When Micro-organism Deposits Become a Macro Problem

The quid pro quo of the patent system is that you tell the public (read: Government) what your invention is and they will let you monopolise it for a while.  The theory is that others can then use the invention once the monopoly has expired, build upon or improve the invention and potentially patent an invention of their own.  In this way, the patent system fosters innovation for the greater good of all mankind.  Of course, this only works if you fully disclose your invention so that others can actually use it.

This was not so hard in many technical fields coming into the 20th century, where mechanical devices reigned supreme off the back of the industrial revolution.  Chemical structure elucidation also came along in leaps and bounds towards the middle of the century with the advent of NMR and mass spectrometry.  These techniques in fact made it easier to describe small to medium molecules, simply by drawing structures. But at the same time, the fields of microbiology and biochemistry were also progressing rapidly, and seemingly the more we knew about bacteria, fungi, proteins and nucleic acids, the harder it was to put it all down on paper.

Enter the Budapest Treaty in 1977.  In recognising the increasing difficulties associated with fully describing micro-organisms, the Budapest Treaty was designed as a solution whereby an inventor may satisfy the written requirements for full description simply by furnishing a deposit of the micro-organism with an authorised depository.  A sample of the deposit may then be made available to anyone who requests it for experimental purposes; for example, to improve upon it, or ensure that their activities do not constitute an infringement of any patent rights residing therein.

Australia acceded to the Budapest Treaty on 7 July 1987 and its provisions remain enshrined in our Patent Act 1990 (Cth): Sections 40(2)(a), 41(1) and 41(2) of the Act collectively state that, paraphrasing, a complete patent specification is taken to sufficiently disclose an invention which is a micro-organism, or an invention which is not a micro-organism but which uses a micro-organism and the micro-organsim is not reasonably available, if the deposit requirements are satisfied in relation to the micro-organism.

The “deposit requirements” are laid out in section 6 of the Act.  These include that the micro-organism was properly deposited with a prescribed depositary institution (IDA) before the filing date of the patent application, and that the specification properly includes relevant information on the known characteristics of the micro-organism, the name of the IDA, and the accession number of the deposit given by the institution.

This all seems perfectly sensible and logistically practicable; i.e. you need to tell others what your deposit is and where to get it. However, section 6(d) also requires that samples of the deposited micro-organism remain ‘obtainable’ from the IDA:

For the purposes of this Act, the deposit requirements are to be taken to be satisfied in relation to a micro-organism to which a specification relates if, and only if: […] at all times since the date of filing of the specification, samples of the micro-organism have been obtainable from a prescribed depositary institution as provided by those rules.

This is where things become a little less manageable for the patent owner, because a sample is not obtainable if it is no longer viable. Of course, as the depositor, this is something over which you have no control – whether your deposit lives or dies is now in the hands of the IDA.

When a deposit is made, the IDA must test “as soon as possible” its viability, and then “at reasonable intervals” thereafter.  As to what constitutes a “reasonable interval” is at the discretion of the IDA, but in the author’s experience this may be several years or more.  It is therefore entirely possible that, unbeknownst to you, your deposits have been dead for some time; with the unfortunate consequence that you no longer satisfy the written requirements of the Act.

Fortunately, the Act caters for this situation.  Section 41(4) provides that, paraphrasing, where the micro-organism is no longer obtainable, but you take steps at a later time (adhering to certain time frames), and as a result of those steps, the micro-organism is again obtainable, then the micro-organism is taken to have been obtainable all along.

There is really only one feasible step that you can take so that your micro-organism is again obtainable, and that is to make a new deposit, for which the IDA will provide you with a new deposit receipt.  As to the timeframes, well, that all depends on how you came to learn that your deposit is no longer viable.

  • If someone else, say your competitor, finds out that your deposit is not viable, for example by requesting a sample of it, and advises the Commissioner of Patents, or the Commissioner otherwise learns of the non-viability, the Commissioner will notify you, and you then have 3 months to make a new deposit.
  • If the IDA notifies you, for example following routine viability testing, again you have three months to make a new deposit.
  • In any other case (if one is possible), you have all the time you like.

In the former two scenarios, 3 months (possibly extendable) is usually plenty of time to make a new deposit of even the slowest growing micro-organisms.  Crisis averted, right? Not exactly.

You now need to notify the Commissioner; either by responding to the Commissioner’s notification setting out the facts relied upon to establish that the deposit requirements are in fact satisfied, or otherwise providing to the Commissioner a copy of the new deposit receipt (for accepted applications and granted patents).

If you have only one Australian patent, then all of this is probably not too difficult.  However, this is seldom the case.  Often, a patent which relies on a micro-organism deposit will be one of a number of family members in Australia, and there may be corresponding applications across multiple jurisdictions.  Other countries each have their own rules and regulations as to how their national Patent Offices need to be notified of your new deposit, and when.  This cumulates into a very large, time-consuming and expensive administrative undertaking, though it arose through no fault of your own.  Of course, if you don’t comply with these requirements, one dead micro-organism could be the downfall of an entire patent family, with your micro-organism deposits becoming a macro problem.

Unfortunately, there is little that you can do but hope that your micro-organism deposits remain viable.  In the meantime, a central submission system for new deposit receipts would be a welcome addition to the services offered by WIPO (the administering body of the Budapest Treaty).

In summary, there are a few take-home messages:

  • Always provide to the IDA recommendations for optimal handling and storage of your micro-organism;
  • Learn at what “reasonable interval” your IDA performs routine testing, and take a pre-emptive approach to maintaining the viability of your deposits;
  • If you are advised that a micro-organism deposit is not viable, take careful note of the timeframes within which the micro-organism must be redeposited and patent offices advised;
  • On the other side of the coin, if you come up against a competitor in a patent dispute, make a request for a sample of their deposits; you will likely need to test them anyway and if they are not viable then you have already put your competitor on the back foot.

This article was written by Dr. James-Robert Cram

If you have any specific enquiries about this article, please contact Debra Tulloch or Paul Jones.