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Mainly intellectual property (IP) issues Down Under

A cylinder by any other name (except basket)

Beach J has ruled that there is no warrant for interpreting “basket” in GSK’s patent to mean “cylinder”, with the consequence that the patent was neither infringed, nor invalid.

GSK’s patent is “for a sustained release paracetamol bilayer tablet with a specified in vitro dissolution profile”. Claim 1 is as follows:

A pharmaceutical composition comprising:

a bilayer tablet having an immediate release phase of paracetamol and a sustained release phase of paracetamol,

the immediate release phase being in one layer and comprising from about 10 to 45% by weight of the total paracetamol; and

the sustained release phase being in the other layer and comprising from about 55% to 90% by weight of the total paracetamol in admixture with a matrix forming polymer or a mixture thereof;

said composition comprising from 600 to 700mg of paracetamol per unit dose and a pharmaceutically acceptable carrier,

wherein said composition has an in vitro paracetamol dissolution profile (as determined by the USP type III apparatus, reciprocating basket, with 250ml of 0.1M HCl at 37C set at a cycle speed of 15 strokes/min) with the following constraints:

Ÿ 30 to 48% released after 15 minutes

Ÿ 56 to 75% released after 60 minutes

Ÿ >85% released after 180 minutes.

I have emphasised the word “basket” above because it is a mistake. It should read “cylinder”. It was also a mistake repeated in the body of the specification. Beach J rejected Apotex’ argument that “basket” was a reasonable option for use in a USP type III apparatus at the priority date. However, none of the expert witnesses had heard of such a thing and Beach J held that the skilled addressee[1] would have recognised it was a mistake and should have read “cylinder”.

Now, the High Court has told us that a patent specification is a document directed to the public, but it is to be read through the eyes of the skilled addressee. So, for example, Gleeson CJ, McHugh, Gummow, Hayne and Callinan JJ said in Kimberly-Clark at [24]:

It is well settled that the complete specification is not to be read in the abstract; here it is to be construed in the light of the common general knowledge and the art before 2 July 1984, the priority date; the court is to place itself “in the position of some person acquainted with the surrounding circumstances as to the state of [the] art and manufacture at the time”.[2]

The courts have developed lengthy lists of propositions to implement that directive.[3] One of the propositions that repeatedly gets cited is the rule that you cannot expand or narrow the meaning of a claim by reference to the body of the specification. So, for example, the High Court in Kimberly-Clark itself helpfully said at [15]:

Where the question concerns infringement of a claim or the sufficiency of a claim to “define” the invention, it has been held in this Court under the 1952 Act that the plain and unambiguous meaning of a claim cannot be varied or qualified by reference to the body of the specification. However, terms in the claim which are unclear may be defined or clarified by reference to the body of the specification.[4]

How to reconcile the two?

Well, Beach J held that, notwithstanding the mistake, the words of the claim were clear and unambiguous and there was no warrant to substitute “cylinder” for “basket”. Warned by Apotex’ counsel, Ms Goddard, that the patent was a public instrument the amendment of which was addressed in the Act by a different mechanism,[5] his Honour summarised his conclusion at [14]:

No case expressly binds me to accept the result contended for by GSK. The hypothetical construct of the skilled addressee cannot be taken so far as to re-write or amend a claim of the specification. That conceptual tool has its limits. After all, the boundary constraint is that I am obliged to construe the claim as it is, rather than what it should have been. I accept Apotex’s contention. Accordingly, GSK must fail on infringement as claim 1 is the only independent claim. But Apotex and Generic Partners fail on invalidity.

His Honour elaborated on these conclusions at much greater length at [368] – [401].

Beach J’s rejection of the attacks on invalidity did not turn on whether “basket” meant “basket” or “cylinder”. Having found that “basket” did mean “basket”, the attacks on fair basis, sufficiency and lack of clarity necessarily failed. However, his Honour would also have rejected them even if “he had found ”some polytropic fairy dust“ could transform ”basket“ into ”cylinder”.

 

If you have a comment or a question, please feel free to post it in the comments section. Or, if you would prefer, email me.

GlaxoSmithKline Consumer Healthcare Investments (Ireland) (No. 2) Limited v Apotex Pty Ltd [2016] FCA 608


  1. or “person skilled in the art” to use the language of the Act in s 7. Section 40 wants the person to be skilled in the relevant art, but that shouldn’t be much, if at all, different.  ?
  2. The citations have been omitted, but they included Samuel Taylor Pty Ltd v SA Brush Co Ltd (1950) 83 CLR 617 at 624?625; Welch Perrin & Co Pty Ltd v Worrel (1961) 106 CLR 588 at 610; Sunbeam Corporation v Morphy-Richards (Aust) Pty Ltd (1961) 180 CLR 98 at 102; Populin v HB Nominees Pty Ltd (1982) 41 ALR 471 at 476.  ?
  3. Sheppard J referred to 10 in Decor v Dart. Hely J identified a raft in Beltreco starting at [70]. The Full Court was rather more succinct at [67] in Jupiters.  ?
  4. The citations I have omitted again include reference to Welch Perrin at 610. This rule is Sheppard J’s second proposition, referred to by Hely J at [74] and elaborated at [76] to [78]and the 4th proposition in Jupiter’s.  ?
  5. Presumably, s 104 and, in the court proceeding context, s 105.  ?

RPL Central also refused special leave

The High Court has also refused RPL Central special leave to appeal.

RPL Central had applied for the grant of an innovation patent entitled ‘Method and System for Automated Collection of Evidence of Skills and Knowledge’.

Middleton J had upheld RPL’s appeal from the Commissioner’s decision to reject the application on the grounds it was not a manner of manufacture. The Full Court allowed the Commissioner’s appeal. In rejecting special leave, the High Court baldly stated:

The Full Court was plainly correct and, accordingly, none of the applicant’s proposed grounds of appeal enjoys sufficient prospects of success to warrant the grant of special leave to appeal. Pursuant to r 41.11.1 of the High Court Rules 2004 (Cth), we direct the Registrar to draw up, sign and seal an order dismissing the application with costs.

So, so far as patenting business methods goes in Australia, it looks like Research Affiliates will be the last word … for a long time.

If you have a question or wish to make a comment, feel free to post it in the comments box or send me an email.

RPL Central Pty Ltd v Commissioner of Patents [2016] HCASL 84

Commonwealth can still sue on the undertaking as to damages

The High Court has refused Sanofi and Wyeth special leave to appeal the Commonwealth’s claims on the clopidogrel undertaking as to damages.

You may recall that, when Sanofi and Wyeth got interlocutory injunctions to stop Apotex entering the market with a clopidogrel product, Sanofi had to give the “usual undertaking as to damages“. The patents, however, were held invalid.

Sanofi and Apotex settled the latter’s claim for damages. However, the Commonwealth also brought a claim against Sanofi and Wyeth under the undertakings as to damages, in broad terms claiming as damages the difference between the (higher) price it paid under the Pharmaceutical Benefits Scheme while the injunctions were in force and the lower price that would have applied if the interlocutory injunctions had not kept Apotex out of the market.

Last year, the Full Federal Court rejected Sanofi’s and Wyeth’s arguments that the Commonwealth could not bring a claim under the undertakings. Lauren John, an associate at Allens, reports that the High Court refused Sanofi’s application for special leave last week.

Links to the High Court dispositions here (Sanofi) and here (Wyeth). Ms John provides more detail here.

If you have a question or wish to make a comment, feel free to post it in the comments box or send me an email.

Productivity Commission reports on IP (in draft)

The Productivity Commission has released its draft report into Intellectual Property Arrangements.

You will be startled to learn that the Productivity Commission has discovered Australia is a net importer of intellectual property. We buy more IP from the rest of the world than we sell to it. Fig. 2 in the Report indicates Australian IP earned AUD1 villion from overseas, but we paid out about AUS4.5 billion for the use of their IP. The Productivity Commission then notes that we provide surprisingly strong IP protection for a country in our position.[1] This finding guides the Productivity Commission’s recommendations which might broadly be characterised as: take the least restrictive option in terms of IP protection (where our international obligations permit).

The Productivity Commission explained its position this way:

Intellectual property (IP) arrangements need to balance the interests of rights holders with users. IP arrangements should:[2]

• encourage investment in IP that would not otherwise occur;

• provide the minimum incentives necessary to encourage that investment;

• resist impeding follow-on innovation, competition and access to goods and services. (emphasis supplied)

So, for example, after much gnashing of economists’ teeth about the (let’s face it, indefensible) term of copyright protection, the Productivity Commission considers that the appropriate term of protection is somewhere between 15 and 25 years.[3] However, what it actually recommends is rather more limited:

4.1: remove the current unlimited term of protection for published works.[4]

5.1: implement Parliament’s At What Cost? IT pricing and the Australia Tax recommendation to make it clear that it is not an infringement of copyright to circumvent geoblocking.

5.2 repeal the remaining parallel import restrictions for books.

5.3 amend the Copyright Act 1968 to replace the current fair dealing exceptions with a broad exception for fair use.

The latter two, so far, have elicited the loudest complaints here and here.[13] Meanwhile, the US’ Register of Copyrights is celebrating the first anniversary of her Fair Use Index.

18.1 expand the safe harbours to online service providers.[5]

Patents

The Productivity Commission reports that there are 120,000 active patents registered in Australia. 93% of these have been granted to non-residents. There are also 25,000 – 30,000 applications each year; of which about 60% ultimately proceed to grant.

According to the Productivity Commission, however, there are too many granted patents which do not contribute social value and are not “additional” – in the sense that they would not have been made if there was no patent protection.[6]

This needs to be remedied. However, the Productivity Commission acknowledges that international agreements put constraints on our freedom of action. There are 10 recommendations for patents.

The key recommendation for standard patents is yet another go at raising the threshold of inventive step.

an invention is taken to involve an inventive step if, having regard to the prior art base, it is not obvious to a person skilled in the relevant art.

This looks very similar to what we already have. As the Productivity Commission envisages matters, however, there are important differences. First, it reverses the onus currently expressed in s 7(2). According to the Productivity Commission, the current position is the opposite of where the onus lies in the USA, Japan, the EU and the UK (amongst others). Rather than a challenger having to prove the invention is obvious, therefore, the patentee will have to prove it is not.

Secondly, the Productivity Commission sees the current requirement that there be only a scintilla of invention being raised. The Productivity Commission sees this low threshold being reflected in the limitation on “obvious to try” being something which the skilled addressee would be directly led as a matter of course. Instead, the Productivity Commission considers that the test should be at least:

whether a course of action required to arrive at the invention or solution to the problem would have been obvious for a person skilled in the art to try with a reasonable expectation of success (as applied by the Boards of Appeal of the EPO).[7]

This change would be buttressed with appropriate comments in the Explanatory Memorandum and, additionally, the insertion of an objects clause into the Act. The latter would be intended to ensure that the Courts focused on the social objectives of the Patents Act including, in particular, the public interest.[8]

On the more colourful fronts, the Productivity Commission also recommended repeal of the abomination innovation patent and amendment of s 18 explicitly to exclude from patentable subject matter business methods and software.[9]

Pointing to analysis which estimates the net present value to R & D of the extension of term for a pharmaceutical patentat at year 10 at $370 million – of which only $7.5 million would accrue to Australia because our industry is so small – while the cost to the Australian government and consumers of the same extension of term is estimated at $1.4 billion, the Productivity Commission also wants a significant tightening up of the regime for extending the term of pharmaceutical patents. The Productivity Commission also opposes any extension of the period of data protection for therapeutic goods, including biologics.[10]

The Productivity Commission also recommends exploring raising the renewal fees payable, particularly in later year’s of a patent’s life.

Registered designs

The Productivity Commission considers the registered design system deficient but, as we have committed to it internationally and there is no better alternative, we are stuck with it.

However, continuing the net importer theme, Australia should not go into the Hague system “until an evidence-based case is made, informed by a cost–benefit analysis.”

Trade marks

I’m just going to cut and paste here: the Government should:

  • restore the power for the trade mark registrar to apply mandatory disclaimers to trade mark applications, consistent with the recommendation of the Advisory Council on Intellectual Property in 2004 (the only people that won’t support this are in the place that counts – IP Australia)
  • repeal part 17 of the Trade Marks Act 1995 (Cth) (Trade Marks Act)
  • amend s. 43 of the Trade Marks Act so that the presumption of registrability does not apply to the registration of marks that could be misleading or confusing
  • amend the schedule of fees for trade mark registrations so that higher fees apply for marks that register in multiple classes and/or entire classes of goods and services.
  • require the Trade Marks Office to return to its previous practice of routinely challenging trade mark applications that contain contemporary geographical references (under s. 43 of the Trade Marks Act). Challenges would not extend where endorsements require goods and services to be produced in the area nominated
  • in conjunction with the Australian Securities and Investments Commission, link the Australian Trade Mark On-line Search System database with the business registration portal, including to ensure a warning if a registration may infringe an existing trade mark, and to allow for searches of disclaimers and endorsements.

Also, s 123 should be fixed up so that parallel importing does not infringe.

Like the rest of us, the Productivity Commission is bemused by the Circuits Layout Act and recommends implementing “without delay” ACIP’s 2010 recommendation to enable “essentially derived variety declarations to be made in respect of any [plant] variety.”

On competition policy, s 51(3) should be repealed and the ACCC should develop guidelines on the application of our antitrust rules to IP.

Innovatively, the Productivity Commission also recommends free access to all publications funded directly by Government (Commonwealth, State or Terriroty) or through university funding.

There are also at least 17 requests for further information.

If you are inspired to make a further submission, you should get it in before 3 June 2016.[11]


  1. Not much discussion here whether the best way to get more technological development is through a strong IP regime or to,scrap the IP system and fully commit to free riding.  ?
  2. Despite the tentative nature of this declaration, it is the first “Main key points”.  ?
  3. Draft finding 4.2.  ?
  4. The Government is trying to do this – see schedule 3 of the exposure draft of the Copyright Amendment (Disability Access and Other Measures) Bill (pdf).  ?
  5. See schedule 2 of the Disability Access and Other Measures bill.  ?
  6. You will have to read Appendix D to find out how the Productivity Commission works out which patents are socially valuable and “additional”.  ?
  7. The EPO cases the Productivity Commission referred to are T 149/93 (Retinoids/Kligman) (1995) at 5.2 and T 1877/08 (Refrigerants/EI du Pont) (2010) at 3.8.3.  ?
  8. Here, the Productivity Commission notes that the Full Federal Court rejected reference to the public interest in Grant.  ?
  9. Dr Summerfield tells you why he thinks that’s a bad idea over here and of course, the Europeans (including the UK in that) do not have all sorts of complications carrying out their nice, clean exclusion.  ?
  10. In an interesting departure from its overarching premise that patents do not really contribute much to innovation because there are other protections such as lead time and trade secrets, the Productivity Commission warns that reliance on data secrecy is sub-optimal compared to patent protection.  ?
  11. Bearing in mind they have to submit their Final Report to Government by 18 August 2016.  ?
  12. In between buying your books from Amazon and Bookdepository, some references to the larger economic issues affecting booksellers here.  ?

Servier best method & amendment

Servier has lost what may be its last round[1] in the arginine perindopril litigation against Apotex. Servier began the litigation back in 2007. Ultimately, it lost with its patent being found invalid on the ground that Servier had failed to disclose the best method of performing the invention. After that ruling, Servier applied to amend its patent to include the best method. Its application failed on discretionary grounds. Now, we have the Full Court’s decision dismissing Servier’s appeal from that refusal.

Best method

Servier’s first argument was that, following the High Court’s Kimberley-Clark decision, all s 40(2)(a) required was a disclosure sufficient to enable a skilled person to produce something within each claim without new invention or additions or prolonged study of matters presenting initial difficulty. Servier argued that there was no separate and independent requirement to disclose the “best method”.

After an extensive review of the case law, the Full Court rejected that argument, ruling that disclosure of the best method was indeed a separate requirement. In this case, Servier had failed to comply with that requirement.

Claim 1 of the patent was for the arginine salt of perindopril. There had been an earlier patent for perindopril and sodium and maleate salt forms had been identified. According to the Specification, the arginine salt form had particular stability advantages in conditions of heat and humidity which resulted in longer shelf life and permitted the use of less expensive forms of packaging. The achievement of these advantages, however, could be affected by the method of production. The Specification described the claimed arginine perindopril only as being produced by “a classical method of salification”.

The experts agreed this description of how to prepare the salt was “pregnant with ambiguity” and following from this evidence the trial judge had found this description was “wholly inadequate” and did not:

allow the skilled addressee to follow a routine process of deduction from that description because it leaves open too many variables.

Servier itself had used two different methods before the filing date – the 1986 method and the 1991 method – and another method – the 2002 study – after the priority date. The evidence showed that the method of salification used and variables such as the solvent used and whether and when to stir significantly affected the properties of the resulting salt, including its stability.

Accordingly, the Full Court upheld the trial judge’s conclusion that Servier had not disclosed the best method known to it of performing the invention.

Amendment

Servier had applied after the trial to amend the Specification to add the best method.

The Full Court affirmed the Pfizer Full Court’s ruling that the best method requirement required disclosure of the best method of performing the invention known to the applicant at the filing date. However, it was possible to remedy a failure to disclose the best method by amendment of the Specification made after the filing date.

The Full Court agreed with the trial judge that the amendment power under s 105 could be invoked even after trial and judgment finding all claims invalid. While there was a proprietal interest in being allowed to amend, it was still necessary for the patentee to satisfy the Court that discretionary grounds did not warrant exclusion.

In this case, however, discretionary grounds warranted refusal. Back in 2004, the examiner had issued a report as a result of which Servier’s patent attorney had advised Servier to include a description of the method of manufacture of arginine perindopril, even if it was well known. The inhouse instructor replied “we will see later”.

Although there was no suggestion of bad faith on the part of the inhouse instructor, the Full Court upheld the trial judge’s conclusion that the inhouse instructor’s decision to ignore the advice of her Australian patent attorney was not reasonable.

The Full Court considered that there was no error of principle in the trial judge’s rejection of the length of the delay as otherwise warranting rejection of the application. However, they would appear themselves have felt the trial judge had been overly generous.

Finally, the Full Court allowed Apotex’ appeal from the trial judge’s order that Apotex pay 66% of Servier’s costs. Rather, Servier should pay 40% of Aptex’ costs of the revocation proceeding and 75% of Aptex’ costs of the amendment proceedings.

Les Laboratoires Servier v Apotex Pty Ltd [2016] FCAFC 27 (Bennett, Besanko and Beach JJ)


  1. Barring (potentially) a special leave application.  ?

IP Australia’s Myriad Guidelines

IP Australia has published its guidelines for examining whether a patent application claims a manner of manufacture under s 18(1)(a) and (1A)(a) in light of the High Court’s ruling in D’Arcy v Myriad.

According to the guidelines, Examiners will find it 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?

In deciding whether the claim is for an established class of invention or a new class of claim, it will not necessarily be relevant that patents have previously been granted for similar subject matter. Examiners are directed to take into account whether the Courts have previously considered the type of subject matter and whether it was rejected or not.

Claims to plants and micro-organisms are not to be considered to fall within a new class merely because they are claims for a plant or micro-organism. Apart from claims to nucleic acid molecules, the guidelines indicate that the Commissioner will consider as excluded subject matter:

• cDNA and synthetic nucleic acids

• Probes and primers

• Isolated interfering/inhibitory nucleic acids,

“where they merely replicate genetic information of a naturally occurring organism”. However, such claims may be patentable where the utility of the invention “lies in genetic information that has been ”made” (e.g. non-naturally occuring chimeric nucleic acid). Other types of biological inventions may also ve patentable where they do not merely replicate the genetic information of a natually occurring organism.

The guidelines should appear in the Manual of Practice and Procedure in January 2016.

Another Infringed Innovation Patent And A Delivery Up Question

Product Management Group (PMG) has lost its appeal from Middleton J’s finding that it infringed Blue Gentian’s innovation patents for a self extending/collapsing garden hose.

The appeal seems like a fairly straightforward application of construction principles and demonstrates, yet again, how slender an innovation need be to secure a monopoly for eight years.

There may, however, be a question for the future whether or not the “substantial contribution” to the working of the “invention” required by s 7(4) must be a positive contribution to the working of the invention.[1]

An interesting point is the Order Middleton J made for delivery up. His Honour did not just require delivery up of PMG’s unsold stock and componentry. In addition, by paragraph 3(c), his Honour ordered that PMG should contact the customers to which it hold sold the infringing products, offer them a refund and request that they return the products to PMG.

Nicholas J considered this travelled well beyond the purpose of an order for delivery up. His Honour considered that purpose was to relieve the infringer from the “temptation” of further infringing and so, in that sense, was in aid of the injunction. Nicholas J considered that an order requiring a party to try and retrieve property to which it no longer had any legal title could not fairly be described as in aid of delivery up and so would have set aside that part of the Order.

In circumstances where the Court had not been favoured with any oral submissions and only brief mention in written submissions, however, Kenny and Beach JJ were not persuaded that his Honour’s discretion miscarried and their Honours would let it stand in this case. However, they warned:

But our rejection of this ground should not be taken as any endorsement of this form of order for the future. We doubt that such an order would ordinarily be appropriate. We do not need to comment further.

This may pose an interesting dilemma for “convicted” infringers: object to such an order or, as the purchasers’ use of an infringing product would itself be an infringement, risk having the successful plaintiff require discovery and then suing the individual customers for infringement too.[2]

Product Management Group Pty Ltd v Blue Gentian LLC [2015] FCAFC 179


  1. Compare Kenny and Beach JJ at [178] to Nicholas J at [284].  ?
  2. On the approach taken vy Yates J in Winnebago (No 4). Of course, the plaintiff might not be willing to pursue individual purchasers of garden hoses, but what about Bunnings and the other hardware chains?  ?

Commonwealth can sue on the undertaking as to damages

The Full Court (Dowsett, Kenny and Nicholas JJ) has upheld the Commonwealth’s power to sue for damages on the undertaking as to damages given by Sanofi and Wyeth when obtaining interlocutory injunctions against generic suppliers.

Sanofi sued Apotex (then called GenRX) for patent infringement when the latter sought to registration in the Therapeutic Goods Register of drug containing clopidogrel. Sanofi obtained an interlocutory injunction preventing the listing and sale of Apotex’ product, on terms of the “usual undertaking as to damages”. Thus, as a condition of obtaining the interlocutory relief, Sanofi undertook to the court:

(a) to submit to such order (if any) as the Court may consider to be just for the payment of compensation, to be assessed by the Court or as it may direct, to any person, whether or not a party, adversely affected by the operation of the interlocutory order or undertaking or any continuation (with or without variation) thereof; and

(b) to pay the compensation referred to in (a) to the person there referred to. (emphasis supplied)

After the trial judge found Sanofi’s patent valid and infringed, the Full Court on appeal held that the patent was invalid. Ultimately, the High Court refused special leave.[1]

The Commonwealth, which was not a party to either the Sanofi or Wyeth proceedings is now claiming compensation from Sanofi and Wyeth under the “undertaking as to damages”. In broad terms, it says it suffered losses because the price it paid under the Pharmaceutical Benefits Scheme was higher than it would have been if the generic parties had not been prevented from listing and selling their products by the interlocutory injunctions.

Sanofi and Wyeth argued that sections 26B, 26C, 26D of the Therapeutic Goods Act[2] precluded the Commonwealth from claiming under the usual undertaking as to damages. The Full Court held, however, that these provisions were ancillary or additional to the Court’s powers under the undertaking. They did not provide an exhaustive code which excluded the operation of the undertaking.

Dowsett J delivered a concurring judgment, suggesting at [20] that some restriction on the scope of the usual undertaking should have been sought and then questioning, if such a restriction had been sought, whether it would have been appropriate to grant the interlocutory injunction:

…. As the Commonwealth was not a party to the proceedings in which the undertakings were given, they were presumably not extracted at its request. I infer that the Court extracted the undertakings. It is not suggested that it lacked the power to do so in order to protect the interests of identified or unidentified third parties. In submitting that the Commonwealth may not recover other than pursuant to s 26C, the Sanofi and Wyeth parties effectively seek to resile from their undertakings. It may be simply too late for them to do so. Any limitations upon the undertakings ought to have been sought at the time at which they were given. The Court would then have had to consider whether such limited undertakings were sufficient to justify the grant of the interlocutory injunctions. The Commonwealth has not put its case in that way. However, in any event, I see no basis for limiting the Commonwealth’s right to seek to enforce the undertakings to the extent that it benefits under them.

If only the regime under sections 26B, 26C, 26D had been available, it looks like Sanofi’s and Wyeth’s exposure would have been limited to situations where they had given false or misleading certificates or did not have “reasonable prospects of success”.[3]

Commonwealth of Australia v Sanofi (formerly Sanofi-Aventis) [2015] FCAFC 172


  1. Similarly, in the Wyeth proceedings an interlocutory injunction was granted on the usual undertaking as to damages, but the patent was ultimately found to be invalid.  ?
  2. These provisions were introduced as part of the package implementing the Australia – United States Free Trade Agreement relating particularly to the 5 year data exclusivity for pharmaceutical test data.  ?
  3. Defined in s 26C(4) as “(4) For the purpose of paragraph (3)(b), proceedings have reasonable prospects of success if: (a) the second person had reasonable grounds in all the circumstances known to the second person, or which ought reasonably to have been known to the second person (in addition to the fact of grant of the patent), for believing that he or she would be entitled to be granted final relief by the court against the person referred to in paragraph (1)(a) for infringement by that person of the patent; and (b) the second person had reasonable grounds in all the circumstances known to the second person, or which ought reasonably to have been known to the second person (in addition to the fact of grant of the patent), for believing that each of the claims, in respect of which infringement is alleged, is valid; and
    (c) the proceedings are not otherwise vexatious or unreasonably pursued.”  ?

IP Australia consults on patenting genetic material post Myriad

Following the High Court’s ruling that Myriad’s claims for isolated DNA relating to BRCA1 were not patentable subject matter, IP Australia has released a “consultation” on how it proposes to treat patent applications claiming genetic material.

The Commissioner considers that the High Court’s ruling excludes from ‘manner of manufacture’ a claim “to an isolated nucleic acid that merely represents information coding for a polypeptide is not patent eligible.”

Accordingly, at this stage, IP Australia contemplates rejecting as not manners of manufactures claims to:

  • Naturally occurring (human) nucleic acid sequences encoding polypeptides or functional fragments thereof -either isolated or synthesised
  • Naturally occurring (non-human) nucleic acid sequences encoding polypeptides or functional fragments thereof – either isolated or synthesised
  • cDNA
  • Naturally occurring human and non-human coding RNA – either isolated or synthesised

On the other hand, IP Australia considers the following could be patent subject matter:

  • Naturally occurring isolated regulatory DNA (e.g. promoters, enhancers, inhibitors, intergenic DNA)
  • Isolated non-coding (e.g. “Junk”) DNA
  • Isolated non-coding RNA (e.g. miRNA)
  • Naturally occurring isolated bacteria
  • Naturally occurring isolated virus Isolated polypeptides
  • Synthesised/modified polypeptides
  • Isolated polyclonal antibodies
  • Chemical molecules purified from natural sources (e.g. new chemical entities, antibiotics, small molecules) Isolated cells Isolated stem cells
  • Probes
  • Primers Isolated interfering/inhibitory nucleic acids (e.g. antisense, ribozymes)
  • Monoclonal antibodies Fusion/chimeric nucleic acids
  • Transgene comprising naturally occurring gene sequences
  • Vectors/microorganisms/animals/plants comprising a transgene

The Commissioner is interested in receiving comments on her proposed practice by 30 October 2015.

Productivity Commission reviews IP

The Productivity Commission has released an issues paper for its inquiry into Intellectual Property Arrangements.

What it was asked to do

In his reference the then Treasurer directed the Productivity Commission to investigate:

The Australian Government wishes to ensure that the intellectual property system provides appropriate incentives for innovation, investment and the production of creative works while ensuring it does not unreasonably impede further innovation, competition, investment and access to goods and services. In undertaking the inquiry the Commission should:
1. examine the effect of the scope and duration of protection afforded by Australia’s intellectual property system on:
(a) research and innovation, including freedom to build on existing innovation;
(b) access to and cost of goods and services; and
(c) competition, trade and investment.
2. recommend changes to the current system that would improve the overall wellbeing of Australian society, which take account of Australia’s international trade obligations, including changes that would:
(a) encourage creativity, investment and new innovation by individuals, businesses and through collaboration while not unduly restricting access to technologies and creative works;
(b) allow access to an increased range of quality and value goods and services;
(c) provide greater certainty to individuals and businesses as to whether they are likely to infringe the intellectual property rights of others; and
(d) reduce the compliance and administrative costs associated with intellectual property rules.

Big job!

As a consequence, there are a “gazillion” questions set out in the Issues Paper. Here’s just a few:

Do IP rights encourage genuinely innovative and creative output that would not have otherwise occurred? If not, how could they be designed to do so? Do IP rights avoid rewarding innovation that would have occurred anyway? What evidence and criteria should be used to determine this? Are IP arrangements in other jurisdictions more effective in generating additional creative output?

To what extent does the IP system actively disseminate innovation and creative output? Does it do so sufficiently and what evidence is there of this? How could the diffusion ofknowledge-based assets be improved, without adversely impacting the incentive to create?

What, if any, evidence is there that parties are acting strategically to limit dissemination?

Do IP rights provide rewards that are proportional to the effort to generate IP? What evidence is there to show this? How should effort be measured? Is proportionality a desirable feature of an IP system? Are there particular elements of the current IP system that give rise to any disproportionality?

What are the relative costs and return to society for public, private and not-for-profit creators of IP? Does the public provision of IP act as a complement or substitute to other IP being generated? Are there any government programs or policies that prevent, raise or lower the costs of generating IP?

What are the merits and drawbacks of using other methods to secure a return on innovation (such as trade secrets/confidentiality agreements) relative to government afforded IP rights? What considerations do businesses/creators of IP make in order to select between options? How does Australia’s use of methods besides IP rights to protect IP compare to other jurisdictions? Why might such differences arise?

The Commission seeks submissions about how the parameters of the IP system came to be set, and on the basis of what evidence and analysis.

How were decisions to extend IP rights in the past (e.g. copyright) assessed? Is an evidence-based approach systematically used to assess changes to the IP system? How transparent have decisions to change the IP system been, including when it comes to legislation and international agreements? Is a stronger evidence base and greater transparency in the public interest, and if so, how should this be accomplished?

Don’t worry. Things get more specific from here. Some of the questions about patents will give you the flavour:

What evidence is there that patents have facilitated innovations that would not have otherwise occurred, or have imposed costs on the community, including by impeding follow-on innovation?

Are there aspects of Australia’s patent system that act as a barrier to innovation and growth? If so, how could these barriers be addressed?

Do patents provide rewards that are proportional to the effort to generate IP? What evidence is there to show this? How should effort be measured? How does the balance of costs and benefits from patent protection compare across sectors and innovations?

What scope is there to better leverage the economic benefits of patents, by taking steps to improve the diffusion of patent information?

Is the patent system sufficiently flexible to accommodate changes in technology and business practices?

Do the criteria for patentability in the Patents Act 1990 (Cwlth) help the patent system to meet its objectives? Would introducing economic criteria for patentability and/or gradually reducing the duration of patent protection substantially improve the efficiency and effectiveness of the patent system?
….

There are numerouse questions in similar vein for the other IP rights and “data”.

Don’t get me wrong. These are all facinating questions. You, or professors and teams of doctoral candidates, could spend lifetimes trying to answer them.[1]

But here’s a thing. Are we really going to withdraw from the World Trade Organisation (with its obligations under the TRIPS Agreement)? Are we really going to pull out of the Australia – USA Free Trade Agreement? Or, given what the Prime Minister is reported to have said, does anyone seriously think we are not going to implement the TPP?

Hmmm. Maybe, at least as far as patents go, we could tell them that [28] of the majority’s ruling in Myriad has solved all the problems.[2] On the other hand, may be you are thinking this might be a good place to try and “fix” Myriad. In that case, you might like to read “Box 3 Beyond the theory” right up the front of the Issues Paper:

While discussions about IP rights are often theoretical, policy decisions about the balance between creators and consumers matter in real ways. Striking the wrong balance can impact the price and availability of books, music, cars, phones or even clothes.

The balance is particularly contentious in pharmaceuticals. Cases exist where patents have allowed pharmaceutical companies to charge what some consider to be unconscionably high prices for life-saving medicines. New compounds and biologic drugs, and their safety and efficacy, are no doubt expensive to develop and test and consumers are often willing to pay almost anything to access them (or the community as a whole through pharmaceutical subsidy schemes). Practices such as patent ‘evergreening’, seeking extended test data exclusivity for biologics, or paying competing firms not to produce generic medicines makes the balance of IP rights all the more contentious. (my emphasis)

Yes, once it has been “discovered”, the price of a new drug or treatment will be higher than if there was no patent. That is the point of the patent (or any other IP right): to allow the holder the opportunity to charge higher than marginal cost. How do you work out whether the price for that expensive drug is “unconscionably high”?


  1. As it happens, you have until 30 November 2015 to get your thoughts in.  ?
  2. Apart of course from those “innovation” patents.  ?