Patenting: patentability requirements, patent drafting, patent prosecution

Transcription

1 Università di Trento Crash Course May 2018 Patenting: patentability requirements, patent drafting, patent prosecution Silvia Valenza Chemistry PhD Qualified Italian and European Patent Attorney

2 Content Introduction to IP rights Focus on patents Patentability requirements Patentable subject-matters Novelty Inventive step Suffciency of disclosure Patent drafting Patenting procedure

3 Introduction to IP rights

4 One product, many IP rights Trade marks NOKIA Product "208" Start-up tone Patents and utility models Data-processing methods Operating system Operation of user interface Copyright Software User manuals Ringtones Start-up tone Images Nokia Corporation Designs Form of overall phone Arrangement and shape of buttons Position and shape of screen Trade secrets Some technical know-how kept "in-house" and not published

5 Overview of intellectual property Legal right What for? How? Copyright Original creative or artistic forms Exists automatically Trade marks Distinctive identification of products or services Use and/or registration Registered designs External appearance Registration* Trade secrets Valuable information not known to the public Reasonable efforts to keep secret Patents New inventions Application and examination

6 Advantages and disadvantages of patenting Advantages Exclusivity enables investment and higher returns on investment Strong, enforceable legal right Makes invention tradable (licensing) Disdvantages Reveals invention to competitors (after 18 months) Can be expensive Patent enforceable only after grant (this can take 4-5 years)

7 Alternatives to patenting Information disclosure (publishing) Cheap Does not offer exclusivity Prevents others from Reveals the invention to patenting the same invention competitors Cheap (but there is the cost of maintaining secrecy) Does not reveal the invention Secrecy (creating a trade secret) No protection against reverseengineering/duplication of invention Difficult to enforce "Secrets" often leak quite fast No effort required Do nothing Does not offer exclusivity Competitors will often learn details

8 How patents are used Protecting products and processes Increasing turnover and profits Attracting investors Licensing Cross-licensing Blocking competitors Building reputation

9 Licensing income of US universities

10 Focus on what is a patent

11 What is a patent? Patents are granted in nearly every country in the world! A patent is an exclusive right granted by a State for an invention that is new, involves an inventive step and is capable of industrial application A legal title which grants the holder the exclusive right to prevent others from making, using or offering for sale, selling or importing a product that infringes his patent without his authorisation PATENT OWNER S PRERMISSION (except for private use or academic research)

12 What right a patent gives not? It is important to note that a patent does not grant the owner the FREEDOM TO OPERATE or the right to exploit the technology covered by the patent but only the right to exclude others. While this may seem a subtle distinction, it is essential in understanding the patent system and how multiple patents interact. In fact, patents owned by others may overlap, encompass or complement you own patent. You may, therefore, need to obtain a license to other people s invention in order to commercialize your own patented invention and viceversa

13 Legal monopoly A patent is an exclusive right granted by a State Nature of the monopoly: Limits of right Territorial in the country for which the patent was granted Duration for a limited time (up to 20 years from the filing date). Technical scope wording of the claims defines the boundaries of the right

14 Patent bargain The disclosure of the invention is the price to be paid for the monopoly In return of finite period of exclusivity in your invention, you disclose it to the public patent offices publish applications after 18 months. At this stage they become visible to everyone. so that others can learn from it and improve upon it Reveal invention (disclosure) Patent applicant Get exclusivity (patent) Public The idea behind the patent system of the world is to encourage not just innovation, but the sharing of innovation.

15 Much information only available in patents Published elsewhere Published in patents 80% found only in patents! Where do secretive competitors publish their R&D?

16 Solutions found in patent documents 90% Free to use 10% Protected You can find many great solutions for free!

17 Fare clic per modificare lo stile del titolo Patentability requirements

18 What exactly can be patented? Patents protect inventions which solve technical problems: chemical substances, pharmaceuticals processes, methods, uses products, devices, systems For an invention to be patented, it must usually be new to the world (i.e. not available to the public anywhere in the world) inventive (i.e. not an "obvious" solution), and susceptible of industrial application In most countries, patents are not granted for business methods or rules of games as such, or for methods of treatment, diagnostics and surgery on the human or animal body.

19 Non patentable subjects Discoveries, scientific theories & mathematical methods Aestethic creations Schemes, rules and methods for performing mental acts Computer programs Invention that may affect public order, good moral or public health Diagnostic, therapeutic and surgical methods of treatment for humans or animals This esclusion is valid for Europe but not for US. The reasoning behind this is that medical practitioners should not be hindered in their work by commercial evils such as patents.

20 Categories of inventions Product inventions new chemical compound(s) A new isomer (of a known compound) A new polymorph (of a known compound) A new formulation or composition New chemical intermediate Process inventions New method for synthesising a compound New method for purifiying or separating New method for analysing, testing or measuring something (eg. Screening assays) New use of a known compound Eg. Second medical use

21 Pharma-biotech products Molecular assays (diagnosis, typization etc) Cellular assays (drug screening) Microorganisms Genetically modified microorganisms cells/animals/plants Drug candidates Engineered molecules (antibodies, hormones)

22 Patentability requirements Invention = new and inventive solution to a technical problem An invention must meet several requirements to be eligible for patent protection: Consist of a patentable subject of matter Is new (novelty requirement) Involves an inventive step (non-obviousness requirement) Is disclosed in a clear and complete maner in the patent application (sufficiency of disclosure)

23 NOVELTY

24 What is a "new" invention? New at the date of filing the patent application New if it does not form part of the "state of the art" "State of the art" means everything made available to the public by means of a written or oral description, by use, or in any other way, before the date of filing of the patent application.

25 ABSOLUTE NOVELTY there are no restrictions whatever as to. the geographical location where or the language or the manner in which the relevant information was made available to the public; also no age limit is stipulated for the documents or other sources of the information One single person (if skilled) is public

26 Written disclosures Papers Patents applications Also those still secret but filed before the filing date of the application Internet Letters/ s Posters Abstracts Thesis

27 Oral disclosures Lecture to a conference Thesis discussion Meeting (at least two persons) a conversation or a lecture or by means of radio, television or sound reproduction equipment (tapes and records)

28 Use or any other ways use producing, offering, marketing or exploiting a product; applying a process or in any other way such as Displays, demonstrations at exhibitions or in television also includes all possibilities which technological progress may offer Prior use test: When, What, How, Where, by Whom

29 What not to do when considering filing a patent application No publication prior to filing e.g. no article, press release, conference presentation/poster/proceedings or blog entry No sale of products incorporating the invention prior to filing No lecture or presentation prior to filing except under a non-disclosure agreement (NDA) Seek patent professional advice soon! File before others do!

30 Examination of novelty 1. Defining the state of the art 2. Determining the content of the relevant prior art 3. Ascertaining whether the invention in question differs from the prior art. Prior art Prior art Prior art Prior art Prior art An invention (as defined by claims)

31 NOVELTY This first patentability criterion is reasonably objective and straightforward Each piece of prior art must be considered individually It is not permissible to combine separated items of prior art together i.e. the disclosure of a document must be considered in isolation It is also not permissible to combine separate embodiments described in a single document (unless the combination is specifically suggested). If several elements are disclosed in one document, but not as a combination, the combination is new

32 Conformance of all features An invention lacks novelty if,and only if, there is a complete conformance of all the features of the invention and one prejudicial disclosure. The claims which define the invention are compared to the state of the art (in the examples or detailed description) Photographic identity Equivalent wording Provided none of the prior art describes precisely what you have done, and at least one difference can be identified, then your invention would be regarded as novel. If there are no differences, then the invention lacks novelty and so will be not patentable

33 GENUS vs SPECIE In considering novelty, it should be borne in mind that a generic disclosure does not usually take away the novelty of any specific example falling within the terms of that disclosure, but that a specific disclosure does take away the novelty of a generic claim embracing that disclosure EXAMPLE: disclosure of copper takes away the novelty of metal as a generic concept (but not the novelty of any metal other than copper). EXAMPLE: disclosure of rivets takes away the novelty of fastening means as a generic concept (but not the novelty of any fastening other than rivets). EXAMPLE: disclosure of the subset "vegetables deprived the wider set "fruits and plants" of novelty.

34 Selection invention Selection inventions deal with the selection of individual elements, sub-sets, or sub-ranges, which have not been explicitly mentioned, within a larger known set or range. Criteria for novelty: narrow sub-range, sufficiently far removed from the preferred embodiments and the end points, the technical effects in the sub-range different from those in the broad range (purposive selection, new technical teaching) A * B A * B A B NOVEL A B Not NOVEL

35 Selection invention A selection from a single list of specifically disclosed elements does not confer novelty. However, if a selection from two or more lists of a certain length has to be made in order to arrive at a specific combination of features then the resulting combination of features, not specifically disclosed in the prior art, confers novelty (the "two-lists principle"). Examples of such selections from two or more lists are the selection of: (a) individual chemical compounds from a known generic formula whereby the compound selected results from the selection of specific substituents from two or more "lists of substituents given in the known generic formula. The same applies to specific mixtures resulting from the selection of individual components from lists of components making up the prior art mixture; (b) starting materials for the manufacture of a final product; (c) sub-ranges of several parameters from corresponding known ranges.

36 Implicit disclosure A document discloses not only subject-matter therein expressly described but also any implicit features which is, to a person skilled in the art, derivable directly and unambiguously. EXAMPLE: use of a rubber as an elastic mean take away novelty of use of an elastic material. EXAMPLE: a known process for the production of a chemical substance takes away novelty of a claim directed to the substance

37 Implicit features Mould for molten steel having an Y shape Prior art: an ice tray having an Y shape Prior art takes away the novelty? No: the materials used in the known application is not compatible with the new one

38 Novel use Use of substance X as an agent for reducing friction [known as a rust-inhibitor] ARE THESE CLAIMS NOVEL? [known as a growth-regulator] Use of substance Y as a fungicide The (new) technical effect associated with the new use is the distinguishing (functional) technical feature USE CLAIMS PROCESS/METHOD CLAIMS

39 Purpose related limitations for claims directed to a physical entity (i.e. product claim), non-distinctive characteristics of a particular intended use should be disregarded. EXAMPLE: Substance X is known as a dye Claim: Substance X for use as a catalyst Claim is NOT NOVEL unless the use referred to implies a particular form of the substance (e.g. the presence of certain additives) which distinguishes it from the known form of the substance. Claim: Use of substance X as a catalyst Claim is NOVEL (second non-medical use)

40 1st medical use methods of treatment, diagnostics and surgery on the human or animal body are excluded from patentability in EP (but not in US) However is patentable any substance or composition, comprised in the state of the art, for use in a method as above, provided that its use for any such method is not comprised in the state of the art. FIRST MEDICAL USE: A claim to a known substance or composition for the first use in surgical, therapeutic and/or diagnostic methods should be in a form such as: " Substance X for use as a medicament", or " Substance X for use as a therapeutic agent " or " Substance X for use as an active pharmaceutical ingredient (API) or " Substance X as an antibacterial agent " or " Substance X for treating disease Y". In the above examples X is already known for an application in a different field than the medical field.

41 2nd medical use If a specific substance X is already known in the medical field but not yet for the specific disease Z. Drafting of a second medical use : Substance or composition X for use in treatment of disease Z. Non allowable drafting of a second medical use: "Use of substance or composition X for the treatment of disease Y..." will be regarded as relating to a method for treatment explicitly excluded from patentability. In US Use claims are not accepted, neither purpose related limitation to product claims Claim: A method for treating disease Z, said method comprising administering an effective amount of substance X to a subject in need thereof

42 Product, process and product-by-process If a product is new the process for making it is automatically new a new process for making a product does not render the product new If a new product cannot be described in term of structural features it can be described/claimed as a product-by-process (provided that it is novel and inventive i.e. it could be distinguished over the prior art) A higher degree of purity does not render a substance new Unless you can prove that the previous attempts for obtaining a particular degree of purity by conventional purification processes have failed

43 Examination of novelty 1. Defining the state of the art 2. Determining the content of the relevant prior art 3. Ascertaining whether the invention in question differs from the prior art. Prior art (A) Prior art (A) Prior art (A) Prior art Prior art Prior art (Y) (X) Prior art (Y) (X) Invention (as defined by claims)

44 INVENTIVE STEP

45 Inventive step Novelty and inventive step are different criteria. The question "is there inventive step?" only arises if the invention is novel. An invention is considered to involve an inventive step (or to be nonobvious) when, relatively to the prior art, the invention would not be obvious to a person skilled in the particular field of technology. The term "obvious" means that which does not go beyond the normal progress (natural evolution) of technology but merely follows plainly or logically from the prior art, i.e. something which does not involve the exercise of any skill or ability beyond that to be expected of the person skilled in the art.

46 The person skilled in the art should be presumed to be a skilled practitioner in the relevant field of technology, who is possessed of average knowledge and ability and is aware of what was common general knowledge in the art at the relevant date He should also be presumed to have had access to everything in the "state of the art", in particular the documents cited in the search report, and to have had at his disposal the means and capacity for routine work and experimentation which are normal for the field of technology in question.

47 Inventive step Inventive step is a clearly subjective criterion; what may be obvious to one person may not be obvious to another. This is perhaps one of the most difficult matter that patent professional have to face with What is not qualified as inventive: Mere change of size Making a product portable The reversal of parts The change of material The mere substitution by an equivalent part or function

48 EPO assessment of inventive step In order to assess inventive step in an objective and predictable manner, EPO applies the so-called "problem-and-solution approach": CLOSEST PRIOR ART Distinguishing features TECHNICAL PROBLEM Tecnical effect? Obvious SOLUTION? Prior art (X)

49 problem-and-solution approach (i) determining the "closest prior art generally that which corresponds to a similar use and requires the minimum of structural and functional modifications to arrive at the claimed invention (ii) establishing the "objective technical problem" to be solved identify the distinguishing feature(s) of the claimed invention in terms of features (either structural or functional) between the claimed invention and the closest prior art, identify the technical effect resulting from the distinguishing feature(s), and then formulate the technical problem (iii) considering whether or not the claimed invention, starting from the closest prior art and the objective technical problem, would have been obvious to the skilled person.

50 Inventive step In the context of the problem-solution approach, it is permissible to combine the disclosure of one or more documents, parts of documents or other pieces of prior art (e.g. a public prior use or unwritten general technical knowledge) with the closest prior art. Relatively good arguments for inventive step or non-obviousness are: Unexpected (good) results A clear technical advantage over prior art Synergistic effect Against technical teaching Long felt need for a solution to the problem Overcoming a technical prejudice Commercial success For being inventive an invention need to result surprising

51 Fare clic per modificare lo stile del titolo PATENT DRAFTING

52 The two function of a patent document A patent document whether a published patent application or a granted patent serves two distinct functions: It discloses (describes) an invention It defines the scope of the legal monopoly According to the national law of most countries a patent application must disclose the invention in a manner sufficiently clear and complete for the invention to be reproduced by a person skilled in the specific technical field. In some countries, patent law requires that the inventor discloses the «best mode» for practising the invention. Wording is an hybrid betwen Technical-scientific Legal

53 PATENT APPLICATION STRUCTURE

54 Content of patent Bibliographic information Inventor, proprietor, date of filing, technology class, etc. Abstract Around 150 words as a search aid for other patent applications Description Summary of prior art (i.e. the technology known most similar to the invention) The problem that the invention is supposed to solve A detailed explanation and at least one way of carrying out the invention (i.e experimental section) Claims Define the extent of patent protection Drawings Illustrate the claims and description

55 CLAIMS The application must contain "one or more claims". These must: (i) "define the matter for which protection is sought"; (ii) "be clear and concise"; and (iii) "be supported by the description". Since the extent of the protection conferred by a European patent or application is determined by the claims (interpreted with the help of the description and the drawings), clarity of the claims is of the utmost importance

56 Sufficiency of disclosure A detailed description of at least one way of carrying out the invention must be given. the description must disclose any feature essential for carrying out the invention in sufficient detail to render it apparent to the skilled person how to put the invention into practice. A single example may suffice, but where the claims cover a broad field, the application should gives a number of examples or describes alternative embodiments or variations extending over the whole area protected by the claims. the "whole area claimed" is to be understood as substantially any embodiment falling within the ambit of a claim.

57 Sufficiency of disclosure (biotech) If an invention involves the use of biological material that is not available to the public and which can not be described in the patent application so as to allow the invention to be reproduced by a person skilled in the art, so that the requirement of the sufficiency of description: no later than the date of filing of the application, a sample of the biological material must have been deposited with a depository institution recognized in the Budapest Treaty of 28 April 1977; must be available on request to any person from the date of publication of the European patent application, the depository institution and the register number of the biological material deposited are indicated in the application the application filed provides all the relevant information available to the applicant on the characteristics of the biological material;

58 Categories of claims PRODUCT /APPARATUS Chemical compound or a mixture of compounds physical entity (e.g. object, article, apparatus, machine, or system of co-operating apparatus PROCESS/USE/method applicable to all kinds of activities exercised upon material products, upon energy, upon other processes (as in control processes) or upon living things For many inventions, claims in more than one category are needed for full protection. the use of substance X as an insecticide equivalent to "a process of killing insects using substance X"

59 Independent and dependent claims A patent application will have one or more "independent" claims directed to the essential features of the invention (those necessary for achieving a technical effect underlying the solution of the technical problem). A compound of formula (I) Any such claim may be followed by one or more claims concerning "particular embodiments" of that invention. Any claim which includes all the features of any other claim is termed a "dependent claim Compound according to claim 1 wherein

60 comprising" vs. "consisting" In patent language the word "comprising requires to be interpreted by the broader meaning: "including", "containing" or "comprehending thus not excluding the presence of any additional component On the other hand, the terms "consisting of components A, B and C exclude the presence of any additional component

61 Inventor/researcher input for patent drafting Prepare an experimental part Which discloses any feature essential for carrying out the invention in sufficient detail to render it apparent to the skilled person how to put the invention into practice Highlight the distinguishing and the essential (structural) features of your invention Highlight the surprising results or the effects/advantages associated to the distinguishing/essential features Try to generalize your experimental part Think about alternatives features (which could still work) Think about ranges and preferred sub-ranges (T, concentrations, ph, times, etc) Prepare a brief description of the state of the art If possible identifying the closest prior art (possibly 1 or two pieces of prior art) Leave the claims drafting to the patent attorney

62 Patent procedure and territorial right

63 Key people in the patent application procedure Patent examiner Applicant Representative, either: a professional representative who is on a list maintained by the EPO (on national patent office) or a legal practitioner entitled to act in patent matters

64 Where to apply for a patent National patent offices National patent valid only in the country where it is granted Non-residents can also apply for a patent One year of "priority" for subsequent applications European Patent Office A European patent is equivalent to national patents in the countries where it is granted (the applicant chooses the countries) Via the Patent Cooperation Treaty Just one application for up to 152 countries After the initial application phase, the international application leads to multiple national patent examination procedures Decisions with cost implications can be delayed until months after filing (e.g. choice of countries to file in) There is no such thing as an international patent!

65 The patent procedure at the UIBM Publication of application Application Filing Search report Reply to Serch Report Grant Annuity fees 9 months 18 months Withdraw? 21 months Approx. 3 years

66 The patent procedure at the EPO Application filing 6 months Search report A publication Publication of application B publication Publication of grant IT GB DE FR ES AT PT Validation (38+2 countries) Opposition period expires 18 months Withdraw? Examination Approx. 3-5 years 9 months

67 The PCT procedure (as first filing) PCT first filing/ priority date 6 months Search report 18 months Publication of application IPRP EP US CN AU JP CA Withdraw? Chapter I (ISR+WO) Chapter II (optional) months

68 The PCT procedure (as estention filing) National 1st Filing Search report Publication Reply to Serch Report Grant 12 months (priority period) PCT filing Foreign filings Publication of application Extra-PCT countries IPRP EP US CN JP CA National phases AU Chapter I (ISR+WO) Chapter II (optional) months

69 PCT 152 contracting states There is no such thing as an international patent!

70 Extra-PCT countries Most relevant non-contracting states Argentina 600 b$ g.d.p. Venezuela 440 b$ g.d.p. Pakistan 240 b$ g.d.p. Kuwait 180 b$ g.d.p. Bangladesh 130 b$ g.d.p.

71 Multinational patents EPO 38 european countries (+2) EAPC 8 euro-asian countries OAPI 17 african French speaking countries ARIPO 19 african English speaking countries GCC 6 asian countries

72 18 months publication = A publication Publication number eg. WO Bibliographic data published Invention disclosed & publicly available eg. in the hands of competitors Prior art effects Eg. Can be cited against your own future application provisional protection Deterrent for competitors not yet granted claims may yet change Infringers can t yet be sued A1 Publication with ISR A2 Publication without ISR A3 Publication of ISR

73 New publication number Claims as granted Often different to A claim Infringer can be sued

74 Patentability vs Fredom-to-operate PATENTABILITY Is what you want to patent described anywhere in the text of the document? It has to be described in sufficient detail to allow the average skilled reader to put the idea into practice. It also has to be specifically mentioned, not merely embraced by a generic disclosure. In order to answer this question ignore the claims of the document Better to look at the mother document = A publication FREEDOM-TO-OPERATE Is what you want to do within the wording of the patent claims? For this purpose the description and examples are largely irrelevant Patent must be granted, enforced and valid Look at B publications

75 Thank you for your kind attention Silvia Valenza PhD Chemistry Qualified Italian and European Patent Attorney