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

The Hard Line on Extensions of Time in Patent Oppositions

Since the Intellectual Property Legislation Amendment (Raising the Bar) Regulation 2013 came into effect on 15 April 2013, new, stricter, rules have applied to parties hoping to obtain an extension of a time period for filing evidence in an Australian patent opposition.

As of the time of writing this article there have been seven published Patent Office rulings on extension requests decided under the new regulations.

Unsurprisingly, considering that an express intention of the new rules was to raise the bar on extensions of time, five of the seven requests considered under the new regulations have been refused. 

However, while the situation looks grim for parties requiring additional time to prepare opposition evidence, things are not as bad as the published decisions might suggest.  By definition, it is typically the most contentious cases that proceed to a hearing and a written decision.  I am aware of a number of recent cases in which extensions of time have been granted, under both the new and old rules, without any need to request a hearing.  Naturally, the majority of clearly worthy applications for extensions will be granted without fuss or fanfare. 

And, as I explain below, there is much to be learned from the failures of those parties that have had to take their requests to a hearing!

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Tags: Australia, Evidence, Extensions of time, Patent Office, Raising the Bar, Regulations

Should Australian Patent Attorneys Be Allowed to Litigate?

As I regularly remind people, Australian patent attorneys are not generally lawyers.  Of course there are examples of patent attorneys who also have general law degrees, and some of them (though not all) also practice as solicitors.  But, for the most part, patent attorneys (including me) are people with relevant technical qualifications (a mandatory requirement in Australia) plus specialised training and experience in the laws and official practice relating to patents, trade marks and registered designs.

The profession in Australia therefore differs from some other countries.  In the US, for example, the title ‘patent attorney’ is reserved for practitioners who have a law degree, and are registered to practice law before the courts in one or more states.  The term for a practitioner who is qualified to practise before the US Patent and Trademark Office, but not in any broader legal capacity, is ‘patent agent’. 

Even so, it is not quite correct to equate an Australian ‘patent attorney’ with a US ‘patent agent’.  Chapter 20 of the Australian Patents Act 1990 authorises patent attorneys to provide intellectual property advice not only with regard to registered rights, but also ‘related matters’, including advice on validity and infringement of patents.  My understanding is that a US patent agent is not authorised to provide legal advice of this kind.

Unsurprisingly, given the historical connections, the UK profession is organised and regulated similarly to the Australian profession.  However, I recently learned that since 1999 it has been possible for a UK patent attorney to apply for a ‘Litigator Certificate’.  Initially, these were granted by the Chartered Institute of Patent Attorneys (CIPA) to ‘suitably qualified and experienced members’.  Since 2012, however, the Intellectual Property Regulation Board (IPReg) has administered the grant of three levels of practising certificates, based on completion of accredited qualifying courses and ongoing continuing professional development (CPD).  The highest level of IPReg certification confers full rights of audience in the UK High Court, Court of Appeal and the Supreme Court in certain classes of proceedings relating to IP rights.

My question today is: should Australia be looking at introducing a similar system to permit patent attorneys to appear, and to instruct counsel, in proceedings before the Australian Federal Court and the High Court?

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Tags: Australia, Law reform, Litigation, Patent attorney profession, Public policy

Australian Patent Office Gets Serious About Inventive Step

Cronk v Commissioner of Patents [2014] FCA 37 (10 February 2014)

The Australian Patent Office has taken the (to my knowledge) unprecedented step of engaging an expert witness to assist in the defence of a Federal Court appeal from a decision to reject a patent application.  Furthermore, in a result that should act as a warning to future applicants finding themselves in a similar position, the approach has been successful!

The commencement on 15 April 2013 of the ‘Raising the Bar’ IP law reforms lifted the standard of inventive step (or nonobviousness) in Australia to a level comparable with that of comparable developed economies, such as the US and Europe.  However, the less stringent former law continues to apply to the multitudes of patents granted prior to the reforms, and to a majority of the thousands of applications that were still pending when the law changed.

But even before the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 had been drafted, IP Australia had announced its intention to begin the process of raising standards through changes in examination practice that would include a more rigorous approach to assessing inventive step.  This may have been the reason for the difficulty experienced by applicant Paul Andrew Cronk in overcoming the rejection of his application no. 2008229901.  An examiner’s rejection of the majority of claims in the application was upheld following a Patent Office hearing.  I wrote about this original decision back in May of 2012.

This outcome was unusual in itself.  Historically it has been very difficult for the Patent Office to maintain objections of obviousness, or lack of inventive step.  The inquiry into whether or not a claimed invention is obvious or not is strongly evidence-based under Australian law.  An applicant who provided even relatively weak evidence of inventiveness has usually been able to prevail, since the examiner is rarely in a position to provide any evidence at all, beyond documents found in the prior art search.

Standing by a rejection of this type was therefore a bold move, leaving the applicant with the options of abandoning the application, or appealing to the Federal Court.  Mr Cronk called the Patent Office on its decision, and appealed.  The Patent Office, in turn, raised the stakes, and obtained new evidence for use in the appeal.  The court has found that the Patent Office’s evidence is more relevant and credible, and dismissed Mr Cronk’s appeal.

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Tags: Appeal, Australia, Evidence, Obviousness, Patent Office

US Still Seething Over WIPO ‘Computers for Commies’ Deal?

Fox News has reported that World Intellectual Property Organization (WIPO) Deputy Director General Jim Pooley has filed a ‘Report of Misconduct’ with the legislative branches of WIPO, and with the US Mission in Geneva.  Pooley, who is the most senior US official at WIPO, has reportedly accused Director General Francis Gurry (an Australian national) of ‘serious misconduct’ and ‘violations of national and international law’.

The allegations made by Mr Pooley are not new, and relate primarily to Mr Gurry’s supposed involvement in a ‘scheme to illegally acquire DNA samples of WIPO employees’ as part of an investigation by Swiss authorities into anonymous letters he had received prior to his election as Director General.  I have written before about these allegations, back in December 2013, at which time Gurry was nominating against three other candidates for a second six-year term as WIPO Director General.  Several members of the US Congress – including both Republicans and Democrats – had written to Secretary of State John Kerry, urging the Obama Administration to support an alternative candidate for Director General in light of the growing ‘scandals’ engulfing Gurry.

At the time, I speculated that the main problem US politicians had with Gurry was not the conduct of a criminal investigation that took place five years earlier, but his more recent involvement in a WIPO program to ship ‘high-end computers’ and other electronic equipment to North Korea and Iran, along with ‘secret agreements’ to open satellite offices of WIPO in Russia and China.  But, as I also said in my earlier article, WIPO is not an arm of the US government, and it is not WIPO’s mission to enforce US foreign policy or to further US interests in the world.

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Tags: International treaties, News, Politics

Patents, Competition and Anticompetitive Conduct

Australia’s competition regulator, the Australian Competition and Consumer Commission (ACCC), has instituted Federal Court proceedings against Pfizer Australia Pty Ltd (Pfizer) for alleged anticompetitive conduct (misuse of market power and exclusive dealing) in relation to its supply to pharmacies of blockbuster cholesterol drug atorvastatin.

Until May 2012, Pfizer held an Australian patent on atorvastatin, and was therefore the sole supplier of the drug to the Australian market, under the brand name Lipitor.  The drug was prescribed to over a million Australians, and had annual sales exceeding A$700 million.  Put simply, the ACCC alleges that Pfizer misused the market power it held during the term of its patent to restrict competition from generic substitutes after the patent expired.

A patent is, of course, inherently ‘anticompetitive’, in that it provides the patentee with exclusive rights to exploit the claimed invention commercially.  The intervention in the free market represented by a patent is justified on the basis that providing a limited-term monopoly-style right is an incentive for people and companies to invest in research, development and commercialisation of innovative new products and services.

However, once the patent expires, other suppliers are free to enter the market with competing products or services based on the formerly-patented invention.

The rights grated by a patent do not, however, permit a patent-owner to do anything they like during the term of the patent.  The term ‘exclusive right’ means a right to exclude others from exploiting the invention.  A patent does not grant the patentee the right to use the invention in ways that are contrary to the law, or that infringe upon the rights of others.

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Tags: Australia, Competition law, Licensing, Pharmaceuticals

Expected Increase in Applications Entering Examination

IP Australia has announced that, from this month, it expects to increase the number of patent applications being sent to examination. 

This means that if you have an application pending at the Australian Patent Office – and particularly if it was filed more than four years ago (including national phase applications based on PCT applications originally filed that long ago) – the likelihood that you will be directed to request examination, assuming you have not already done so, is on the rise.

For those who are unfamiliar with the Australian patent examination process, we have a ‘voluntary’ examination request system.  Filing of an application, and requesting examination, are separate steps, each of which requires the payment of a specified fee.  Currently the fee for filing a standard patent application is A$370, while the normal fee to request examination is A$470 (reduced to A$300 if IP Australia has previously conducted an international search on an originating PCT application).

The system is not entirely voluntary, however, and one circumstance in which an applicant can be compelled to request examination is if the Patent Office sends a notice (known as a ‘direction’) requiring an examination request to be filed.  Following a period during which fewer of these directions have been sent, IP Australia is expecting to issue significantly more of them from now on.

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Tags: Australia, Examination, Patent Office