Business Methods – RPL Appeal Fails

December 15, 2015

The Full Bench of the Federal Court of Australia has handed down its decision in Commissioner of Patents v RPL Central Pty Ltd [2015] FCAFC 177.  Unfortunately, the Full Bench has overturned the favourable decision of the primary judge, and considers that the claimed computer-implemented method (which the court characterised as a ‘business method’ or ‘scheme’) is directed to unpatentable subject matter.

The claimed invention relates to a computer-implemented method for assessing an individual’s competency relative to a recognised qualification standard.  The court held (at [37]) that claim 1 of the patent involves:

– using a computer to retrieve the criteria using the Internet. This involves the user using conventional web-browser software;
– the computer processes the criteria to generate corresponding questions relating to the competency of the individual to satisfy the elements of competency and performance criteria associated with the recognised qualification standard;
– those questions are presented;
– the individual answers the questions and, if he or she chooses to do so, uploads documentation from his or her computer.

Following its own earlier reasoning in Research Affiliates LLC v Commissioner of Patents [2014] FCAFC 150, the court found (at [101]) that the claimed method is, in substance, the implementation by a generic or standard computer of an unpatentable idea or business method:

‘RPL Central does not claim any invention or ingenuity in any program or operation of a computer, or implementation by a computer to operate the method. Accordingly, the ingenuity of the inventors must be in the steps of the method itself. The method does utilise the speed and processing power and ability of a computer but there is no suggestion that this is other than a standard operation of generic computers with generic software to implement a business method. This is the method of taking the information as to available criteria for Units of Competency and reframing those criteria into questions and presenting them to, and receiving the answers from, the user together with any documents that the user wishes to append. The reframing of the criteria into questions may be outside the generic use of a computer but the idea of presenting questions, by reframing the criteria, is that: an idea. It is not suggested that the implementation of this idea formed part of the invention.’

The court did note at [96] that not all computerised schemes or business methods are unpatentable but that:

‘There must be more than an abstract idea; it must involve the creation of an artificial state of affairs where the computer is integral to the invention, rather than a mere tool in which the invention is performed.  Where the claimed invention is to a computerised business method, the invention must lie in that computerisation. It is not a patentable invention simply to “put” a business method “into” a computer to implement the business method using the computer for its well-known and understood functions.’

The court further noted at [104] that the fact that a method cannot be carried out without the use of a computer is insufficient to:

‘…render the claimed invention patentable if it involves simply the speed of processing and the creation of information for which computers are routinely used. In those circumstances, the claimed invention is still to the business method itself.’

This decision will undoubtedly encourage the APO to maintain their restrictive stance against computer-implemented inventions. Though there is a possibility that RPL Central Pty Ltd may apply for Special Leave to appeal the decision, and that the High Court of Australia may overturn the decision, this is still some time away.In the meantime, we suggest the following drafting tips:

Draft the specification to focus on a solution to a technical problem specifically arising in computer technology.
Describe the technical implementation in detail.
Do not state or imply that the solution can be solved in the human mind, or by pen & paper.
Describe how the invention improves the function of the computer itself or effects an improvement in another technology.
Draft the claims to a specific machine or system configured in a specific way, rather than a computer-implemented method.

APO Publishes Examination Guidelines re Gene Patents Pursuant to Myriad High Court Decision

December 15, 2015

Australian Patent Office
Examination Practice following
the High Court decision in D’Arcy v Myriad Genetics Inc
Background
On 7 October 2015 the High Court delivered judgment in D’Arcy v Myriad Genetics Inc [2015] HCA 35.
The decision related to Myriad’s patent (686004) on the isolated nucleic acid sequences encoding the BRCA1 mutant polypeptide and to methods of testing for the presence of mutations of the representative BRCA1 gene, and thus an increased likelihood of developing breast or ovarian cancer. The High Court was asked to decide whether claims 1-3, directed to the isolated BRCA1 nucleic acid, defined patent eligible subject matter (i.e. a manner of manufacture).
The High Court unanimously decided that claims 1-3 did not define a manner of manufacture. The Court found that, while formulated as claims to a product (i.e. a nucleic acid molecule), the substance of the invention was the information embodied in the sequence of nucleotides of the molecule. The Court decided that the information was an inherent part of the molecule and not “made” (ie created or modified) by human action.
The Court made clear that it was not concerned with “gene patenting” generally and did not make any finding with respect to the remaining claims of the patent.
In considering the High Court’s decision and particularly the majority it is apparent that the Court:
• Rejected a formulistic approach to the law of manner of manufacture and a narrow interpretation of its decision in NRDC.
• Focused on the substance rather than merely the form of the claimed invention.
• Considered circumstances where the claimed invention departed from established bounds of the concept of manner of manufacture.
• Articulated considerations that apply when a “new class of claim” is involved.
The majority did not deliberate about “products of nature” versus “artificially created products” but found that, in a case where the substance of the claimed invention was genetic information that was not “made”, the claiming of the alleged invention as an isolated product did not confer eligibility. The substance was outside the established bounds of patentability and extending the concept of manner of manufacture to that subject matter was not justified.
Practice
In general the law is to be applied on a case by case basis taking into account the principles and approach taken by the High Court. Subject to other requirements of patentability (eg utility, novelty, inventiveness) consideration needs to be given to the extent to which the claimed invention in substance falls within established categories of eligible subject matter (to which the principles of NRDC are relevant) and, if not, whether other considerations articulated by the Court apply.
In considering these matters it is useful to ask:
1. What is the substance of the claim (not merely its form)?
2. Has the substance of the claim been “made” or changed by man, or is “artificial”?
3. Does the invention have economic utility?
4. Does the invention as claimed represent a new class of claim?
The substance of the claim
As stated above, the first step is to identify the substance of the claim. The specification, including the claims, provides the information to do this. Relevant factors include:
• The form of words and breadth of the claim.
• The size of the class of compounds covered by the claim.
• Does the compound embody or convey genetic information that is of importance to the utility of the claimed invention.
• The emphasis of the claim.
• What did the applicant invent, is the product a step along the way to a process or method that is the real invention.
Was the substance of the claim “made”
Determining whether the substance of the claim is “made” or is “artificial” involves a comparison between the state of affairs before the invention, and the state of affairs as a result of the invention. Relevant factors include:
• Whether the substance of the claim was ‘”made” (ie created or modified, by human action). It is not enough that the subject matter of the claim is artificial.
• What are the physical differences between the claim and the natural state.
• What was the labour required to produce the product.
• “Made” can include created or modified but not merely through replication.
• Isolation or purification can represent making or modification when the substance of a claim is properly directed to a chemical product.
Utility
The requirement for economic utility is set out in the decision in NRDC.
New class of claim
When on the basis of the consideration above or otherwise it becomes apparent that a claim in substance relates to a new class involving a significant new application or extension of the principles of patentability, the Commissioner must consider other factors (See Myriad at [28]).
To decide whether a claim relates to a new class, it is not relevant that patents have previously been granted for similar subject matter. Examiners should take into account categories of alleged inventions that the Courts have previously dealt with and whether that subject matter has been rejected.
In general the Courts have indicated that, subject to other requirements, patents are available for products, methods of making and using products, and methods that otherwise result in a new and useful effect. Technical subject matter that has been previously considered by Courts without rejection include:
• Recombinant or isolated proteins.
• Pharmaceuticals and other chemical substances.
• Methods of treatment.
• Methods of applying herbicides.
• Applications of computer technology.
Claims to plants and micro-organisms should be considered carefully as there are significant factors supporting eligibility of this subject matter. These include the terms of the Patents Act, including provisions implementing the Budapest Treaty, the decision of the High Court in The Grain Pool of WA v The Commonwealth [2000] HCA 14 and treaty obligations.
Consequently, such claims are not to be considered to fall within a new class merely because they are directed to plants or micro-organisms. Rather they are to be examined against normal requirements including whether what is in substance claimed is “made” in a sense indicated above.
Aside from the subject matter rejected in the Myriad case, the Courts have excluded a range of other subject matter including the fine arts, mere schemes, abstract ideas and mere intellectual information – See Part 2.9.2 of the Manual of Practice and Procedure.
Where it is apparent that the substance of the invention lies outside an established category of patent eligible subject matter, examiners should object. The matter may only be resolvable in the context of a hearing or on appeal to the Federal Court.
Application
Where the substance of a claimed invention falls within an established category, is for a product made, or a process producing an outcome as a result of human action, and has economic utility it will meet the basic manner of manufacture requirement. Other considerations, such as whether an invention is lacking on the face of the specification or is subject to statutory exclusions, may still apply according to established practice – see Parts 2.9.2 and 2.9.3 of the Manual of Practice and Procedure.
Following the High Court’s decision claims to the following subject matter are clearly excluded because in substance they can only be considered as a claim to genetic information that is not made:
• Isolated naturally occurring nucleic acid molecules whether:
o DNA or RNA.
o Human or non-human.
o Coding or non-coding.
Claims to the following are excluded where they merely replicate the genetic information of a naturally occurring organism:
• cDNA and synthetic nucleic acids.
• Probes and primers.
• Isolated interfering/inhibitory nucleic acids.
Subject matter of this type may be patentable where the utility of the invention lies in genetic information that has been “made” (eg non-naturally occurring chimeric nucleic acid).
Other biological inventions should be considered according to the same general principles above. If what is claimed properly falls within the requirements for existing categories of products and processes (eg is not for or merely replicates the genetic information of a naturally occurring organism) it will be patent eligible.

Patentability of Computer-Implemented Business Methods

November 13, 2014

Patentability of Computer-Implemented Business Methods

Research Affiliates LLC v Commissioner of Patents [2014] FCAFC 150

This is an appeal decision of the Full Bench of the Federal Court of Australia in relation to a decision of the primary Judge in Research Affiliates LLC v Commissioner of Patents (2013) 300 ALR 724; [2013] FCA 71.
The issue of concern relates to what is considered patentable subject matter, and, in particular “whether computer implementation of an otherwise unpatentable business scheme is sufficient to make the claimed method properly the subject of letters patent”.
The Patent Application
The Patent is entitled “Valuation Indifferent Non-Capitalization Weighted Index and Portfolio”. The field of the invention is stated as pertaining:
“…generally to securities investing and more specifically to construction and use of passive portfolios and indexes”
The summary of the invention, as set out in the specification as a first aspect of invention, is that it provides a method of constructing data indicative of a non-capitalisation weighted portfolio of assets, the method being implemented in a computer system and comprising a series of steps commencing with the receipt in the computer system of data gathered in regard to a plurality of assets. Other aspects of the invention provide a system for constructing a non-capitalisation weighted portfolio of assets and a computer-implemented non-capitalisation weighted portfolio of assets construction system. In each case, a computer is used to receive the data and to provide “weighting means” for weighting each of the plurality of assets.
Claim 1 defines:
A computer-implemented method for generating an index, the method including steps of:
(a) accessing data relating to a plurality of assets;
(b) processing the data thereby to identify a selection of the assets for inclusion in the index based on an objective measure of scale other than share price, market capitalization and any combination thereof;
(c) accessing a weighting function configured to weight the selected assets;
(d) applying the weighting function, thereby to assign to each of the selected assets a respective weighting, wherein the weighting:
(i) is based on an objective measure of scale other than share price, market capitalization and any combination thereof; and
(ii) is not based on market capitalization weighting, equal weighting, share price weighting and any combination thereof;
thereby to generate the index.

It is noteworthy that the Full Bench made the following observations regarding the present specification at [84]:
“Aside from the method being one that is ‘computer-implemented’, there is nothing in the character of the steps comprising the generation of the securities portfolio index that relates the method to any particular hardware or software implementation. There is no description in the specification providing the detail of computer implementation.”
Relevant Law Considered
Section 18(1)(a) of the Act provides that an invention is a patentable invention if, so far as claimed in any claim, it is a manner of manufacture within the meaning of s 6 of the Statute of Monopolies 1623 (Imp) (Statute of Monopolies).
“Invention” is defined in Schedule 1 of the Act as “any manner of new manufacture the subject of letters patent and grant of privilege within s 6 of the Statute of Monopolies, and includes an alleged invention”. Section 6 of the Statute of Monopolies provides that what is patentable is “…any manner of new Manufactures”.
The Full Bench reiterated that guiding principles relating to a “manner of new manufacture” are set out in the landmark case of NRDC and include:
• There is a ‘manufacture’ whenever a process produces, either immediately or ultimately, a useful physical result in relation to a material or tangible entity;
• The method the subject of the relevant claim must have as its end result an artificial effect falling squarely within the true concept of what must be produced by a process;
• To fall within the limits of patentability, the process must be one that offers some advantage which is material in the sense that the process belongs to a useful art as distinct from a fine art and that its value to the country is in the field of economic endeavor.
A summary of Australian authority on claims relating to computer implemented methods was also provided by the Full Bench in reviewing CCOM , Catuity , Grant and RPL .
Importantly, the Full Bench, appeared to endorse the findings in RPL in which a computer operated business method was found patentable because “the involvement of the computer…is inextricably linked with the invention itself”; and that the specification and the claims provided significant information about the invention which was to be implemented by means of the computer and that the computer was “integral” to the claimed invention.
Primary Submissions
Research Affiliates
Research Affiliates fundamental submission is that the claim, considered as a whole, meets the requirements of NRDC, in that its subject matter results in an “artificial effect”, it consists of “an artificially created state of affairs” and the significance of the artificially created state of affairs is economic. It points to the relevance of the submissions in NRDC (at 268) that “a process produces, either immediately or ultimately, a useful physical result in relation to a material or tangible entity” and that, consistently with authority, a relevant artificially created state of affairs may be constituted by operating a computer in a particular way.
The Commissioner of Patents
The Commissioner, distinguished the present circumstance from the reasoning in NRDC, where the claim was to a method and the result of the effect or the product of the method was an artificial effect. The present case claims a method where the result of the method is an index and an index is not patentable subject matter per se.
The Commissioner submitted that the index is in the category of subject matter which, has never been considered to constitute a patentable invention, as it falls in the class of “mere records of intelligence”. The Commissioner argues that while Research Affiliates’ approach might represent a better method of constructing an index intellectually, it has no physical effect on “the computer architecture”. Further, it is argued that to implement an unpatentable method in a standard computer does not convert what is otherwise inherently unpatentable into something that is patentable.
The Court’s Considerations and Findings
The Appeal by Research Affiliates was rejected by the Court and the claims found not to be to a patentable invention under s18(1)(a) of the Act.
In reaching this conclusion, the Full Bench made the following relevant observation at [105]:
“The use of a computer necessarily involves the writing of information into the computer’s memory. This means that there are a number of “physical effects” in the sense of transformed data and memory storage during the claimed process. The claimed index in this case is data that exist in computer-readable form. The question is whether this is sufficient to make the claimed method properly the subject of letters patent”
In answering this question, the Full Bench noted that the analysis of the invention should not be a mechanical application of the criteria set out in NRDC, but the invention is to be understood as a matter of substance and not merely as a matter of form .
To that end, the Full Bench found at [117]:
“The computer-implementation is an essential integer of the claimed process. That is, of course, important… However, in examining whether a claimed invention is properly the subject of letters patent, it is necessary to look not only at the integers of that claimed invention but also at the substance of that invention.”
The Full Bench determined that the invention set out in the specification is directed to the generation of index itself; and that the method is not one that has any artificial or patentable effect other than the implementation of a scheme which happens to use a computer. It found that the computer itself is only described in the specification in general terms and without any indication that any unusual technical effect, or steps foreign to the normal use of a computer is used. (Emphasis added). It also noted that the specification in a preferred embodiment describes that the invention may be implemented on a computer, but not necessarily only by a computer.
The Full Bench found that, whilst the invention may have been directed to an inventive idea, the idea was abstract and any inventive step arises in the creation of the index as information and as a scheme. It was found that there is no suggestion that any part of the inventive step lies in the computer implementation or in improving computer technology .
Consequently the Full Bench found that the process does not provide “either immediately or ultimately, a useful physical result in relation to a material or tangible entity” per NRDC.

Summary
It is clear that the Court does not support the idea that an otherwise unpatentable business method or scheme will be afforded patentability by the mere implementation of the method on a computer in a standard manner.
The Full Bench makes it clear that despite the claims defining “A computer-implemented method…”; the substance of the invention in the specification as a whole is key to determining whether such a method is directed to patentable subject matter.
However, the Full Bench has “left the door open” for computer implemented methods to be deemed patentable if there is evidence in the specification that the computer is inextricably linked to the invention, or the method steps result in an improvement in what it calls ‘computer technologies”.
The Australian Patent Office has indicated that it will continue to assess whether a computer is inextricably linked to the invention rather than ‘incidental’ to the invention; and whether there is a specific effect generated by the computer or an improvement in the operation of the computer using the method.

Lars Koch
Partner, Engineering and ICT Group

Pizzeys Patent and Trade Mark Attorneys

Recent Cases of Significance to Life Sciences – Myriad & Lundbeck

November 5, 2014

Alphapharm v H. Lundbeck

On 5 November 2014, the High Court, by a 3:2 majority, confirmed that the APO has the power to extend the deadline* for filing a request for an extension of term of a pharmaceutical patent, provided that the request is made during the normal term of the patent (*the deadline is the later of 6 months after patent issuance or 6 months after first regulatory approval). The case can be viewed here – http://www.austlii.edu.au/au/cases/cth/high_ct/2014/42.html .

D’Arcy v Myriad Genetics

On 5 September 2014, an enlarged bench of the Full Federal Court unanimously confirmed that isolated nucleic acid sequences are patentable subject matter. The case can be viewed here -http://www.austlii.edu.au/au/cases/cth/FCAFC/2014/115.html .

Clarification re Deadline for Filing of Receipts for Budapest Treaty Deposits in NZ under new NZ Patent Law

September 10, 2014

It has come to our attention that some AU/NZ firms are reporting that, under the new patent law which commences in NZ this weekend, a Budapest Treaty Deposit Receipt must be filed with IPONZ within 3 months of the date of the deposit.

By way of background, Section 43 of the new Act states:

43 Deposit requirements for micro-organisms
• (1) The deposit requirements are satisfied in relation to a micro-organism to which a specification relates if, and only if,—
• (a) the micro-organism was, on or before the filing date of the specification, deposited with a prescribed depositary institution in accordance with the rules relating to micro-organisms; and
• (b) the applicant for the patent provides to the Commissioner, within the prescribed period, a receipt for the deposit from the prescribed depositary institution; and
• (c) the specification includes, at the filing date of the specification, all relevant information on the characteristics of the micro-organism that is known to the applicant; and
• (d) at all times since the end of the prescribed period, the specification has included—
• (i) the name of a prescribed depositary institution from which samples of the micro-organism are obtainable as provided by the rules relating to micro-organisms; and
• (ii) the file, accession, or registration number of the deposit given by the institution; and
• (e) at all times since the filing date of the specification, samples of the micro-organism have been obtainable from a prescribed depositary institution as provided by those rules.
(2) For the purposes of subsection (1)(b), the receipt for the deposit must be in the prescribed form (if any).

The “prescribed period” is set out under new Regulation 59:

59 Deposit requirements for micro-organisms
• (1) The prescribed period for the purposes of section 43(1)(b) of the Act is 3 months after the date that the micro-organism is deposited with the prescribed depositary institution.
(2) The prescribed form of receipt for the purposes of section 43(2) of the Act is a copy of a receipt issued by a prescribed depositary institution under rule 7 of the Budapest Regulations, and, if that receipt is not in English, the applicant must provide a verified translation of the receipt.
(3) In this regulation, Budapest Regulations—
• (a) means the regulations made under the Budapest Treaty; and
• (b) includes any amendments from time to time made to those regulations.

We can advise that we have been in direct contact with the senior adviser for patent practice at the IPONZ and have queried him re the deadline for filing the deposit receipt with IPONZ.

Although the advice of the other AU/NZ firms is consistent with the literal interpretation of Section 43 and Regulation 59, the senior adviser for patent practice at the IPONZ has assured us that Regulation 59 will NOT be taken to apply until a national phase or a convention application is filed in New Zealand (i.e. they will not operate until there is a patent application on file with IPONZ).

The senior adviser at the IPONZ confirmed that there will be a “clarification” of the operation of the new rules and possibly a change made in the near future. While this change will not occur by 13 September 2014, it is not the intention of the IPONZ to require that an applicant file a Budapest Treaty deposit receipt with the IPONZ within 3 months of the deposit.

So, in summary, while the advice of other AU/NZ firms may reflect a literal interpretation of the new rules, the advice fails to advise that the IPONZ intends to issue a clarification on the timing requirements and that there will NOT be a requirement to file a Budapest Treaty deposit receipt with the IPONZ within 3 months of the deposit.

Patents – NZ – New Act takes effect on Sat, 13 September 2014

August 19, 2014

We remind you that the new NZ Patents Act takes effect on Saturday, 13 September 2014.

• There will be a new requirement to request examination, either voluntarily or in response to a Direction. The deadline for requesting examination is 5 years from the date of filing, or 2 months from the date of the Direction, whichever is earlier.
• As a consequence of the above requirement, all divisional applications will need to be filed (and examination requested) within 5 years of the filing date of the first NZ application. In the case of a national phase application, the date of filing of the first NZ application is the date of filing of the PCT application.
• A re-examination procedure will be established.
• Renewal fees will become payable on an annual basis from the 4th to 19th anniversaries. For cases which are already filed, the date of the next renewal deadline will remain unchanged.
• The prior art base will be expanded to a “global” or “absolute” novelty standard.
• A one year grace period will be established with respect to self-publication of the invention.
• Examiners will be able to raise inventive step rejections for the first time.
• The timeframe for achieving allowance will be reduced to 12 months from the date of the first office action.
• Subject matter – human beings and biological processes for their generation, methods of treatment and diagnosis for humans, plants, and computer programs per se will all be expressly excluded from patentability.

It will be appreciated that there are benefits (procedural, substantive and cost) associated with filing under the old system. If you wish to avail yourself of those benefits, then your NZ application should be filed (or nationalised in the case of ex-PCT cases) on or before Friday, 12 September 2014.

If you require more detailed information, please don’t hesitate to contact your attorney at Pizzeys.

Renewal Fees Under New NZ Patents Act

May 27, 2014

As previously advised, a new Patents Act will come into force in NZ on Saturday, 13 September 2014 (the effective changeover date will actually be Friday, 12 September 2014).

The new Act will be more stringent on applicants, and accordingly we suggest that imminent filings (both direct and national phase) be brought forward to Friday, 12 September 2014. We will remind you again of this closer to the changeover date.

Whilst the Regulations remain unsettled at this time, the fees related to renewals have been published.

• Under the present regime, official renewal fees are due on the 4th anniversary of filing (NZ$170), the 7th anniversary of filing (NZ$340), the 10th anniversary of filing (NZ$540) and the 13th anniversary (NZ$1,000) of filing.
• Under the new regime, official renewal fees will be due annually on each of the 4th-9th anniversaries (NZ$100), the 10th-14th anniversaries (NZ$200) and the 15th-19th anniversaries (NZ$350).

For existing NZ patents which have a renewal deadline in the future, the due date for payment of that next renewal will remain unchanged (i.e. it will remain as the 4th, 7th, 10th or 13th anniversary). However, once that next renewal is paid, then further renewals will need to be paid on an annual basis.

Practice Tip:

• If you have a NZ patent which has its 13th anniversary renewal due after 12 September 2014, then there is a cost benefit associated with paying that renewal fee prior to 12 September 2014. Paying prior to 12 September 2014 will involve official fees of NZ$1,000 and no further renewals will be payable during the last 7 years of the patent term. In contrast, paying after 12 September 2014 will involve official fees of NZ$2,150 (being NZ$200 for each of the 13th & 14th anniversaries, plus NZ$350 for each of the 15th-19th anniversaries). Thus, there is a saving of NZ$1,150 to be achieved by paying early.

New Patent Statute for NZ – 13 Sep 2014

April 1, 2014

As reported in an earlier circular, the long-awaited new NZ Patent Statute will take effect on 13 September 2014.

 

Overall the new statute seeks to modernise and harmonise NZ patent law with international standards.  Some of the key points are as follows:

 

  • The prior art base will be expanded from “local novelty” (publications available in NZ) to “absolute novelty” (publications available on a worldwide basis).
  • NZ examiners will be allowed to raise objections based on lack of inventive step.  Previously, they could only reject based on lack of novelty.
  • It will be necessary to request examination.  Previously, examination occurred automatically.
  • Renewals will become payable on an annual basis.  Previously, they were payable on the 4th, 7th, 10th & 13th anniversaries of filing.
  • A re-examination procedure will be introduced.

 

The new law will apply to NZ cases filed (or nationalised in the case of ex-PCT applications) on or after 13 September 2014 (we note this is a Saturday, so the effective deadline is Friday 12th).  Whilst we do not consider the changes to be remarkable, it may be beneficial to consider bringing forward planned NZ filings in order to beat the changeover date.

 

Regards, Bill

Multi-lateral PPH program commences 6 Jan 2014

December 20, 2013

On 6 Jan 2014, the bi-lateral PPH program between AU and the US will be superseded by a multi-lateral PPH program including the following participating countries:

• Australia
• Canada
• Denmark
• Finland
• Japan
• Korea
• Norway
• Portugal
• Russia
• Spain
• United Kingdom
• United States

Allowance of at least one claim in one of the above jurisdictions will enable the applicant to request PPH in the other jurisdictions.

Similarly, where one of the above countries has acted as the International Searching Authority/International Preliminary Examination Authority, then a Written Opinion which is favourable in respect of at least one claim can be used to trigger the PPH in the other jurisdictions.

Regards, Bill
Pizzeys

Australian High Court Considers Patentability of Methods of Medical Treatment

December 5, 2013

Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd [2013] HCA 50 (4 December 2013)

 

Introduction

 

The Australian High Court has handed down a 4:1 majority decision confirming that a method of medical treatment can be a “manner of manufacture” (i.e. patentable subject matter).  This is the first time that this issue has been directly considered by the Australian High Court.

 

Background

 

Sanofi is the owner of a patent which claims a method of preventing or treating psoriasis by using a compound called leflunomide.

 

Apotex registered leflunomide on the Australian Register of Therapeutic Goods with the intention of selling it for the purpose of treating rheumatoid arthritis and psoriatic arthritis.  Most persons with psoriatic arthritis either have, or will develop, psoriasis.  Thus, the treatment of psoriatic arthritis will often simultaneously involve the treatment of psoriasis.

 

There were two issues considered by the High Court.

 

  • Firstly, is a method of medical treatment a “manner of manufacture” (i.e. patentable subject matter)?
  • Secondly, can a person infringe such a patent by supplying a product with instructions that it be used to treat a different disease?

 

Patentability

 

Four of the five judges (French CJ, Crennan J, Kiefel J & Gageler J, with Hayne J dissenting) found that a method of medical treatment can be a “manner of manufacture” and hence patentable.  This was unsurprising, given previous decisions by lower courts in Australia.

 

However, it is noteworthy that the majority arrived at this conclusion in the context of a patent directed to a method of medical treatment involving the use of a pharmaceutical.  Members of the court made statements (obiter dicta) which were adverse to the patentability of methods of medical treatment which involve “the activities or procedures of doctors (and other medical staff) when physically treating patients”. 

 

Specifically, Crennan J and Kiefel J, in their joint judgement, stated (at paragraph 287):

 

There is, however, a distinction which can be acknowledged between a method of medical treatment which involves a hitherto unknown therapeutic use of a pharmaceutical (having prior therapeutic uses) and the activities or procedures of doctors (and other medical staff) when physically treating patients. Although it is unnecessary to decide the point, or to seek to characterise such activities or procedures exhaustively, speaking generally they are, in the language of the NRDC Case, “essentially non-economic” and, in the language of the EPC and the Patents Act 1977 (UK), they are not “susceptible” or “capable” of industrial application. To the extent that such activities or procedures involve “a method or a process”, they are unlikely to be able to satisfy the NRDC Case test for the patentability of processes because they are not capable of being practically applied in commerce or industry, a necessary prerequisite of a “manner of manufacture”.

 

The medical device industry might take issue with the characterisation of a portion of their business as “essentially non-economic”.  Further, they might be concerned that the Australian High Court has foreshadowed a possible future move towards a more restrictive approach to non-pharmaceutical methods of medical treatment.

 

Infringement by Supply

 

Where use of a product would infringe, then supply of that product can also be an infringement in certain circumstances which are set out in Section 117 of the Patents Act.  One of those circumstances is supply with instructions or inducement to use the product in an infringing manner.  Another circumstance is supply (of a non-staple product) where the supplier had reason to believe that the product would be put to the infringing use.

 

Apotex’s instructions specifically said that its product was not indicated for non-arthritic psoriasis.  According to the majority, the requisite instructions or inducement was not present.  Further, the court held that the evidence did not show, and did not allow the inference to be drawn, that Apotex had reason to believe that its products would be used in the infringing manner.  In doing so, they overturned the Full Federal Court on this point.

 

Link to Full Decision

 

The full decision can be found here:         http://www.austlii.edu.au/au/cases/cth/HCA/2013/50.html

 

Regards, Bill