CRISPR Patent Dispute – Is It Just Too Big to Settle?

The proceedings at the US Patent and Trademark Office (USPTO) Patent Trial and Appeal Board (PTAB), to determine who is entitled to foundational patent rights relating to CRISPR/Cas9 ‘gene editing’ technology, have been steadily progressing since my last update back in January.  As a reminder, the parties vying for ownership of these rights are a group led by Berkeley Professor of Chemistry Jennifer Doudna and her collaborator Emmanuelle Charpentier, and a group led by Feng Zhang at the Broad Institute, Inc and MIT.  Although a little reductive, it is convenient for me to refer to these two groups as ‘team Doudna’ and ‘team Zhang’ respectively. 

In a very recent development, on 11 April 2016, the ‘senior party’ in the proceedings (team Doudna) filed a notice stating that ‘in accordance with Standing Order ¶ 126, Senior Party hereby notifies the Board that the parties have discussed settlement, and have made a good faith effort to settle the interference, but no agreement has been reached at this time.’  It was necessary for the notice to be filed on or before this date, because the PTAB encourages parties to settle priority disputes between themselves where possible, and the referenced paragraph of the Standing Order in fact makes it compulsory for settlement discussions to be initiated by the ‘last named party’ (which, again, happens to be team Doudna in this case) within three months of an interference being declared.  The CRISPR interference was declared on 11 January 2016.

Interestingly, however, when the PTAB judges raised the matter of settlement discussions during a telephone conference on 10 March 2016, counsel for team Zhang stated that ‘we have not had that opportunity one way or the other to discuss settlement’ while counsel for team Doudna confirmed his understanding that ‘there has not been any formal discussions between the parties’.

So up until two months after the interference was officially declared there had been no discussions about a possible settlement.  Then, during the final month of the period for commencing mandatory discussions, suddenly ‘a good faith effort’ was made to settle the dispute, but no agreement was reached.  Pardon my cynicism, but if you believe that the timing of these events reflects a genuine effort at settlement, then perhaps I can interest you in the purchase of a nice bridge!  On the contrary, it seems pretty clear that at least team Doudna (whose obligation it was to initiate mandatory settlement discussions, and file the notice) has no desire to settle the interference.  In fact, it is quite likely that neither party has any real interest in settlement.

Although I have previously expressed the opinion that a settlement agreement may provide a better outcome for all concerned, I no longer believe that this is a viable option.  I now think it likely that the technology is just too valuable for either party to give ground, particularly at this early stage.  In all likelihood, these interference proceedings are going to run their full course.  Yes, they will be incredibly expensive, but the cost is just a drop in the ocean compared to what is at stake in the main game of commercialising CRISPR/Cas9 technology.

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Tags: Biotechnology, Commercialisation, CRISPR, Genetic technology, Interference, US

Appeal ‘Incompetent’ – Is This A Problem With Patent Opposition in Australia?

The Australian Patents Act 1990 provides for a pre-grant opposition process.  Specifically, once an application has passed examination, and is accepted, there is a three-month period during which anybody may file an objection, i.e. ‘opposition’, to the grant of a patent.  This allows third parties, such as competitors of the patent applicant, to raise prior art and/or new arguments or grounds for rejection, that may not have been readily available to the examiner.  Opposition provides an additional mechanism for preventing invalid patents from being granted.

Opposition proceedings can be quite involved, although they are generally much simpler and cheaper than court action.  The objecting party, i.e. the ‘opponent’, is required to file a Statement of Grounds and Particulars, outlining the basis for the opposition, so that the applicant can understand, at an early stage, the case it will be required to answer.  Subsequently the opponent must file its evidence in support of the opposition, which may include prior art documents or other information, and/or written testimony of expert witnesses that is relevant to the validity of the accepted patent claims.  The applicant then has an opportunity to file its own answering evidence, and finally the opponent may file further evidence, strictly limited to addressing new issues raised in the applicant’s evidence.

The opposition then typically proceeds to a hearing before an officer at the Australian Patent Office, following which a written decision is issued.  There are a few possible outcomes from an opposition.  At the two extremes, the opposition may be dismissed (i.e. the opponent’s case is found to fail completely) or may be upheld (i.e. all of the opposed claims may be found irredeemably invalid).  However, many cases fall somewhere between these two extremes, with an opposition being only partly successful, and/or the Hearing Officer finding that successful grounds of opposition might nonetheless be overcome by some form of amendment to the patent specification and claims.

An example of this last type of outcome is the subject of a recent decision of the Federal Court of Australia in Merck Sharpe & Dohme (Australia) Pty Ltd v Genentech Inc [2016] FCA 324, which highlights a potential pitfall of the pre-grant opposition process in Australia.  In particular, there are cases in which amendments may be legitimately made that result in claims that are nonetheless potentially invalid, but which cannot be effectively challenged prior to the patent being granted.

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Tags: Amendments, Appeal, Australia, Novelty, Obviousness, Opposition

How to Patent Your Invention in Australia and the US

For many of the Australian clients I work with, the most important markets are Australia (i.e. the ‘home’ market) and the US (because of its size and relative accessibility).  This means that when it comes to protecting their innovative technologies, obtaining patents in these two countries is at the top of these clients’ lists of priorities.  I am therefore often asked how best to achieve this objective, how much it will cost, and how long it will take.

The typical ‘lawyer’ answer is, of course, ‘it depends’!  Do you want patents only in Australia and the US, or are there other countries of interest?  When and why do you require these patents?  Do you want to obtain patents as quickly as possible, or are there strategic advantages in drawing out the pendency (and finalisation of the scope of rights) for as long as possible?  What is your budget for the patenting program, both in the short term and over the coming years?

Assuming that you are able to answer these questions, it should be possible to develop a strategy that meets all of your requirements.  In this article I will go into further detail of one fairly typical and effective approach, along with some of the relevant considerations and potential variations.

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Tags: Australia, Examination, Paris Convention, Patent filing, PCT, PPH, Strategy, US