1. Professor: Marnie Brown Welcome

2. My email address is mlbrown@konkuk.ac.krmlbrown@konkuk.ac.kr

3. This course assumes that students have little or no background experience or knowledge of Intellectual Property Law. All class materials and instruction are in English. The grade for the course is based on a paper, a presentation and class performance/attendance. Paper - 30% Presentation in pairs 50% Class performance and attendance - 20%

4. This Week Patents, Patent regimes and the application process Patentability and infringement

5. Homework Answer: What are the pros and cons of first-to-invent as opposed to first to-file?

6. Contemporary Intellectual Property (Law & Policy) An application for a patent may be withdrawn at any time before the patent is granted and any withdrawal of such an application may not be revoked. The publication of the patent is important for at least two reasons. First, at this time all correspondence and details of the invention are released into the public domain destroying the last vestiges of secrecy. Second, this is date from which the patentee can sue for infringement. If the patent is granted, the initial protection for the invention is for four years. Thereafter, the patent must be renewed annually on the payment of increasing fees up to a maximum of 20 years.

7. A standard UK patent usually takes between two to three years to grant, but in some areas and in some other offices it is longer. For example, the EPO can take between four to six years to grant a biotechnology patent. An accelerated examination and search fees together. This means that a patent can be granted within a few months of publication. The Gowers Review has called for an accelerated grant process to complement the accelerated examination and combined patent search and examination procedures.

8. Post-grant amendments Sections 27(1) and 75(1) of the Patents Act 1977, as amended, provide the Comptroller and the courts with discretion to allow the amendment of a patent once it has been granted; the former section deals with circumstances when the request is from the proprietor himself, and the latter with cases when the validity of the patent is in dispute, for example, in infringement or revocation proceedings. EPC 2000 reforms found in Article 138(3) now mean that a proprietor, or consenting co- proprietors, can apply to amend or revoke a patent in any proceedings in which validity can be an issue, even if it is not an issue in the particular circumstances.

9. In exercising their discretion, the comptroller and the courts must also now have regard to relevant principles in the European Patent Convention, for example, regulations made under the convention or EPO guidelines or rulings from the EPO Boards of Appeal or Opposition Division. This is to ensure closer approximation and consistency of approach in signatory countries. The UK-IPO now offers a service whereby requests for amendments are made publicly available and those who may oppose them are given notice of the application to amend. You cannot apply to amend your patent in favour of more subject matter or a broader monopoly. Amendments can only maintain, or more usually restrict, the scope of protection originally received.

10. Patent law protects inventions, but interestingly there is no legal definition of invention. Rather, the eligibility of a new product or process for patent protection is considered in a two-step process: First, a patent examiner will consider what is not an invention under the law, or at least what will not be entitled to patent protection. Secondly, a patent office will test an invention against the positive criteria for patentability, which are novelty (does the invention already exist and is it in the public domain?), inventive step (is the invention sufficiently innovative to represent a significant move forward in the field?) and industrial applicability ( can the invention be made or used in any kind of industry?).

11. These criteria operate as threshold devices to determine if a particular invention makes sufficient contribution to human knowledge and experience to merit the award of a monopoly. Article 27 (1) of the TRIPS Agreement ensures that all countries are agreed that these are the relevant criteria for patentability. But it is the interpretation given to these by national courts where differences emerge.

12. Once granted, a patent confers on the patentee a range of rights and the monopoly is arguably the strongest within intellectual property law. But as with all intellectual property rights, limits can be placed on that monopoly, such as Crown use or compulsory licenses. Moreover, what can be given can also be taken away, and patents are vulnerable throughout their life to a claim for revocation, that is, that the patent should be struck from the patent register because it was erroneously granted. Infringement proceedings are often met with a counter-claim for revocation. It is therefore necessary to consider infringement and revocation together.

13. Excluded subject matter European patents shall be granted for any inventions, in all fields of technology, provided that they are new, involve an inventive step and are susceptible of industrial application. Excluded subject matter that is non-patentable is found in Articles 52(2), (3) and 53 Article 52(2) The following in particular shall not be regarded as inventions within the meaning of paragraph 1: (discoveries, scientific theories and mathematical methods Aesthetic creations; Schemes, rules and methods for performing mental acts, playing games or doing business, and programs for computers;

14. (d) presentations of information (3) Paragraph 2 shall exclude the patentability of the subject-matter or activities referred to therein only to the extent to which a European patent application or European patent relates to such subject matter or activities as such. Article 53 Exceptions to patentability European patents shall not be granted in respect of: (a) inventions the commercial exploitation of which would be contrary to ‘ordre public’ or morality; such exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation in some or all of the contracting States;

15. (b) plant or animal varieties or essentially biological processes for the production of plants or animals; this provision shall not apply to microbiological processes or the products thereof; (c) methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body; this provision shall not apply to products, in particular substances or compositions, for use in any of these methods.’ The Act does not provide for a definition of an invention, just a list of things which are excluded, whether or not they would be regarded as inventions.

16. Aerotel Ltd v Telco Holdings Ltd & Others [2006] EWCA 1371 This case involved two appeals which raised issues about the interpretation of Article 52 and the approach of the British Courts to considering excluded subject matter. The Aerotel appeal concerned a system and method of making a telephone call from any available telephone station using a prepaid code. An action for infringement was met with a counter claim for revocation on the grounds that the invention was merely a method of doing business. Aerotel won, however because the primary claim was to a new method of doing business as such. The court began by distinguishing the class of excluded matter under Article 52 from the matter mentioned in Article 53. Article 52 deals with things that are not considered to be inventions, while Article 53 is concerned with exceptions to patentability. The importance of the distinction lies in the fact that the exceptions should be construed narrowly, but the same does not apply to non-inventions

17. The approach in the United Kingdom has been to ask if the invention makes a ‘technical contribution’ to the state of the art – that is, to the sum total of human knowledge – and if so, it will be patentable so long as the contribution is not solely in the realm of excluded matter. A technical contribution is one which produces as a technical effect, and in most cases this means a real- world change in the state, operation, or function of something tangible. The problem is that the term technical contribution suffers from an ‘inherent vagueness’. The Court in Aerotel set about reformulating the test to be applied for technical contribution. This is: (1) properly construe the claim; (2) identify the actual contribution; (3) ask whether it falls solely within the excluded subject matter; (4) check whether the actual or alleged contribution is actually technical in nature.

18. The fourth criterion is merely a final check which should be deployed only when the application has passed the first three criteria. The presence or absence of a technical effect is therefore only a subsidiary matter which speaks to patentability rather than exclusion. The UK-IPO issued a practice notice on 2 November 2006 detailing the new approach to patentable subject matter and instructing patent examiners to follow it with immediate effect. It means that an application is excluded from further consideration only if the subject matter falls wholly into one or more excluded category. If, when considering the test as a whole, a patent examiner believes that it would be fruitless to conduct a search then s/he can issue a report to this effect.

19. Discoveries, scientific theories and mathematical methods This category is thought to contain items which are too abstract or indistinct to be the proper subject of patent protection. The most interesting example is however, discoveries. Anton van Leeuwenhoek of Holland (1632-1723) is credited as being the father of microscopy. His invention of new methods to grind and polish lenses led him to be the first person to see and describe bacteria. Clearly he did not invent those bacteria but merely discovered them using an invention. Conversely, discoveries often lead to inventions. For example, Sir Alexander Fleming was working in 1928 on colonies of the bacterium Staphylococcus Aureus, which can be dangerous to humans, when a batch accidentally became contaminated by a mould that killed of the bacterium. This was penicillin – the first antibiotic – and further work by Fleming and others led to production of penicillin in large, high quality doses. A patent was eventually granted for a method of mass production of penicillin.

20. One of the problems that has been thrown up for the biotechnology industry has been the objection that attempts to patent biotechnological products in nothing more than an attempt to patent a living thing, that is something already pre- existing in nature and so merely a discovery. If human intervention can bring about a specific technical effect or application of discovery then the embodiment of that technical effect or application can be subject of a patent. Similarly, merely to find a naturally occurring substance is a pure discovery, but if you are able to put it to some tangible use, for example, as an antibiotic, then it may be patentable in respect to this technical effect. An invention requires some evidence of human ingenuity in realising a particular use for a discovery or in making it available to the public an a form which previously it was not. An element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element. A patent would not give a patentee any claim over naturally occurring elements within the human body.

21. Aesthetic creations Example of aesthetic creations are excluded include literary, dramatic, musical and artistic works. This should sound familiar as the realm of protection offered primarily by copyright. The principal reason why aesthetic creations are excluded is because they are not technical in nature and do not, normally, represent a technical contribution to our experiences. Their contribution lies elsewhere and their appreciation is entirely subjective. This is not to say that inventions cannot have aesthetic features, merely those features cannot form the basis of patent protection if their sole contribution is in the realm of aesthetics. If, however, an aesthetic feature produces a de facto technical effect, then it may be patentable.

22. Schemes, rules and methods for performing mental acts, playing games or doing business, and programs for computers Schemes, rules, and methods for performing mental acts, playing games or doing business are similarly excluded in the first instance because of their abstract or intellectual character. Much has been made in recent years, however, of the patentability of computer programs in Europe with a raft of conflicting EPO decisions and even a failed attempt to harmonise the position in a European Directive. Mental acts Examples of methods of performing mental acts include schemes for doing arithmetic, learning to read or speaking anew language. Similarly, a claim which merely lays out the steps for decision making or the performance of a particular task will be rejected.

23. Halliburton Energy Services v Smith International (North Sea) Ltd [2006] RPC 2 Patents of features of drill bits of drilling in rock Two claims Purely intellectual content Held that it was a method for performing a mental act and would be excluded or require redrafting

24. Fujitsu Ltd’s Application [1997] RPC 608 Applicant’s applied for UK patent claiming priority from an earlier Japanese application in respect of an invention for a Method and Apparatus for creating synthetic crystal structure images’ Conventional computer programmed to perform the act. Held that it was related to both a mental act and computer programme. It was relevant for the court that an significant amount of (human) input from an operator was required in order to carry out the task. Methods of solving a problem or providing advice remain examples of excluded methods of performing a mental act even if performed by a computer

25. Playing games The rules on patentability of games were recently shaken up by the decision in Shopalotto.com ltd’s Application. Shopalotto.com Ltd’s Application A computer apparatus configured to provide a lottery playable via the internet was unpatenable. Patentee argued that it should be considered a board game. No original contribution to the art. Just a computer game via web server.

26. Methods of doing business Innovative ways of tackling everyday business problems are not normally a patentable. These include new methods of bar- coding banking materials to improve customer services, display mechanisms on buses to let customers know if they are picking up or dropping of, a scheme to allow prisoners to trade sentence for corporal punishment, and a method to facilitate introductions between people wearing mutually recognisable artefacts, such as rings. The mantra is the same, does the invention make a technical contribution or not?

27. It was previously thought that the exclusion of a method of doing business referred to the conduct of an entire business endeavour, but this has been rejected by the court of appeal in Aerotel/Macrossan where it was held that there is no reason for such matters or completed transactions. Methods of doing business which solve technical problems can be patentable. This was confirmed by the European Patent office in Pension Benefit systems/Controlling pension benefits systems which related to a computer system that performed a number of pension-related tasks, including calculations speculation, and the control of the benefit system to ensure periodic payments to subscribers. It was technical in nature so therefore okay.

28. The UK-IPO Manual points out that many business arrangements implemented over the internet have been refused protection. These include: A method for offering personalised financial products over the internet A method of creating and distributing advertising material A system to allow a client to monitor progress made on a building site via the internet. A system for ordering food over the internet.

29. Computer programs Patents for computer programs and computer implemented inventions have received special attention in recent years. The current approach to their patentability has probably been best summed up by the Shopalotto.com’s Application: The real question is whether there is a relevant technical effect, or, more crudely, whether there is enough technical effect: is there a technical effect over ad above that to be expected from the mere loading of a program into a computer? Ask what it contributes to the art over and above the fact that it covers a programmed computer. If there is a contribution outside the list of excluded matter, then the invention is patentable, but only if the only contribution to the art lies in excluded subject matter, it is not patentable.

30. Presentations of information The concern of this exclusion is the content of information. No claim will be sustained if it relates solely to the expression of information or the conveyance of meaning. Patent law is not in the business of giving protection to pretty pictures, TV images, radio signals, books, sounds, diagrams, codes or symbols which derive their value from the meaning they convey to human beings. Any method or means of conveying information which is characterised only by the content of information will be excluded. It does not matter that some physical device or apparatus is used to convey the information nor that such advice or apparatus can be moved around.

31. Crawford v Jones [2005] EWHC 2417 (Pat) The application related to a display system for buses to indicate to passengers whether the bus was in picking-up or setting down only mode. The claims were Boarding and Exit Bus indicators, being visual or audible apparatus. Notwithstanding, the application was refused, inter alia, as solely a method of presentation of information. The only advance in the art was the nature of the information displayed on the front of the bus but this was not of a technical nature. If presentation of information is of a technical nature then it might be patentable!

32. Key points on exclusions under Article 52 It is essential to read the provisions of the law carefully. If we look back at Article 52(2) it states: “The following in particular shall not be regarded as inventions…” and Article 52(3) states: ‘The provisions of paragraph 2 shall excluded patentability of the subject – matter of activities referred to in that provision only to the extent to which a European patent application of European patent relates to such subject-matter or activities as such’. This means that the list of exclusions is non-exhaustive and indeed in the UK the Secretary of State has the power to expand it (s.1(5) of the Patents Act 1977) The as such qualification is extremely important. It means that only claims which fall squarely within a category of excluded matter will be struck down. Inventions which straddle patentable and non-patentable matter can survive if the technical features meet the other criteria for patentability.

33. Exceptions to patentability Morality, ordre public and plant and animal varieties It has sometimes been claimed that morality has nothing to do with patent law, but this is clearly nonsense. The decision whether or not to grant a patent is not some mechanist process which merely involves a checklist of technical details. Rather, it entails many nuanced considerations and value judgments on whether the numerous criteria for patentability have been met. The entire intellectual property system is based on fundamental notions of merit and justice concerning the appropriateness or otherwise of granting protection in the form of a monopoly. This is what the morality provision in patent law is about. Exploitation of the invention is the real problem. Morality is extremely subjective and the increasing presumption in favour of patentability have led the patent systems to view the provision narrowly.

34. Harvard/Oncomouse [1991] EPOR 525 The EPO allowed a patent on a transgenic animal that had been bred as a research tool for cancer studies despite objections that it was immoral to patent life, especially when the life was created simply to suffer. The benefit to mankind outweighed the suffering of these animals and as such was no bar to patent protection. Patent stood after 12 years of battle restricted to cover the exact special features of the mice. Abhorrent test these days!

35. Methods of treatment of the human or animal body EPC 2000 moves this provision from article 52(4) under EPC 1973 to Article 53(c). Previously, methods of treatment were excluded from protection because they were considered not capable of industrial application, and now they are specifically excluded as exceptions to patentability. This is unlikely to make any difference in practice, but it is thought to be excluded as exceptions to patentability. Not all methods of treating the human or animal body are excluded, only those related to ‘therapy’ and ‘surgery’

36. Therapy Therapy concerns the medical treatment of disease, including cure and prevention. The approach is the same whether we are considering animal or human bodies. The medical or veterinary nature of the treatment is an important determinant in deciding whether a claim falls foul of the provision. This is because the provision is designed so as not to hinder professionals in their job, therefore if the method can be performed by someone who does not have the specialised professional skills, it is more likely to imply that the method is patentable. By the same token, if a procedure requires professional oversight then the invention will normally fall within the exclusion.

37. Surgery Surgery involves any non-insignificant intervention on the body by operation or manipulation in an a attempt to maintain the life or health of the human or animal body. The law does not draw a distinction between therapeutic and non-therapeutic interventions, it is concerned only to know if the method of intervention is surgical in nature. Thus cosmetic surgery techniques are generally excluded as well as curative surgery. Moreover, ‘surgery’ enjoys a wide definition in the sense that it is not restricted to methods that involve a direct invasion of the body; hence the term manipulation covers non-invasive techniques such as re-setting of broken bones or repositioning. Once again, however, the need for technical skill and expertise in the performance of the method is a significant factor in establishing if the exclusion applies.

38. Question Do you think that the work of tattoo or piercing artists would count as ‘surgery’ under the law?

39. Diagnostic methods practised on the body There has been some confusion and dispute over the years about the precise meaning of the exclusion of diagnostic methods, and this has now been considered to clarify the subject matter. G01/04 Diagnostic methods, decision of 16 December 2005 This case involved a referral on a point of law from the president of the EPO to the enlarged Board of Appeal. In summary, the essential question was whether ‘diagnostic methods practised on the human or animal body’ excluded only those claims to methods containing all of the procedural steps necessary to a medical diagnosis. Only claims which encompass all of the steps required to come up with a definitive diagnosis are excluded from protection. Methods that may represent interim steps will be patentable if they do not lead to a diagnosis themselves.

40. Next week – Patents Continued