Posts Tagged ‘Patent’
IP Australia has issued an Issues Paper on the proposed amendments to the Patents Act:
(1) to insert an “objects” clause; and
(2) to exclude from patentable subject matter inventions which it would be “offensive” to commercially exploit.
An objects clause
The consultation paper proposes 2 alternative “objects” clauses:
…. the purpose of the legislation as being to provide an environment that promotes Australia’s national interest and enhances the well-being of Australians by balancing the competing interests of patent rights holders, the users of technology, and Australian society as a whole.
the purpose of the patent system is to provide an environment that enhances the well-being of Australians by promoting innovation and the dissemination of technology and by balancing the competing interests of patent applicants and patent owners, the users of technology, and Australian society as a whole.
Now, one could very well wonder what possible help either of these statements might give a court if they were enacted. The consultation paper even notes that the Parliamentary Draftsman is rather ambivalent about the value of objects clauses in general:
Some objects provisions give a general understanding of the purpose of the legislation…Other objects provisions set out the general aim or principles that help the reader to interpret the detailed provisions of the legislation.
The first option is what ACIP proposed. ACIP considered its proposal a simplified version of the Objects identified in art. 7 of TRIPS:
The protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations.
The consultation paper thought that Option 1 does not sufficiently recognise the economic and social welfare concerns of patent law and did not sufficiently recognise the interests of patent applicants as well as patent owners (formerly known in Olde English as patentees). As the consultation paper explains:
The economic goals of the patent system are to promote economic growth, trade and investment by encouraging innovation and the dissemination of knowledge and technology.
The patent system encourages innovation by giving patentees a period of market exclusivity in which to recoup their development costs through commercialisation of their inventions. In exchange, patentees are required to disclose the details of their inventions to the public. The patent system contributes to social welfare by providing Australians with access to new technologies and developments that otherwise would not have occurred and that improve our quality of life (for example new pharmaceuticals and medical technologies and improvements to safety and waste management technologies).
However, the patent system will only meet its economic goals if the positive effects of the patent system in stimulating investment in innovation and providing society with access to new technology are balanced against the potential negative effects of patents restricting access to follow-on innovation and increasing costs, and so restricting supply of new patented technologies.
This is better, at least the first 2 paragraphs (if one bears in mind that economists – to the extent they accept the role of patents – think of the market exclusivity as providing an incentive rather than a “reward”). The third paragraph is rather more ambivalent.The danger the third paragraph raises is that it could be used as a basis for excluding something from patentability because someone might use the patent to raise prices or the other evils identified. But, while there are some provisions in the Patents Act that address, or attempt to deal with, these issues, in many respects they seem more properly the territory of (take a deep breath) competition law.
Offensive commercial exploitation
What the consultation proposes is a new exclusion to be added to s 18:
… for an invention the commercial exploitation which would be wholly offensive to the ordinary reasonable and fully informed member of the Australian public.
Apparently, the test of the ordinary reasonable and fully informed member of the Australian public is intended to ensure that the exclusion is “applied in a consistent, predictable and neutral manner”. However, it is also proposed to assist the Commissioner by explicitly empowering the Commissioner in his or her discretion to seek “non-binding” advice on ethical matters.
What seems to trigger the exclusion commercial exploitation in an wholly offensive way rather than at the specific subject matter itself. At what point is the appropriateness of the commercial exploitation determined? Will it be enough that the invention could be exploited in an wholly offensive way? The BRCA controversy erupted when Myriad announced it was going to start charging licence fees for its products. Would the ordinary, reasonable and fully informed Australian have considered its patent wholly offensive before that announcement? This rather suggests that the problem falls within the second type issue identified by ACIP: about how the patent is used, are better dealt with through Crown Use and other compulsory licence arrangements.
If you have views you want to inflict, they should be submitted by 27 September 2013.
Find the issues paper here.
Well written piece in The New Yorker outlining the role of the US International Trade Commission in patent disputes and President Obama’s veto of the ITC’s order to block imports of “older” Apple products.
Mind you, make sure you are not eating your cornflakes over breakfast or sipping your decaf skinny latte when you get to the paragraph:
Samsung’s lawyers may take their talents to Seoul, Tokyo, London, or other venues in which home-court advantage is increasingly important ….
Prof. Wegner apparently saw it differently.
Lid dip: Miguel Belmar
Nicholas J has ruled that Myriad’s patent for isolated gene sequences relating to BRCA1 are patentable subject matter for the purposes of Australia’s Patents Act 1990.
Claim 1 of the Patent (No. 686004 entitled “In vivo mutations and polymorphisms in the 17q-linked breast and ovarian cancer susceptibility gene”) is for:
An isolated nucleic acid coding for a mutant or polymorphic BRCA1 polypeptide, said nucleic acid containing in comparison to the BRCA1 polypeptide encoding sequence set forth in SEQ.ID No:l one or more mutations or polymorphisms selected from the mutations set forth in Tables 12, 12A and 14 and the polymorphisms set forth in Tables 18 and 19.
At , Nicholas J explained the scope of this claim:
Claim 1 extends to isolated DNA, RNA and cDNA that has a BRCA1 polypeptide encoding sequence as shown in SEQ ID No.1 with one or more of the mutations or polymorphisms specified in the relevant tables.
To qualify as patentable subject matter in Australia s 18(1)(a) prescribes that the claimed invention must be a “manner of manufacture”.
This term, much to the chagrin of modernising law reformers, derives from s 6 of the Statute of Monopolies 1623. In the “watershed” NRDC ruling in 1959, Dixon CJ, Kitto and Windeyer JJ declared that the meaning of “manner of manufacture” is not to be derived as a matter of mere etymology. Rather it poses a question:
“Is this a proper subject of letters patent according to the principles which have been developed for the application of s. 6 of the Statute of Monopolies?”
and in answering that question, it must be recognised that the concept has a “broad sweep” intended to encourage developments that are by their nature unpredictable. Hence, their Honours indicated the processes at issue in that case were patentable subject matter because they led to, or resulted in, an artificially created state of affairs, that had some discernible effect, which had economic significance. A very teleological approach from the supposed patron saints of strict legalism!
Nicholas J found that the isolated gene sequences claimed in Myriad’s patent were an artificially created state of affairs having economic significance.
His Honour at  rejected Myriad’s first line of defence claiming that there was a change in chemical structure simply by the process of isolating the gene sequence. Rather, more generally, the nucleic acid or gene sequence in its isolated form was sufficient to qualify as an artificially created state of affairs:
First, the concept of patentable subject matter is expressed in very expansive language.
Secondly, at  the nucleic acid did not exist in isolated form in the cell:
in the absence of human intervention, naturally occurring nucleic acid does not exist outside the cell, and “isolated” nucleic acid does not exist inside the cell. Isolated nucleic acid is the product of human intervention involving the extraction and purification of the nucleic acid found in the cell. Extraction of nucleic acid requires human intervention that necessarily results in the rupture of the cell membrane and the physical destruction of the cell itself. And purification of the extracted nucleic acid requires human intervention that results in the removal of other materials which were also originally present in the cell. It is only after both these steps are performed that the extracted and purified product may be properly described as “isolated” in the sense that word is used in the disputed claims.
Thirdly, at  isolating the substance could require “immense research and intellectual effort”.
In that case, it was only as a result of an intensive research effort that the isolated micro-organism in question could be made available for use in the manufacture of the new antibiotic. It was fortuitous for the patentee that it was its employees who were first to isolate the new micro-organism and first to deploy it in the manufacture of the new drug. That will not always be so. It would lead to very odd results if a person whose skill and effort culminated in the isolation of a micro-organism (a fortiori, an isolated DNA sequence) could not be independently rewarded by the grant of a patent because the isolated micro-organism, no matter how practically useful or economically significant, was held to be inherently non-patentable. In my view it would be a mistake, and inconsistent with the purposes of the Act, not to give full effect in such situations to the broad language used by the High Court in NRDC.
His Honour had earlier noted at  that, while the isolated substances contained genetic information, the patent did not claim information per se, rather, it was for a substance. Furthermore, at  because the claim was limited to the gene sequences in isolated form, it did not cover or extend to the naturally occurring DNA or RNA.
Nicholas J also noted that it was longstanding practice for the Commissioner to grant patents over gene sequences. Both ACIP (pdf) and the ALRC had recommended that this not be changed. The Government had announced (pdf) it accepted those recommendations and Parliament had implemented a different range of measures through the Raising the Bar Act, especially by introducing an explicit experimental use exception in s 119 C and the extension of the usefulness requirement by the introduction of new s 7A which was likely to affect the patentability of ESTs or expressed sequence tags.
Cancer Voices Australia v Myriad Genetics Inc  FCA 65
Emmett J has dismissed Research Associates’ appeal from the Commissioner’s rejection of an attempt to patent a method for calculating an Index for using in financial investing.
Claim 1 was for:
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.
Emmett J held that this was not a manner of manufacture as required by s 18(1)(a) of the Patents Act 1990.
His Honour appears to have rejected this on a number of bases. First, his Honour appears to have characterised the claim as akin to a mere scheme, abstract idea or mere information and not resulting in a physical effect or physical effect of the right kind:
65. A mere scheme, abstract idea, or mere information, is not, of itself, patentable. Some physical effect is required. Thus, where the representation of a curve, or the representation of Chinese language characters, or the writing of information to a smart card, is produced by a computer, there is a component physically affected or a change in state in a part of a machine, which makes the invention patentable.
66. Research Affiliates accepts that the only physical result generated by the method of the claimed invention is a computer file containing the index. That is because the method is implemented by means of a computer. Research Affiliates places significance on the fact that the result of the claimed method is the generation of the index by a computer.
67. However, the index generated is nothing more than a set of data. The index is simply information: it is a set of numbers. It is no more a manner of manufacture than a bank balance, whether represented as data in a bank’s computer, written on a piece of paper or kept in a person’s memory. While it is true that the index may be stored in the computer’s RAM, or on a memory device, or can be transmitted, that can be said of any data generated by a computer. If that were sufficient to satisfy the requirement of an artificially created state of affairs, any computer-implemented scheme would be patentable, merely by reason of the fact that it happens to be implemented by a computer. (emphasis supplied)
Secondly, in what might be a foreshadowing of the Raising the Bar amendments about to come into force, Emmett J was highly critical of the level of disclosure of how to implement the alleged invention:
68. While the Specification appears to be intended to create the impression of detailed computer implementation, the Specification says almost nothing about how that is to be done. The reliance placed on the Colonial Index embodiment is a good example of what is not in the Specification. The discussion in the Specification provides no substantive detail regarding the implementation of the claimed method. The upshot of the discussion is merely that the method is implemented by a computer, but there is no disclosure of how that is to be done.
70. The method of the claimed invention does not involve a specific effect being generated by the computer. The mere use of a computer necessarily carries with it the writing of information into the computer’s memory. There is a stark contrast between a computer-generated curve, or a representation of Chinese characters, or the writing of particular information on a smart card, on the one hand, and the quite unspecific index, on the other. There is no practical application in the method of the claimed invention for the improved use of computers. The effect of the implementation of the method is not to improve the operation of or effect of the use of the computer. There is nothing in the Specification or claim 1 that discloses how to produce the index. Thus, there is nothing in the Specification or claim 1 to indicate:
- how data is accessed in step 1;
- the nature of the processing undertaken in step 2 to identify the selection of assets;
- how the weighting function is accessed in step 3;
- how the relevant measure of scale is chosen in step 4; or
- how the weighting function is applied in step 4 to assign a weighting to each asset.
71. The case propounded by Research Affiliates depends upon the proposition that information of economic significance, once entered into or produced by means of a computer, becomes an economically valuable artificially created state of affairs, and thus patentable. That proposition must be rejected.
Thirdly, Emmett J found that the alleged invention lacked the necessary quality of “newness” or “inventiveness” on the face of the Specification:
72. The implementation of the method of the claimed invention by means of a computer, at the level articulated in claim 1, is no more than the modern equivalent of writing down the index on pieces of paper. On the face of the Specification, there is no patentable invention in the fact that the claimed method is implemented by means of a computer. The Specification asserts a patentable invention, not in the use of the computer, but in the particular series of steps that give rise to the generation of the index. Those steps could readily have been carried out manually. The aspect of computer implementation is nothing more than the use of a computer for a purpose for which it is suitable. That does not confer patentability.
This suggests a considerable broadening of what constitutes the “face of the Specification” as comprehended in, for example, Bristol-Myers Squibb v Faulding‘s attempted reconciliation of Ramset and Mirabella. Emmett J concluded with what might, with respect, be thought to be an unobjectionable proposition:
73. The enquiry into what constitutes a patentable invention is still evolving. It is not to be tied to particular notions of what was understood to be a manufacture at any particular point in time. However, while new developments in technology might be seen to widen the notion of what is patentable, the modern availability of computers as a standard means of implementing arithmetic or computational processes, which could have been implemented manually in the past, does not carry with it any broadening of the concept of a patentable invention.
On this approach, perhaps, the Court, or the Commissioner, could have concluded readily that the alleged invention, as characterised by Emmett J would fail the inventive step requirement in s 18(1)(b)(ii) without resort to the manner of manufacture “threshold”.
Research Affiliates LLC v Commissioner of Patents  FCA 71
Dr Summerfield, over at Patentology, explores matters in detail.
Following the conclusion of consultations about the draft Intellectual Property Legislation Amendment Regulations (the regulations to implement the “Raising the Bar” amendments), IP Australia has published a document outlining the outcomes of the consultation process.
The document outlines what IP Australia is proposing to do/implement in relation to:
- preliminary search and opinion
- search fee
- priority date
- other things
- filing of evidence in oppositions
- extensions of time to file evidence
- fees for notice of intention to defend
defence(TM oppositions) (lid dip: Andrew Sykes)
- cooling off period for patent oppositions (not in the public interest)
- dismissing trade mark oppositions for inadequately particularised grounds
- document service
- no changes to basis for adding grounds / particulars to a notice of opposition
- no change to costs provisions
- suspension regime for patent / trade mark attorneys will be retained
- customs seizure: regulations will be amended to require importers to provide full name, telephone number and address for service in ‘claim for release’ forms
- email address will not be made mandatory
- applicants for patents will have 2 months to respond to a direction to request examination after examination has been deferred
- acceptance period after 1st report on patent application has been issued will be reduced to 12 months
- “IP Australia will not require a statement of entitlement at filing for standard patents (or at national phase entry for PCT applications). Instead, the statement will be required when the applicant requests examination, as part of the approved form.” Applicants for an innovation patent will still need to provide the statement when filing the application
- The Commissioner / Registrar will retain discretion to decide whether hearings should be decided on the papers without oral presentation
- Apparently, there are technical corrections that will be implemented to
Patentology looks at the good news for SMEs and some of the things rejected, here.
Last month, the Parliamentary Secretary for Industry and Innovation, Mark Dreyfus, has appointed a panel to review the patenting of pharmaceuticals in Australia.
Now the Panel have published a Background and Issues Paper.
The Panel’s initial impressions of key issues include:
- a number of concerns have been raised about the length and breadth of protection provided by the extension of term provisions, that is, the duration of the extension and the types of pharmaceutical patents eligible.
- Are the recent amendments to increase the thresholds for the grant of an Australia patent appropriate in the context of pharmaceuticals? If not, why not and what further changes are necessary?
- Do the systems for opposition and re-examination provide appropriate avenues for challenging the granting and validity of a pharmaceutical patent?
- Do interlocutory injunctions, as the law is currently applied, provide appropriate relief in cases involving pharmaceuticals?
- Is Australian law on contributory infringement appropriate in relation to pharmaceuticals?
- Are follow-on patents being used to inappropriately extend protection for pharmaceuticals? If so, how? And, if they are, is this sound policy and what changes, if any, are needed?
- should the period of data exclusivity be extended in line with the patent term
- patent certificates: a generic company must provide a certificate stating that it believes that it is not marketing, and does not propose to market, the therapeutic goods in a way that would infringe a valid patent, or that the generic company has given the patent owner notice of the application
- the mess arising from copyright in product information documents
Be warned: submissions are due by 21 January 2013, hearings are proposed for February 2013, a draft report in March 2013 and the final report in April 2013.
They also have a blog - don’t forget to bookmark it!
The Parliamentary Secretary for Industry and Innovation, Mark Dreyfus, has appointed a panel to review the patenting of pharmaceuticals in Australia.
According to the Terms of Reference, the review:
will evaluate whether the system for pharmaceutical patents is effectively balancing the objectives of securing timely access to competitively priced pharmaceuticals, fostering innovation and supporting employment in research and industry.
Central to this will be an analysis of the pharmaceutical extension of term provisions of the Patents Act 1990 (s.70).
The review will also consider whether there is evidence that the patent system is being used to extend pharmaceutical monopolies at the expense of new market entrants. In doing this, the review will consider how patents for new formulations are granted, consider the treatment of new methods of manufacturing and new uses of known products, the impact of contributory infringement provisions and the impacts of extending patent monopolies on entry of generic pharmaceuticals into the market.
The panel consists of 3 members:
- Mr Tony Harris, former NSW Auditor-General and Parliamentary Budget Officer, as Chair
- Professor Dianne Nicol, Associate Dean, Research, of the University of Tasmania, and
- Dr Nicholas Gruen, CEO of Lateral Economics.
A public consultation process will form part of the review which appears to include consultation with stakeholders and an opportunity for public submissions.
According to the press announcement, the panel is due to submit its final report by April 2013.
Of course, there is already a review of compulsory licensing under way following the BRCA controversy. I do not know if it is related to this review or not, but back in May, Senator Heffernan questioned the Director-General of IP Australia about what steps the Government may have been taking to recover payments under the Pharmaceutical Benefits Scheme to pharmaceutical companies for patents subsequently found invalid. The Senator alleged that the sums involved amounted to hundreds of millions of dollars. The Director-General referred the Senator to the Department of Health and Aging, which has responsibility for these matters.
IP Australia today released the second tranche of exposure draft regulations implementing the Intellectual Property Laws Amendment (Raising the Bar) Act 2012.
This tranche deals with schedule 3 (reducing delays in resolving patent and trade mark applications) and schedule 6 (simplifying the IP system).
Comments still need to be submitted by 21 November 2012.
Go here, and scroll down (past the first tranche if you already have them).
Dr Summerfield prepared a marked up version of the regs as the first tranche would amend them and discussed the new search fee implications.
Bennett J has refused Servier’s attempt to join several Apotex entities located outside Australia in its infringement action against the Apotex Australian arm.
Servier is the patentee of Australian patent No 2003200700 for the arginine salt of perindopril (perindopril arginine). Apotex Pty Ltd obtained listing with the Therapeutic Goods Administration (TGA) for a generic version of perindopril arginine. It commenced proceedings under s 138 of the Patents Act to revoke Servier’s patent.
Servier counter-claimed for infringement. Apotex Pty Ltd conceded the product it proposed to import would infringe Servier’s patent, if valid, and consented to an injunction prohibiting the importation and sale of its product pending the outcome of the revocation action.
Subsequently, Servier wished to join several related Apotex entities, all located and operating outside Australia, to its infringement allegations pursuant to Part 10.4 of the Rules. The infringements alleged were common design and authorisation. Bennett J had previously granted Servier leave to serve its infringement proceedings for another of its perindopil patents against at least 2 of the Apotex entities in question, Apotex Inc. and Apotex Pharmacem Inc.
As there can be no liability for authorisation or common design unless there is an act of primary infringement (i.e., someone must actually do something which is an act of infringement such as making or importing or selling or using the patented invention), Servier sought relief on a quia timet basis; i.e., the risk that infringements would occur in the future.
A second point is of general application.
The old rule in terms conferred a discretion on the Court whether or not to permit service out. Servier pointed out that Rule 10. , in contrast, is not expressed to be discretionary and, accordingly, it was entitled to an order for service out having satisfied the criteria specified. Bennett J was having none of that:
- rule 10.43 set out matters an applicant for service out needed to satisfy, it did not constrain the Court;
- after reference to s 37M, her Honour pointed that
- Rule 1.31 empowered the Court to make any order in the proceeding having regard to the nature and complexity of the proceeding and taking into account proportionality
- Rule 1.32 empowered the Court to make any order that the Court considers appropriate in the interests of justice (which included the power not to make an order) and
- Rule 1.34 permitted the Court to dispense with compliance with the Rules
(Although it was unnecessary for her Honour to mention it, Rule 1.35 also permits the Court to make orders inconsistent with the rules.)
Apotex Pty Ltd v Les Laboratoires Servier (No 2)  FCA 748