Good afternoon. My name is Doctor William Ettouati. I am Director of Industry Relation and Development at the UCSD the Skaggs School of Pharmacy and Pharmaceutical Sciences. And this afternoon, I am going to cover two topics. One is IP and patents, as well as strategy. This is going to be a really, a 50,000 feet view of what IP is. It's really going to provide you information as where to look. And I will talk about a subject that is of great importance, and I'm glad there was a number of questions asked in previous lectures. About biosimilars and what they are and where the markets is, as well as where, what is the status in the US, okay? So with that, let's start. So, this is the overview of the presentation, as I mentioned to you. we'll go for about 10 minutes on intellectual property and patents, followed by Biologics Market. Give you an overview, and then go on with the, either Follow Biologics and Biosimilars. By the way, the returns are used interchangeably, depending on the countries where you are at. So, what is IP? Well, IP is really to provide legal protection for inventors in order to prevent the other people from making use of their ideas. it's basically an exclusive rights for that invention. It's granted primarily by states and government to the inventor. The inventor can be either a company or an individual. And the holder as the sole right over the invention, and we'll see it's not as simple as this, as well as must be this close to the public. And it depends, again, on the time of disclosure, either in Europe or in the US. Who grants patents? Well, there's the United States Patent and Trading Office, the USPTO, which a lot of information I have on the slides where IP comes from. The issue patent and trademark registration. And as I mentioned, to both either individuals or businesses, and in Europe, the European Patent Office also has specific rules. There's obviously also patents in Japan. There is patents in a number of countries. Which is actually something very important when you are an investigator working in a university, and you have a novel invention. While the patent filing can become extremely expensive. For example, just to file a provisional patent in Europe costs up north of $30,000. So, you better make sure that before you file a patent, you are going to have a good understanding that you have something that is going to be of value later on. So, let's talk primarily about pharmaceutical patent, because I think these are quite important, that's what we are talking about. The first one is what I call composition of matter. These are the best patents you can get. It claims an active chemical substance, new chemical entity, and it's either defined by the name, the structure or both. And it's the same also for biologics where you have composition of matter. These are really the best that you can have. The second best is potentially the product by process pattern. Let's say you don't have the patent on the compound, but you have a patent on the process to manufacture the drug. If somebody else has another process, and you have a process that's different and they don't have a composition of matter. You might be actually able to sell that product using your novel process, and that's sometimes a problem in litigations. You have put pure process patent, which are claim other chemical processes use to manufacture. So very often, when you have a patent that is first of all a composition of matter patent. You, in addition to that you will file actually process patent. So, nobody can copy your process because each patent is going to be attributed for each component, and one might expire before the other. For example, your composition of matter patent could expire before your process patent. And if you have basically wrapped up all the processes that would be to manufacture a certain compound or a certain drug. Then, you could potentially block anybody else to enter the market formulation patents, we talked about this as well. Doctor Best actually mentioned this in another lecture, specialty pharma does this very, very well. Injectable Tylenol, injectable Paracetamol. There's a company here in San Diego that filed a patent on injectable Paracetamol and they actually got a patent approved. They actually were able to raise quite a sustainable amount of money on that method of use, and that's something that's also very interesting. If you did not, let's say study a certain and a certain indication, and you were not diligent enough in you patent to apply. And to say well, we have already some data and an indication, but we're not going to pursue it. And somebody else comes in and say, well, you know, I looked at this patent. We can actually have a new IP file for a method of use, for another indication. you can lose substantial amount of dollars when with that. This is to give you an idea only in the pharmaceutical and biotechnology idea field from 2002 to 2011, on the number of patents that were filed in Europe. Let's talk about a number. I'm going to bring up a couple of things during these slides which are major change to the patent law. And it's interesting. I was on a what it's called this morning, which talked about the America Invent Act. This is probably the most important law that was signed by President Barack Obama in September of 2011, actually I think it's 2012. I apologize for that. and this is going to have a major impact on how this is actually changing the way people are filing patents. The primary thing that it changes is the method to determine priority for patent applications from a first to file to a first, from a first to invent, I'm sorry, to the first to file. What does that mean? Le'ts say you made a discovery five years ago, but you didn't bother to file any IP, okay? And you present sort of we have a discussion, and you tell me about your invention but you haven't filed yet. And I'm really a dubious character and I'm thinking whew this sounds really good, I'm going to write a patent. Well, March of this year, 2013, I can file a patent. And you are going to be out of luck. And the reason you are going to be out of luck is you're going to have to prove, you're going to have a year to prove that your invention actually was yours. So, if you have a great record keeping in terms of notebooks, in terms of specific things that you have had, you can then say well, wait a minute. You know, this guy really is untrustworthy, and this was my invention and he stole it from me. And you're going to have to prove to the patent office that actually you are the first inventor. Whereas before, you know, it was basically from the perspective of the first to fi, to to invent, so there was never an issue. This actually, and there, there is a lot of controversy in the area. this, to some extent, favor really large companies, okay? Because if you have a large company, then you can file almost on anything. So, if you are an investigator working here at UCSD or working in another academic institution. Well, before you file your patent, you want to make sure you have enough data because as I told you it's very costly to file. In the US, it's not very expensive to file a provisional. But in Europe, it's going to cost you $30,000. So, this is something that has major implications. And I'm not, not going to spend a huge amount of time, but you're going to have to evaluate pre-filing publication of research. We're going to also look at freedom to operate. There's a number of things that you have to look at. You're going to have to look at in terms of developing prosecution techniques. And that's where your patent attorneys, you're going to want to make sure that your patent attorneys know well about that law. there's a lot of things that are going to happen. Another law that's very important that relates to university is the Bayh-Dole Act. Which is for university that may elect to retain title to inventions developed under federally funded research programs. And these are important because the university, first of all, has to grant royalty free non-exclusive license to the government. Let's assume you work here and you had an IH grant. And you discover the cure for flu, the general cure for flu no matter what strain you discover that. Well, to some extent that could become national security issue. And the government could request that and you decide you want to charge a $100,000 a dose. Well, the government could say well, you know what? That is not acceptable. We paid for that research that you were doing here. Therefore, we need to have the right to it. So, that's what this act covered. The other thing is that the university must give preferences to small businesses. Again, that's very important if you are a university faculty and you are filing a patent. And let's say nobody comes to the table, okay? To get, or let's say a big company comes to the table and wants to license the IP. But you also want to license the IP. Well, they have to give you the same treatment. And at the end of the day, the terms are the same. You basically, you know, are favored to have, really, the license on the IP. Now, you have to demonstrate a number of things. I.E., like that you're going to be able to commercialize it and everything else. If it's just so, you can sit on it, that's a different story. And what's also important is that if you are an inventor in a university setting for federally funded projects and your name is on the invention. When the university generates revenue by licensing the IP and the product is being sold, you are actually going to get a piece of the action. And that's important because that continue to increase people to do novel discovery. All of these, by the way, can found into actually UCA, which is the University of California, but also the US Patent Office.