 So as Richard only started us with, this is certainly an auspicious time to be having a conference on IP and health and to consider how the patent system should be fine-tuned to promote the development of better products and simultaneously ensure public access to the fruits of that work. In that endeavor, I think inventive step is certainly a tempting target. I always tell my students that the doctrine is like a water tap. It's a powerful control over how many patents go out, you turn it on or turn it off. And it also controls the relationship between successive generations of innovators, how far up the quality ladder the next guy has to get in order to merit a patent on something like a new use. But as Catherine Modridge recounted, it's not a tap that's easy to churn. She gave us a long series of cases and a lot of intensive thought, but the factors that were started with are still the factors that remain in place today. Her presentation reminded me very much of former Chief Justice Rehnquist of the U.S. Supreme Court. He hated multi-factor tests and he would have certainly gotten rid of this one. He regularly did, but what he would do is he'd replace a ten-factor test with a two-factor test and each of those factors would have five-step parts. So he would get absolutely nowhere and that seems to be what we have here as well. Trevor Cook offered us another approach adopting new types of rights that can be more closely tailored to the specific goal that a particular kind of exclusivity was intended to encourage. The regulatory data protection was, to my mind, the most interesting because there were several parts to play with, as John suggested in his talk about reforms. And as the Zeitgeist story showed, it can be more effective than patent protection. Maybe not for repositioning, as John also talked, but it does seem to be effective for some patents to create a longer period for new discoveries. And yet it allows for other socially important activity. So the data can be generated by a second comer if the right-holder gets too greedy and the clinical trial data itself can be made public. And that's great because it allows for a meta-analysis across a variety of different products and that's something that we can learn from. The second set of panels dealt directly with the access question on more accurately, at least Chris, preventing the patent holder from impeding access. So Chris Souther's discussed the use of competition law to protect the patent period, 20 years or fewer years if the patent is in fact invalid. And so he talked about preventing the patentee from paying for delay, preventing it from making competition, less alluring by dropping prices, and preventing other kinds of hanky-panky after patent expiration. Note, though, that none of this increases access during the patent term. Catherine Stevens discussed that problem and she talked about allowing access to products where they are cheaper and then bringing them back into another market. Now that's a big issue in the United States because the prices of our pharmaceuticals are extraordinarily high. The term reasonable prices has no meaning in the United States as it relates to medicine. And yet we sit right next to Canada where the prices are controlled and therefore considerably lower. But again, the right holder tries to prevent that this time by exploiting the territoriality of patents and demanding rules of national exhaustion. That, as we heard, was blocked in a limited way in the EU. But even though the U.S. has a doctrine of international exhaustion, there is, as Trevor pointed out in the Q&A, regulatory hurdles that can be imposed and the regulatory authorities are being asked to do that in the United States. And as Catherine mentioned, parallel importation can have bad effects in the country of export. So in the U.S. Canada situation, we see pharmaceutical firms cutting off Canadian drug stores that sell more medicine than there are local patients who have that particular disease. So I am left with concerns about access. Now the U.S. Supreme Court tried to deal with that by attacking the subject matter of patents and making it harder to get patents on inventions related to the life sciences. Matt Aboia examined that issue and found the U.S. cases barring patents on laws of nature, natural phenomena, and abstract ideas did indeed decrease patenting but was an incredibly blunt instrument. The effect is too broad, it results in high costs and legal uncertainty and has a heavy impact on small entities. My own take on this is that it has to be remembered that our access problems are much worse than yours. So we have no price control, again the term reasonable prices has no resonance. We have a weak experimental use defense, almost nothing, and expensive insurance that can make it hard to get a first diagnosis and patentees who make it impossible to get a second diagnostic opinion. So maybe these cases show that the Supreme Court does a really, really bad job but what it might be demonstrating is that the balance between proprietary and access interest in the United States is just altogether wrong. And then we heard from Wolf Sardar and gave some more sophisticated approaches to these problems, things like reference pricing, negotiation strategies, collective purchasing, theories of competition law that deal with abuse of the patent system, theories that are intended to control price taking into account the cost of development and the need to encourage very risky research. I would love to see an example of that. These attempts to refine and balance the patent system, they're all very interesting. However, they do leave one important question and that's how do we encourage research on diseases that are not incentivized by the patent system. Helen Tone was scheduled to be here today but had to cancel as you heard for personal reasons but I'm an avid follower of her work so I thought I'd use some of my time to finalize concerns for situations where the strong patent protection are required by international law is highly inapposite. So one question of course is access for the global south. The patent system may lead to innovation but medicines are of no value to those who can't afford it. Now part of that problem is assuaged by some of what we heard today, measures that control abuse of prices and also compulsory licensing. I would have loved to see that last slide that Wolf showed us because my impression is that that's not working all that well and has been very controversial so I would have glad to have heard more about that. But there's also another extremely worrisome problem. In many cases the treatments just plain aren't there. First patents simply cannot incentivize research on diseases that selectively afflict the poor because those patients have no profit potential. There's no part of the goal to motivate research. Patents are about voting with money and these patients have no money. So drugs for neglected diseases such as tropical diseases have an abysmal approval rate. There's also a problem for diseases suffered by small populations which is, I guess, part of the repositioning issue. Now one answer to that, as Richard noted in the past thing, is philanthropy. Giving the example of the Bill and Melinda Gates Foundation which has really taken on malaria and produced some really interesting results. A second idea is prizes. So famously that's how the problem of determining a ship's longitude was solved and there's now something called the Longitude Prize for innovations in the medical arena. Both of these approaches have problems though. Adequate funding is one. Choosing the right goal to reward is another. And recognizing the solution is interestingly a third. So John Harrison had a very hard time convincing the Longitude Committee that the solution to the problem was a clock. You can go see it in Greenwich. The philosopher Thomas Poguy has proposed setting up something he calls the Health Impact Fund which would use quality adjusted life years, qualities to determine whether a solution was successful. Interestingly, this system would not only reward inventing new therapies because profits depend on actually making people healthy. It also encourages the development of versions of the product that would meet local needs especially the needs of the poor. For example, people who don't have refrigerators, a version of the drug that doesn't require refrigeration. And it also would encourage the development of delivery systems to get the therapy to where it's needed. But again, there's a funding issue and a surprisingly contentious question on what actually constitutes the quality of life. What is the good as Kathy put it in her introductory talk this morning? So those solutions have limit. But there's a growing literature on what I've called IP without IP which is a term coined by Mario Biascioli. This literature recognizes that the money that comes from IP rights is only one driver. That there are other motives that can be harnessed to promote IP, intellectual production. So chefs, comedians, fashion, academics, there's very little IP in these fields and yet a huge amount of original production based on norms of attribution and originality enforced by various sanctions. Gossip, Twitter, blogging, ostracism, and among comedians apparently fisticuffs. Now to be sure there's reason for skepticism. Among other things, groups have to be relatively small for social sanctions to work. Some of this IP without IP has lots of IP like cookbooks, potential TV deals, or there's IP lurking in the background. So IBM for example supports Linux so its customers have a free operating system on which they can use the applications they buy from IBM. In a law-free environment, participants can easily be taken advantage of, have their work ripped off and commercialized by somebody else. And most important, this system doesn't appear workable when development costs are high. But as Amy Kapcinski pointed out in an impression article she wrote in 2017, there is a model of IP without IP that has some real potential even for expensive and decentralized undertakings, and it's interestingly the vaccine network. So the coronavirus has led us all to take social measures, washing our hands, singing happy birthday, self-quarantining, limiting travel, closing schools, but what we really want of course are medical interventions, vaccines and treatments to prevent infection and improve survival rates. Now this is another sphere where IP is not very helpful. Developing these interventions requires surveillance to identify new viruses quickly. It also requires genetic sequencing, data about and samples from patients, the creation of new reagents for diagnostics and treatment purposes. To do this rapidly, that information has to be shared so IP could in fact be a disaster. In any event, much of this information is not protectable like patient data. And for interventions themselves, it might not make any sense to patent. So if a cure for the new coronavirus were found, public pressure alone would keep the price down. And that's likely the reason that to date the pharmaceutical industry has shown very little interest in the COVID-19 situation. The world has however been thinking about this problem since at least the influenza epidemic that followed World War I. In 1947 the World Health Organization, the WHO, created the flu network which now includes some 140 national influenza centers in 110 countries. They collect local data and send it to the collaborating centers of which there are now six. The one I know best is the US CDC, but there are ones in other places in the US and the UK, China, Australia and Japan. They do things like standardized diagnostic and lab practices, engage in and coordinate vaccine development, and much of the work happens in the national influenza centers and also in other participating labs. Now it's relatively easy to see why scientists eagerly join in the effort. Contributing brings joy, right? It's what they went into science to do, cured diseases. They also get reputational benefits, networking benefits because they need new people, opportunities to learn new research techniques and create inputs like reagents useful in their other work. But the effort requires a lot of money, cooperation among scientists, and no defections. Things like what is distressingly supposedly happening in Wuhan where there are attempts to patent the approaches that appear to be working. So it's a real test of IP without IP. And indeed the whole thing broke down in 2007 when Indonesia furnished the H5N1 virus to researchers and then didn't receive credit for their work or worse enough of the medicines developed to treat their population. Its threat to withhold samples in the future led to a five-year high-profile global negotiation within the WEHO and to something called the Pandemic Influence Preparedness Framework or PIP Framework. It's a really interesting model. It invisions funds supplied by private enterprise in addition to government and charities and so it provides a crucial template for interfacing the public and the private. Under this framework, insiders, those doing the work in the labs, agree to attribute all contributions in their publications and to structure their research to involve the local labs that contributed information. These were both problems under previous versions of this effort and of course they're the main reason for scientific cooperation so that you can get attribution and get involved in the research. There's also a defined set of materials that can't be the subject of patents. Interestingly some of the same things the U.S. Supreme Court says you can't patent. So the genomic DNA of the virus. Insiders also agree to submit all sequences they discovered to a public database and they can use a genuinely public database or they can use EpiFlow which has its own set of restrictions on people who use the database. Disputes are settled informally through the WEHO. For outsiders, access to information generated is governed by contract and there are standard agreements available such as standardized material transfer agreements. Apart from the defined list, patenting is possible so developing countries had wanted to mandate compulsory transfers of patents and know how compulsory licenses but that was not included in the framework in order to promote private participation and here disputes are resolved by binding arbitration. So my understanding is that the framework was developed around the work on the H1N1 virus and was successful there but whether it's in play right now is an interesting question. I couldn't find evidence for it on the WEHO's website and according to Ellen it's something called the Coalition for Epidemic Preparedness Innovations which is funded solely by charities and government that's taking the lead on finding an approach to the current coronavirus. She apparently has strong doubts that the funding is sufficient and has been calling on Big Pharma to consider its ethical duty to participate some more but to me without any kind of legal support it seems unlikely that that's going to happen and this framework certainly furnishes an interesting model so I'm curious if it's in use now and also whether it can be generalized to the development of cures for other diseases maybe some of the panelists here or other people here know but I would certainly like to find out. So thank you very much.