Re: Second MBBS Revisited
Anfos Sin
Foundations of Medicine I (FOM I) is taken by students in the first year of the MD program. FOM I provides an overview of biological function and organ systems over 37 weeks. Foundations of Medicine II (FOM II) is taken in the second year for 30 weeks and focuses on the pathophysiology of disease. The course meets for 18 hours a week, between 8 a.m. and noon.
The course is taught through a variety of teaching methods including lectures and small group events that employ case-based learning activities. Dissection-based anatomy runs throughout most of the first year, integrating across all of the organ system blocks. Self-directed learning is emphasized in the second year as students participate in five hours of problem-based learning each week.
The primary goal of FOM I is for medical students to achieve foundational knowledge in the basic sciences, with an emphasis on gaining a detailed understanding of common and representative medical illnesses. By the end of year one, students are knowledgeable in human biology and the impact that psychological, social, cultural and economic forces have on human health. They are able to discuss the epidemiology and prevention of major medical conditions. Knowledge gained in FOM I will be revisited and expanded the following year in FOM II.
Building on foundational knowledge obtained in FOM I, the primary goal of FOM II is for medical students to achieve essential knowledge and skills related to the pathophysiology and epidemiology of diseases. In addition, students develop a broad understanding of treatment paradigms for common medical disorders. By the conclusion of year two, students have a broad understanding of the full spectrum of human illnesses and therapy.
Students take a summative exam at the end of each block. The summative exam includes both the National Board of Medical Education (NBME) and faculty-authored questions. There is also a practical anatomy exam at the end of each organ-system block in FOM I. Students must pass all of the exams, receive a passing score on individual student evaluations (which include a professionalism component) and have a consistent attendance record for mandatory events.
As the scientific community continues to tackle some of the world's most challenging diseases, research and innovation has led to the discovery of new uses for previously known medicines. Patents that cover these new uses are often called "second medical use" patents.
Join members of Gowling WLG's global Intellectual Property Group as they explore these and other questions in this on-demand webinar. Focusing chiefly on the UK, Canada, Russia and China, we outline the key opportunities and obstacles surrounding second medical use patent protection, and help you understand what to expect when a second medical use patent reaches the court.
John: Alright. It looks like we're pretty stable there right now so I'll get started. There will be some people, I suspect, joining but I think we're pretty much leveling off right now. Good morning. Good afternoon. Good evening. Welcome everyone to our latest webinar in the Life Sciences series. Today we're going to talk about second medical use patents and this is part one of a two part series and this is focused on infringement and enforcement. As you can imagine this topic is a large topic. We decided to break it up into two sessions. So, everybody here probably understands that even after a medication has been discovered and a use is found, innovation still happens. Research still happens and companies still look for new uses for that medication. Patents try and recognize that you can have a new unknown use for previously known medication. Perhaps one of the most famous examples is thalidomide. Back in the 50's it was used for morning sickness during pregnancy and, unfortunately, it led to a lot of birth defects and side effects that were undesirable and led to the termination of that approval. But then research into the product continued and over the years they found that it was actually useful in multimeloma and in skin lesions and leprosy. Again, you can see how initially there was one indication that was patented and approved and then a second indication later on came about, and for a while that drug had a new life based upon the new use. But one of the challenges that new use for known medications creates is what happens if a generic decides to come to market claiming the old use, as an indication, but not the new use. Is that infringement? And it creates a lot of interesting discussion about whether that new use is still being used even though the second entrant is not actually indicative of that second use. So that's what our panel's going to be looking at today is how do you enforce the second medical use patents.
With that stage set, a couple of small little housekeeping matters. This session will be recorded and we'll make it available afterwards. If you want to go back and look at anything that we've said. We also have a Q&A button on the bottom. Feel free to use that. We'll answer questions at the end but that's how we'll deal with questions.
So, who are we? My name is John Norman. I'll be your moderator today. I head up the life sciences group in Canada and Russia. I'm a patent litigator and I work in Canada out of the Ottawa office. Our first panelist, Alex Gloor. Good partner of mine. We work closely together. He is a partner in our Ottawa office as well and he is a patent litigator. Our second panelist, Jenny Davies. Jenny is a legal director in London and she is a specialist in life sciences. Next we have Vlad Ugryumov. He is also a partner in our Moscow office. He is a specialist in patent litigation and patent prosecution. Last but not least, Dr. Jian Xu. He is in our Beijing office. Jian is qualified both as a lawyer and as a patent agent/patent attorney. So what's going to happen today is I'm going to pose a number of questions to the panelists and they will answer that question based upon how the law is set up in their jurisdiction.
Before we get there I thought it would be helpful just to set out some of the claim types that we'll be talking about today. I don't want to get too far into this but just to let everybody know what we're talking about and most people will probably be familiar with these claim types. But there are four claim types that we'll be talking about and different jurisdictions approach and deal with them differently. So the first one, EPC 2000. Most people will know this as the type or the style it is is substance X for use in a method for treating disease Y. The next claim type we will be discussing is the Swiss style claim and basically the form of this is the use of compound X in the manufacture of a medicament for the treatment of disease Y. As you will notice it's got the manufacturer component in there and that can be particularly important when the use itself has to be tied back to commercial activity. The third type that you will hear our panelists discuss is the German or the Bare Use. Very straightforward. Very simple. Use of compound X for the treatment of disease Y. The last type, which is a little more challenging in certain jurisdictions, is a Method of Treatment claim and this style is essentially method of treating disease Y in a patient comprising and administering to patient compound X. So with that sort of rough outline of claim types I'd now like to turn it over to our panelists and ask them some questions and have them answer them based upon their jurisdiction.
So the first question is, what claim style or claim type for second medical use patents is available and appropriate in your jurisdiction? Let's start off with Russia. Vlad, can you give us an answer to that question?
Vlad: Thank you, John. In Russia almost all types of second medical use claims are allowed except for EPC 2000 claims that are the main second medical use claims in Europe and in some other jurisdictions. Those claims are not allowed in Russia because under the local practice a substance itself must be novel while the new use of an old substance can't impart novelty and inventiveness for such claim. Among three remaining claim formats that are allowed in Russia, German type claims are the strongest form the enforcement prospective while the Method of Treatment claims are the weakest and I'll speak about this in a minute.
Jian: Compared with Russia, China is much less flexible for the style of claim types. China, as many people know, like many countries do not allow patents to be granted for Method of Treatment of disease or diagnosis. But China does allow the need to protect novel medical use of non-compounds which is medical use. In practice, China basically only adopts those three type claims that John had mentioned which is absence of ... claim types for Europe and which is about the use of compound X for the manufacture of a former compilation for treating disease Y. Just to give an example, suppose compound X is found to be effective to treat the Coronavirus, in China you cannot draft a claim like use of compound X for treating Coronavirus disease like with German types. Instead use is drafted in first form like use of compound X for the manufacture of a former compilation for the treatment of Coronavirus disease. So that's the style that's allowed in China.
Jenny: The UK is in some ways similar to China. Method of Treatment claims are not allowed in the European Patent Office. So, stealing Jian's example, the use of substance X for the treatment of Coronavirus would be regarded as Method of Treatment and excluded from patentability. So what is allowed in the European Patent Office? Historically the Patent Office allows patent applications for the second medical use in the Swiss form claim. That's use of substance X for the manufacture of a medicament for treating disease Y. That was the kind of accepted approach for some time. There was a rule change in the Patent Office on the 28th of January, 2011. So prior to date, if you've got a filed patent application you're allowed to continue to obtain Swiss form claims from that application, as long as the priority date predates 28th of January, 2011. After that date your only allowed, in Europe, to have claims in the EPC 2000 format. But because of the transition period we will continue to see Swiss form claims in patents until 2031 and what we're seeing coming through the course is patents with a combination of Swiss form and EPC 2000 claims. So people can hedge their bets. So the main claim today, as I just mentioned is EPC 2000 claims. Those are substance X for use in the treatment of disease Y, and those claims are treated in Europe in the same way as other claims. So you still have the kind of typical requirements having to show novelty and inventive step and we'll talk about that more in the next webinar. The last thing I'll just mention is that you can also have First Medical Use claims in Europe so you can have substance X for use of a medicament in the more kind of general sense.
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