Federal Appeals Court Affirms the Role of ‘Balance’ in Scheme for Extending Term of Pharmaceutical Patents

On 18 March 2022, the Full Court of the Federal Court of Australia issued decisions relating to term extensions of patents covering pharmaceutical products: Commissioner of Patents v Ono Pharmaceutical Co. Ltd [2022] FCAFC 39 (‘Ono’); and Merck Sharp & Dohme Corp. v Sandoz Pty Ltd [2022] FCAFC 40 (‘MSD’).  The two decisions have (at least) three things in common.  First, both were decided unanimously by a panel comprising Chief Justice Alsop and Justices Yates and Burley.  Second, both found against the patentee, with the court reversing the primary judge’s decision in Ono granting an extension of term, and confirming the primary judge’s decision in MSD nullifying a previously granted extension of term.  And, third, both referred to the principle set out in the objects clause (section 2A) of the Patents Act 1990 that ‘the patent system balances over time the interests of producers, owners and users of technology and the public’ (emphasis added).

The scheme for extending the term of pharmaceutical patents inherently involves a balancing act.  Its primary purpose is to ensure that patentees are not excessively disadvantaged by delays in securing regulatory approval to market patented products.  For example, if a drug is not approved for use until 10 years or more after a patent application is filed, the patentee may have less than half of the standard 20 year patent term remaining to compensate for its investment in discovery and development before becoming exposed to generic competition.  On the other hand, an extended period without competition necessarily exposes the wider public to higher costs of medical treatment.  In an effort to balance these competing interests, the relatively complex provisions of the Patents Act aim to ensure that a ‘typical’ pharmaceutical patentee benefits from up to 15 years of exclusivity, by granting extensions of the patent term of up to five years, i.e. to a maximum of 25 years from filing.  (A 2013 review of pharmaceuticals patents – which the government initially declined to release – found that 53% of such patents have an effective life of 15 years, while 89% have an effective life of over 10 years.)

The primary provisions of the Patents Act governing extensions of patent term are:

1. section 70, which sets out the conditions that must be satisfied before a patentee can apply for an extension of the term of its patent;
2. section 71, which sets time limits for filing of applications for extensions of term; and
3. section 77, which specifies how the duration of an extension of term is to be calculated. 

In each of Ono and MSD, the patentee sought to obtain an advantage, or avoid disadvantage, by arguing for beneficial interpretations of the extension of term provisions.  In each case they failed.  And in both cases the Full Court upheld the principle that the purpose of the extension of term scheme is to balance the competing interests of the patentee of a pharmaceutical substance against the public interest in the unrestricted use of the pharmaceutical invention after expiry of the patent.  In Ono, in particular, the Full Court rejected the proposition that sections 70, 71, and 77 should be construed to achieve a commercial outcome for the patentee.  In MSD the Full Court again invoked the principle of ‘balance’ in declining to permit an extension of term based on a later Australian marketing approval, in circumstances where the patentee had already obtained the benefit of an ‘export only’ approval of a substance falling within its patent claims with an effective life of over 15 years.

The relevance of the Full Court’s focus on balancing of interests, and its references to the objects clause, could extend beyond these cases.  The three judges here are all among the five who recently heard the appeal in the Thaler ‘AI inventor’ case, in which the competing interests of developers and owners of ‘invention machines’, and of the broader public (who might not see the same benefit in granting patent monopolies on automatically-generated inventions), are potentially at stake.  It will be interesting to see whether they adopt a similar approach to weighing up the balance of interests in that case, also.

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Tags: Appeal, Extension of patent term, Objects clause

Extensions of Term for ‘Swiss-Style’ Claims Involving Recombinant DNA Technology? Federal Court Says ‘No’!

A Full Bench of three judges of the Federal Court of Australia has overturned an earlier decision of the Administrative Appeals Tribunal, and has ruled that extensions of patent term are not available for second and subsequent medical uses of pharmaceutical substances that are produced by recombinant DNA technology: Commissioner of Patents v AbbVie Biotechnology Ltd [2017] FCAFC 129 (AbbVie).  In particular, the court found that so-called ‘Swiss-style’ claims are not directed to pharmaceutical substances, and therefore cannot be the subject of a term extension, even if they involve the use of pharmaceutical substances that have been ‘produced by a process that involves the use of recombinant DNA technology’ (to use the terminology of section 70(2)(b) of the Patents Act 1990).

In Australia, the normal maximum term of a patent, i.e. 20 years from its original filing date, can be extended by up to five years in the case of certain pharmaceutical products, to compensate for the time that is typically required to complete trials and obtain the regulatory approvals necessary to actually commence marketing of a commercial drug.  Generally, extensions are available only for patents covering the pharmaceutical substances themselves – patents on methods of making or using the substances are not extendible (section 70(2)(a)).  The one exception to this rule relates to the use of recombinant DNA technology in the production of a pharmaceutical substance (section 70(2)(b)).

The term ‘recombinant DNA’ (rDNA) refers to a process of bringing together genetic material from multiple sources to create gene sequences that are not present in nature.  One well-established medical application of rDNA technology is the production of human insulin for the treatment of diabetes.  By inserting the human insulin gene into a bacterium (such as E. coli) or yeast, the resulting organism becomes a biological insulin factory.  Insulin produced in this way has almost completely replaced the use of insulin from animal sources, such as pigs and cattle. 

The Australian extension of term provisions implement a policy under which even though a pharmaceutical substance (such as insulin) may already be known, a patent directed to the (known) substance when made by a new process involving the use of rDNA technology can nonetheless be awarded an extension of term.  This provides an additional patent incentive for companies to invest in research and development of recombinant techniques for production of medications.

AbbVie Biotechnology Ltd (‘AbbVie’) owns a number of Australian patents relating to a pharmaceutical substance known as adalimumab, marketed under the name HUMIRA, which is produced by a process of rDNA technology.  The drug was originally approved in Australia in 2003, for treatment of rheumatoid arthritis.  It was subsequently demonstrated to be effective for the treatment of rheumatoid spondylitis, Crohn’s disease and ulcerative colitis, and was approved for use in treating these further conditions in 2006, 2007 and 2013, respectively.  AbbVie has patents covering these further medical uses of HUMIRA, each of which includes ‘Swiss-style’ claims.

AbbVie applied to the Australian Patent Office to extend the terms of its three further medical use patents, however a Deputy Commissioner of Patents determined that they were not eligible for extensions of term under section 70(2)(b).  AbbVie appealed to the Administrative Appeals Tribunal of Australia (‘Tribunal’), which reversed this aspect of the Deputy Commissioner’s findings, deciding that Swiss-style claims can form the basis for an extension of patent term.  Nonetheless, AbbVie’s applications for extension of term were still rejected, because the Tribunal agreed with the Deputy Commissioner that they had not been filed within the applicable time limits.

The Commissioner of Patents appealed the Tribunal’s findings in relation to the eligibility of Swiss-style claims to the Federal Court, which has allowed the appeal, and affirmed the Deputy Commissioner’s original decision.  This does not surprise me greatly – when I wrote about the Tribunal’s decision last year, I said that I believed it to be wrong, and that I thought it quite likely that the Commissioner would appeal.

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Tags: Australia, Extension of patent term, Genetic technology, Pharmaceuticals, Public policy

Recombinant DNA Technology and Extensions of Patent Term – ‘Swiss-Style’ Claims Continue to Confuse

A recent decision by the Administrative Appeals Tribunal of Australia has addressed the question of whether a patent directed to a second or subsequent medical use of a known pharmaceutical substance can be eligible for an extension of term, in the particular case that the substance is produced using recombinant DNA technology: AbbVie Biotechnology Ltd Commissioner of Patents [2016] AATA 682 (‘AATA decision’).  In deciding that so-called ‘Swiss-style claims’ can support an extension of term (assuming that all other requirements are satisfied), the AATA has reversed the finding of a Delegate of the Commissioner of Patents that such patents are not eligible for term extensions: AbbVie Biotechnology Ltd [2015] APO 45.  (Never fear if you are unfamiliar with the meaning of the terms ‘recombinant DNA technology’ and/or ‘Swiss-style claims’ – I explain further below.)

In Australia, the normal maximum term of a patent, i.e. 20 years from its original filing date, can be extended by up to five years in the case of certain pharmaceutical products, to compensate for the time that is typically required to complete trials and obtain the regulatory approvals necessary to actually commence marketing of a commercial drug.  For an original medical use of a substance, the availability and duration of any extension of term depends upon when a product including the substance is first listed on the Australian Register of Therapeutic Goods (ARTG).  Generally, extensions are available only for patents covering the pharmaceutical substances themselves – patents on methods of making or using the substances are not extendible.  The one exception to this rule relates to the use of recombinant DNA technology in the production of a pharmaceutical substance.

AbbVie Biotechnology Ltd (‘AbbVie’) owns a number of Australian patents relating to a pharmaceutical substance known as adalimumab, which is produced by a process of recombinant DNA technology.  This drug is marketed under the name HUMIRA, and is supplied in the form of an injectable solution for the treatment of a number of diseases.  It was originally approved, and listed on the ARTG on 10 December 2003, for treatment of rheumatoid arthritis.  It was subsequently demonstrated to be effective for the treatment of rheumatoid spondylitis, Crohn’s disease and ulcerative colitis, and these additional indications were added to the ARTG on 10 August 2006, 29 June 2007 and 23 July 2013 respectively.  AbbVie has patents covering these further medical uses of HUMIRA, each of which includes ‘Swiss-style’ claims.

AbbVie applied to the Australian Patent Office to extend the terms of its three further medical use patents.  The Delegate determined that they were not eligible for extensions of term, even if the extension applications had been filed in time (which he found they were not, because the applications should have been based upon the original 2003 listing on the ARTG, not the 2006, 2007 and 213 listings).  On appeal, the AATA reversed the first aspect of the Delegate’s findings, deciding (wrongly, in my view) that Swiss-style claims can form the basis for an extension of patent term.

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Tags: Australia, Extension of patent term, Genetic technology, Pharmaceuticals, Public policy

Patents and the Trans-Pacific Partnership Agreement, Part 2

In addition to provisions relating to the scope of available patent rights and general procedures, which I wrote about in the first part of this series, the Trans-Pacific Partnership (TPP) Agreement prescribes certain minimum standards for terms of protection – including extensions or adjustments to patent term in certain circumstances.  These provisions apply particularly to regulated products, including  pharmaceuticals and biologics (a.k.a biopharmaceuticals).

In this article I will look at three specific aspects of the TPP:

1. the obligation to provide for adjustment of the patent term to compensate for ‘unreasonable delays’ in the grant of a patent, about which I expect Australia to do nothing;
2. the obligation to provide for extensions of the term of patents relating to pharmaceutical products as compensation for time lost in obtaining regulatory approval, about which I do not believe Australia needs to do anything; and
3. the obligation to provide an effective period of at least eight years of data exclusivity, and/or other protection for biologics, in respect of which I think Australia has a real problem following the High Court’s decision in D'Arcy v Myriad Genetics Inc [2015] HCA 35.

To make matters more interesting, on 3 December 2015, the US Industry Trade Advisory Committee on Intellectual Property Rights (ITAC-15) released its report on the IP provisions in the TPP [PDF, 198kB].  The report has been prepared pursuant to a statutory requirement that ‘advisory committees provide the President, the U.S. Trade Representative, and Congress with reports not later than 30 days after the President notifies Congress of his intent to enter into an agreement.’  The Committee is generally positive about the patent-related provisions, however it is not without its criticisms and concerns about those relating to pharmaceutical term extensions and biologics.

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Tags: Conventions, Extension of patent term, Genetic technology, International treaties, Trans-Pacific Partnership

On Extensions of Patent Term and Genetic Technologies

Two recent decisions issued by the Australian Patent Office address the requirements for extending the term of a patent encompassing a pharmaceutical substance ‘when produced by a process that involves the use of recombinant DNA technology’: ImmunoGen, Inc. [2014] APO 88 and Novartis Vaccines and Diagnostics S.r.l. [2015] APO 2.

What is interesting about both these cases is that, while recombinant DNA techniques are employed in manufacturing the pharmaceutical products, neither patent directly claims a new product resulting from the use recombinant DNA technology.  In both cases, the patent claims are principally directed to processes for making the products, and extensions of term have nonetheless been granted. 

The decisions relate to the anti-cancer drug KADCYLA, and the meningitis vaccine BEXSERO, both of which will now enjoy an extended term of patent protection in Australia.

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Tags: Australia, Extension of patent term, Genetic technology, Pharmaceuticals

High Court Majority Upholds LEXAPRO Patent Time Extension

On 5 November 2014, the High Court of Australia handed down its decision confirming (by a three-to-two majority) that it is possible to obtain an extension of time within which to apply for an extension of the term of a patent relating to a pharmaceutical substance, so long as the extension application is filed prior to expiry of the patent: Alphapharm Pty Ltd v H Lundbeck A/S [2014] HCA 42.

This decision is an important milestone in a long-running saga relating to the antidepressant drug escitalopram, originally marketed in Australia as LEXAPRO, and covered (at least until 13 June 2009) by Australian patent no. 623,144.  The patent is owned by H Lundbeck A/S, which had applied to extend the term of the patent to 9 December 2012, as compensation for delays in obtaining regulatory approval to market LEXAPRO in Australia.  But, for reasons that I explained in an earlier article on the case, Lundbeck required an extension of time to allow its application for an extension of term to be considered, because it was filed about ten years too late!

The issue before the High Court was whether, under the relevant provisions of the Patents Act 1990 and the Patents Regulations 1991, the Commissioner of Patents has the power to extend the time for filing an application for an extension of term in any circumstances.  The Court’s answer to this is, in essence, ‘yes’ – if the application to extend the term of the patent, and the associated request for an extension of time, are filed prior to the patent’s expiry.

This does not, however, bring an end to the matter.  There is a separate question of whether it was appropriate, in the particular circumstances of this case, for the extension of term to be granted, which is still making its way through the appeals process.  Hot on the heels of the High Court’s ruling, a single judge of the Federal Court of Australia has handed the latest round in this part of the dispute to Lundbeck, dismissing an appeal from the Commissioner’s decision to allow the extension:

Alphapharm Pty Ltd v H Lundbeck A/S [2014] FCA 1185.

A great deal of money is at stake in all of this.  A number of generic pharmaceutical companies released their own escitalopram products following the original expiry date of the Lundbeck patent (a risky strategy, given that they were certainly aware of Lundbeck’s extension application by that time).  The patent itself has already been found valid and infringed by a Full Bench of the Federal Court of Australia (in H Lundbeck A/S v Alphapharm Pty Ltd [2009] FCAFC 70), and all avenues of appeal from that decision have been exhausted.  Thus if the term extension is ultimately upheld (as it has been at every turn so far), damages will be due to Lundbeck for infringement of the patent between 13 June 2009 and 9 December 2012.

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Tags: Appeal, Australia, Extension of patent term, Extensions of time, Pharmaceuticals

High Court to Consider Pharmaceutical Term Extension Question

In the latest development in a long-running saga, the High Court of Australia has agreed to hear an appeal over whether or not it is possible to obtain an extension of time within which to apply for an extension of the term of a patent relating to a pharmaceutical substance.

The substance in question in this case is the antidepressant drug escitalopram, marketed in Australia as LEXAPRO, and covered (at least until 13 June 2009) by Australian patent no. 623,144 owned by H Lundbeck A/S.  Lundbeck is looking to extend the term of the patent to 9 December 2012, which it would be entitled to do as compensation for delays in obtaining regulatory approval to market LEXAPRO in Australia.  But, in order to do this successfully, it requires an extension of time to allow its application for an extension of term to be considered, because it was filed about ten years too late!

So far, the Australian Patent Office, the Administrative Appeals Tribunal, and a (unanimous) Full Bench of three experienced judges of the Federal Court of Australia have all upheld Lundbeck’s claim to the extension of time. 

However, the additional three-and-a-half years of patent term presumably represents a great deal of money in prospective damages to be paid by generic pharmaceutical manufacturers, who have been selling products in competition with LEXAPRO, and so they not given up on appealing!  And, it seems, rightly so – because on 11 April 2014 the High Court of Australia granted ‘special leave’ (transcript at Alphapharm Pty Ltd v H Lundbeck A/S & Ors [2014] HCATrans 79), allowing generic manufacturer Alphapharm Pty Ltd to appeal the Federal Court decision.

In fact, Alphapharm was only 50% successful in its bid.  The High Court declined to take the question of whether it was ‘reasonable’ for Lundbeck to be granted an extension of an entire decade any further, presumably feeling that the tribunals below had weighed up all of the relevant factors correctly.  The High Court appeal will therefore be limited to the single question of whether an extension of time to apply for an extension of term is available at all under the provisions of the Australian Patents Act 1990 and Patents Regulations 1991.

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Tags: Appeal, Australia, Extension of patent term, Extensions of time, Pharmaceuticals

Should Pharmaceutical Patent Term Extensions Be Shorter?

Last month, the Federal Minister for Industry, Ian Macfarlane, stated that the government had no intention of releasing the final report of the Pharmaceutical Patents Review.  Last week, following the submission of at least one request under the Freedom of Information Act (although I understand there were others), the report was made available on IP Australia’s website.

The release of the report is described as being in response to ‘stakeholder interest’, which is true enough!  It is accompanied by the following government statement:

The Pharmaceutical Patent Review was commissioned by the previous government and conducted by an independent panel. The review panel provided its final report to the previous government in May 2013, which did not release the report.

The government notes that the report is one of a number of reviews of the pharmaceutical system conducted during the term of the previous government. The government has no plans to respond to the report at this stage but may take information in the report into account when considering future policy. The views expressed and recommendations made in the report are those of the review panel and do not necessarily reflect government policy.

In other words, ‘we did not commission it, the people who did commission it did not release it, we were not going to release it until we were forced to, and we are going to ignore it anyway!’

The report is some 234 pages in length, and I have no intention of trying to cover everything in it, particularly considering that it is unlikely to influence government policy.  However, one of the key issues addressed by the review – whether the current system for extending the term of certain pharmaceutical patents is appropriate – is certainly worthy of further discussion.  All members of the review panel recommended a reduction in the duration of extended patents.

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Tags: Australia, Extension of patent term, Pharmaceuticals, Public policy

Pharmaceutical Patents Review Buried by Successive Governments

It appears that a review of pharmaceutical patents in Australia – which had a particular focus on extensions of patent term – is dead. 

On 11 February 2014, the Minister for Industry, Ian Macfarlane, responded to a ‘Question in Writing’ from Western Australian MP Melissa Parke.  Ms Parke had asked (back in December) when we might expect the final report of the Pharmaceutical Patents Review to be released.  The Minister’s response: ‘The Government has no plans to release the final report at this stage.’

I have followed the saga of the Pharmaceutical Patents Review on this blog since its inception:

1. it was announced on 15 October 2012, by what was then a Labor government under Julia Gillard;
2. on 21 November 2012 the review panel released a ‘background and suggested issues paper’, providing a somewhat miserly two month period (over the Christmas and New Year break) for public submissions;
3. as I reported in February 2013, the terms of the review, the composition of the panel, and the compressed time frame drew criticism from some quarters;
4. a draft report issued on 2 April 2013 included a number of proposed recommendations, including two options for reducing the duration of extensions of patent term granted to pharmaceutical patents as compensation for delays in obtaining regulatory marketing approval; and
5. in June 2013 I wrote about continuing efforts by the generic pharmaceutical industry in Australia to press the case for reduced patent terms in the final report.

Over this period, there were two changes in leadership in Australia.  In June 2013, Prime Minister Julia Gillard was deposed by Kevin Rudd, while in September there was a Federal election which resulted in a switch to the current Liberal-National Party (LNP) government under Tony Abbott. 

In my first article of 2014, I speculated about whether there would be some progress on this review, or whether it would simply be set aside by the new government.  It seems we now have an answer to that question.

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Tags: Australia, Extension of patent term, Pharmaceuticals, Public policy

Pharma Patents Review Proposes Reduced Term Extensions

On 2 April 2013, the Australian Government’s Pharmaceutical Patents Review published its draft report.  I last wrote about the review when the panel released its Issues Paper last November.  The draft report is some 250 pages long, including appendices, and I do not intend to attempt a full review here!  Interested parties are encouraged to read the complete draft, bearing in mind that the period for providing written responses is extremely short, expiring on 30 April 2013.

The draft report includes 15 draft findings, many of which (if implemented) would not result in substantive changes to the provisions of Australian patent law.  For example, there are recommendations as to how the Government should conduct itself in future international trade negotiations, for future reviews of the performance of the patent system to be undertaken, and for changes in the way the regulatory approval process, the Australian Register of Therapeutic Goods and the Pharmaceutical Benefits Scheme are managed and documented.

Here, I wish to focus on just one area of the draft report, namely its two alternative proposals for a reduction in the extension of term available to pharmaceutical patents as compensation for the effective loss of benefit due to delays in obtaining regulatory approval.  It appears to me that, perhaps as a result of the very short timeframes provided to the review panel, these proposals have not been adequately thought-through. 

Arguments for a reduced extension of term are bolstered by a dizzying array of tables, calculations and charts, which in my view serve only to obscure the basic policy question underlying the provision of an extension of term on pharmaceutical patents – for how long, in any given case, is Australia prepared to pay a premium for a patented drug before the introduction of generic competition?  Currently, the answer to that question is ‘for up to 15 years’.  Reducing this period would obviously save money – which is the primary argument presented in the draft report.

However, it is a basic fact of modern life that we must pay for the things we want, and that (by and large) we get what we pay for.  Yet there is a notable absence in the draft report of any evidence that a shorter term would provide a better ‘balance’ between the interests of the originating drug companies and those of the Australian community.

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Tags: Australia, Extension of patent term, Law reform, Pharmaceuticals

Attorneys Slam Australian Pharmaceutical Patents Review

In a submission to the Governments Pharmaceutical Patents Review [PDF], the peak body representing Australian registered patent attorneys, the Institute of Patent and Trade Mark Attorneys of Australia (IPTA) has accused the Terms of Reference for the review, and the composition of the review panel, of being biased towards the interests of generic drug manufacturers.  IPTA has also criticised the timing of the review and the short period provided for public submissions, and alleged that the overall conduct of the review sends a ‘negative message to the research-based pharmaceutical industry’.

IPTA’s complaints have been fully supported by a submission [PDF] made on behalf of the Australian Federation of Intellectual Property Attorneys (FICPI Australia).

I have written about this latest review of the patent system on two previous occasions – firstly when it was initially announced, and then again when the ‘Background and Suggested Issues Paper’ was released.  I expressed similar concerns to those of IPTA regarding the limited two-month period for public submissions, particularly considering that this spanned Christmas and the New Year, when many Australians take annual holidays and some companies – and all Australian universities – have official ‘close-down’ periods.

I was also concerned about the impact of yet another review, when it seems that the Australian patent system has been under incessant review and reform for a number of years, and particularly considering that the broad Terms of Reference for the Pharmaceutical Patents Review overlap with other recent and ongoing enquiries relating to patentable subject matter, the use of innovation patents, gene patenting, and compulsory licensing.  One might form the impression that somebody is determined to keep reviewing the system from different angles until they eventually get the answers they want, whatever those might be!

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Tags: Australia, Extension of patent term, Law reform, Pharmaceuticals

Lundbeck Wins Latest Round in LEXAPRO Term Extension Bout

Aspen Pharma Pty Ltd and Ors and Commissioner of Patents and H Lundbeck (Joined Party) [2012] AATA 851 (4 December 2012)

Extension of term – appeal from grant of an application for an extension of time – whether extension available under Patents Regulations 1991 – whether misunderstanding of the law a relevant ‘error or omission’ – whether exercise of discretion justified

The Administrative Appeals Tribunal (AAT) has upheld a decision of the Australian Patent Office granting an extension of time of 121 months for pharmaceutical manufacturer H Lundbeck A/S to request an extension of term of its Australian patent no. 623,144, covering its antidepressant drug escitalopram, marketed in Australia as LEXAPRO.

In the absence of the requested extension of term, the LEXAPRO patent expired on 13 June 2009.  With an extension of term – based upon the listing of the earlier drug CIPRAMIL on the Australian Register of Therapeutic Goods (ARTG) – the expiry date of the patent becomes 9 December 2012.  Although this extended term will itself have expired before it can even be formally granted, a number of generic pharmaceutical manufacturers have been marketing their own escitalopram products throughout the intervening period, and may therefore be liable to pay damages to Lundbeck corresponding with these sales.

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Tags: Australia, Extension of patent term, Extensions of time, Pharmaceuticals

Pharma Patents Review Releases Issues Paper, Launches Blog

On 21 November 2012 the Australian Government’s Pharmaceutical Patents Review panel released a ‘Background and Suggested Issues Paper’ [PDF, 609kB], which outlines the panel’s initial impressions of the key issues for the review.  This review was originally announced by the Parliamentary Secretary for Industry and Innovation, Mark Dreyfus QC, on 15 October 2012 (see Yet Another Patent System Review – Pharmaceutical Patents).

According to the panel’s announcement, the paper seeks to ‘begin engaging with anyone who has an interest in this area [i.e. pharmaceutical patents] and to provide a stimulus for written submissions.’

The paper includes a number of specific questions, however it is said said that these are intended only to provide ideas for developing submissions.  The panel is seeking a broad spectrum of views, and does not want anyone to feel constrained by its suggested questions!

There are two aspects of the announcement which we find quite interesting, at least from our own personal perspective.  Firstly, the review does not merely have a web page – as is now absolutely standard – but has set it up as a blog at pharmapatentsreview.govspace.gov.au.  The panel intends to use the blog to explore the relevant issues with stakeholders, and interested parties will be able to interact directly with the panel throughout the review process by commenting on individual posts (including the announcement of the issues paper itself).

Secondly, Patentology’s article Pharmaceutical Extensions of Term: Is It Time for a Fix? is cited in the issues paper (footnote 20), which came as a pleasant surprise!

Written submissions are due by 5pm on 21 January 2013.  This is actually quite a tight deadline, considering that the month between Christmas and the end of January is the main summer vacation period for many Australian stakeholders.

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Tags: Australia, Extension of patent term, Law reform, Pharmaceuticals

Yet Another Patent System Review – Pharmaceutical Patents

On Monday this week (15 October 2012), the Parliamentary Secretary for Industry and Innovation, Mark Dreyfus QC, announced a new review of pharmaceutical patents in Australia.

Our initial reaction?  A great sigh… because surely what the Australian patent system needs right now is yet another review, enquiry or proposal for reform!  Frankly, stakeholders in the system – including innovators (small and large) and their professional advisors – are already reeling from the pace of evaluation and change being imposed upon the patent system in Australia.

In the first decade of the 21^st century, a number of reviews of the patent system were initiated under the Howard conservative government – including the Australian Law Reform Commission (ALRC) enquiry into Gene Patenting and Human Health, and the Advisory Council on Intellectual Property (ACIP) review of Patentable Subject Matter (see ACIP Reports on ‘Patentable Subject Matter’) – without any action being taken to implement any of the resulting recommendations.

That inaction was wrong.  It was wrong firstly because it failed to address the real concerns of the Australian public, and users of the patent system, that were identified in the enquiries.  Secondly, it was wrong because for a government to commission a review, receive a report, and then take no real action on the recommendations made, is nothing more than a waste of valuable resources and taxpayers’ money.

However, in the past few years there appears to have been an over-correction, as our elected representatives and taxpayer-funded bureaucrats have engaged in a seemingly continuous series of new enquiries and real reforms. 

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Tags: Australia, Extension of patent term, Law reform, Pharmaceuticals

Pharmaceutical Extensions of Term: Is It Time for a Fix?

In light of news from Europe today, via the IPKat, it is becoming ever more clear that the law in Australia regarding the grant of extensions of term for pharmaceutical patents is flawed, and out-of-step with all of our major trading partners.

We have covered this topic before, most recently in the article Australia Slips Further Out-of-Step on Pharmaceutical Extensions, in which we highlighted the disparity between the Australian law and its Japanese counterpart.  We had previously discussed the difference in approaches between Australia and the US.  A new ruling from the Court of Justice of the European Union (CJEU) now establishes that a similar disparity exists between Australian and European law and practice.

The upshot of this is that patentees in Australia may obtain a shorter term of protection for various classes of pharmaceutical inventions, when compared with trading partners such as the US, Europe and Japan.  While some may see this as a benefit – shorter patent terms mean earlier availability of generic competitors, resulting in lower prices – the flip side is that jurisdictions with lesser protections tend to seen as less attractive for investment.  This may mean less funding for R&D to be conducted in Australia, fewer innovative drug manufacturers operating in this country, and a reduced focus on the specific needs of the Australian community and environment.

If Australia wishes to stand side-by-side with other advanced developed economies, to maintain and develop local capabilities for drug discovery and development, reduce its reliance on primary industry, and progress along the path of becoming a ‘knowledge economy’, we need to ensure that the laws protecting IP in this country are on a par with those nations against which we would compare ourselves.

As matters stand right now, this is clearly not the case when it comes to patent protection for pharmaceutical inventions.

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Tags: Australia, Europe, Extension of patent term, Japan, Pharmaceuticals, UK, US

No Extension for Patent on Drug ‘Combination’ That Is Not a ‘Mixture’

The Children's Medical Center Corporation [2011] APO 80 (7 October 2011)

Pharmaceutical extensions of term – whether indication for use of therapeutic goods in combination with another substance constitutes an inclusion of the combination on the register – whether a combination of separate known dosage forms is a ‘pharmaceutical substance per se’

The drug thalidomide is an anti-angiogenic agent – it suppresses the formation of new blood vessels in tissues and organs, something which occurs in only limited circumstances in healthy individuals, but which can occur in an uncontrolled manner in certain disease states, such as cancers.

Australian patent no. 2005202596 (‘patent’), in the name of The Children’s Medical Center Corporation (‘patentee’),  relates to combinations comprising anti-angiogenic compounds – particularly thalidomide – with anti-inflammatory compounds (including steroids).  The patent is the grandchild of an application originally filed on 4 November 1997, so its maximum 20-year term will expire on 4 November 2017.

The patentee sought an extension of the term of the patent of five years, until 4 November 2022, based upon registration of  thalidomide on the Australian Register of Therapeutic Goods (ARTG).  This registration includes indications for the use of thalidomide in combination with various steroids for treatment of multiple myeloma.

In this decision of Delegate Dr L. F. McCaffery, the Australian Patent Office has refused to extend the term of the patent on two grounds:

1. thalidomide in combination with a steroid does not constitute goods included on the ARTG, where there is an indication for the combination in an entry for thalidomide; and
2. a combination of separate known dosage forms does not constitute a ‘mixture’ within the meaning of the term ‘pharmaceutical substance per se’.

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Tags: Australia, Extension of patent term, Pharmaceuticals

Celgene Denied Term Extension on REVLIMID Patent

Celgene Corporation [2011] APO 37 (3 June 2011)

Pharmaceutical extensions of term – whether patent for a subsequent medical use of a known compound can be extended – whether registered product contains a compound within the scope of patent claims – whether date of amendment of ARTG registration can be used as the basis for extension application

In a decision by Hearing Officer Dr Steven Barker, the Australian Patent Office has refused to grant to Celgene Corporation extensions of the term of two patents relating to the pharmaceutical product marketed as REVLIMID.

The active ingredient in REVLIMID is lenalidomide, a drug which is a close relative to the infamous thalidomide.  Lenalidomide was originally developed as a treatment for multiple myeloma (a rare cancer of the blood), and has more recently been shown to be effective in treating the class of genetic blood disorders disorders known as myelodysplastic syndromes (MDS).

Celgene’s application to extend the term of its patents was based specifically on the use of REVLIMID in the treatment of MDS.  This particular indication was first added to the Australian Register of Therapeutic Goods (ARTG) in May 2010, although the product itself had been registered since 2007.

The Hearing Officer found not only that the applications for extension of term were filed out-of-time, but also that neither of the two patents is eligible for an extension of term based on the registration of REVLIMID.  In particular, this decision indicates that:

1. patents for subsequent medical uses of drugs (e.g. having claims of the form ‘compound X when used for the treatment of condition Y…’) cannot be extended on the basis of a registration of a product containing the compound;
2. for a patent directed to specific novel forms of a compound to receive an extension of term, evidence must be provided showing that the registered product actually contains the compound in the specific form claimed; and
3. an application for an extension of patent term must be based upon the original registration of a product, and not upon a subsequent registration or amendment by which an additional indication is included on the ARTG.

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Tags: Australia, Extension of patent term, Pharmaceuticals

Extension of Time Granted to Correct Extension of Term Error

Aphapharm Pty Limted & Ors v H Lundbeck A/S [2011] APO 36 (1 June 2011)

Back in July last year, we reported on the decision in H Lundbeck A/S v Alphapharm Pty Ltd [2009] FCAFC 70 (11 June 2009), which related to the refusal of a pharmaceutical extension 0f term for Lundbeck’s patent no. 623,144, which covers the S- or (+)-enantiomer of the antidepressant compound citalopram (see Pharmaceutical Extensions and International Inequities for further details).

A new Patent Office decision, by Hearing Officer Karen Ayres, is a direct consequence of the earlier Federal Court decision.  In particular, in an attempt to recover the patent term extension it had lost as a result of the court’s decision, Lundbeck filed a fresh application for an extension of term.  However, in order for this application to proceed, Lundbeck requires an extension of time of no less than 121 months, from the date upon which the request should have been filed originally.

The Patent Office initially proposed to grant the requested extension.  Four parties opposed.

Following a contested opposition, and a hearing, the Patent Office has confirmed the decision to allow Lundbeck extension of time within which to apply for the extension of term.

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Tags: Australia, Extension of patent term, Extensions of time, Pharmaceuticals

Australia Slips Further Out-of-Step on Pharmaceutical Extensions

On 28 April 2011, the Japanese Supreme Court ruled that a term extension can be allowed for a patent covering a subsequent therapeutic product based on the same active ingredient as a product having an earlier regulatory approval date.  This decision further confirms that the approach taken in Australia is at odds with many of the nation’s major trading partners.

We have written previously about pharmaceutical extensions of term (see Pharmaceutical Extensions and International Inequities).  The basic principle is simple enough – where a patentee experiences delays in its ability to exploit a patent due to the requirements of obtaining regulatory approval (e.g. permission to market a drug for treatment of humans), it may apply for an extension to the normal 20-year patent term as whole or partial compensation for such delays. 

To prevent the patentee from unfairly extending its monopoly, there are restrictions on the grant of an extension of term.  In particular, it is generally the case that an extension is only available on the basis of the first inclusion of a therapeutic product on the relevant register.  Thus a subsequent patent, directed perhaps to some variation, improvement, or new delivery method, might not be eligible for extension if the active ingredient had previously been registered in its own right.

The recent Japanese decision appears to adopt a more lenient approach to such restrictions than is currently the case in Australia, and seems more in line with the US approach.

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Tags: Australia, Extension of patent term, Japan, Pharmaceuticals, US

Pharmaceutical Extensions and International Inequities

H Lundbeck A/S v Alphapharm Pty Ltd [2009] FCAFC 70 (11 June 2009)
Ortho-McNeil Pharmaceutical, Inc. v. Lupin Pharmaceuticals, Inc., No. 09-1362 (Fed. Cir. May 10, 2010)

"White powder" (or, indeed, powder or other chemical substances of any colour) is not within Patentology's usual area of expertise, and we generally rely upon various colleagues to educate us in this area.

Yet we could not help but notice two recent decisions, one in Australia and one in the US, which resulted in completely opposite outcomes in otherwise analogous circumstances.  We will therefore endeavour to explain our take on these decisions.

In order to do so, we will need to provide a little background, firstly on the provisions for extending the term of pharmaceutical patents, and secondly on the specific chemical issues in these cases.  If you are familiar with this background, click here to jump to the conclusions.

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Tags: Australia, Extension of patent term, Pharmaceuticals, US