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The patent war over escitalopram in Australia is still going!

One aspect of the Alphapharm / Lundbeck case I had forgotten (if I appreciated it at the time) was that Lindgren J quashed the extension of the patent’s term under s 70ff.

In June 2009, after the Full Court upheld Lindgren J’s decision, Lundbeck made a new application for an extension of term and also applied under s 223 for an extension of time to make that application – an extension of some 10 years or so.

In June 2011, the Commissioner granted Lundbeck’s application for an extension of time over oppositions by Alphapharm, Aspen and others. The AAT dismissed an appeal Aspen et al. and Aspen et al. have appealed from the AAT’s decision to the Full Court. That appeal is still pending.

Pending the outcome of the appeal, Yates J has now refused Aspen et al. a stay on the Commissioner’s decision to extend the term of the patent.[1]

Accepting that it was not ordinarily desirable that there be parallel proceedings before both the Commissioner and the Court, Yates J considered it was not appropriate to exercise his discretion to stay the proceedings before the Commissioner in this case.

While a number of considerations were advanced by both sides, the central consideration was that Lundbeck could well lose the ability to sue for some infringements if it was successful in extending the term of its patent. The issue here is that under s 120(4) proceedings for infringement must be brought within 6 years of the infringing conduct. Aspen et al. were not able to point to any real prejudice outweighing that.[2]

It may be of interest to note that the point in common between the 2 sets of proceedings is Aspen _et al._’s contention that the Commissioner has no power to grant the extension of term now under s 70(4) as she has already exercised the power (albeit invalidly) in granting the extension quashed by Lindgren J.[3]

Aspen Pharma Pty Ltd v H Lundbeck A/S [2013] FCA 324

ps [4]

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Most of the substantive Raising the Bar amendments came into force today.

Amongst other things, schedule 1 of the Raising the Bar Act introduced a raft of changes designed to raise the threshold of patentability – i.e., make it harder to get a patent.

These include:

• introducing the really diligent searcher of prior art for obviousness via changes to s 7(3)[1] so that it will be permissible to combine any piece of prior art with common general knowledge (if the skilled addressee could reasonably be expected to combine the two), not just those elements of the prior art that the skilled addressee could be reasonably expected to have found;
• a new concept of utility based on the US approach; and
• doing away with the ’old’[2] fair basis requirement in s 40 as interpreted by the High Court in that Lockwood ruling.

Instead of fair basing, a patent will be required by s 40(2) to disclose:

(a) 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) the best method known to the applicant of performing the invention; and …

and s 40(3) will read:[3]

“The claim or claims must be clear and succinct and [fairly based on the matter described] supported by matter disclosed in the specification.”

Provisional specifications will have to meet the requirements set out above in s 40(2)(a) also.

This is intended to introduce into Australian law the requirements under the UK’s 1977 Act: s 72(1)(c).

The Court of Appeal[4] provides an interesting example of how these new rules should work in it Merial ruling. Merial had (at least) 2 patents relating to its Frontline brand of flea-treatment products. One of these, the 881 patent survived the attack on sufficiency of description, but the other, the 564 patent did not.

Kitchin LJ identified the crucial difference between the 2 patents at [85] – [86]:

…. This was a matter to which the judge expressly referred at [77]:

”77. In contrast to the examples in 881, the examples of 564 simply specify different concentrations of the active ingredients. The examples do not contain any formulation details beyond saying that there should be present a crystallisation inhibitor, an organic solvent and an organic co-solvent.”

This then was the critical difference between the disclosures of the two patents. Omnipharm failed to establish that the practical guidance given by the examples of the 881 patent was not sufficient to enable the skilled team to work across the breadth of the claims. But the 564 patent claimed a combination of actives and did so without any worked examples at all. It provided no real practical assistance over and above the common general knowledge.

Kitchin LJ accepted Merial’s argument that the UK Act did not impose an obligation to include examples of the way the claimed invention worked. However, his Lordship considered that was not why the trial judge, Floyd J, upheld the attack. Rather, the description was insufficient because it did not give sufficient guidance about which ingredients to choose and in what proportions. So, Kitchin LJ explained at [89]:

I reject these submissions. I think it is clear from [151] – [152] that the judge did not find that the absence of any detailed examples was, in itself, fatal to the sufficiency of the 564 patent. What rendered it insufficient, in his view, was the absence of proper exemplification of a formulation of the invention in the context of a specification which was generally inadequate to guide the skilled person to success and provided no real practical assistance beyond the teaching of the prior art and the common general knowledge. The specification contains no more than a very broad indication of the components of the formulation and, as the judge found, it is not a sufficient description to enable the skilled person to arrive at formulations across the breadth of the claims without undue effort.

One illustration of the problem with the 564 patent was set out earlier at [83]:

The disclosure in relation to solvents and co-solvents is something the judge also had well in mind, as is clear from [66]-[67]. Here he referred to the dielectric constant ranges which the solvent and co-solvent must meet, and that the co-solvent must have a boiling point below 100°C. He also referred to the lists of suitable solvents and co-solvents. This information would not, however, be of any practical use to the formulator who, as Dr Walters explained, would have to fall back on his general knowledge of solvents and techniques for enhancing spreading and skin penetration in order to decide on the appropriate solvent system to use.

Neither the Court of Appeal nor Floyd J at first instance set out at length the legal principles underlying insufficiency for these purposes. However, Floyd J had earlier set out his understanding of ‘classical insufficiency’, Biogen insufficiency and ‘insufficiency through ambiguity’ at [361] – [454] in Zipher.

Omnipharm Ltd v Merial [2013] EWCA Civ 2 via IPKat

ps.: those who attended David Brennan’s talk last year will find his ‘Monash paper’ in 38(1) Monash University Law Review 78.

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The Commonwealth Government’s Pharmaceutical Patents Review has published a draft report.

The draft Report is some 200 or so pages long; contains 4 draft findings and 15 draft recommendations (although recommendation 5 relating to the extension of term regime proposes 2 different alternatives).

There appears to be considerable, fascinating data reported. The scope and detail of the draft report will plainly require much further consideration.

At the policy level, the draft report considers there has been a significant failure of co-ordination between the various regulatory bodies that deal with issues relating to pharmaceuticals and patent protections:

Draft recommendation 10.1: The Government should establish a non-statutory Pharmaceutical System Coordinating Committee (PSCC) that reports to Parliament on an annual basis on the success and effectiveness of the patent, marketing approval and PBS systems, particularly where these interface. The PSCC should ensure there is sufficient engagement and coordination between the relevant agencies and take account of costs to government, efficiency of registration and approval processes and respond to issues raised by industry. The PSCC should comprise senior officials from at least DIICCSRTE, IP Australia, DoHA (Pharmaceutical Benefits Division and TGA), DFAT, Finance and Treasury (as chair).

This appears to reflect a general concern with the need for greater policy and practical concern throughout the report. See e.g. draft recommendation 7.2 (calling for an external (to IP Australia) patent oversight committee) and draft recommendation 3.2.

Recommendation 6.1 proposes retaining extension of term just for pharmaceutical products and not extending it to methods of use or manufacture. The bipolar recommendations 5.1 and 5.2, however, explore different ways of prescribing the term of the extension.

Other topics addressed in the draft report include: the impact of international agreements on Australia’s welfare, evergreening and follow-on patents, data protection

Comments on the draft report are required to be submitted by 30 April 2013.

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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 [70], 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 [105] 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 [108] 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 [109] 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 [75] that, while the isolated substances contained genetic information, the patent did not claim information per se, rather, it was for a substance. Furthermore, at [76] 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 [2013] FCA 65

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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 [2013] FCA 71

Dr Summerfield, over at Patentology, explores matters in detail.

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In a decision which no doubt has some further distance to run, Newey J (sitting in the Chancery Division of the High Court in England) has ruled that the owner of copyright does not have a proprietary interest in the proceeds (read profits) made by an infringer of the copyright.

Harris et al. are alleged to be the person (or persons) behind the Newzbin file sharing sites which, amongst other things, have been found to infringe the movie studios’ copyrights in a range of films (here and here, where Arnold J ordered the ISPs to block access).

In December last year, the Newzbin sites appear to have closed down, claiming they had run out of money.

Having obtained freezing orders (formerly called Mareva injunctions) against the assets of the defendants (such as the house in which Mr Harris lives and the Maclaren car he parks in its driveway), the movie studios sought “proprietary injunctions” over the assets as well. This seems to involve a court determination that the assets in question were the property of the movie studios rather than the defendants. For example, Newey J explained the difference between the (already in place) freezing order and the injunctions now sought by reference to Millett LJ’s description:

“The courts have always recognised a clear distinction between the ordinary Mareva jurisdiction and proprietary claims. The ordinary Mareva injunction restricts a defendant from dealing with his own assets. An injunction of the present kind, at least in part, restrains the defendants from dealing with assets to which the plaintiff asserts title. It is not designed merely to preserve the defendant’s assets so as to be available to meet a judgment; it is designed to protect the plaintiff from having its property expended for the defendant’s purposes”.

The movie studios based their argument on observations in the Spycatcher cases that Peter Wright may have held the rights in Spycatcher on constructive trust for the Crown in view of his breaches of duties of confidence and fidelity.

Newey J seems to have rejected this claim partly on the basis that there were cases binding on him (albeit apparently disapproved by the Privy Council) ruling that there was no such proprietary interest and partly on the basis that s 18 of the Copyright Act 1956 had expressly deemed the copyright owner to be the owner of infringing copies and provided remedies in conversion and detention. That remedy, however, had been repealed by the Copyright Design and Patents Act 1988 as unjust and unfair.

There are some interesting issues for Australians.

First, the conversion/detention remedy on the basis of deemed ownership has not been repealed (but is now discretionary) – see s 116 (but the Full Court may not be too keen on the remedy – see [94] of French and Kiefel JJ (as their Honours then were).

Secondly, in Lenah Game Meats, Gummow and Hayne JJ did say at [102]:

A cinematograph film may have been made, as in Lincoln Hunt, in circumstances involving the invasion of the legal or equitable rights of the plaintiff or a breach of the obligations of the maker to the plaintiff. It may then be inequitable and against good conscience for the maker to assert ownership of the copyright against the plaintiff and to broadcast the film. The maker may be regarded as a constructive trustee of an item of personal (albeit intangible) property, namely the copyright conferred by s 98 of the Copyright Act[96]. In such circumstances, the plaintiff may obtain a declaration as to the subsistence of the trust and a mandatory order requiring an assignment by the defendant of the legal (ie statutory) title to the intellectual property rights in question[97]. Section 196(3) of the Copyright Act provides that an assignment of copyright does not have effect unless it is in writing signed by or on behalf of the assignor.

Gaudron and Callinan JJ also agreed.

Newey J considered, however, that:

i) The point under consideration (viz. whether copyright in a film made unlawfully was subject to a trust) was rather different to that with which I am concerned (viz. whether a copyright owner has a proprietary claim to the fruits of infringement); and

ii) The Australian approach to constructive trusts is by no means the same as that in this jurisdiction. In particular, as the Full Court of the Federal Court of Australia noted in Grimaldi v Chameleon Mining NL (No. 2) [2012] FCAFC 6 (in paragraph 574)

His Lordship’s second point may be thought to be a second factor why an Australian court might take a different approach to his Lordship’s conclusion.

As to the first point, one might well think, if such a constructive trust arose, that the trustee would have to account for the fruits of the use of the trust property and possibly even handover such fruits as were still in his possession.

Finally, the Privy Council’s rejection of the authority binding on Newey J (and the determination of the movie studios) may well indicate that Newey J’s decision is just the first step in the war.

Twentieth Century Fox Film Corporation v Harris [2013] EWHC 159

Lid dip: Fiona Phillips

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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:

Schedule 1

• preliminary search and opinion
• search fee
• priority date
• other things

Schedule 3

• filing of evidence in oppositions
• extensions of time to file evidence
• confidentiality
• fees for notice of intention to defenddefence (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

Schedule 4

• suspension regime for patent / trade mark attorneys will be retained

Schedule 5

• 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

Schedule 6

• 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

Links to:

Public Consultation Update papers

IP Australia’s Press Release

IP Australia’s helicopter summary of Raising the Bar, more links and IP Australia’s summaries for patents, copyright, trade marks and designs.

Patentology looks at the good news for SMEs and some of the things rejected, here.

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The Productivity Commission has released its draft Report on Compulsory Licensing of  Patents.

There are 10 chapters and 4 appendices.

The main (draft) recommendations at this stage are the repeal of s 133(2)(b), 135 and 136 of the Patents Act. The Productivity Commission also in substance renews the call to repeal s 51(3) of the Competition and Consumer Act.

The primary object to these recommendations is to make the avenue for relief against the restrictive trade practices (antitrust conduct) of a patentee the Competition and Consumer Act 2010 (Cth). The Productivity Commission also recommends that the Competition and Consumer Act 2010 be amended “to explicitly recognise compulsory licensing of a patent as a remedy under that Act.

The Productivity Commission considers that the current requirements under s 135 requiring demonstration that the reasonable requirements of the public are not being met and consideration of the interests of Australian industry to be inconsistent with promoting community-wide welfare.

In its place, the Productivity Commission proposes that a new test be introduced into the Competition and Consumer Act making a compulsory licence available where:

(a) Australian demand for a product or service is not being met on reasonable terms, and access to the patented invention is essential for meeting this demand.

(b) The applicant has tried for a reasonable period, but without success, to obtain access from the patentee on reasonable terms and conditions.

(c) There is a public interest in providing access to the applicant, having regard to:

• costs to the patentee from granting access to the patented invention

• benefits to consumers and the licensee from the licensee’s access to the invention

• longer-term impacts on community wellbeing.

(d) The terms of any compulsory licence order are consistent with public interest, having regard to:

• the right of the patentee to obtain a return on investment commensurate with the regulatory and commercial risks involved

• the right of the public to the efficient exploitation of the invention.

Bearing in mind that there have been very few private actions based on the antitrust or restrictive trade practices provisions and even fewer successful actions (and, for that matter, very few, if any, applications for a compulsory licence under the Patents Act), this new test plainly has the potential to significantly change the nature of a patentee’s rights. That could be very well affected by the interpretation applied to “being met on reasonable terms” in para (a) and “long term impact on community wellbeing” in para (c) and the extent, if any, that the proposed test is applied based on incentives to innovate before the invention is made (ex ante) or after the invention has already been made (ex post).

A change in this balance would appear to be intended as the Productivity Commission is concerned that the existing competition test in s 133 of the Patents Act is triggered only by anti-competitive behaviour where what is needed, according to the Productivity Commission, is a test based on enhancing competition.

If you wish to make a submission, it should be submitted by 8 February 2013 as the Final Report is due to be submitted to Government by 29 March 2013.

So far, there have been 35 submissions.

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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!

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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.

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