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INDUSTRIAL APPLICATION ART 52(1) / S1(1)(C): INVENTION MUST BE "CAPABLE OF INDUSTRIAL APPLICATION" Art 57: This means it "can be made or used in any kind of industry, including agriculture"Ensures that inventions have some practical application
3 ORIGINAL AREAS OF USE-
Methods of medical treatment o Now excluded under Art 53 instead Crackpot machines (e.g. cold fusion machines, perpetual motion machines) o Could also be rejected on grounds of lack of sufficient disclosure (cannot be reproduced in a working manner) Inventions that are not yet fully developed o E.g. early research milestones in biotechnology
? Research tends to be a very long pipeline
? One of the first developments is finding a new chemical or molecule
? At that stage, unclear what specific function it has and more research is required, but it is likely to be of significance
CONCERNS-Granting the patent to early might allow it to be used as a "mining licence" o This might slow scientific progress by blocking of an area o The patent owner might slacken pace of research after receiving the patent over the area Might result in unfair reward o The effort expended in hunting for the area might be less than the research required subsequently C.f. "prospect theory" o An inventor granted a patent for early milestones is better motivated to finish the invention since there is less risk for development o Inventors have more confidence in collaboration since they are assured of protection without having to keep it a trade secret o Other scientists are not excluded since there is the experimental use defence and compulsory licensing
ELI LILLY V HUMAN GENOME SCIENCES  UKSC 51 - JUST SHOW PLAUSIBLE BENEFIT.-
HGS discovered a new human protein neutrokine-a and the coding sequence for it o Member the TNF ligand superfamily, which are useful in inflammation and other immune responses o Specification described it as potentially useful for the diagnosis, prevention or treatment of a wide variety of immune disorders (no data as to which it would be) EL brought opposition proceedings against the European patent o Opposition Division held the patent invalid for lack of industrial application (Art 57)
o TBA overturned this decision EL also brought revocation proceedings in the UK o Before TBA decision, Kitchin J held that the patent was invalid for lack of industrial application (upheld by the CA despite the contrary TBA ruling) UKSC (Lord Neuberger): Lower courts failed to properly follow the principles laid out by TBA jurisprudence, the patent was valid o Purpose of patent is to "provide a temporary monopoly as an incentive to innovation, while at the same time facilitating the early dissemination of any such innovation through an early application" and publication o CA reasoning would require tests to show that the protein has therapeutic use
? This is expensive and difficult to keep secret before the application is made o Set out 15 general principles
? 3: "merely "speculative" use will not suffice"
? 4: Patent + common general knowledge must enable the skilled person to reproduce or exploit the invention
? 7: Absence of "experimental or wet lab evidence ... is not fatal"
? 8: "A "plausible" or "reasonably credible" claimed use, or an "educated guess", can suffice"
? 9: This can subsequently be confirmed by later evidence
? "Where the protein is said to be a family or superfamily member"
? 11: Can assign a role based on the common role of all known members
? 13: If the disclosure is "important to the pharmaceutical industry", the disclosure of the sequences of the protein and its gene may suffice, even though its role has not "been clearly defined" o Here, the disclosure of the existence and structure of the protein within a superfamily and its gene sequence was sufficient to satisfy Art 57
? All known members had certain functions with T-cells so neutrokine-a could be expected to have a similar role
? Just because the known members also had additional differing qualities doesn't mean that the common features are irrelevant o Although the drafting of the Patent was unsatisfactory, it would not "have diverted the notional addressees" (appropriately skilled person) from what they would otherwise think it meant o "the fact that further work was required to see whether the disclosure actually had therapeutic benefits does not, at least without more, undermine the validity" o "Just as it would be undesirable to let someone have a monopoly over a particular biological molecule too early, because it risks closing down competition, so it would be wrong to set the hurdle for patentability too high"
? Where the line should be drawn is a matter of policy UKSC (Lord Hope): CA standard of susceptibility to industrial application was "a more exacting one" than the TBA's o CA wrongly required that a "particular use for the product had actually been demonstrated", instead of that the product "had plausibly been shown to be usable" o Shouldn't look for an "immediate concrete benefit" beyond a "reasonable expectation that the molecule would be usable for the purposes of research work"
Everyone agreed that early research milestones are controversial and that Art 57 should be interpreted purposively to avoid granting mining licences Disagreements on what is required for a "real practical use" or application o Clearly had to include evidence of "reasonably credible" or "plausible" prediction of use (not merely speculative) o CA: Thought EPO reached a different conclusion because it had different evidence and procedure o UKSC: CA had not considered the idea that use in research is sufficient, which is indicated by EPO case law SO the UKSC approach is more lenient in allowing research use to satisfy the "industrial application" requirement
METHODS OF MEDICAL TREATMENT Previously excluded on the grounds of not being capable of industrial application-
EPC 2000 replaced the exclusion with a standalone provision in Art 53(c) o Excludes "methods for treatment of the human or animal body by surgery or therapy" and also "diagnostic methods practiced on the human or animal body" PA 1977 replicates this in s4A
Public policy justification-
EBA: Allow practitioners to take action by means of investigative methods without being inhibited by patents ISSUE (Bostyn): Doubtful whether this rationale is still of value o All other features of medicine are patentable, including the products used in such methods, so there is no reason to retain this historical exclusion SUPPORT (Sims): Patents for methods are unnecessary because they do not require the same expenditure to develop as pharmaceuticals o Disclosure may not be of the best method for performing the invention o There are sufficient other incentives such as recognition and publication, whereas patents would just increase the costs of healthcare
This exclusion has been interpreted extremely narrowlyStrong emphasis on the term "method" o Hence allowing for patenting of drugs and pharmaceuticals used in the method o New uses of a particular drug are also not considered methods
DISTINCTION BETWEEN THERAPEUTIC AND NON-THERAPEUTIC METHODS-
Du Pont (1987): Weight loss treatment was for cosmetic purposes only Salminen/Pigs III (1989): Blowing hot air at pigs to make them move out from under the mother and avoid suffocation was not a therapeutic method o Their behaviour "cannot be fairly regarded as a malfunction" Only methods of treatment by therapy are excluded
DIAGNOSTIC METHODS  EPOR 15-
Reference to EBA on the scope of "methods of diagnosis" exclusion EBA: Diagnostic methods must be interpreted narrowly o The method must include all steps of diagnosis o Since diagnostic methods are increasingly complex so that it becomes more difficult for practitioners "to have the means to carry them out", they will not be much more hampered by patents o 4 components to a diagnostic method (ALL must be present)
? Clinical examination (data collection)
? Comparison with standard values
? Finding significant deviation during the comparison
? Deductive medical or veterinary decision An analysis of a sample (e.g. blood or saliva) that is diagnosed in the lab is not a method practiced on the human body
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