Biomedical Engineering - Brevetti e Proprietà Industriale

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1 Politecnico di Milano Chiara Moreschini PATENTS AND INTELLECTUAL PROPERTY MANAGEMENT Prof.ssa Chiara Franzoni AA 2021/22 2 Some of the material included in this book is a modification of the slides provided by Professor Chiara Franzoni during the course of Patents and Intellectual Property Management (Politecnico di Milano, AA 2021/22) and of the slides included in the Intellectual Property Teaching Kit of the EPO and EUIPO. The author credits Professor Chiara Franzoni, the EPO and the EUIPO as the providers of the original. Neither Professor Chiara Franzoni, the EPO nor the EUIPO are responsible for the correctness of the changes. 3 INDEX 1. P atents ; Pag. 4 2. T he requirements ; Pag. 16 3. T ypes of ips ; Pag. 30 4. T he patent procedures ; Pag. 50 5. IP strategy – extracting value from intangibles ; Pag. 64 6. IP portfolio management ; Pag. 77 7. I P violations ; Pag. 83 8. A ssessing the value of IP s ; Pag. 92 4 1. PATENTS WHAT ARE PATENTS Patents are property rights over a n invention 1 . They confer the exclusive right to exploit commercially an invention for a limited period of time . Patents are right to exclude others to reproduce, do or use the invention covered by the patent, as long as the use are commercial (non - commercial use are usually excluded by the patents, so others c an use the invention in those cases). • The right is granted to those who have put the resources in the invention (supporting company and/or inventors) ; • The right is granted for a limited amount of time ; • The right is conditional on fulfilling a set of requirements . The right arises only at the end of a patenting procedure, aimed at ascertain the existence of the requirements ; • The right is given in exchange of a revelation (disclosure) of the invention in the open domain ; • When the patent expires , everyone can use the invention without further costs or delays . WHAT ARE IPs Patents are Intellectual Property Rights ( IPRs , or IPs in short) 2 established on inventions • Intellectual work/creativity can produce other creations besides inventions (e.g., pictures, music, designs, databases, ..). Some of these creations can also be subjected to IPs. • IPRs is the general name of property rights established on all types of outcomes derived from the intellectual activity. COMMERCIAL EXPLOITATION Rights to commercially exploit mean: a) Prevent others from making, using, offering for sale, selling or importing products that incorporate the invention in the country where the patent was granted Non - commercial uses for academic research/teaching or private use are allowed (experimental exception) b) Right to re - assign , sell or license these rights . 1 On technical inventions and not artistic ones, which are covered by other types of Ips. 2 IP = intellectual property rights ( even if it is shorted with IP it indicates the rights of intellectual properties ) 5 Example : mRNA technology https://www.youtube.com/watch?v=TfYf_rPWUdY https://www.nature.com/articles/d41586 - 021 - 02483 - w https://www.nature.com/articles/d41586 - 020 - 01444 - z The mRNA technology : Paul Krieg, Douglas Melton (Harvard) 1984 produced biologically active mRNA in lab (seen as tool to study gene function). Gave reagents to Promega Corp. to produce for labs. Robert Malone (Salk Institute - La Jolla) 1987 cells could create proteins from mRNA delivered into them with liposomes (seen as drug - making tool). Method patented by Vical inc. in 1989 But mRNA was very unstable, quickly degradating and injections were potentially dangerous. Vical partnered with Merck to build an influenza vaccine with mRNA, but abandoned project. Trans gene licensed technology for vet applications, but abandoned plan to build mRNAs vaccines for humans. Several teams and companies attempted to train the immune system to attack cancer cells with mRNA - encoded proteins. But working with mRNA was expensive and success too uncertain. During the 90s the interest for the technology faded. Once the process of mRNA was understood making it useful in a vaccine o r in a technological process was full of technical problems, so the understanding of a natural process was not covered by a patent because it was a mere description of a natural process (not a creation), but the development of tec h niques that allowed to us e these process es to produce vaccines and fabricate in a lab mRNA w ere an invention that could be patented. In 1997 Katalyn Karik ò working with Drew Weissman at UPenn on developing an mRNA - based vaccine for HIV/AIDS. She noted that injecting mRNA in body of mice provoked strong inflammatory reactions. In 2005 modified them RNA, replacing a nucleotide urodine with psudouridine. Modified mRNA prevented alerts from the immune system. - Filed a patent with UPenn and founded RNARx. They did not licence the patent from Upenn. - Cellscripts licensed patent from UPenn for $300,000. BioNTech (inc. 2008) and Moderna (inc. 2010) later sub - l icensed the patent for >$100M. - Other approaches to reduce immune reactions were developed (e.g., CureVac), but it is still unclear if these are equally good. 6 In the meantime, LNP (lipidnanoparticle), a complementary technology, was developed. LNP consists in using ionizable lipids charged in lab and use these to replace liposomes as vessels of injected mRNA. LNP preserve the properties of mRNA longer, reduces toxicity and makes manufacturing more efficient. Patents owned by UBC (Pieter Cullis), later refined by Moderna. - 2012 Defense Advanced Research Projects Agency (DARPA)decided to fund deve lopment of mRNA massively. All major pharmaceutical companies opened mRNA divisions. Moderna alone received $25M. - Moderna first focused on mRNA drugs, then re - positionedon vaccines, but small success. By end of 2019, out of 9 vaccine candidates started, only one had reached broad human testing. Covid19 out break prompted global race against the virus. - January 10 ,2020: Covid19 genome published online - Mid February, 2020: 3D protein structures of Covid19 solved (needed to identify vaccine targets) - March, 2020: candidate vaccines announced : Moderna ( patent filed February 28 ) and BioNTech - Pfizer ( Patent filed April22 ) - Both vaccines tested and approved in 2021.Were the first vaccines based on mRNA that ever received approval. Record efficacy >95%. - mRNA now under development for other vaccines and drugs. What the example tells us • Inventions are often the result of a long and intricate trial - and - error . • Many teams in universities and companies and lots of resources poured from universities, funding agencies, VCs, and investors. • Often require a set of complementary inventions to become effective, non - toxic, cheap, manufacturable on a l arge scale , so a single patent often requires other patents to be used . • At the time of discovery the real potential is often unclear . • Returns materialize (if at all) after many years . • Science – technology: porous borders. • Some inventions remain free and other go into the public domain before they become profitable. 7 AN OVERVIEW OF IPS IN FIGURES (WIPO, 2021) There are about 3.3M total patents filed worldwide in 2020 (about 2M unique inventions 3 ) that r aised since 2009 and are a p p roximately stable since 2017/18. About 16 million patents are estimated currently in use with a +7% growth . Asia is the most invented continent, which China and Korea which are the most invented countries . 5 largest patents office in the wo rld, called IP5 : USPTO, EPO, JPO, SIPO, KIPO WIPO = World Intellectual Property Organization 3 One invention can be patented in many c ountries so every invention can have different patents depending on the number of countries in wihch it is registered. 8 The decrease in 2019 is due to the fact that in that year China has become more severe on the release of patents and the rules to release a patent have become more restrictive (not related to the Covid pandemic). +13.7% 13.4M total trademarks worldwide are g rowing since 2009 with a s teep growth since 2016. Pandemic did not hit I P s 9 Most of the patents worldwide are in the fields of computer technology, digital communications, medical and pharma technologies, mechanical elements, etc… and are distributed differently in the different countries. EUROPEAN PATENTS https://www.youtube.com/watch?v=Ut5KH966Rbs The European Patent Office ( EPO ) is not part of the European Union and involves many countries that does not belong to the EU. Red countries = countries of EPO belonging to EU Blue countries = countries of EPO not bel onging to EU Patents deposited at EPO are not just from countries belonging to the EPO but also coming from outside countries such as USA, Japan and China. Germany is the most inventive country in Europe. 10 SOME HISTORY • 1474 Senate of the Republic of Venice : "Any person in this city who makes any new and ingenious contrivance, not made heretofore in our dominion , shall, as soon as it is perfected so that it can be used and exercised, give notice of the same to our State Judicial Office, it being forbidden up t o 10 years for any other person in any territory of ours to make a contrivance in the form and resemblance thereof". • First known law for the granting of a patent and ensure that the invention of something in Venice was covered by rights (even for people n ot originally from Venice but that invented something in Venice) • It was subject to an evaluation on invention merits/uses . At that time it was patented only what was tought to be useful, otherwise the law was not applied; instead nowadays there is no judgm ent on the utility of the patents and all the inventions can be patented, regardless of their utility. • The awards were made one by one as contracts • Max duration • The patent was not codified (described in words), but the inventor was expected to keep a certain number of apprentices in the shop, to ensure that the invention would not remain secret. • It was not valid outside the Republic of Venice. It was possible to obtain a patent in Venice for inventions (also of others) that were not known in Venice • 1625 England : Monopoly Patent Statute : • Very fragmented legislation in the following centuries. • Each state had its own norm and one could get a patent for something invented elsewhere. Competition between states. • There was an evaluation of utility by a committee of wise men. • 1852 England establishes the first patent office • However at that time the patent offices were working alone in each states, so a patent in a state could be copied by someone else in other countries and patented there. • 1883 Paris Convention : • International protocol . It establishes common rules on what is patentable. • Each state recognizes the rights of inventions filed in other states (therefore the novelty requirement becomes general: only what has never been invented before in all signatory states is new). So a pa tent in a country can be registered in all the other countries so that the original patent can be valid worldwide without being copied. • It is still in force and the member countries of the WTO ( World Trade Organization ) must adhere. 11 ECONOMIC RATIONALE OF PATENTS Tangible goods can be easily appropriated but they also have rival use (private) , which means that if someone uses that tangible good no one can use it anymore (for example i f I eat an apple, nobody else can have it ). Instead i ntangible good does not have rival use, so if someone use that intellectual property also other people can use it simultaneously (for example i f I use mRNA technique , others can use it as well in the same time). So intangible goods are: • N on - rival : use of a person does not hamper use of another ; • N on - excludable : once a person has learned to use, you cannot make the person ‘unlearn’ , so once the intangible good has been transferred to someone else it cannot be given back. Because of these prop erties the i ntangible goods are imperfectly appropriable compared to the tangible goods (that are easy to appropriate), so someone cannot have a perfect property of them and the property is difficult to keep. That’s why patents are needed to protect the property of intangible goods. Economic problem n.1 The first problem related to patent is incentivize people to patent inventions and not keep for themselves the discoveries because they worry others will steel them. Intangible goods should have a price , otherwise these goods will be used limitless and with no payback for the effort to develop the good protected by the patent, so no one would be interested in developing new inventions. The problems related to the development of new inventions are: a) Eco nomic growth depends on productivity , which is our ability to extract value from resources ; b) Innovations make it possible to exploit resources more effectively or efficiently and induce economic growth (for examples f arming with tractors, irrigation systems, hybrid seeds ) c) R&D is e xpensive (increasingly capital - intensive) , it has u ncertain results because it may not work, developing times are uncertain , a better invention might take over, I might find something different from what I'm looki ng for . Moreover e ven if I am successful, I could be copied / imitated . In that case, the results of my effort would benefit others . Solution n.1? The solution to that first problem is to g rant an exclusive right to those who put effort/resources in the inventive activity in order to p ayback R&D costs and i ncentivize future R&D . The rights are given to the person or the legal subject that invented the good covered by the patent or/and to the entities that financed the research. 12 However we are talking only abut rights to protect the intellectual property and not about money yet ; if the invention will be useful there will be someone who will pay to use or have that property and will receive money thanks to the rights owned (patent) . For examples in Italian universities if a professor makes a discovery without using money or resources from the universities the rights belong t o the professor alone, otherwise the patents is shared between the university and the professor. In other cases such as companies usually the companies keep the rights of the intellectual property developed by the employers, but it depends also on the cont ract between the employers and the companies (there are also special arrangements). Usually the companies are entitled to the patent (while the inventors don’t) in the following cases: • If you are hired by the company as a researcher your work is to invent something so you don’t have the right to have the patent and you do not receive any extra salary ; • If you are hired by the company but not as a researcher and you invent something while working the company will have the right to have the patent but they will pay an extra salary ; • If you have a job in the company but in your free time you develop an invention you are entitled to patent the invention but then you have to offer the patent to the company which will buy the patent from you (because it is supposed that you learned the knowledge needed for the invention while working in the company so it has some rights on the invention). Otherwise the inventors and the companies or different companies can have co - assigned patents . However the laws in the different countries regarding these rules can change from country to country and even in time in the same country Economic Problem n.2 If only one has the right to produce there could be some problems wrt the case in which there is a competit i on on the market between many companies : a) The market becomes a monopoly . Under this condition, the market price is higher than what it would be under perfect competition. Furthermore, it can be shown that the monopolist does not have the convenience to produce the maximum possible quantit y underused capacity , so it is better to have a healthy competition on the market; b) The inventor may want to keep the invention for her/himself , stripping society of the possibility of more development and higher welfare that would now be possible (lost welfare) , because he/she will be the only one to produce the product so will gain more ; c) Other inventors would waste time and money to reinvent the same thing (wasteful invention) . 13 Monopoly is inefficient because since there is only one player on the market the price is higher wrt the case in which there are competitors and the production is not the maximum possible; in economics terms we say that there is a “ d ry loss ”, which means we could have produced a nd consumed more if we were not in a monopoly. So w e want a limited monopoly to avoid problem of the market and the limits are set by the patents, which ensure rights to the inventors but avoid the creation of a monopoly by granting a TEMPORARY right , LIMITED IN SCOPE and in LOCATION . Solution n.2? To solve this problem we can ensure that the patents have the following characteristics : 1. Grant a temporary exclusive right (monopoly) with a maximum duration, generally 20 years , so the patents must be limited in time ; 2. Limit the right by s cope/breadth (content) , so that the patent will cover only a specific product/application and not others; 3. Limit the right by l ocation (geographic) , so that the patent will be valid only in the countries in which it is officially registered; 4. Require disclosure in exc hange , so the d escription should enable society to copy , immediately in unprotected countries and after expiry in protected countries. à creation of a healthy l imited and conditioned monopoly WRAP - UP: PATENT LAW • The e conomic rationale behind patent law is to strike a balance between PRIVATE INTERESTS and PUBLIC INTEREST : • Provide a strong incentive to conduct research and development leading to new knowledge and technical advancement. • Provide a strong incentive to immediate disclosure and rapid dissemination of the new knowledge created. • Limit use to minimum necessary (duration, breadth/scope and extension) for incen tivizing creativity • Ensure maximum and immediate replicability of innovation upon expiry. • The economic rationale translates into a set of legal norms which regulate the IP system. These are rather detailed. • International treaties also regulate the mutual recognition of IPs across countries. 14 CONSERVATIVE APPROACH OF PATENT LAW There is a need to balance private and public interests and to do that the law have to prescribe rules following these guidelines: 1. Granted only to the first innovation and avoids delays in disclosure. 2. Do not award a prize to discovery, other than the granting of temporary exclusivity , so the prize is conditional on market approval: it discourages unnecessary innovations . 3. Granted only in exchange of a detailed description of the innovation , so minimizes duplication times / costs upon expiry , otherwise the patent would be too wide and could cover too many thighs . 4. Limited duration , maximum of 20 years, then it becomes free for all. 5. Costly and requires the payment of annual fees , so discourages the protection of worthless innovations , so that if the patent becomes no longer useful you simply stop paying the fees in the country you want and in that country the property can be used freely . 6. Obligation to grant a fair price in certain cases, for example essential dr ug and avoids non - use of useful inventions . If the price is unreasonable the state can intervene and change the price of the good to make it affordable to people who need it 7. Do not automatically extend to countries where it has not been requested or ext ended (facilitates copying in disadvantaged countries) PATENT LAW Patent laws currently in force is the result of in - depth and partly open debate and is different in every country but has the same guidelines everywere, regarding for example duration and scope . Economist's problems are the definition of an optimal duration and the scope of the patent . a) Duration [ length ] : the number of years in which the right to exclusivity is ensured. b) Breath [ scope ] : number of variants of innovation protected by a single patent. 1 invention à 1 patent Optimal duration (Nordhaus 1969) Optimal duration of a patent has become equal in every country thanks to the Nordhaus model , that fixed the maximal duration for each kind of patent, depending on the field of application, the extent of the patent, the money required to develop the patent, etc… 15 If we were only to incentivize innovation , the duration would be endless , while i f you were only to pay attention to the minimization of dry loss , duration would be zero. As a result of the compensation of these 2 forces, the optimal duration : a) I s always a positive finite number of years ; b) I s shorter for products with inelastic demand (when consumption depends little on the price , for example life - saving drugs); c) G rows as the breath of the patent decreases (if the patent is large it can last less ) ; d) G rows with the costs of innovation ( for example R&D of drugs has costs > consumer electronics) ; e) D epends on the discount rate and therefore grows with the prospect of high inflation . For economists, there would be no reason to have a single optimal du ration. The optimal duration should ideally vary in relation to the reference market and the processing technology. In practice, however, the legislation sets a standard duration (since 2001 set at 20 years for all WTO countries). Are patents the best way to achieve socially desirable goals? As we already saw, the 2 economic problems to be solved regarding patents are : 1. Incentivize people so that they invent ; 2. Limitize the presence of monopoly . Patents are a way to solve these problems, but there could be other options . For example for the first problem we could insert prizes for the companies who firs t accomplish some goals, for example give a prize for the first company that develop a certain v accine. The problem of this alternative however is that it does not work for certain inventions, because some invention could be not requested or useful as they are developed, so they would receive no prize, but they could become useful later. So we have to take into consideration the following aspects to decide patents are a good solution: a) The desirability of patents is especially questioned in some areas: • Research tools à could block/hamper downward inventio ns; • Developing countries à people could not afford prices . b) Patents are not the only possible way to encourage innovation , h owever the se systems are useful when you know in advance what you want to achieve : • Prizes for innovation • Competitions of ideas/broadcasting ( for example www.kaggle.com) 16 2 . THE REQUIREMENTS REQUIREMENTS FOR OBTAINING A PATENT When granting a patent , the society gives away the right to freely use or produce something, so there must be clear requirements to meet in order to grant a patent, otherwise there would be inequalities between the rights gained by the inventor and the losses of the society. T he Paris Convention set 3 main requirements to obtain a patent, that exist worldwide but t heir interpretation may differ fro m one country to another and are technical criteria : 1. Industrial application ( invention ) ; 2. Novelty ; 3. Inventive step ( non - obviousness ) . Moreover there are 2 additional criteria , that however don’t count into the 3 main ones written in the Paris Convention : a) Licit ( ethical ) ; b) Sufficiently described . We will now describe the EPO interpretation of those 3+2 criteria. 1. INDUSTRIALLY APPLICABLE Patents protect technical inventions, which solve technical problems , so the invention protected needs to have a function , so it must produce a practical effect that can be used in some application. For example inventions that can be patented because they have industrial applications are : • Chemical substances, p harmaceuticals • Machinery • Processes, u ses, methods • Designs (ergonomy, …) • Systems • Products, devices • Genetically - modified organisms Basically the law says w hat CANNOT be considered industrial and what is NOT an invention , but it does not say exactly what is industrial, so the application of this rule can be difficult or unclear in some cases (gray areas). 17 The "European Patent Convention" does not define an invention, but says what it is NOT an invention , so it CANNOT be patented: 1. All non - industrial applications , for example scientific discoveries that describes some process or phenomenon, that are simply a description and has no industrial application (but for example if the discovery lead to the invention of something that can be applicable in some field then that invention that integrates the scientific discovery can be patented) ; 2. Mathematical m ethods and software algorithms , but it depends on the country weather or not the specific type of mathematical or informatic method can be patented; • Software? à No in EU, unless they are incorporated in to a hardware. Yes in US 3. Artistic creation s , but there is a special protection for them ( copyrights ) ; • Ornamental designs? Yes, in several countries, under patents for ornamental designs. EU: preference for “registered community design” 4. Methods of surgical treatment and therapies on humans and animals , for example the protocols for treating a certain dise ase or surgery protocols ; • Surgical devices? Yes (the devices, not the protocols!) 5. Species and varieties of plants and animals , that are discovered or created in laboratory, but with exceptions. • Micro - organisms? Yes, if for an industrial use (for example bacteria used in drug production) • Genetically modified animals? Yes, but if not against morality (see later) 2. NOVELTY An invention is novel w hen it is NOT part of the state of the art until a certain instant. State of the art = everything made available to the public before the DATE OF FILING ( also called priority date ) The evaluation of the patentability in this case consist in finding out if the invention is new wrt the date of filing , called also priority date , which is th e date in which the invention has been given to the patent office ; that is the reference to assign the right to the patent to someone if there are more tha n one reques t for the same invention. I t is hard to proof which one was the first one that ha d the idea , but it is much simpler to compare the dates in which the inventors deposit the patent’s request to the patent office of his/her country , so this is why we take as reference the date of filing. However in the US and in other countries (Japan, Ita ly) there is also the so called the grace period , which implies the possibility to prove that the invention has been invented before the date of filing and that counts as priority date , so other dates than the date of filing can be taken into account. This grace period however is applicable at most for 1 year before the filing date. 18 Novelty is also based on the content of the patent , because the novelty relates to the specific claims that a patent makes for the invention covered. For example a certain solution already in use could be patented if it is referred to a new and non - obvious solution specified in the claims, that is a novel solution. à Description of a patent What does the description contain? • à example of teapot with 2 spouts • Prior art • T eapot with one spout • Drawback of prior art • time - consuming • Problem to be solved • reduce filling time for multiple cups • Solution • provide a second spout • Advantage of the invention • filling time is reduced 19 à Novelty: Exceptions In general, every circulation before filing invalidates the novelty, even when this is done by the inventor . The r ationale is that a person that sees the invention in the open domain has the right to copy if a patent has not been file d : • If something is already in use , that invalidates the novelty; • If something has been exhibited somewhere, that invalidate s the novelty ; • If someone has filed the application for a patent but then didn’t finish the process to obtain the patent, that invalidate s the novelty for later inventions like that , even if the patent was not given but just filed the application for the patent . 4 Exceptions are: a) Disclosure at specific trade shows and exhibitions included in a list ; b) Theft of the idea , for example if you can prove that the someone else has filed the application of the patent before but he has theft the invention from you, than you can invalidate the first pa tent and obtain the patent for that invention (but the prove are often difficult to find) In some countries there is a so called 'grace period' , which allows the author to patent even after disclosure, as long as within a certain time limit. In this cas e, the burden of proving that priority is prior to filing is yours . During this period the inventor can still go to the patent office to request the patent even if the invention was already released or already in use; so in this case if the inventor can pr ove that the invention was done before the date of filing this latter date is substituted with a prior date . This is done to ensure the patent to inventions that at the beginning didn’t seem to be useful. Grace periods exist in Japan, USA, Italy for a duration of 12 months , while in the other countries of EPO there are no exceptions to the date of filing (no grace period) . 4 This last case is also used to free an invention from patents, so someone can file the applica tion for something but then doesn’t finish the process to get the patent, in this way the invention cannot be patented by anyone else, or also to ensure that someone can use some invention freely (but does not want to pay all the fees requested to obtain a patent for himself) without the risk that someone will patent it. 20 Example of grace period: The Cohen - Boyer patent on Recombinant DNA • Stanley Cohen (Stanford) à method for introducing antibiotic carrier plasmids into certain types of bacteria; method for isolating and cloning genes • Herbert Boyer (UCSF) à method for cutting DNA segments that contained certain proteins and for attaching the segments to other piec es of DNA • 1972 Begin collaborating à Recombinant DNA technique • 1973 Write working paper and presented at conferences. • 1974 Patent a method for introducing DNA segments into plasmids. The plasmids, thus modified, are used to clone specific portions of previously identified DNA segments. Filed under 12 - months grace period. • Stanford earned about $255M for use in the US • Beyond the US the patent could not be extended, because it was filed under the grace period à Assessing novelty To assign the novelty the patent office checks that the invention proposed is new and search in prior art to decide whether the proposal is novel or not, based on the claims of the patent requested. Claims are very important because they describe exactly w hat will be patented and what not. E xample of teapot : In the example of the teapot for example note that they do not say teapot but pouring vessel, so that it covers also the use with liquids other than tea. So it is very important to write the claims so that they are not too specific and the patent can be used to cover many application but also not too general otherwise it could be already be patented by someone else or could not be accepted. 21 à Do’s and don’ts for safeguarding novelty Don’ts • Do not publish any articles, press releases, conference presentations , posters , proceedings, lectures or blog posts, etc. before you file the patent (date of filing). The only possibility to show the invention to someone else before filing it is to do it under a non - disclosure agreement ; • Do not sell any products incorporating the invention before you file . Do’s • Sign a non - disclosure agreement (NDA) ; • Seek professional advice at an early stage , for example if a costumer wants a preview on the product before filing the patent; • File before anyone else does! 3. INVENTIVE STEP (NON - OBVIOUSNESS) Often new invention s are combinations of already existing inventions so the question that often a patent office have to answer is if the combination of the invention already existing is sufficiently new and NON - OBVIOUS to be patented or not. The law says that the inventive step sufficient = non - obvious w hen it is not obvious to the PERSON SKILLED IN THE ART in view of the state of the art . The person skilled in the art is defined as: • A skilled practitioner in the relevant technical field ; • Someone who h as access to the entire state of the ar t; • A person aware of general technical knowledge ; • A person capable of routine work . à He knows EVERYTHING, but has ZERO imagination! So we define something o riginal when it is non - trivial for a person expert in the state of the art. An invention may be a new combination of two previously existing things. In this case, it is the combination is novel, but the inventive step may or may no t be sufficient/obvious. F or example two non - new objects, when combined, can give an original combination , even if the single components already existed. 22 à Assessing inventive step We can subdivide the inventive step in 3 stages : 1. Study of the prior art ; 2. Analysis of the problem to be solved ; 3. Inventive solution different from the already existing ones. E xample of teapot 3: Solution 23 a) A dditional criteri on 1 : LICIT In addition to the 3 main requirements set by the Paris convention, there are 2 additional criteria to be met. The first one is that the p atent cannot be released if they are n ot licit , which means they must be not unlawful and not contrary to public order and morality . There are also many gray zones in this area related to the morality and ethics, which has often not so defined boundaries. F or example: • Human embryos: à NO • Techniques for human cloning: à NO • Genetic selection techniques aimed at discrimination or eugenics: à NO • Torture techniques: à NO • Genetically modified animals : à GRAY AREA Genetically modified animals : Yes, but only if the suffering inflicted on the animal is justified in view of the benefit ( Animal suffering vs p otential benefit ) Example: The Oncomouse The oncomouse is a genetically modified m ouse such t h at it is easy that it develops some kind of tumors in order to be used in pharmaceutical testings. Is it moral to modify a genome such that the mouse will likely develop the tumor? 1985 : Invented at Harvard 1989 : patent granted in the US. 1989 : rejected by the EPO because superior animals are not patentable. 1992 : Wins the appeal and the patent is granted in Europe Challenged on the basis of lawfulness / morality. 2002 : Rejected by the Canadian Supreme Court It is later withdrawn 24 a) A dditional criteri on 2 : S UFFICIENCY OF DISCLOSURES the second additional criteria is the s ufficiency of disclosure , which means that the patent must have a detailed description of at least one way of carrying out the invention , so that the invention can be replicated by a person skilled in that field . Since the application is meant to be read by experts (= people skilled on the state - of - the - art ), it is neither necessary nor desirable that details of well - known technolo gies are given. However, the description MUST disclose any feature essential for carrying out the invention in sufficient detail , such that it should be possible to the skilled person to put the invention into practice. The sufficient disclosure is needed because at the expire of the patent we want the society to be able to replicate the invention without problems so that it can be usable. T o be sufficiently detailed the invention should be replicable by a person skilled in that field . If the invention is not well explained the examiner could withdraw the application for the patent , not only because without a sufficient disclosure the invention could not be replicable but also because it is useful to check the novelty of the invention in fact. Patents often cite things that existed before and use other patents already existing, s o when providing the disclosure of the new invention a problem is whether or not should we give also the details of the patents we are using. The answer is NO and we should not give al the details of the already patented components but just a sufficient di sclosure on the novelties, providing CITATIONS for all the other patented things, without the need of describe specifically all details of the things already patented and use d . In this way we create a c itation networks that connect all the inventions that uses common components or patent . Through the number of citations of a certain patent we can also evaluate whether a patent is useful and important, because many other patent will cite and use it. If you need someone else’s patent , you should pay the rights to that one to use his patent or anyway have his permit, so citations are also useful also to check who is using a certain patent and whether he has the rights to use it. Note: scientific principles are often explained in the text of the patent, but an invention that works is not invalid, even when the reasons of its functioning are not known or proved in a scientific sense. 25 ASSESSING THE REQUIREMENTS To give a patent , the examiner should answer to the following questions, weather the invention is: 1. I ndustrially applicable ? YES / NO 2. N ew / novel ? YES / NO 3. Inventive ? YES / NO The lack of one of this criteria would invalidate the patent . If instead the answers are 3 YES, and assuming it is also licit and sufficiently described , then it can be granted. Often novelty and inventiveness need to be refined/reduced until the answer is YES. The description can also be im proved. Often the application is modified many times before it meets all the requirements, because it can happen that some of the requirements are not met but the patent is not completely withdrawn, for example the applicant can reduce the claims of the patents in a way such that the novelty requirement o r other requirements are satisfied. The evaluation of the requirement is conducted on the content of the patent document and its comparison to the prior art . After a patent has been granted , the patent can be also taken to court, that can overrule the decision of the examiner and reject the patent if they can prove that the examiner didn’t do a good job in examining the patent application. CONTENT OF A PATENT DOCUMENT • Title • Abstract • Short summary of the invention • Description • Field of the invention , so the technical area to which the invention relates • Background of the invention , so the details of the prior art • Detailed description of the invention : how does the invention provide a technical solution to the technical problem? • Brief description of the drawings • Detailed description of at least one way of carrying out the invention , also called embodiment of the invention • Claims • What is the scope of the invention/the protection sought ? The claims are especially critical for assessing novelty and inventiveness • Drawings (if any) 26 Title, abstract and descriptions are important to introduce the invention and clarify in which fields the invention is going to be used, but the most important part are the claims 5 that describe what is inventive about a certain thing and will define what will be protected exactly by th e patent, if granted . à More about the claims The claims could contain p roduct or method ( process ) but can also be a combination (system) of both product and process . Example of claims of the COVID - 19 vaccine: Example of claims: Claims are not all on the same leve l but we can distinguish d ependent and independent claims : 1. Independent claims : describe the invention in its broadest scope and are claims that have meaning also when read alone ; 2. Dependent claims : any claim which includes all the features of any other claim and have no meaning if there aren’t with other claims. Often the independent claim is too general to be protected so it needs dependent claims that specify further the invention and make is specific enough to be patented. The dependent claims start with the formula “ according to the claim N, … ” so they specify first the independent claim to which they refer and then describe a specific use of the product related to the independent claim cited. à Chain of dependent claim s 5 Claims = rivendicazioni 27 Example of independent claim (1) and dependent claims (2 - 3 - 4): Example: H ö vding airbag cycle helmet Swedish inventors Anna Haupt and Terese Alstin from Lund University . Problem : Regardless of safety, people do not like to wear helmets while riding their bike as it ruins their hair - do and does not look cool Solution : Airbag helmet : • A collar containing an airbag with helium as the inflating agent and sensors including gyroscopes and accelerometers • Priority date: 26 October 2005 (Sweden) T he inventive concept is in this case is a both a product and a method , as we can see from the H ö vding claim in PCT application : Product claims : 1 - 9 Method claims : 10 - 12 1. A system for protecting a portion of the body of a user in case of an abnormal movement, such as a fall or a collision, wherein said system comprises an apparel and an airbag arranged therein, characterized in that said airbag comprises: A first part suitable for surrounding a neck portion and back hear portion of a user after inflation and a second part suitable for forming a hood surrounding a skull of a user after inf lation, said first part and second part being folded and arranged in said apparel before inflation. 2. The system according to claim 1 , further comprising: an in o c u lator for releasing a fluid for inflating said airbag and control means for controlling said systema and said inflator. 3. … 28 … 9. … 10. A method for protecting a head of a user in case of an abnormal movement, such as a fall or a collision characterized by.. 11. .. 12. The method according to claim 11 , comprising: inflating said first part ina. Afirst step; inflating said second part in a second step when the pressure in said first part has reached a predetermined pressure. Is it novel? Priority date: 26 October 2005 . • Test for novelty: Did any document/publication exist before 26 October 2005 that, when taken alone, discloses the invention claimed in the patent application? • The examiner searched the state of the art up until that date and cited three prior art docume nts that were similar to the proposed invention: • DE1975451A1 dated 10 June 1999 • DE3616890A1 dated 26 November 1987 • WO0154523 dated 2 August 2001 International search report states claims 1 to 9 may not be novel and/or inventive so the inventor had the following o ptions : a. Abandon the patent application or b. Request a preliminary examination and/or c. E nter the national/regional phase in various countries Decision : t o continue prosecution by requesting optional international preliminary examination report (IPER issued) . à The claims had to be amended to ensure they were novel and inventive Add more dependent claims that define more specifically what is new and inventive about the product, so that the patent specifies more the applicability of the invention and what is new about it. In fact if the claims are too general the patent could not b e granted because it is already covered by existing patents. In the case of the example the idea to obtain the patent was to refine the claims such that they specify that the helmet is composed of 2 parts and one is inflated before the other; which was n ovel wrt the patents already present in the prior art. What did the examination report say and what happened next? • Examination report: claims 1 to 12 are new and inventive. • Consequences: entry into national/regional phase in various countries and regions, including China, Europe, Japan, Russia, Sweden and the United States. 29 Comparison between original PCT claim 1 and the amended claim 30 3. TYPES OF IPs INTELLECTUAL PROPERTY RIGHTS There are many types of intellectual property rights regarding different fields of application: 1. Patents 2. Copyrights 2.1 Copyrights of the software 2.2 Copyright of databases 3. Utility models 4. Design protection 5. Trademarks 6. Denominations of origin 7. Industrial secret Those types of IPs are not just different but complementary . Let’s now see each type o f IP more specifically. 1. PATENTS Already analyzed in the previo us chapters. 2. COPYRIGHTS As we already saw one of the requirements to grant a patent is the industrial applicability, but when this requirement is not met, we need another type of IP that can cover the invention, such as artistic inventions or other types of things that have not a practical application but still need to be protected. In this case we use copyrights and instead of “invention” we talk about “ creations ”, to underline the absence of practical use but still the presence of an artistic part to be protected. Copyright is a form of protection granted to authors of original works of a creative and artistic nature , including but not limited to: • L iterature • M usic • F igurative arts • A rchitecture • T heater • C inematrograph y • V ideogame • A ny other artistic creation … 31 The copyright grants the author the exclusive right to commercially exploit the work and the moral right to claim authorship . à Rights given by the copyright The copyrights are regulated by the Berne Convention (1886) , similar to the Paris convention for patents, that grants the owner of the copyright the exclusive right to : 1. Reproduce / replicate the work , so no one can reproduce or copy the creation without the approval of the author; 2. Make derivative material (translations, arrangements of songs ) ; 3. Distribute copies also in case that the copy already exist; 4. Exhibit / exhibit the work in public . à Duration of the copyright As for the patents , also t he copyright is always limited in time (expires) . The duration of the copyrigths is not like the patents’ duration, which is the same all over the world, but it changes from country to country, and it depends also on the specific type of copyright. However there is a general rule set by the Berne convention that states tha t the copyright must be at least the life of the author + 50 years (for the heirs) . • In the EU since 1993 it has been fixed at: life + 70 years ; • The duration depends on the country, the type of work and the authors E xample : Collective works: 70 years after the death of the last author (for example for a band the songs are protected by copyright for 70 years after the death of the last alive member of the band) . Copyrights, unlike patents , arise in the very moment of creation , so the author does not have to file an application like for the patents , but in the same moment of the creation is born it is protected by the copyright . Also c oncerning the use of the creation it’s not like a patent, for which the invention cannot be used until it’s patent ed because otherwise the author cannot patent it anymore later : the copyright starts to exists automatically when the creation is born so the author can use and show the creation immediately . This does not mean that the copyrights are not registered. In fact in o rder to demonstrate in court that the copyright belongs to someone or in other cases we need a register that prove that the copyright belong to the author, but when the copyright is reg istered the date that is taken into account is not the filing date , but the date of birth of the creation covered by copyright. 32 à Registration of the copyright There are offices and procedures specific for registering copyright . R egistration constitutes a simplification of evidence , for example in case that the copyright is taken to court, but failure to register does not generate the nullity of the right . There is not a limit date until which the author has to register the copyright before he/she loses the rights on the creation, like for patents, but the author can register the copyright whenever he/she wants after the creation. Example : Office of SIAE for the music copyrights ’ registration . If I have deposited a work with SIAE, I can name whoever reproduces it, without having to prove that the work is mine. If I have not filed it, I can name who reproduces it, but I have to prove that it was mine since a date prior to the abuse . à Requirements of the copyright The copyrights have 2 r equirements , similar to the ones for patent: 1. Novelty : If the work is original, it is generally verified , so this requirement is generally not a big issue in obtaining a copyright, but the very difficult requirement to be met is the next one, that is originality; 2. Originality ( non - triviality ) : it is the difficult requirement to be met for the copyright, b ecause it is difficult to demonstrate that a creation is so different and original from the already existing ones , such that it deserves to be protected. True criterion : new works often originate from the new combination of some thing pre - existing. It should be assessed whether the combination is innovative enough to be a new creative act So originality is the most important principle regarding the copyrights; if the creation is trivial it does not deserve to be protected by co pyrights. However there is not an exam to gain the copyright, like in case of the patent that is examined by persons skilled in the art, because when registering a copyright the office will only register the creation and file the copyright. The requirem ents of the copyright will be evaluated only if the copyright is taken to court and it will be evaluated if the requirements are actually met. Example : Musical arrangement: it is a new creative work (but derivative) . 33 A remake of a song or a movie must be different enough from the original one to be protected; moreover the copyright exclude anyone else to make derivative materials of the original creation (right number 4 granted by the copyright) , so to gain the copyrigh t on a remix or a remake the author of the remake must also have the approval of the author of the original creation to obtain the new copyrigh t. COPYRIGHT S FOR SOFTWARES AND DATABASES There are 2 special use s of copyrights to protect software’s and databases, that nowadays are very important creations that have to be protected but in some countries do not meet the requirements to gain a patent. 2.1. Copyright protection of software Softwares in some countries are seen as mathematical formulas and they la c k in applicability , so they do not meet the requirement of industrial application to gain a patent; in those cases the softwares can be protected by copyrigths . In all countries where softw are patentability is excluded, the software is protected by copyright . However to gain the copyrights the software must have sufficient inventive step wrt the already existing software’s , because it has to meet the requirement of originality, so if it cont ains part already existing in some other software it must be original enough to be protected. European countries g rant copyright on software since 1991 , but e ach country has its own regulations and registration procedures . Even in the US, where software is patentable, it is also protected by copyright. In US the software can be both patented and receive a copyright ( à multiple protection ), while in European countries it can only be protected by copyrights. 2.2. Copyright protection of databases The protection of databases has become a very important issue nowadays and it is supported by copyright regulations, but it also has a special ( sui generis ) protection . The protection of databases is a very difficult ma tter , because in a lot of cases the data contained in databases are property of the people who generated that data, for example the data collected on the internet about the behavior of the users are property of the users. So the solution to protect the dat abase that has been developed is that the thing that can be protected is the structure and organization of the database , and not the single data contained in the database, that can belong to someone else ( like the users). 34 So to be protected by copyrights, the d atabases must be new and original for what concerns the structure and the organization of the database and not the data contained in the database! In the EU it entitles to 15 years coverage . Example of structure of a database to be protected IP protection for database covers the structure and organization of the database, not the content (information, data), which may or may not be proprietary ! N.B. Property of the softwares’/databases’ copyrights The property of the copyrights of software or databased is not counted in terms of life of the person who developed the software/database, which is usually a very large group of developers, but it starts with the generation of the software/database (and then for databases is for example 15 years) . In those cases, the possess of the copyrights goes to the company. N.B. March - in rights March - in rights are rights that exist in some country and avoid the inventor or the possessor of a patent to have the patent and don’t use it or keeping it for himself and preventing anyone else to use it, because that could avoid the society to have inventions that could improve someone’s life. So when someone who is in possess of some rights and doesn’t allow anyone else to use t he patent in some country he/she can be “ expropriated ” from the patent through the use of the march - in rights, that allow than other people to use that invention. 35 3. UTILITY MODELS The utility model is an IP used to protect devices that improve the eff iciency or ease of use of a machine, tool, object or process or one of its parts. Utility models are similar to patents in terms of what they can protect (more later) , in fact t hey are often considered a second - tier means to protect inventions ( “ petty patent ” ), used to protect ideas with a small inventive step , that cannot be patented because they don’t fully meet the requirements to have a patent . So if an invention is not inventive enough to be patented it can be still covered by some rights g iven by the utility models , for example they are useful to protect small improvements in cases in which the R&D department is not big enough to ensure big and inventive innovations Usually utility models are used by small and medium companies, that cannot afford to maintain the costs associated to patents or are not able to afford the cost of R&D departments needed to have a big inventive step , but can afford to create only product with small inventive changes , that however they want to protect . They are very used for example in Italy, where there is a very high number of SMEs (Small - Medium Enterprises) and there they last 10 years. à Utility models: what can be protected Utility models offer protection for technical inventions , including: • A pparatus and devices ; • C hemical substances ; • M edicinal products . The following do NOT qualify for utility model protection: • D iscoveries, scientific theories, mathematical methods ; • B lueprints, patterns, teaching methods, rules for playing games, accounting systems, programs for computers ; • P rocesses (e.g. manufacturing and working processes) ; • B iotechnological inventions ; • A nimal and plant varieties . 36 à Utility models: procedure The utility model do NOT exist at the international level and there is no convention such as the Paris convention that regulates the use of utility models worldwide, but they exist separately in each country ( via the national route ). Moreover each country call them in different ways. There are s eparate procedu res for each state , that differ according to national law . There are up to 12 months