surgery and therapy and diagnostic methods carried out directly on the human and animal body cannot be claimed in the EU system. So to sum up what we've gone through in this lecture, we've talked about the relevant claim types in biotech. We have talked about genetic sequences and how we could claim these and we have shown that anonymous DNA sequences for instance, they cannot be claimed. Let's look at amino acid sequences after they release enzymes based on function, there is also a possibility of making very specific claims on this. The antibody area, we've touched upon and seen the possibilities of claiming antibodies for various purposes. And finally, when we're dealing with microorganisms, cell lines and stem cells, we've touched that and seen about the possibility, and with the Budapest Treaty, what is required, and the morality around the stem cell research, and making biotech business out of that. There are some serious issues around that. Thank you very much. [MUSIC]
