Drafting of patent specifications post - Raising the Bar Dr Andrew Jones | Principal | Foundry Intellectual Prop

1. Drafting of patent specifications post - Raising the Bar Dr Andrew Jones | Principal | Foundry Intellectual Property

2. Overview • Why? What’s changed? • Old law • New law • But what does it mean? • IP Australia • Explanatory memoranda • UK and European legislation and case law • What do we need to be thinking about when drafting patent specifications under the new regime? • Case study

3. Why am I talking? • The Intellectual Property Laws Amendment (Raising the Bar) Act 2012 came into full force • on 15 April 2013 • The “New law” affects all patent specifications we now draft, including: • Provisional specifications • Complete specifications • Divisional specifications • What (if anything) needs to change?

4. Old law • Section 40 Specifications • (1) A provisional specification must describe the invention. • (2) A complete specification must: (a) describe the invention fully, including the best method known to the applicant of performing the invention; and (b) where it relates to an application for a standard patent—end with a claim or claims defining the invention; and (c) where it relates to an application for an innovation patent—end with at least one and no more than 5 claims defining the invention. • (3) The claim or claims must be clear and succinct and fairly based on the matter described in the specification. • (4) The claim or claims must relate to one invention only.

5. New law • Section 7A Meaning of useful • (1) For the purposes of this Act, an invention is taken not to be useful unless a specific, substantial and credible use for the invention (so far as claimed) is disclosed in the complete specification. • (2) The disclosure in the complete specification must be sufficient for that specific, substantial and credible use to be appreciated by a person skilled in the relevant art. • (3) Subsection (1) does not otherwise affect the meaning of the word useful in this Act.

6. New law • Section 40 Specifications • (1) A provisional specification must disclose the invention in a manner which is clear enough and complete enough for the invention to be performed by a person skilled in the relevant art. • (2)  A complete specification must: (a)  disclose the invention in a manner which is clear enough and complete enough for the invention to be performed by a person skilled in the relevant art; and (aa)  disclose the best method known to the applicant of performing the invention; and (b)  where it relates to an application for a standard patent—end with a claim or claims defining the invention; and (c)  where it relates to an application for an innovation patent—end with at least one and no more than 5 claims defining the invention. • (3)  The claim or claims must be clear and succinct and supported by matter disclosed in the specification. • (3A)  The claim or claims must not rely on references to descriptions or drawings unless absolutely necessary to define the invention. • (4)  The claim or claims must relate to one invention only.

7. Priority date • Old law: • Regulation 3.12 Priority dates generally • (1) Subject to regulations 3.13 and 3.14 and subregulation (2), the priority date of a claim of a specification is the earliest of the following dates: (a) the date of filing of the specification; (b) if the claim is fairly based on matter disclosed in 1 or more priority documents, the date of filing the priority document in which the matter was first disclosed; • …

8. Priority date • New Law: • Division 2—Priority date of claim • Regulation 3.12 What this Division is about • … • (4) In this Division, a document clearly discloses an invention if the document discloses the invention in a manner that is clear enough, and complete enough, for the invention to be performed by a person skilled in the relevant art. • Regulation 3.13C  Priority date for complete application associated with provisional application • (1)  This regulation applies to a claim if: (a)  the specification containing the claim that defines the invention was filed for a complete application that is associated with a provisional application under section 38 of the Act; and (b) a document mentioned in subregulation (2), or more than one of the documents mentioned in paragraph (2)(a) considered together, clearly discloses the invention in the claim.

9. In summary – Sufficiency • Out with the old – A complete specification mustdescribe the invention fully • Kimberly-Clark Australia Pty Ltd v Arico Trading International Pty Ltd [2001] HCA 8 • The question is, will the disclosure enable the addressee of the specification to produce something within each claim without new inventions or additions or prolonged study of matters presenting initial difficulty? • In with the new – A complete specification must disclose the invention in a manner which is clear enough and complete enough for the invention to be performed by a person skilled in the relevant art

10. In summary – Support • Out with the old – The claim or claims must be clear and succinct and fairly based on the matter described in the specification • Lockwood Security Products Pty Ltd v Doric Products Pty Ltd (2004) 212 ALR 1 • a comparison between the claims and what is described in the specification only, and it does not call for any inquiry into an "inventive step", or inventive "merit" or a "technical contribution to the art" • the question is whether there is a real and reasonably clear disclosure in the body of the specification of what is then claimed, so that the alleged invention as claimed is broadly, that is to say in a general sense, described in the body of the specification • a claim based on what has been cast in the form of a consistory clause is not fairly based if other parts of the matter in the specification show that the invention is narrower than that consistory clause. The inquiry is into what the body of the specification read as a whole discloses as the invention • In with the new – The claim or claims must be clear and succinct and supported by matter disclosed in the specification

11. But what does it mean? • What IP Australia said: • Section 7A – inserts the requirement that a specific, substantial and credible use for the invention is disclosed in the patent specification. These amendments will strengthen the test for usefulness and prevent the claiming of speculative inventions that would require further experimentation to put the invention into practice. • Paragraph 40(2)(a) – replaces the full description requirement with the requirement that the specification discloses the invention in a manner which is clear enough and complete enough for the invention to be performed by a person skilled in the relevant art. This better aligns the Australian requirement for disclosure in a complete specification with requirements elsewhere and ensures that the description provides sufficient information to make the invention across the full width of the claims. • Subsection 40(3) – replaces ‘fair basis’ with the requirement that the claims are fully supported by the description. This better aligns the Australian standards for claim scope with overseas standards.

12. But what does it mean? • What the Explanatory Memorandum said: • In order to meet its objective of supporting innovation, the patent system must strike a balance. It must provide sufficient protection to reward innovation, but not so much protection as to block future or follow-on innovation. Concerns have been raised that the thresholds set for the grant of a patent in Australia are too low, suppressing competition and discouraging follow-on innovation. Particular concerns have been raised that patents are granted for inventions that are not sufficiently inventive, and that the details of inventions are not sufficiently disclosed to the public.

13. Explanatory Memorandum - Utility • The item bolsters the existing requirement that the claimed invention be useful with the requirement that the invention has a specific, substantial and credible use. The intent is that specific, substantial and credible be given the same meaning as is currently given by the US courts and the US Patent and Trademark Office.

14. Explanatory Memorandum - Sufficiency • The item is intended to modify the wording of paragraph 40(2)(a) of the Act so as to require enablement across the full width of the claims, while adopting language that is consistent with that used in other jurisdictions. • … • The intention is that paragraph 40(2)(a) be given, as close as is practicable, the same effect as the corresponding provisions of UK legislation and the European Patent Convention.

15. Explanatory Memorandum - Support • A lengthy body of case law has developed interpreting the ‘fair basis‘ requirement, culminating in the High Court decision Lockwood Security Products Pty Ltd v Doric Products Pty Ltd. This decision clarified the application and operation of the fair basis requirement: the requirement being met where there is consistency between what is claimed and what the body of the specification read as a whole discloses as the invention. The High Court also noted that recent UK case law on ‘support’ is of no assistance in interpreting fair basis under the Australian patents legislation. • … • This item is intended to align the Australian requirement with overseas jurisdictions’ requirements (such as the UK). Overseas case law and administrative decisions in respect of the ‘support‘ requirement will be available to Australian courts and administrative decision-makers to assist in interpreting the new provision.

16. UK and EPC legislation • The Patents Act 1977 (UK): • Making of application • 14. (1) Every application for a patent - (a) shall be made in the prescribed form and shall be filed at the Patent Office in the prescribed manner; • … (2) Every application for a patent shall contain - (a) a request for the grant of a patent; (b) a specification containing a description of the invention, a claim or claims and any drawing referred to in the description or any claim; • … (3) The specification of an application shall disclose the invention in a manner which is clear enough and complete enough for the invention to be performed by a person skilled in the art. • … (5) The claim or claims shall - (a) define the matter for which the applicant seeks protection; (b) be clear and concise; (c) be supported by the description; and (d) relate to one invention or to a group of inventions which are so linked as to form a single inventive concept.

17. UK and EPC legislation • Article 83 EPC – Disclosure of the invention • The European patent application shall disclose the invention in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art. • Article 84 EPC – Claims • The claims shall define the matter for which protection is sought. They shall be clear and concise and be supported by the description.

18. UK and European case law • Sufficiency and support – the “consideration” in return for grant of a monopoly. • A complex area of patent law, and one that is very much dependent on the facts of each particular case. As such there are many, many UK and European cases that discuss sufficiency and support issues, all of which restate the general principals but then apply them to specific circumstances. • The old sufficiency requirement in Australia is not dissimilar to that in the UK and Europe, just much less onerous. • However, fair basis (post Lockwood v Doric) is only a small subset of the support requirement in the UK and Europe, which draws in many other (very subjective) issues.

19. UK and European case law – Sufficiency • Biogen Inc. v Medeva plc [1997] RPC 1 at [63]: • “… the specification must enable the invention to be performed to the full extent of the monopoly claimed.  If the [specification] discloses a principle capable of general application, the claims may be in correspondingly general terms.  The [applicant] need not show that he has proved its application in every individual instance.  On the other hand, if the claims include a number of discrete methods or products, the [applicant] must enable the invention to be performed in respect of each of them.” • The date at which the specification must disclose the invention in a manner which is clear enough and complete enough for the invention to be performed by a person skilled in the art is its filing date (Biogen).

20. UK and European case law – Sufficiency • T435/91 (Detergents/Unilever) • T0409/91 (Fuel oils) • Kirin-Amgen Inc v Hoechst Marion RousselLimited [2005] RPC 9 • …

21. UK and European case law – Sufficiency • Eli Lilly & Co. v Human Genome Sciences, Inc. [2008] RPC 29 at [239]: • The specification must disclose the invention clearly and completely enough for it to be performed by a person skilled in the art. The key elements of this requirement which bear on the present case are these: • i) the first step is to identify the invention and that is to be done by reading and construing the claims; • ii) in the case of a product claim that means making or otherwise obtaining the product; • iii) in the case of a process claim, it means working the process; • iv) sufficiency of the disclosure must be assessed on the basis of the specification as a whole including the description and the claims; • v) the disclosure is aimed at the skilled person who may use his common general knowledge to supplement the information contained in the specification; • vi) the specification must be sufficient to allow the invention to be performed over the whole scope of the claim; • vii) the specification must be sufficient to allow the invention to be so performed without undue burden.

22. UK and European case law – Enabling disclosure • “Principle capable of general application” • Kirin-Amgen Inc v. Hoechst Marion Roussel Limited [2005] RPC 9 at [112] and [113]: • This gave rise to a good deal of argument about what amounted to a "principle of general application". In my opinion there is nothing difficult or mysterious about it. It simply means an element of the claim which is stated in general terms. Such a claim is sufficiently enabled if one can reasonably expect the invention to work with anything which falls within the general term. • … • [T]he notion of a "principle of general application" applies to any element of the claim, however humble, which is stated in general terms. A reference to a requirement of "connecting means" is enabled if the invention can reasonably be expected to work with any means of connection. The patentee does not have to have experimented with all of them.

23. UK and European case law – Enabling disclosure • “Discrete methods or products” • Biogen – “…if the claims include a number of discrete methods or products, the [applicant] must enable the invention to be performed in respect of each of them.” • H. Lundbeck A/S v Generics (UK) Ltd [2008] RPC 19 at [34]: • [T]he law of sufficiency, both in the United Kingdom and in the EPO, is that a class of products is enabled only if the skilled man can work the invention in respect of all members of the class. The specification might show that this has been empirically demonstrated or it might disclose a principle which can reasonably be expected to apply across the class.

24. Enabling disclosure • Broad claims: • Where the claims encompass a broad field (for example, a broad class of products), an enabling disclosure may involve a number of generic method(s) of production (each enabling different subgroups within the broad field), or a number of examples or alternative embodiments or variations, sufficient to enable the person skilled in the art to perform the invention over the whole scope of the claims, without an unreasonable amount of trial and error.

25. Enabling disclosure • Claims defined by a function achieved: • Where the claim defines a class of functionally-defined products and the specification teaches a process for making a vast number of products that may or may not have the function as claimed, the disclosure will not be enabling for the claimed invention, unless it teaches the person skilled in the art how to ascertain which of the products actually has the required properties. Where such a screening method is provided, a further consideration is whether the time required to screen every product would impose an undue burden on the person skilled in the art.

26. Enabling disclosure • Synergy: • Synergism between compounds is unpredictable in nature and not all combinations of any two or more compounds will necessarily exhibit this property.  Consequently, where the specification claims a synergistic combination and the specification contains little or no guidance on, for example, appropriate concentrations or ratios of the compounds that will provide the synergistic result, it may impose an undue burden on the person skilled in the art to test all possible combinations to determine those that fall within the scope of the claims.

27. UK and European case law – Undue burden • The specification must be sufficient to allow the invention to be so performed without undue burden. • Eli Lilly & Co. v Human Genome Sciences, Inc. [2008] RPC 29 at [241]: • The question whether a burden is undue must be sensitive to the nature of the invention, the abilities of the skilled person and the art in which the invention has been made. The court must consider whether the effort required of the skilled person is undue having regard to the fact that the specification should explain to him how the invention can be performed. Each case must be decided on its own facts.

28. UK and European case law – Undue burden • Kirin-Amgen Inc v Hoechst Marion Roussel [2005] RPC 9 at [128] • T0226/85 (Stable bleaches) • T722/95 (Cellulose/WEYERSHAEUSER) • …

29. UK and European case law – Support • T0409/91 (Fuel oils): • Art. 84 EPC also requires that the claims must be supported by the description, in other words it is the definition of the invention in the claims that needs support. In the Board's judgment, this requirement reflects the general legal principle that the extent of the patent monopoly, as defined by the claims, should correspond to the technical contribution to the art in order for it to be supported, or justified. This means that the definitions in the claims should essentially correspond to the scope of the invention as disclosed in the description. In other words, the claims should not extend to subject-matter which, after reading the description, would still not be at the disposal of the person skilled in the art.

30. UK and European case law – Support • Biogen Inc. v Medeva plc [1997] RPC 1 at [57]: • [F]or matter to be capable of supporting an invention … it must contain an "enabling disclosure," that is to say, it must disclose the invention in a way which will enable it to be performed by a person skilled in the art. • at [71]: • This shows that there is more than one way in which the breadth of a claim may exceed the technical contribution to the art embodied in the invention. The patent may claim results which it does not enable, such as making a wide class of products when it enables only one of those products and discloses no principle which would enable others to be made. Or it may claim every way of achieving a result when it enables only one way and it is possible to envisage other ways of achieving that result which make no use of the invention.

31. UK and European case law – Support • H. Lundbeck A/S v Generics (UK) Ltd [2008] RPC 19 at [30]: • “Inventive concept” is concerned with the identification of the core (or kernel, or essence) of the invention—the idea or principle, of more or less general application which entitles the inventor's achievement to be called inventive. The invention's technical contribution to the art is concerned with the evaluation of its inventive concept—how far forward has it carried the state of the art? • And, at [60-62], a warning about claims to “desirable ends”.

32. Test for support in Australia • A two-step test (based on Biogen) will be applied by Examiners at IP Australia : • Does the body of the specification provide an enabling disclosure of the invention defined by the claims (this is the same test as for s40(2)(a))? • Is the extent of the monopoly claimed broader than is justified based on the description of the invention in the body of the specification and its contribution to the art?

33. UK and European case law – Support • EPO Guidelines for Examination – 6.2 Extent of generalisation • The extent of generalisation permissible is a matter which the examiner must judge in each particular case in the light of the relevant prior art. Thus an invention which opens up a whole new field is entitled to more generality in the claims than one which is concerned with advances in a known technology. A fair statement of claim is one which is not so broad that it goes beyond the invention nor yet so narrow as to deprive the applicant of a just reward for the disclosure of his invention. The applicant should be allowed to cover all obvious modifications of, equivalents to and uses of that which he has described. In particular, if it is reasonable to predict that all the variants covered by the claims have the properties or uses the applicant ascribes to them in the description, he should be allowed to draw his claims accordingly.

34. Drafting tips • These tips may or may not be relevant to your daily practice – the patent specifications causing the angst are almost 20 years old and drafting practice has moved on, especially when many patent attorneys will already be drafting specifications to a European/US standard anyway. However, it can’t hurt to bear the following in mind when drafting. • As always, it’s a balancing act – seeking the broadest possible protection, but on a budget with only a certain amount of information readily to hand…

35. Drafting tips • Anticipate sufficiency and support requirements and draft accordingly: • Is what I am claiming a “principle of general application”? • Am I claiming discrete methods or products, each of which will need enabling? • If so, how will I enable each of them? • What is the minimum number of examples I am going to need to enable broad claims? What will these examples need to teach the skilled addressee? Is the client going to hate me? • Make sure that your description does indeed enable the invention (i.e. nothing is missing) • Don’t infer that a reasonable prediction could be made – explicitly state it! • Factor support/sufficiency into your consideration of how broadly to claim the invention • Include supportable fall back positions/dependent claims

36. Drafting tips • Ask yourself what is the technical field of the invention, who would be the person skilled in the art and what sort of contribution to the art does the invention make? Consider whether it would be worthwhile including a discussion of this in the specification (bearing in mind, of course, that “the invention” may change during examination). • Whilst a person skilled in the art can use their common general knowledge to “fill any gaps” in the specification, consider whether it might be worthwhile including additional subject matter in the specificationto pre-emptively plug those gaps – it may be better not to have to argue with an Examiner or in a Court whether such-and-such is or is not part of the common general knowledge.

37. Drafting tips • Functional claims are OK, and will be treated in the same manner as all other claims. However: • Describe as many different embodiments as possible which could be used to provide the function. • Ensure that, based on your description, a reasonable prediction can be made that all embodiments of the claims are enabled/supported. Say this in the specification (it is then for the other side to refute). • Describe what tests/experiments would be required to determine whether something meets the functional requirements and falls within the scope of the claims. Make sure this is not too burdensome.

38. Drafting tips • Claiming by result is OK in some circumstances, but be prepared to include lots of examples and have good fall-back positions. • Undue burden is your enemy – pre-empt this as best you can. • Describe how a person skilled in the art could confirm that the result has been achieved. • Describe how features of the claims might be chosen in order to increase the likelihood of the result being achieved. • Describe as many different ways as possible which could be used to provide the result.

39. Drafting tips • Ensure that your dependent claims are also enabled (you never know what will be your broadest surviving claim). • Intermediate generalisations will provide support for dependent claims. • Describe each feature separately and in a generic sense with respect to the invention. • Describe the purpose of the features of dependent claims and any additional advantages they may provide.

40. Case study • Australian patent no. 702534 – Lockwood Security Products Pty Limited • 1. A latch assembly including, a casing, a latch bolt mounted on the casing so as to be movable relative thereto between an extended latching position and a retracted release position, a first actuator operable from an inner side of the assembly to cause movement of the latch bolt to said release position, locking means operable from said inner side of the assembly to adopt an active condition and thereby render said first actuator inoperable, a second actuator operable from an outer side of the assembly to cause movement of the latch bolt to the release position, and lock release means which is responsive to said operation of the second actuator so as to thereby render said locking means inactive.

41. Case study • According to the present invention, a latch assembly of the foregoing kind is characterised in that it includes lock release means which is responsive to operation of the second actuator to render the locking means inactive. • … The locking means preferably includes at least one cam controlled detent which is movable between actuator locking and actuator release positions. It is also preferred that the lock release means is operable to influence the detent cam in a manner such that operation of the second or outer actuator causes the detent cam to move to a position corresponding to the actuator release position of the detent. The cam may be spring biased towards that corresponding position, and retaining means may be operable to allow or prevent such movement according to whether or not, respectively, the second actuator is operated.

42. Case study • Old law: • s40(2)(a) invention described fully?  (At least by implication) • s40(3) Fairly based?  (So said the highest Court in the land) • New law: • s40(2) is the invention described in a manner which is clear enough and complete enough for the invention to be performed by a person skilled in the relevant art? • s40(3) is the invention supported? • What might be needed to meet these requirements under the new law?

43. Case study • What would have happened to this claim in the UK or in Europe? • …

44. Lockwood’s UK claim 1

45. Useful resources • IP Australia’s Patent Manual of Practice & Procedure • Section 2.11.3A Clear Enough and Complete Enough Disclosure • Section 2.11.7A Support for the Claims UK Manual of Patent Practice • Sections 14.72 to 14.90 – Completeness of Disclosure • Sections 14.142 to 14.156.1 – Support by the Description EPO Guidelines for Examination (part F) • Chapter III – Sufficiency of disclosure • Chapter IV – Claims (Part 6. Support in description) Explanatory Memorandum Patent Law in Australia (Second Edition), by Colin Bodkin British and Irish Legal Information Institute (www.bailii.org)

46. Contact Details Dr Andrew Jones Australian and New Zealand Patent Attorney Principal |Foundry Intellectual Property (02) 9564 6171 andrew@foundryip.com.au| www.foundryip.com.au