Australian Government Seeks $60M Damages Over Invalid Patent

A court ruling has revealed that the Commonwealth of Australia (i.e. the Federal Government) is seeking to recover $60 million it considers has been ‘overpaid’ for the anti-clotting drug marketed by Sanofi (formerly Sanofi-Aventis) and Bristol-Meyers Squibb under the brand name PLAVIX: Commonwealth of Australia v Sanofi-Aventis [2015] FCA 384.

Sanofi was the owner of Australian Patent No. 597784, which includes claims directed to the compound having the international non-proprietary name clopidogrel.  As noted above, clopidogrel has anti-clotting activity, and is prescribed primarily to prevent heart attack and stroke in high-risk patients, such as those who have a history of these conditions.  The brand-name drug PLAVIX was immensely profitable – according to Wikipedia, it was the second best-selling drug in the world, grossing over US$9 billion in global sales in 2010.  (And, since this is the Internet, Wikipedia also reveals that clopidogrel may have beneficial uses in cats.)

In 2007, generic pharmaceutical manufacturer Apotex Pty Ltd, wanting to introduce its own clopidogrel product to the Australian market, commenced proceedings against Sanofi in the Federal Court of Australia seeking revocation of its patent.  Sanofi, in turn, accused Apotex of threatening infringement.

For the duration of the resulting proceedings, injunctions imposed by the court, along with undertakings that Apotex provided, prevented it from introducing a generic product, leaving patients, and the Australian Government, with no alternative to the premium-priced brand-name product PLAVIX.  Eventually, Sanofi’s patent was found to be invalid, implying that a cheaper generic version of the drug could have been made available all along. 

The notional difference in price between the brand-name product and a hypothetical generic alternative is the basis for the Government’s claim for $60 million in damages.

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Tags: Australia, Damages, Interlocutory injunction, Pharmaceuticals

How International Treaties Help Inventors With Patent Strategy

There is no such thing as a ‘world patent’.  As matters currently stand – and as I expect them to remain beyond the term of my natural life – there is no country on Earth that is willing to completely forego the right to determine what qualifies for a patent monopoly within its borders, or the right to collect ongoing fees to maintain this privilege.

So, anybody wishing to obtain patent protection in multiple markets will necessarily need to pursue some form of application in each corresponding jurisdiction.  With every country having its own patent laws (and this is true even in places, such as Europe, where some form of regional process is available), obtaining all of these patents can certainly become a complex, time-consuming, and expensive procedure.

Fortunately, however, over the years a majority of countries have got together to establish some basic standards, agreements and conventions that provide at least some certainty and simplification for inventors and companies seeking protection for their inventions in multiple jurisdictions.  In this article I want to talk briefly about the three I regard as being the most significant:

1. the Paris Convention for the Protection of Industrial Property, which ensures that all members will recognise the priority of an application filed in another member country for at least 12 months;
2. the Patent Cooperation Treaty (PCT), which creates a central mechanism for filing an ‘international application’ that can delay the costs and complexity of individual national/regional filings for at least 18 months longer than would otherwise be possible; and
3. the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), which sets minimum standards for patentability, guarantees non-discriminatory treatment of applicants and applications, and sets limits on the scope of national laws to exclude specific subject matter from patent-eligibility.

Knowing a little about these three international agreements is a good start on developing an international patenting strategy, although I would always recommend that you ultimately seek the assistance of somebody who works within these systems all the time, and is familiar with their many detailed benefits, and pitfalls.

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Tags: Conventions, Paris Convention, Patent Cooperation Treaty, PCT, Treaties, TRIPS

What’s ‘Provisional’ About Provisional Applications?

Last week I wrote about one of the benefits of filing a provisional patent application – the ability, in most cases, to mark corresponding products or services as ‘patent pending’ or equivalent.  I have been thinking, however, that there is a bit more to be said about provisional applications.

Provisional applications are, in my experience, not very well understood among the general community.  For example, there remains a pervasive belief that a provisional application is something that can be prepared and filed quickly, casually and cheaply, and that this will provide all the protection needed for the first 12 months.  This may once have been true, in a somewhat limited sense, but it is certainly not the case in Australia any more.  It has, in any event, never been true for applicants who wish to pursue patent rights in foreign jurisdictions based on an initial provisional filing in Australia.

In fact, it is generally best to treat provisional filing with the same gravity as any other patent application process.  What, then, is the benefit of provisional applications?  And should you be filing them?

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Tags: Priority claim, Provisional applications, Strategy

Provisional Patent Pending?

One of the most common questions asked by any applicant or inventor after a new provisional application has been filed is: ‘can I now say “patent pending” about my product/service?’

You might think that the answer to this would be straightforward.  Ultimately, the client just wants a ‘yes’ or ‘no’ answer.  Indeed, most patent attorneys will answer ‘yes’ without hesitation.  The main thing – we will tell our clients – is not to represent that you actually have a patent when all that you actually have is an application.

But is it really so simple?

I was given pause recently when someone asked this very question of IP Australia (@IPAustralia) on Twitter.  The answer that came back (across four Tweets that I have here concatenated into a single reply) was this:

A standard patent can only be enforced once it is granted. ‘Patent pending’ is used by some applicants to indicate they have lodged a patent application which has not been granted. A provisional patent is not a patent application per se and won’t result in a granted patent and hence saying 'patent pending' for a provisional application would be misleading.

I cannot say that I agree with this, and in particular I do not think there is anything misleading in using the phrase ‘patent pending’ while there is any form of application on-foot that has the potential to lead ultimately to granted patent rights.  However, there are laws that apply to the representations made in relation to patents and applications, and applicants do need to be careful about the claims they make with regard to patent rights.

The topic is therefore worthy of some closer investigation.

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Tags: Australia, Marking, Priority claim, Provisional applications

Patenting Perpetual Motion

You cannot build a ‘perpetual motion machine’.  The fundamental principle underlying practical perpetual motion (were it to exist) is the production of endless motion without any external source of energy, and despite the practical realities of resistance (e.g. friction) and other sources of energy loss.  In other words, perpetual motion cannot be achieved unless a device is able to produce more energy than it consumes.

Any arrangement purporting to achieve such a result – whether mechanical, electrical, chemical, thermal or otherwise – violates one or both of the first and second laws of thermodynamics.  Physicists, engineers and mathematicians have a very large number of practical and theoretical reasons to be enormously confident that breaking these laws is an impossibility.

If you do not accept the truth of the statements in the above paragraphs, then this may not be the article you are looking for.  You can go about your business – move along!

The issue I want to examine here is not whether you can build a perpetual motion machine (to reiterate – no), but whether you can get a patent for one.  You might think that it should not be possible to secure patent rights over something that violates fundamental laws of physics, and therefore cannot possibly work.  However, such patents have been issued in the past.  During the last two decades the Australian Patent Office has actually granted at least two patents where the nature of the ‘invention’ was advertised in the title – Australian patent no. 671694, ‘Perpetual motion turbine and compressor set’ and no. 687320, ‘Perpetual motion devices (energy producing devices)’.

More generally, applications directed to alleged perpetual motion machines are sufficiently common that the International Patent Classification (IPC) even includes subclasses F03G 7/10 and F03G 17/04 specifically assigned to ‘perpetua mobilia’.  A total of 16 standard patents have been granted in Australia since 1990 for inventions classified in these subclasses.  A number of applications in these subclasses are currently pending.

In short, therefore, it has certainly been possible, in the past at least, to obtain a patent for an alleged perpetual motion machine.  In the following, I shall explain why this was so, and why it may no longer be the case since the passage of the Intellectual Property Laws Amendment (Raising the Bar) Act 2012.

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Tags: Australia, Patent law, Raising the Bar, Utility/usefulness