Please note that IP Australia will be increasing many official fees in the coming months. 

Most of the fee increases will take effect from 1 July 2012.  However, filing fees will be increased from 1 October 2012.

Most significantly, a new patent renewal fee will be introduced for the 4^th anniversary of the filing date (at present, the first patent renewal fee is payable on the 5^th anniversary).  This new and additional renewal fee will be payable for any patent which has its 4^th anniversary fall on or after 1 July 2012.

Full information can be found by following these links:

Patents
Trade Marks
Designs
Plant Breeder’s Rights

Regards, Bill

Dear Clients & Colleagues,

The Intellectual Property Laws Amendment (Raising the Bar) Act 2012 passed into law with the Governor General’s assent on 15 April 2012.

Most provisions in the Act come into effect on 15 April 2013.  However, exemptions for researchers and regulatory use apply immediately from 15 April 2012.

As explained in earlier circulars, other changes (which come into effect in 2013) include:

·         A broadening of the prior art base for inventive step.

·         The elimination of the option of modified examination.

·         The effective prohibition of omnibus claims.

·         Stricter requirements for disclosure, support and utility.

·         A more restrictive amendment practice.

Please feel free to contact us if you have any queries.

Regards, Bill

PIZZEYS

In an earlier bulletin we flagged some likely changes to the AU Patent System. 

We can now report that the Bill passed the Senate on 27 February 2012.  It is anticipated that the House of Representatives will pass the changes into law by mid 2012.

A summary of what we consider to be the most significant changes can be found below.

Prior Art Base for Inventive Step

At present, in order to be eligible as prior art for inventive step considerations, the prior art reference must be one which would have been reasonably “ascertained, understood and regarded as relevant” by the skilled person.  This additional requirement filters out some prior art references. This requirement will be removed.  Consequently, all prior art references will be eligible for inventive step considerations.

Preliminary Search & Opinion

At present, search and substantive examination is combined. A preliminary search and opinion system will be introduced.  This will be similar to EP.  We are somewhat concerned that the APO may also attempt to introduce a deadline for the filing of divisional applications calculated from the date of the issuance of the preliminary search and opinion, although there has been no mention of this to date.

Exam & Re-Exam Based on Prior Use

At present, the APO conducts exam and re-exam based only on documentary prior art.  Non-documentary prior art (e.g. public demonstration or sale) is not considered by the APO in exam and re-exam.  The APO will be able to consider non-documentary prior art during exam and re-exam.

Experimental Use Exception

At present, there is no statutory experimental use exception to infringement. An experimental use exception will be introduced.

Omnibus Claims

At present, omnibus claims (e.g. Apparatus substantially as herein described) are permitted.  Omnibus claims will no longer be permitted.

Modified Exam & Deferment of Exam Deadline

At present, it is permissible to seek a 9 month extension of the initial deadline for requesting exam.  Further, when requesting exam, it is possible to request either normal exam or modified exam (the latter being an abbreviated exam based on an issued foreign patent – US, EP, NZ, CA).  Deferral of the exam deadline will no longer be possible.  Modified exam will no longer be available.

Incorporation of Patent Attorney Firms

Requirements that made it difficult to incorporate will be removed.

Regards, Bill

In an earlier circular, we flagged a joint announcement by the Australian and New Zealand patent offices to move towards integration of some functions.

There has now been a further announcement (linked below) setting out a 3-year timetable for a 3-stage roll out.

In brief, the intention is to:

·         begin work sharing between the 2 patent offices in 2012,

·         create a single application process for both countries in 2013, and finally

·         create a single examination process for both countries in 2014.

We will, of course, keep you informed as this moves forward.

http://www.ipaustralia.gov.au/resources/sem_process.shtml

Regards, Bill

PIZZEYS

bbennett@pizzeys.com.au

Christopher Gary Parmenter [2011] APO 26 (28 April 2011)

Sometimes the oddest cases have the biggest impact.

The present case relates to “A Method of Cultivating Plants”.  More specifically, it relates to a method of harvesting plants, particularly cannabis, during the lunar apogee (for those who are curious, this is the time at which the moon is most distant from the earth).

The APO accepted the patent application and then unilaterally decided to initiate a re-examination based upon “a routine quality review”. 

In the re-examination, the APO rejected all claims and relied upon the grounds of lack of novelty and lack of inventive step.  The inventive step rejection was made and sustained in the absence of any evidence from experts regarding factual matters such as, for example, the state of the common general knowledge in the art at the priority date.

The applicant argued that this was contrary to the strong statements of Lindgren J in the trial decision in the Emperor Sports case (Emperor Sports v The Commissioner of Patents [2005] FCA 996) prohibiting “speculation” on the part of the APO regarding matters of fact.

The APO rejected this argument and relied on paragraphs 23 & 24 of the appeal decision in the Emperor Sports case (Commissioner of Patents v Emperor Sports Pty Ltd [2006] FCAFC 26)) which the APO says overturned Lindgren J on this point.  The paragraphs in question say that the “Commissioner can draw legitimate inferences…that may be rationally drawn from technical knowledge”.  The APO has latched onto this part of the appeal judgment as empowering them to make (and maintain) inventive step rejections without supporting evidence regarding the underpinning factual matters.

We now have a situation in which the APO adopts a very different approach in ex parte matters (i.e. exam and re-exam) as opposed to inter parte matters (i.e. opposition).  On the above approach, an examiner can potentially maintain an inventive step rejection in the absence of any factual evidence.  However, an opponent cannot make the same case without strong supporting evidence from skilled persons. 

The APO feels that the rationale for the different standards applied in exam and opposition resides in the fact that, during exam, the onus lies with the applicant to satisfy the Commissioner of the validity of the claim whereas, during opposition, the onus shifts to the opponent to make out their case for invalidity.

Enjoy – but don’t inhale!

http://www.austlii.edu.au/au/cases/cth/APO/2011/26.html 

regards, Bill

PIZZEYS

Dear Clients & Colleagues,

·         It is now possible to search case histories through the APO (AUSPAT) database back to 2006. 

·         It is also possible to do full text searching of specifications back to 1904.

·         Please refer to:   http://pericles.ipaustralia.gov.au/ols/auspat/

·         Please note that the database offers 3 different kinds of searches: Quick, Structured and Advanced.  Our experience is that the Structured and Advanced searches are not yet stable (they often return nil results and/or they time out).  Accordingly, the Quick search option is recommended in the short term.

Regards, Bill

PIZZEYS

bbennett@pizzeys.com.au

We draw your attention to the fact that a number of changes to the AU Patent System are presently under consideration. 

The draft Bill can be viewed here: http://www.ipaustralia.gov.au/pdfs/news/ip_laws_exposure_draft_bill.pdf

A summary of what we consider to be the most significant proposed changes can be found below.

Finally, we mention that there is also a separate draft Bill in circulation which proposes to restrict the patentability of biological materials.  This other Bill is highly contentious and the proposed wording of the exclusion is being negotiated.

Regards, Bill

PIZZEYS

bbennett@pizzeys.com.au

The AU & NZ IP Offices recently announced an intention to create:

• a combined trade mark register for AU & NZ, and
• a combined patent application/examination procedure for AU & NZ.

Whilst the implementation of these proposed changes is still in the future, we believe that there is now even further reason to consolidate representation of AU & NZ matters with a single representative firm.

The joint announcement regarding the integration of the patent systems can be found here:

http://www.ipaustralia.gov.au/pdfs/general/SEM_factsheet.pdf

regards, Bill
PIZZEYS
bbennett@pizzeys.com.au

My colleague, Vaughan Barlow, details the ramifications of the Patent Amendment (Human Genes and Biological Materials) Bill (2010), currently being debated before the Australian parliament.

The Bill seeks to ban the patenting of all biological material that is “identical or substantially identical to such materials as they exist in nature”. If passed, this legislation may significantly jeopardize the biotechnology, pharmaceutical, medical and agricultural industries in Australia.

The full article is posted on the Patent Barista site here:

http://www.patentbaristas.com/wp/wp-content/uploads/2011/02/Patentability-of-biological-materials-in-AU-FINAL-VPB.pdf  

regards, Bill
PIZZEYS
bbennett@pizzeys.com.au

We wish to draw your attention to a significant change of official practice at the APO in relation to divisional applications.

Where a divisional application presents claims for examination which have been previously rejected in the parent (or grand-parent) application, then the APO will give the applicant only 2 months to respond and overcome the rejection (rather than the usual 21 months).

If the applicant does not overcome the rejection within the 2 month period, the APO will offer the applicant the opportunity to be heard before any further action (e.g. formal refusal of the application) will occur.

Full information regarding this new procedure for the case management of divisional applications can be found in the Examiner’s Manual (please refer to part 2.10.11).  You can find the Examiner’s Manual here: http://www.ipaustralia.gov.au/pdfs/patentsmanual/WebHelp/Patent_Examiners_Manual.htm

The APO has just issued the first 5 formal refusals of applications under this new system.  Please note that in each of these 5 applications, the applicant failed to respond in the 2 month period AND the applicant failed to respond to the opportunity to be heard.  In each of the 5 cases, the application was then formally refused by the APO.  Links to each of the 5 formal refusals are provided below.

Schering - http://www.austlii.edu.au/au/cases/cth/APO/2011/10.html

Scott Laboratories - http://www.austlii.edu.au/au/cases/cth/APO/2011/9.html

McNeil PPC - http://www.austlii.edu.au/au/cases/cth/APO/2011/8.html

Qualcomm - http://www.austlii.edu.au/au/cases/cth/APO/2011/6.html

Senomyx - http://www.austlii.edu.au/au/cases/cth/APO/2011/5.html

Regards, Bill

PIZZEYS

bbennett@pizzeys.com.au

Research Affiliates, LLC. [2010] APO 31

Last month we drew your attention to a decision of the APO (Iowa Lottery) in which the APO rejected an application directed to a business method (pooling of jackpots) implemented in a computer environment.  In our commentary, we noted that we could not reconcile the APO’s approach with the governing precedential law and we made some practical suggestions as to how an application might be crafted in order to maximise its prospects of success.  Our commentary can be found here:

http://australianpatentlaw.wordpress.com/2010/11/12/apo-casts-doubts-on-business-methods/

The APO has now issued a further decision (Research Affiliates) in which an application directed to a business method (portfolio management) implemented in a computer environment has been rejected.  The decision can be found here:

http://www.austlii.edu.au/au/cases/cth/APO/2010/31.html

It is clear from the sequence of decisions, and from informal discussions with senior members of the APO, that a decision has been taken within the APO to reject business method applications until such time that a rejected case is taken on appeal and the law is “clarified”.

In the meantime, our practical advice is now moving towards “delay and defer” prosecution whilst a suitable case is taken forward on appeal.

Regards, Bill

PIZZEYS

bbennett@pizzeys.com.au

LTS Lohmann Therapie Systeme AG and Schwartz Pharma Ltd and Commissioner of Patents [2010] AAT 809

In September 2009, we reported on an Australian Patent Office (APO) decision relating to an application for an extension of patent term for a trans-dermal patch.  The application for an extension of patent term was denied by the APO on the basis that the claim was not directed to a “pharmaceutical substance” as is required by Section 70(2)(a).  Our report on the APO decision denying the application for an extension of patent term can be found at the below link.  As you can see, we found the APO’s decision uncontroversial, given that the claim was limited by reference to a “backing layer”.

http://australianpatentlaw.wordpress.com/2009/09/23/case-note-on-extension-of-term-for-patches-implants/

The patentee appealed the APO decision to the Administrative Appeals Tribunal (AAT).  The AAT has now handed down a decision confirming the APO’s denial of the application for an extension of patent term.  The AAT appeal decision can be found here:

LTS Lohmann Therapie Systeme AG and Schwarz Pharma Ltd and Commissioner of Patents [2010] AATA 809 (22 October 2010)

Whilst we find the AAT’s confirmation of the original APO denial uncontroversial, we are concerned by the AAT’s reasoning and particularly by the AAT’s comments at paragraph 32 where the AAT is critical of an unrelated APO decision (the Organon decision) in which the APO granted an extension of term for a patent directed to a steroid-impregnated, polymeric implant.  In the Organon decision, the APO formed the view that the proper approach to deciding whether a claim is directed to a “pharmaceutical substance” (and hence eligible for an extension of term)is to look at the level of integration between the formulation and the associated delivery device.

At paragraph 32 of the appeal decision, the AAT suggests that the proper approach is to narrowly construe the phrase “pharmaceutical substance” to mean “the active ingredient(s)”.  If the AAT’s approach is correct, then an extension of term will only be available for patents which have claims directed to novel & inventive active(s).  The presence in the claim of any non-active will disqualify the patent from an extension of term. 

It is our view that the AAT has seriously erred in construing “pharmaceutical substance” in this extremely narrow way.  Our view for a broader construction is supported by the fact that “pharmaceutical substance” is defined in Schedule 1 of the statute as meaning “a substance (including a mixture or compound of substances) for therapeutic use...”.

We now wait to see how the APO will deal with the next application for an extension of term where the claim is limited by reference to some non-active constituent.

Regards, Bill

PIZZEYS

bbennett@pizzeys.com.au

We have previously flagged that the APO might modify their practice in relation to the “obvious to try” standard.

We have now observed that the examiner’s manual was amended on August 2^nd. 

Please see:http://www.ipaustralia.gov.au/pdfs/patentsmanual/WebHelp/Patent_Examiners_Manual.htm

According to the APO, an invention will be obvious to try if there is a “reasonable expectation that the solution might well solve the problem”.

This appears to echo the High Court’s decision in Aktiebolaget Hässle v Alphapharm Pty Limited [2002] HCA 59, which expressly endorsed the reasoning of the US Court of Appeals for the Federal Circuit in In re O’Farrell (853 F.2d 894) as the better approach under Australian law. 

The Australian Examiner’s Manual now recognises that Australian law includes the requirement that anything suggested as “obvious to try” must carry with it a “reasonable expectation of success” in order to make the invention obvious.  As in US law under O’Farrell, rebuttal of the factual assertion that any anticipated success is “reasonable” may therefore help overcome objections that the invention is obvious because it was “obvious to try”.

In practice, Australian examiners may not be so bold as to assert “obvious to try” as the sole reason for a claim rejection in view of the overarching principle that the skilled person must be “directly led” to the invention for it to be obvious. 

Indeed, recent examination reports are asserting that references “provide motivation to make the invention” and “directly lead the skilled person to the invention” and only then stating as a consequence of those direct leadings that a “reasonable expectation of success” has been established. 

Regards, Bill

PIZZEYS

bbennett@pizzeys.com.au

Invention Pathways Pty Ltd [2010] APO 10

Hot on the heels of the Bilski decision in the US, the Australian Patent Office has now refined the Australian test for the patentability of business methods. 

The patent application in question relates to a “Method for Commercialising Inventions”.  The main independent claim read as follows:

1. An invention specific commercialization system to facilitate success of inventions, the system including the steps of:

a) applying for patent protection for the invention in a country which is party to the Paris Convention,

b) conducting a review of specific commercialization process required by the invention,

c) preparing a research and development plan, testing the business dynamics of the invention,

d) conducting prototype testing, developing a prototype cost/benefit analysis,

e) determining product positioning and packaging,

f) conducting a manufacturing checklist,

g) entry of the information collected in steps a) to f) into an electronically fillable checklist having a prescribed time limit for each step to form a commercial entry strategy (CES) with a number of sub-steps, the CES prepared on the basis that each of the sub-steps in the CES are to be completed by a corresponding deadline, all deadlines falling within 30 months from the earliest priority date of the patent application, the checklist being computer-implemented and stored in computer or human readable format in data storage means and associated with processing means to allow updating of the checklist; and

h) policing compliance with the deadlines for the completion of the sub-steps through the production of reminders based on the prescribed time limits in the checklist to ensure that all sub-steps are completed within the deadlines. (underlining added)

Prior to the subject decision, the governing precedent was Grant v Commissioner of Patents [2006] FCAFC 120 (“Grant”).  Grant stood for the proposition that a method must produce “a physical effect in the sense of a concrete effect or phenomenon or manifestation or transformation”.  Grant went on to say that a change in the state or memory of a computer may be a “physical effect”.

In the subject case, the applicant argued that the entry of information into the electronically fillable checklist, and the storage and updating of same, satisfied the “physical effect” requirement of Grant.  The Australian Patent Office rejected this argument.  At paragraphs 36-38, the Australian Patent Office stated:

36.          In Grant the Court clearly was stating a view that without a physical effect in the sense of a “concrete effect or phenomenon or manifestation or transformation” a claimed method could not be considered to be within the realms of patentability but, as I have indicated, I do not take it to suggest that patentability is merely determined on the presence of a physical effect. Rather it clearly must be an effect of such substance or quality that the method considered as a whole is “proper subject of letters patent according to the principles which have been developed for the application of s. 6 of the Statute of Monopolies".

37.          The decisions in Grant and Catuity both referenced US law and in Bilski I note the Supreme Court confirmed that in the US the “the prohibition against patenting abstract ideas cannot be circumvented by attempting to limit the use of the formula to a particular technological environment” or adding “insignificant post-solution activity” (Diehr at 191-192). It was said in that decision:

“To hold otherwise would allow a competent draftsman to evade the recognized limitations on the type of subject matter eligible for patent protection. On the other hand, when a claim containing a mathematical formula implements or applies that formula in a structure or process which, when considered as a whole, is performing a function which the patent laws were designed to protect (e. g., transforming or reducing an article to a different state or thing), then the claim satisfies the requirements of 101.”

38.          Insignificant post-solution activity has been taken to include steps such as the inputting, storage or displaying of data. I take from this aspect of US law however only confirmation of the unremarkable conclusion that one must consider whether the subject matter of a claim considered as a whole falls within the scope of patentable subject matter and that this cannot be achieved merely by pointing to some physical effect or transformation that, while present in the claimed method, does not alter its fundamental character. In applying the decision in Grant I therefore consider that the “concrete effect or phenomenon or manifestation or transformation” referred to must be one that is significant both in that it is concrete but also that it is central to the purpose or operation of the claimed process or otherwise arises from the combination of steps of the method in a substantial way. Consequently while the step of building a house involves a concrete physical effect it is peripheral to the method of acquiring a house and indeed could hardly be said to characterise the subject matter of the method such that it is considered an artificially created state of affairs. I consider the same to apply to a business scheme implemented in some part by computer and do not believe the patentability of such a method can arise solely from the fact that, in a general sense, it is implemented in or with the assistance of a computer or utilises some part a computer or other physical device in a incidental way. (underlining added)

In summary, the subject case has qualified the “physical effect” requirement by now making it clear that the physical effect must be “central to the purpose or operation of the claimed process or otherwise arises…in a substantial way”.

In addition to qualifying the patentability of business methods, the subject case also had meaningful comments about the ability of the Commissioner to inform herself regarding factual matters.  In particular, the Commissioner rejected arguments and evidence submitted by the applicant in relation to the state of the common general knowledge in the art (see paragraph 55).  Further, the Commissioner rejected arguments submitted by the applicant on the question of whether prior art references would have been considered by the skilled person (see paragraph 67).  We expect that this aspect of the decision will embolden Australian examiners to maintain rejections more often in the future.

The full decision can be viewed here:

http://www.austlii.edu.au/au/cases/cth/APO/2010/10.html

Regards, Bill

PIZZEYS

bbennett@pizzeys.com.au

The APO is proposing official fee increases with effect from 1 August 2010.

Most of the proposed increases are insignificant.

However, there is one new fee which will close off an existing loophole for avoiding excess claims fees.  Those who regularly prosecute applications in Australia will be aware that the APO applies an excess claims fee based on the claim count at the moment of allowance (the official fee is A$100 for each claim beyond the first 20 claims). 

To date, it has been possible to delete claims prior to allowance in order to reduce the claim count, and then add back the deleted claims after allowance.  However, the APO is now proposing a new fee which will apply in circumstances where an applicant adds back claims after allowance (the proposed new fee is A$100 for each added claim beyond the first 20 claims).

If you wish to take advantage of this loophole, then you should expedite prosecution such that the amendment to “add back” excess claims occurs before 1 August 2010.

The official announcement can be seen here (see item 222A):

http://www.ipaustralia.gov.au/pdfs/news/DIISR%20-%20IPAustralia%20-%20Fee%20Review%20Summary%20%20Proposed%20Regulation%20Changes.pdf

PostScript:  After making this post, we discovered from discussions with the APO that the official fees will be levied when the amendment to add back claims is *allowed* (as opposed to the date on which the application to add back the claims is made).  Of course, this means that any application to add back claims should be made well in advance of the deadline.

regards, Bill (bbennett@pizzeys.com.au)

PIZZEYS

Dear Clients & Colleagues,

Those of you who regularly prosecute patents in Australia will be aware that Australia has a unique approach to inventive step/non-obviousness.  Specifically, Australian law differs from international norms in two fairly notable ways:

(a)   Firstly, not all prior art references are citable.  Rather, in order to be citable, a prior art reference must firstly be shown to be a piece of prior art information that the skilled person could have been reasonably expected to have “ascertained, understood, and regarded as relevant”.  Notably, prior art references have been excluded from consideration because (i) the prior art reference was published a short time before the priority date of claim under consideration and was not widely available (Wrigley), (ii) the prior art reference was not in the English language (Euroceltique), and (iii) the prior art reference was not directed to solving the same problem as the problem solved by the claimed invention (Lockwood);

(b)   Secondly, since the landmark High Court decision in Aktiebolaget Hassle v Alphapharm Pty Ltd [2002] HCA 59, “obvious to try” does not make an invention obvious in Australia.  In that High Court decision, the standard for determining inventive step/non-obviousness was stated as follows: “Would the notional research group at the relevant date in all the circumstances…directly be led as a matter of course to try [the invention claimed] in the expectation that it might well produce [a useful desired result].”  This meant that, in circumstances where a range of alternatives was available (this often being the case in the chemical arts), there must be evidence that the person skilled in the art would go directly to the claimed alternative for inventiveness to be destroyed. 

It is widely known that moves are afoot to better harmonise Australian law with international norms via the elimination of the “ascertained, understood and regarded as relevant” prerequisite for a prior art reference to be citable.  What is perhaps less well known is that the APO is quietly moving to issue rejections based on the “obvious to try” standard.  We will, of course, be on the lookout for any office actions which adopt this improper approach.

regards, Bill (bbennett@pizzeys.com.au)

PIZZEYS

Smith & Nephew Pty Ltd v Wake Forest University Health Sciences [2009] FCAFC 142

It is a requirement under Australian Patent Law that the claimed invention be a “manner of manufacture”.  This archaic term finds its roots in the Statute of Monopolies of 1623, and it is still used today to govern patentable subject matter under Australian law (Sub-Section 18(1)(a)).

It has been long-held that mere “collocations” of integers (where there is no working interrelation between the claimed integers) are not a manner of manufacture.  This is in contrast to patentable “combinations” of integers (where there is a working interrelationship between the claimed integers which yields a new and useful result).

The subject case is an appeal from a pre-trial decision to grant interlocutory relief.  The subject matter relates to a system for negative-pressure wound therapy.  The claim in question reads as follows:

An apparatus for applying negative pressure to a wound beneath a fluid-impermeable seal comprising:

a screen means for positioning beneath said seal for preventing overgrowth of tissue in the wound, said screen means being sufficiently porous to allow gases to reach the wound and sufficiently rigid to prevent wound overgrowth, said screen means comprising an open cell polymer foam section configured to overlie the wound such that said negative pressure is maintained within said foam and applied to the wound;

a flexible tube having an inlet and inserted into said open cell polymer foam section and an outlet end for extending from beneath said seal and for supplying said negative pressure;

and wherein said apparatus is in an aseptic package.

The pre-trial judge did not consider manner of manufacture to be an issue, as it was accepted by all parties that the integers of the claim (other than the aseptic package integer) interacted with each other to produce a new product, and a new and useful result.

However, on appeal, the appeal court seized on the fact that the aseptic package integer does not contribute to the actual functioning of the apparatus.  Thus, the appeal court formed the view that the claim defined a patentable combination, plus a separate aseptic package.

Regrettably, the patentee argued that the aseptic package feature was an essential feature of the invention.  Based on this construction advanced by the patentee, the appeal court proceeded to take the surprising view that the presence of a non-interacting, essential feature in the claim meant that the claim, as a whole, was directed to a collocation rather than a combination.  Hence, the appeal court concluded that there was a serious question over the validity of the claim.  Hence, the pre-trial court’s decision to grant interlocutory relief was reversed.  The matter will now return to the trial court for the substantive trial.

It is very important to note that, had the patentee argued that the aseptic package was merely a preferred and inessential feature, then it appears that the court would not have arrived at this most surprising result.  Thus, it is hoped that this extraordinary result will not be repeated in other cases.

The case can be viewed here:

http://www.austlii.edu.au/au/cases/cth/FCAFC/2009/142.html

regards, Bill

PIZZEYS

(bbennett@pizzeys.com.au)

David Gerard Clark v Ronald Neville Langford [2009] APO 19

The Australian patent statute provides the Commissioner with a discretionary power to extend a deadline where the deadline is missed due to an “error or omission” on the part of the person concerned (i.e. applicant/patentee) or on the part of their agent.

The Australian Patent Office has just handed down a decision which the author finds most surprising.  In the case in question, the patentee instructed their agent to renew the patent well in advance of the deadline, but the patent was not renewed due to a failure to act on the part of the agent.  The agent had some health issues which were said to contribute to the failure to fulfil the patentee’s instructions.

At first instance, the APO was satisfied that an extension should be granted.  However, a third party opposed the extension and the matter was set down for a hearing.  Interestingly, neither party adduced further evidence.  Rather, the case was decided on the basis of the evidence supplied by the patentee in support of the original request for extension of time.  This consisted of a declaration by the patentee stating that they instructed the agent, and a declaration by the agent corroborating that they received the instructions and that they failed to act, at least in part due to health issues.

Interestingly, the hearing officer was satisfied that the patentee had the requisite intention to renew.  However, the hearing officer was not satisfied, on the evidence before him, that the agent made an error or omission.  Frankly, we find the logic of the decision most surprising.  We do not believe that this case will be followed in future cases.

The decision can be viewed here: http://www.austlii.edu.au/au/cases/cth/APO/2009/19.html

regards, Bill

PIZZEYS

(bbennett@pizzeys.com.au)

Dear Clients & Colleagues,

The Australian Federal Court has handed down a decision which highlights the virtues of diligently reviewing the scope of issued Australian claims in view of newly-emerged prior art.

In the litigation in question, there was a corresponding British patent which had been held invalid in view of certain prior art.  The competitor of the patentee initiated a revocation action against the Australian patent.  Subsequent to the commencement of revocation proceedings in Australia, the patentee sought the leave* of the court to amend its claims in order to add narrower claims.

*prior to court proceedings commencing, amendments can be made by the patentee as of right, provided that the claims are not broadened, and provided that no new matter is claimed - however, once court proceedings are commenced, amendments can only be made with the consent of the court.

The exercise of the court’s discretionary power is dependent on the court being satisfied that the patentee has given a full disclosure of the patentee’s motivation for seeking the amendment, that the patentee has not sought to obtain an unfair advantage from the unamended patent, that there has not been any unreasonable delay in seeking the amendment, and that there are not any other circumstances that might lead the court to refuse to exercise its discretionary power in favour of allowing the amendment.

In the case in question, the court refused to exercise the discretionary power to allow the amendment.  The two main factors relied upon by the court in not allowing the amendment were (a) delay on the part of the patentee, and (b) the patentee was seeking an unfair advantage by also retaining the original broader claims.  In relation to the second factor, the court noted that the patentee was seeking to add narrower claims which better reflected what was said by the patentee to be the crux of the invention, whilst concurrently maintaining the broader claims which went beyond the scope of the invention as asserted by the patentee.

Practice Tips

Patentees should diligently review their issued Australian claims whenever new art comes to light, and should seek to diligently make any amendments prior to any court proceedings commencing, if possible.

Conversely, competitors are well advised to initiate court proceedings if they believe that the patentee has claimed too broadly and that there may be reasons why the court will not allow claim amendments by the patentee.

The case can be viewed here: http://www.austlii.edu.au/au/cases/cth/federal_ct/2009/1019.html

regards, Bill

PIZZEYS

(bbennett@pizzeys.com.au)

Dear Clients & Colleagues,

You may recall that in 2008 we flagged a trial decision in which a Professor successfully resisted his employer’s efforts to assert proprietary rights in an invention made in the course of the Professor’s employment.

The rights of employers/employees are not dealt with by statute in Australia.  Rather, in the absence of an agreement expressly dealing with ownership of IP, the issue of ownership is dealt with under the common law and according to equitable principles.

Over the years the decided cases have established that, where the employee is “paid to invent”, then the invention will usually belong to the employer by virtue of an implied duty to assign.  Hence, the default position is that a researcher will usually be obliged to assign to the employer.

Against the above background, the 2008 trial decision in favour of the Professor came as somewhat of a surprise.  The trial court held that, on the particular facts of the case, the Professor was not obliged to assign.  The trial court looked to many factors in arriving at this conclusion.  However, one of the reasons relied upon was that academia is different to the private sector, and it is often the case that academics are not “paid to invent” in the same way that researchers in the private sector usually are paid to invent. 

The 2008 trial decision caused many Universities to review their employment contractswith their academic researchers.

The appeal decision has just been handed down.  The appeal court has upheld the trial decision.  The appeal decision can be found here:

http://www.austlii.edu.au/au/cases/cth/FCAFC/2009/116.html

regards, Bill

PIZZEYS

(bbennett@pizzeys.com.au)

Dear Clients & Colleagues,

In order to be eligible for an extension of term, the patent in question must claim “one or more pharmaceutical substances per se”, and there must have been a delay of more than 5 years between the date on which the patent was filed and the date of first marketing approval.

Historically, difficulties have arisen where the pharmaceutical substance is claimed in combination with a delivery device, typically a patch or implant.  There are a number of office decisions where patents for trans-dermal patches have been found ineligible for an extension on the basis that such a claim is not directed to a “pharmaceutical substance per se”.

You may recall that we recently flagged a patent office decision (N. V. Organon) in which a patent for a steroid-impregnated, polymeric implant was found to be eligible for an extension.  In departing from previous practice, the patent office held that the proper approach was to look at the level of integration between the pharmaceutical substance and the associated delivery device in deciding whether the claim should be regarded as being directed to a pharmaceutical substance per se (extension possible) or to a pharmaceutical substance in combination with a separate feature (extension not possible).

Pursuant to the N.V. Organon decision we suggested that, wherever possible, the claims of a patch patent should not be limited by reference to the backing layer of the patch as this was likely to be held to be a “separate feature” which would make the patent ineligible for extension.

The patent office has now handed down its first patch decision subsequent to the N. V. Organon decision.  The claims in question included reference to the backing layer.  As we predicted, the office found the patch patent ineligible for extension.  The case can be viewed here –

http://www.austlii.edu.au/au/cases/cth/APO/2009/16.html

In this latest patch case, we observe that the patentee erred in claiming the backing layer.  The invention actually resided in the polymeric matrix formulation into which the active was impregnated.  The additional claim limitation of “an inert backing layer” appears to have been un-necessary to achieve patentability and had the unintended consequence of making the patent ineligible for extension.

regards, Bill

PIZZEYS

(bbennett@pizzeys.com.au)

Dear Clients & Colleagues,

You may recall that last year we flagged a trial decision in which the trial court held that the patentee of a continuation/divisional cannot rely on the grace period provisions in circumstances where the continuation/divisional is filed more than 12 months after the first public disclosure/sale.

In the case in question, the first/parent patent application was filed within 12 months of the first sale and relied upon the grace period provisions.  However, the second/continuation patent application was filed outside of the 12 month period following the first sale.  At trial, the continuation was held invalid in view of the first sale.

We are pleased to report that the appeal court has upheld the patentee’s appeal.  The appeal court has unanimously found that the continuation/divisional should receive the same grace period benefits as the parent application.  Thus, continuations/divisionals can now be validly derived from a timely filed parent application.

The appeal decision can be viewed here:

http://www.austlii.edu.au/au/cases/cth/FCAFC/2009/84.html

regards, Bill

PIZZEYS

(bbennett@pizzeys.com.au)

Dear Clients & Colleagues,

You may recall that we sent a circular last year reporting on the first trial decision to consider the patentability standard for an innovation patent (an 8-year patent).  Our detailed discussion of last year’s trial decision can be found here –

http://www.pizzeys.com.au/Articles/Article7.htm

Yesterday, our appeal court affirmed the trial court’s decision.  The appeal court’s decision can be found here -

http://www.austlii.edu.au/au/cases/cth/FCAFC/2009/81.html

The appeal court has confirmed that an invention is eligible for an 8-year patent if:

(a) there is a difference between the claimed invention and the prior art, and

(b) the difference, per se, makes a “substantial contribution to the working of the invention”.

Hence, the test is focussed solely on the functionality of the distinguishing feature.  The test does not consider the merit of the invention, or whether it represents an advance over the prior art.

It will be appreciated that the standard for patentability is significantly lower than international standard for inventive step/non-obviousness.

The filing of an innovation patent should be considered for lower level inventions, and/or for inventions which are commercially important, and/or for inventions which are likely to be litigated.

Pharmaceutical re-formulations would seem especially well suited for this type of patent.

regards, Bill

PIZZEYS

(bbennett@pizzeys.com.au)

Dear Clients & Colleagues,

The APO has just handed down a significant decision which impacts on the type of pharmaceutical subject matter which is eligible for an extension of term.

Before discussing the case which has just issued, it is worthwhile briefly sketching out the prior landscape.

Per Section 70 of the Australian Patent Statute, in order to be eligible for an extension of term, the patent must claim “one or more pharmaceutical substances per se”. 

The “per se” limitation has been held to mean that the claim cannot be limited by reference to how that pharmaceutical substance is made, or by reference to dosage regimes or the like.

“Pharmaceutical substance” is defined in the statute as being “a substance (including a mixture or compound of substances) for therapeutic use…”.  There have been several patent office decisions which have considered the meaning of “a substance (including a mixture or compound of substances) for therapeutic use…”.

The first case was LTS Lohmann Therapie-Systeme GmbH & Co KG [2002] APO 12.  The subject matter of this case was a transdermal patch.  In this case, the Commissioner concluded that, if the claim defined features specifying the “spatial configuration” of the entities within the mixture, then the claim was not directed to a pharmaceutical substance per se.  The Commissioner reasoning focused on the fact that, once spatially confined, the substance ceases to be a “mixture”.  There has been some criticism of the decision.

The second case was Sanofi-Aventis [2007] APO 35.  The subject matter of this case was a bi-phasic controlled-release dosage form.  After initial rejection, the Commissioner concluded that the word “compound” must be understood in the sense that it is used within the pharmaceutical industry rather than the narrow meaning in pure chemistry.  Hence, the bi-phasic form was a “compound”.

The third case was Euro-Celtique, S.A. [2007] APO 13.  The subject matter in this case was a transdermal patch, although the claim did not expressly claim the backing layer and there was some small distinction over the earlier LTS case which did expressly claim the backing layer.  Notwithstanding this point of distinction, it was held that the claim was not to a substance per se due to the implied presence of a backing layer.

In the present case, N.V. Organon [2009] APO 8, the subject matter is a vaginal ring for delivery of steroids.  The claim defines a polymer core, in which the steroids are impregnated, and a permeable polymer skin surrounding the core.  The critical question was whether such a structure was “a substance (including a mixture or compound of substances).”  In following the Sanofi decision, the Commissioner held that “substance” and “compound” should be given broad meanings in order to reflect the statutory intent.  At paragraph 21 of the decision, the Commissioner states that the “spatial configuration” reasoning of LTS “ceases to be persuasive” and is not determinative of the question.  Ultimately, the Commissioner held, at para 23, that the question to be asked is “whether the characteristics of what is claimed more predominantly lies with it being a substance rather than a substance in combination with a separate integer”.  The Commissioner concluded that one must look to the “level of integration or interaction” when deciding whether the claim is to a substance, or to a substance in combination with a separate integer.  In this case, the steroids were impregnated into the polymer core, and therefore the claim was to a substance rather than to a substance in combination with a separate feature.

PRACTICAL SUMMARY

The test is now one of “integration” between the active ingredients and the other feature(s).  On this basis, it would appear that at least impregnated transdermal patches are now suitable subject matter for an extension.  Similarly, impregnated polymer implants are clearly good subject matter.  Undoubtedly, there are other similar drug delivery products which are now also suitable for extension of term (e.g. pulmonary delivery, etc).

regards, Bill

PIZZEYS

(bbennett@pizzzeys.com.au)

Dear Clients & Colleagues,

The APO has just handed down a significant decision which impacts on the type of pharmaceutical subject matter which is eligible for an extension of term.

Before discussing the case which has just issued, it is worthwhile briefly sketching out the prior landscape.

Per Section 70 of the Australian Patent Statute, in order to be eligible for an extension of term, the patent must claim “one or more pharmaceutical substances per se”. 

The “per se” limitation has been held to mean that the claim cannot be limited by reference to how that pharmaceutical substance is made, or by reference to dosage regimes or the like.

“Pharmaceutical substance” is defined in the statute as being “a substance (including a mixture or compound of substances) for therapeutic use…”.  There have been several patent office decisions which have considered the meaning of “a substance (including a mixture or compound of substances) for therapeutic use…”.

The first case was LTS Lohmann Therapie-Systeme GmbH & Co KG [2002] APO 12.  The subject matter of this case was a transdermal patch.  In this case, the Commissioner concluded that, if the claim defined features specifying the “spatial configuration” of the entities within the mixture, then the claim was not directed to a pharmaceutical substance per se.  The Commissioner reasoning focused on the fact that, once spatially confined, the substance ceases to be a “mixture”.  There has been some criticism of the decision.

The second case was Sanofi-Aventis [2007] APO 35.  The subject matter of this case was a bi-phasic controlled-release dosage form.  After initial rejection, the Commissioner concluded that the word “compound” must be understood in the sense that it is used within the pharmaceutical industry rather than the narrow meaning in pure chemistry.  Hence, the bi-phasic form was a “compound”.

The third case was Euro-Celtique, S.A. [2007] APO 13.  The subject matter in this case was a transdermal patch, although the claim did not expressly claim the backing layer and there was some small distinction over the earlier LTS case which did expressly claim the backing layer.  Notwithstanding this point of distinction, it was held that the claim was not to a substance per se due to the implied presence of a backing layer.

In the present case, N.V. Organon [2009] APO 8, the subject matter is a vaginal ring for delivery of steroids.  The claim defines a polymer core, in which the steroids are impregnated, and a permeable polymer skin surrounding the core.  The critical question was whether such a structure was “a substance (including a mixture or compound of substances).”  In following the Sanofi decision, the Commissioner held that “substance” and “compound” should be given broad meanings in order to reflect the statutory intent.  At paragraph 21 of the decision, the Commissioner states that the “spatial configuration” reasoning of LTS “ceases to be persuasive” and is not determinative of the question.  Ultimately, the Commissioner held, at para 23, that the question to be asked is “whether the characteristics of what is claimed more predominantly lies with it being a substance rather than a substance in combination with a separate integer”.  The Commissioner concluded that one must look to the “level of integration or interaction” when deciding whether the claim is to a substance, or to a substance in combination with a separate integer.  In this case, the steroids were impregnated into the polymer core, and therefore the claim was to a substance rather than to a substance in combination with a separate feature.

PRACTICAL SUMMARY

The test is now one of “integration” between the active ingredients and the other feature(s).  On this basis, it would appear that at least impregnated transdermal patches are now suitable subject matter for an extension.  Similarly, impregnated polymer implants are clearly good subject matter.  Undoubtedly, there are other similar drug delivery products which are now also suitable for extension of term (e.g. pulmonary delivery, etc).

regards, Bill

PIZZEYS

(bbennett@pizzzeys.com.au)

Dear Clients & Colleagues,

The APO has just handed down a significant decision which impacts on the type of pharmaceutical subject matter which is eligible for an extension of term.

Before discussing the case which has just issued, it is worthwhile briefly sketching out the prior landscape.

Per Section 70 of the Australian Patent Statute, in order to be eligible for an extension of term, the patent must claim “one or more pharmaceutical substances per se”. 

The “per se” limitation has been held to mean that the claim cannot be limited by reference to how that pharmaceutical substance is made, or by reference to dosage regimes or the like.

“Pharmaceutical substance” is defined in the statute as being “a substance (including a mixture or compound of substances) for therapeutic use…”.  There have been several patent office decisions which have considered the meaning of “a substance (including a mixture or compound of substances) for therapeutic use…”.

The first case was LTS Lohmann Therapie-Systeme GmbH & Co KG [2002] APO 12.  The subject matter of this case was a transdermal patch.  In this case, the Commissioner concluded that, if the claim defined features specifying the “spatial configuration” of the entities within the mixture, then the claim was not directed to a pharmaceutical substance per se.  The Commissioner reasoning focused on the fact that, once spatially confined, the substance ceases to be a “mixture”.  There has been some criticism of the decision.

The second case was Sanofi-Aventis [2007] APO 35.  The subject matter of this case was a bi-phasic controlled-release dosage form.  After initial rejection, the Commissioner concluded that the word “compound” must be understood in the sense that it is used within the pharmaceutical industry rather than the narrow meaning in pure chemistry.  Hence, the bi-phasic form was a “compound”.

The third case was Euro-Celtique, S.A. [2007] APO 13.  The subject matter in this case was a transdermal patch, although the claim did not expressly claim the backing layer and there was some small distinction over the earlier LTS case which did expressly claim the backing layer.  Notwithstanding this point of distinction, it was held that the claim was not to a substance per se due to the implied presence of a backing layer.

In the present case, N.V. Organon [2009] APO 8, the subject matter is a vaginal ring for delivery of steroids.  The claim defines a polymer core, in which the steroids are impregnated, and a permeable polymer skin surrounding the core.  The critical question was whether such a structure was “a substance (including a mixture or compound of substances).”  In following the Sanofi decision, the Commissioner held that “substance” and “compound” should be given broad meanings in order to reflect the statutory intent.  At paragraph 21 of the decision, the Commissioner states that the “spatial configuration” reasoning of LTS “ceases to be persuasive” and is not determinative of the question.  Ultimately, the Commissioner held, at para 23, that the question to be asked is “whether the characteristics of what is claimed more predominantly lies with it being a substance rather than a substance in combination with a separate integer”.  The Commissioner concluded that one must look to the “level of integration or interaction” when deciding whether the claim is to a substance, or to a substance in combination with a separate integer.  In this case, the steroids were impregnated into the polymer core, and therefore the claim was to a substance rather than to a substance in combination with a separate feature.

PRACTICAL SUMMARY

The test is now one of “integration” between the active ingredients and the other feature(s).  On this basis, it would appear that at least impregnated transdermal patches are now suitable subject matter for an extension.  Similarly, impregnated polymer implants are clearly good subject matter.  Undoubtedly, there are other similar drug delivery products which are now also suitable for extension of term (e.g. pulmonary delivery, etc).

regards, Bill

PIZZEYS

(bbennett@pizzzeys.com.au)