Federal Court Offers Little Insight on How Far the Bar Has Been Raised on the Standard of Disclosure in Patent Specifications

Last week I wrote about a recent Australian Federal Court decision on patent-eligibility of a computer-implemented invention, Encompass Corporation Pty Ltd v InfoTrack Pty Ltd [2018] FCA 421.  There is, however, a further aspect to this decision that may turn out to be of greater significance because, in addition to attacking Encompass’ patents on subject matter and novelty grounds, InfoTrack also sought to have the patents invalidated on the basis that the disclosure in the specification was deficient under the requirements of section 40 of the Patents Act 1990.  I believe that this is the first time that the current provisions, since commencement of the Intellectual Property Laws Amendment (Raising the Bar) Act 2012, have received substantive judicial consideration.  Furthermore, given that the decision has been appealed by Encompass (case no. NSD734/2018), and a Notice of Contention filed by InfoTrack, it seems highly likely that the post-Raising the Bar provisions of section 40 will soon be reviewed by a Full Bench of the Federal Court of Australia.  If so, then we may find out just how far the bar has actually been raised on the disclosure requirements.

The former version of section 40 required, among other things, that a patent specification ‘describe the invention fully’, and that the patent claims defining the invention must be ‘fairly based on the matter described in the specification’.  Over time, the courts interpreted these provisions as, in most cases, requiring only that the description should enable a person of ordinary skill in the relevant field to implement something falling within the scope of the claims without further invention, and should provide a ‘real and reasonably clear disclosure’ of the invention that is broadly consistent (or, at least, not inconsistent) with what is claimed.  In practice, this was a pretty low bar that generally allowed applicants to make relatively broad claims despite possibly having disclosed only a single, specific, implementation of an invention.

By comparison, the current version of section 40 requires that a patent specification ‘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 that the claims must be ‘supported by matter disclosed in the specification’.  The intended effect of these changes is, firstly, to require that the description provide sufficient information to enable the skilled person to perform the invention across the full scope of the claims and, secondly, that the scope of the claims should not be broader than is justified by the extent of the disclosure and the contribution made by the invention.  While these intentions are not necessarily apparent from the wording of the provisions, the idea is that they are implied through the use of similar terminology to that used in other jurisdictions (particularly Europe and the UK), as indicated in the Explanatory Memorandum that accompanied the Raising the Bar legislation.

If the changes to the law achieve their intended effects, then the standard of disclosure required, and the concurrence of the relationship between the description and claims, should be substantially enhanced.  I would have to say, however, that there is little in the first instance decision in Encompass v InfoTrack to indicate just how far the bar has been raised.  This appears, at least in part, to be a result of the way the case was argued, which led the court to give greater attention to what the new provisions are not, rather than to what they are.  In any event, it is to be hoped that consideration by the Full Court will be more enlightening.

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Tags: Australia, Enablement, Law reform, Raising the Bar, Support

The Need to Perform ‘Complex, Time-Consuming and Expensive’ Clinical Trials Does Not Make a Patent Invalid

Patents play an important role in the development of new pharmaceutical compounds, and therapies based upon the use of such compounds.  The primary global model for drug development is based upon private enterprise and competition.  Within this model, the carrot of a potential patent ‘monopoly’ provides an incentive for companies to deploy the considerable resources – with costs commonly estimated in the billions of dollars – necessary to discover, research, trial, and market new drugs and therapies.  Although not everyone agrees that this is the best approach, it is difficult to dispute that it has, nonetheless, contributed to the delivery of great benefits to humanity over the past century or so.

Within the realm of conventional ‘small molecule’ drugs (i.e. setting aside, for present purposes, recent developments in biotechnology and biologics) four broad categories of patent protection can be identified.

1. New compounds.  When an innovator discovers or synthesises a compound that was not previously known to exist and/or to have any useful therapeutic effect, a patent may be obtained for the compound itself.
2. Formulations.  While it is one thing to identify a biologically-active compound, it is often another altogether to find a safe and effective way of delivering it to a patient.  When an innovator develops a new and/or more effective formulation (e.g. a particular tablet or other oral dosage form), a patent may be obtained for that formulation, even if the active ingredient is well-known and no longer patentable.
3. New therapeutic effects.  When an innovator discovers that a compound already known to have one or more therapeutic effects has a further, and unforeseen, therapeutic use (e.g. in the treatment of a different disease or condition), a patent may be obtained for a method of using or making the compound specifically for the new therapeutic purpose.
4. Improved methods of treatment.  When an innovator discovers that a known compound with a known therapeutic use can be made even more effective, e.g. by combining it with other compounds or therapies, or using a different dosing regime, a patent may be obtained for the new method of treatment.

Of course, a patent will only be validly granted in any of these cases if all of the legal requirements for patentability – novelty, inventive step, sufficiency of description, and so forth – are all satisfied.  These requirements are intended to balance the rewards available to innovators against the rights of the broader community to access knowledge and to engage in free competition.

From a policy perspective, getting the balance right is particularly important in the case of pharmaceutical products.  If it is too difficult to obtain a valid patent, there may be insufficient incentive for companies to invest billions of dollars in new drug development.  On the other hand, it is important to keep in mind that, one way or another, it is the wider community – either individually, or through taxes in countries where healthcare is substantially subsidised by government – that ultimately pays for that development, through the higher prices charged for patented drugs.  Allowing patents to be granted too easily therefore may therefore represent a significant social cost.

A major component of the cost of bringing a drug to market is the need to conduct extensive clinical trials in order to prove the effectiveness and safety of the drug, and thus to obtain regulatory and marketing approval.  Such trials typically take years to complete, following the initial discovery of a new compound, or of a new use for an existing compound.  However, a patent application must be filed as early as possible to ensure that any available protection is secured in the event that the trials are successful.

A recent appeal decision of a Full Bench of the Federal Court of Australia sheds light on how the balance between an innovator’s need to file early, and the community’s right to receive a full disclosure of the invention, is struck in the case of a patent for a new therapeutic use of a known compound: Warner-Lambert Company LLC v Apotex Pty Limited (No 2) [2018] FCAFC 26.  The court has confirmed that the fact that the clinical trials required to establish an effective and safe dosage of a drug for a new therapeutic use may be ‘complex, time-consuming and expensive’ will not render invalid a patent that was filed prior to conducting this essential research.

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Tags: Australia, Enablement, Pharmaceuticals, Sufficiency

Sweet! Patent Office Finds Specification ‘Clear Enough and Complete Enough’ to Support Full Scope of Polypeptide Claims

The Intellectual Property Laws Amendment (Raising the Bar) Act 2012 raised the standard of disclosure in a patent specification, requiring that it be ‘clear enough and complete enough for the invention to be performed by a person skilled in the relevant art’: Patents Act 1990, section 40(2)(a).  This change from the old ‘fair basis’ provision was intended to align Australian patent law with that of the UK and Europe, requiring the disclosure to be commensurate with the scope of the claims, i.e. that the description should be sufficient to enable the skilled person to perform the invention across the full width of the claims.

So far, there has been no judicial consideration of this new enablement requirement, and until recently there was just one Patent Office decision, CSR Building Products Limited v United States Gypsum Company [2015] APO 72, in which the Hearing Officer found that claims directed to light-weight, fire-resistant gypsum panels did not meet the required standard.  In particular, the panels were claimed in terms of their properties – core density, core hardness, Thermal Insulation Index, and fire resistance – however it was found that the specification did not provide a sufficient disclosure of how to achieve those properties, other than by manufacturing and testing samples.  In this particular case, there were a number of process and starting material parameters that could be varied, but no guidance in the specification on how to adjust these parameters to achieve the claimed properties with reasonable certitude.  (For more information on the CSR decision, see Disclosure and Support in Australian Patent Specifications: Raised Bar Trips Applicant in Opposition.)

As of 14 November 2017, however, we now have a second decision from the Patent Office on the ‘clear enough and complete enough’ requirement, this time in favour of the patent applicant: Evolva SA [2017] APO 57.  In this case, the claims relate to ‘methods and materials for enzymatic synthesis of mogroside compounds, and in particular to glycosylating mogrol using Uridine-5’-diphospho dependent glucosyltransferases (UGTs).’  While that might make sense to  biotechnologist, for the rest of us the invention basically covers methods of making compounds similar to those that are naturally-occurring in the fruit of the vine siraitia grosvenorii (luo han guo or monk fruit), which is native to China and Thailand.  The extract of this fruit is 300 times sweeter than sugar, and thus can be used as a low calorie sweetener.

Evolva’s claimed method involves using an enzyme (polypeptide) to catalyse a reaction resulting in the desired mogroside compounds.  Effective polypeptides are defined in the patent specification in terms of five amino acid sequence listings.  However, the claims are not limited to these sequences, but are drafted to encompass polypeptides ‘having at least 90% sequence identity’ to the sequences set out in the listings.  The examiner had objected that the specification did not provide a ‘principle of general application’ which would enable the invention across its full scope, and that the skilled person would therefore need to produce and test every polypeptide having up to a 10% difference from the listed sequences in order to determine which would work, and which would not.  Therefore – the examiner concluded – the claims were not enabled across their full scope, and the ‘clear enough and complete enough’ requirement of section 40(2)(a) was not satisfied.

While this case might seem, at first blush, to be analogous with the CSR decision, the Hearing Officer here reached the opposite conclusion, overruled the examiner’s objections, and directed that the application proceed to acceptance.  The case demonstrates how the question of what constitutes an enabling disclosure is very much specific to the technology at issue, and to the skills and abilities of the person skilled in the art.  It also provides useful further guidance, in the absence of any judicial consideration as yet, on how the Patent Office will approach application of the ‘enablement’ requirement in section 40(2)(a) of the Patents Act 1990.

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Tags: Australia, Biotechnology, Enablement, Raising the Bar, Sufficiency

Disclosure and Support in Australian Patent Specifications: Raised Bar Trips Applicant in Opposition

Back in November 2015, the Australian Patent Office issued the first published decision to consider enhanced requirements for patent specifications that were introduced by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012: CSR Building Products Limited v United States Gypsum Company [2015] APO 72.

The decision arises from an opposition by CSR Building Products Limited to the grant of a patent on an application by United States Gypsum Company.  The invention disclosed and claimed in the application relates to a new form of light-weight fire-resistant gypsum panels used in construction, e.g. as wall or ceiling panels.  This subject matter may not seem very exciting to most readers, however the decision itself should be of interest to all Australian patent applicants.

The Commissioner’s Delegate who heard the opposition determined that US Gypsum’s claims satisfied the requirements of the novelty and inventive step.  However, they failed to meet the new requirements for ‘disclosure’ and ‘support’.

In very broad terms, the ‘disclosure’ requirement obliges a patent applicant to teach the skilled reader how to put the invention into practice.  Under the ‘old’ law (prior to 15 April 2013) it was enough to teach just one way of doing so, and the applicant might then be entitled to claim as broadly as the prior art would allow.  Under the updated law, however, the idea is that the teaching provided by the applicant should enable the skilled reader to perform the invention across the full scope of the claims.  Broad claims should therefore require a more comprehensive disclosure of how to work the invention in a correspondingly wide range of implementations.

The ‘support’ requirement dictates, from a different perspective, how broadly the applicant may be permitted to claim their invention.  Whereas ‘disclosure’ is about the ‘how’ to work the invention, ‘support’ is about ‘what’ the inventor has actually contributed to the world.  Under the old law of ‘fair basis’ it was pretty much enough for an applicant to be consistent about how broad a patent they would like to receive, regardless of the actual contribution made.  Under the updated law, if the inventor has merely developed one new and improved way to do something, then that may be as much as she is entitled to claim.  However, if an invention is based upon the discovery of a new and previously unknown general principle that can be applied, without further invention, to produce a range of improved results, then this may provide support for a correspondingly broad claim.

The US Gypsum decision illustrates how the bar has been raised on disclosure and support, and demonstrates how the new provisions may be applied to prevent the grant of unduly broad patents.

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Tags: Australia, Enablement, Raising the Bar, Support

Raising the Bar on Australian Patent Drafting Standards

As regular readers will be aware, for the past few months I have been working with CCH Australia to assist in updating the patents commentary in its Australian Industrial and Intellectual Property ‘loose-leaf’ service (which is also available as an online service).  Among other content, this service provides full text legislation and detailed commentary on copyright, designs, patents and trade marks.

The most recent update to the patents commentary includes coverage of the reforms introduced in the Raising the Bar Act which are directed principally to the quality and scope of patent specifications.  This article discusses some of these reforms, and the corresponding updates to the CCH commentary.

Background

The Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Cth) introduced numerous reforms to the Patents Act 1990 (Cth), many of which have been designed to lift the standards required for a valid patent to levels comparable with Australia’s major trading partners, such as the US and countries of the European Union.

The impact of some of the reforms is largely beyond the control of patent applicants and their professional advisors.  For example, the introduction of a more stringent test for inventive step means that any existing prior art may have a greater narrowing effect than it would have under the former law.  While skilled drafting of the original patent specification will, as always, maximise the options open to the applicant when unforeseen prior art arises, there is no drafting technique that will enable an applicant to claim a scope of protection for an invention that is simply no longer available under the raised inventive step standard.

There are other reforms, however, that are directed principally to the quality of the specification, and to ensuring that the scope of the patent monopoly claimed by the applicant is justified by the extent of the disclosure provided in the specification.  The skill of the draftsperson certainly plays a role in ensuring that the applicant is able validly to claim the full extent of patent protection to which they are entitled.  Conversely, if a patent specification is inadequate then the applicant may be prevented from claiming a broad scope of protection, even in the absence of pertinent prior art.

Fortunately, most Australian patent attorneys are accustomed to drafting specifications to the standards required by the major foreign jurisdictions.  Now, however, those same standards must be applied even when preparing patent specifications that will be filed only in Australia.

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Tags: Australia, CCH, Enablement, Raising the Bar, Support, Utility/usefulness

Patent Reform Exposed Part IV – Enablement

This article focuses on IP Australia’s proposed changes to Section 40 of the Patents Act 1990, which are intended to introduce a formal ‘enablement’ requirement into the Australian patent law.

Presently, paragraph 40(2)(a) requires a complete (i.e. nonprovisional) specification to ‘describe the invention fully, including the best method known to the applicant of performing the invention’.  Broadly speaking, the requirement to ‘describe the invention fully’ encompasses aspects of what in the US would be termed ‘written description’ and ‘enablement’, but without fully encompassing either of these distinct concepts.

More particularly, a sufficient description under the current law must make the nature of the invention plain, and must make it plain how to make or perform the invention.  Recent Australian case law confirms, however, that these requirements will be met if the description enables the skilled person to produce something falling within the scope of each claim without exercise of inventive ingenuity or undue experimentation or study to overcome any initial difficulties in following the teachings in the specification (Kimberly Clark Australia Pty Ltd v Arico Trading International Pty Ltd [2001] HCA 8).

There is currently no requirement in Australia, as exists in most other jurisdictions, that the description provide enablement across the ‘full scope’ of the claims.  IP Australia therefore proposes to raise the enablement requirement to this international standard.

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Tags: Australia, Enablement, Law reform, Patent law, Raising the Bar