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

University of California Unsurprisingly Appeals Decision to Terminate CRISPR Patent Interference

In February, I reported the decision of the US Patent and Trademarks Office (USPTO) Patent Trial and Appeal Board (PTAB) in the patent interference proceedings initiated by the University of California (‘UC’) against the Broad Institute of MIT and Harvard (‘Broad’) in relation to CRISPR/Cas9 gene editing technology.  That decision was that there is ‘no interference in fact’, meaning that Broad’s development of the CRISPR/Cas9 system for use in eukaryotic cells (i.e. complex cells with, among other characteristics, distinct nuclei) was a non-obvious advance over UC’s development of the system for use in simpler prokaryotic cells (specifically, bacteria), and that there is thus scope for both parties to hold distinct patents.  At the time, I noted that the PTAB decision was subject to a possible appeal to a US Federal Court – most likely the specialised Court of Appeals for the Federal Circuit (CAFC) – and predicted that UC would file an appeal, in view of the substantial commercial interests at stake.

I am therefore not at all surprised to now be reporting that UC has indeed appealed to the CAFC.  In a press release announcing the appeal, UC has confirmed that it ‘seeks to have the PTAB reinstate the interference’, and quotes Edward Penhoet, a ‘special adviser on CRISPR to the UC president and UC Berkeley chancellor’ as saying that:

Ultimately, we expect to establish definitively that the team led by Jennifer Doudna and Emmanuelle Charpentier was the first to engineer CRISPR-Cas9 for use in all types of environments, including in non-cellular settings and within plant, animal and even human cells

Broad has responded with its own media statement saying, in relation to the appeal, that:

Given that the facts have not changed, we expect the outcome will once again be the same.
We are confident the Federal Circuit will affirm the PTAB decision and recognize the contribution of the Broad, MIT and Harvard in developing this transformative technology.

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

USPTO Board Terminates CRISPR Patent Interference

On Wednesday 15 February 2017, the US Patent and Trademarks Office (USPTO) Patent Trial and Appeal Board (PTAB) handed down its much-anticipated decision in the patent interference proceedings initiated by the University of California (‘UC’) against the Broad Institute of MIT and Harvard (‘Broad’) in relation to CRISPR/Cas9 gene editing technology.  That decision, in short, is that there is ‘no interference in fact’.  That is to say, the three judges making up the PTAB panel have determined that Broad’s development of the CRISPR/Cas9 system for use in eukaryotic cells (i.e. complex cells with, among other characteristics, distinct nuclei) was a non-obvious advance over UC’s development of the system for use in simpler prokaryotic cells (specifically, bacteria), and that there is thus scope for both parties to hold distinct patents.

In its full decision [PDF, 412kB], the PTAB summarises its findings as follows:

Broad has persuaded us that the parties claim patentably distinct subject matter, rebutting the presumption created by declaration of this interference. Broad provided sufficient evidence to show that its claims, which are all limited to CRISPR-Cas9 systems in a eukaryotic environment, are not drawn to the same invention as UC’s claims, which are all directed to CRISPR-Cas9 systems not restricted to any environment. Specifically, the evidence shows that the invention of such systems in eukaryotic cells would not have been obvious over the invention of CRISPR-Cas9 systems in any environment, including in prokaryotic cells or in vitro, because one of ordinary skill in the art would not have reasonably expected a CRISPR-Cas9 system to be successful in a eukaryotic environment. This evidence shows that the parties’ claims do not interfere. Accordingly, we terminate the interference.

This is a considerable win for Broad which, subject to a potential appeal, has for now delivered a fatal blow to UC’s hopes of invalidating a number of Broad’s CRISPR-related patents and applications.  Unsurprisingly, Broad has reacted to the decision by declaring its full agreement with the PTAB, while UC maintains its belief that the evidence is on its side.  The stock market also reacted quickly to the news, adding US$200 million to the value of the Broad-connected biotech company Editas Medicine Inc.

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

CRISPR Patent Interference Hearing – How to Define an ‘Invention’ and Why It Matters

On 6 December 2016, and for the first time since the University of California (‘UC’) first sought to provoke interference proceedings over CRISPR/Cas9 gene editing technology in April 2015, the parties in dispute over just who has the rightful claim to inventorship appeared at an oral hearing before three judges of the US Patent and Trademark Office (USPTO) Patent Trial and Appeal Board (PTAB).  Remarkably, considering the complexity of the scientific, technical and legal issues involved, UC and opposing claimant the Broad Institute of MIT and Harvard (‘Broad’) each had just 20 minutes to present its arguments, plus an optional five minutes for rebuttal of the other side’s submissions.  According to a journalist present at the hearing, it was all over in 45 minutes total.

It is important to understand, however, that while the judges’ decision here (which is expected within about two-to-three months) could put an end to the interference proceedings at the PTAB, the hearing was not actually about the ultimate question of who was first to invent the CRISPR technology at issue.  It was more about what each party may, or may not, have actually ‘invented’, and whether there is even any interference to be decided.

For any readers coming across this story for the first time, you could go back and read all of my articles on the topic (and the many good sources of information linked therein).  However, the key points may be briefly summarised as follows:

1. UC Berkeley Professor of Chemistry Jennifer Doudna and her collaborator Emmanuelle Charpentier were the lead researchers on a team that, in around 2012, developed CRISPR/Cas9 – a biotechnology system consisting of an engineered RNA and a ‘cutting’ protein that can be used for highly-targeted gene editing;
2. a US patent application is pending (serial no. 13/842,859), which is based on the UC team’s work and a series of filings beginning in May 2012;
3. the UC team’s original work related to the discovery of the CRISPR system in relatively simple bacterial cells (examples of ‘prokaryotes’, or simple cells without distinct nuclei), but in January 2013 they were successful in applying the technology to human cells (examples of ‘eukaryotes’, or more complex cells with, among other characteristics, distinct nuclei);
4. roughly in parallel, a team led by Feng Zhang at the Broad reported similar success using CRISPR to edit human genes;
5. a number of US patent applications were filed, beginning in December 2012, based upon the Broad team’s work (i.e. more than six months later than Doudna’s earliest filing);
6. the Broad requested prioritised examination under the USPTO’s Track One program and, as a result, was awarded the first patent on the basic CRISPR technology – US Patent No. 8,697,359, ‘CRISPR-Cas systems and methods for altering expression of gene products’, issued on 15 April 2015.

The UC applications, and the earliest Broad applications, were filed under the ‘old’ US system, according to which the applicant entitled to receive a patent is the first one to invent the claimed subject matter.  This differs from the ‘first-to-file’ priority system that has long existed throughout the rest of the world, and in the US since 16 March 2013.  Under the first-to-invent system, the administrative procedure used to determine who should receive a patent when there are competing claims is called an ‘interference’.

Therefore, the UC parties suggested that the USPTO should institute interference proceedings, in order to determine who is really entitled to own the patent rights to the CRISPR/Cas9 technology, which it did on 11 January 2016.  However, the purpose of the recent hearing was not to determine who was the first inventor, but rather to decide exactly what is the invention at issue, and whether the interference should proceed any further at all.

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

Does Australia Have a (US-Style) Two-Step Test for Patent-Eligibility?

In its Mayo/Myriad/Alice series of cases, the US Supreme Court has established a two-step test in order to determine whether a claimed invention defines patent-eligible subject matter or not.  In the first step, the claims are examined to determine whether they are ‘directed to’ a patent-ineligible concept, i.e. an abstract idea, law of nature or natural phenomenon.  If not, then the subject matter of the invention is eligible for patenting.  Otherwise, the analysis proceeds to step two, in which the claims are further analysed to determine whether or not they comprise some additional element, or combination of elements, that is ‘sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the [ineligible concept] itself.’

In contentious cases the focus has generally fallen upon the second step of the analysis.  This is not surprising, considering that the reason these cases are contentious in the first place is because they are typically those in which the claims appear on their face to encompass ineligible subject matter, e.g. abstract ideas in the case of computer-implemented inventions such as in Alice, or natural phenomena such as the isolated DNA in Myriad or the presence of metabolites in blood samples in Mayo.  It might be said in such cases that ‘the vibe’ of the claim is that it looks like it might be ineligible, and that it is therefore necessary to proceed to step two in order to determine whether or not this initial impression is correct.

However, two recent decisions of the US Court of Appeals for the Federal Circuit (CAFC) confirm that the first step of the Mayo/Myriad/Alice framework is not merely a formality, but must be given proper consideration.  Enfish, LLC v. Microsoft Corp. (Fed. Cir. 2016) [PDF, 605kB] concerned software-implemented methods and systems operating on a new and more efficient database format.  The court found at the first step of the Alice analysis that the claims were not directed to an abstract idea, on the basis that ‘[s]oftware can make non-abstract improvements to computer technology just as hardware improvements can’ and that it is ‘relevant to ask whether the claims are directed to an improvement to computer functionality versus being directed to an abstract idea’.  In McRO, Inc. v. Bandai Namco Games America Inc. (Fed. Cir. 2016) [PDF, 341kB] the court found that claims directed to generating automated lip-synchronization and associated facial expressions for 3D animated characters (e.g. in video games) were, similarly, not abstract, and patent-eligible at the first step of the test.

It should not come as any great surprise that the first step of the Alice framework actually has some teeth.  The test is supposed to apply to patent claims in all fields of technology, and clearly there are very many patents and applications that relate to wholly uncontentious subject matter for which patent-eligibility is barely a consideration.  In all such cases, the claims are effectively passing at the first step of the test.  The surprise, for many, is that the CAFC has finally started to recognise and apply this reality in relation to computer-implemented inventions.

This raises the question of whether there is an analogous process that takes place in Australia.  As a practical matter, I believe that there is, however it has not been explicitly set out by the courts, and it remains an unacknowledged aspect of examining patent claims for eligibility.  This is unfortunate, because the existence of an implicit step in the eligibility analysis is an obstacle to consistency and objectivity in the assessment of patent claims.

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Tags: Australia, Business processes, Computer programs, Genetic technology, Patentable subject matter, US

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

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

CRISPR Interference Update

Two weeks ago I wrote about the interference proceedings that have been instituted by the US Patent and Trademarks Office (USPTO) in order to determine who is rightfully entitled to fundamental patent rights in relation to CRISPR gene-editing technology, under the former ‘first-to-invent’ priority rules.  The contest is between a team led by Berkeley Professor of Chemistry Jennifer Doudna and her collaborator Emmanuelle Charpentier, and a team at the Broad Institute, Inc and MIT led by Feng Zhang.  In that article, I explained generally how interference proceedings work, the distinction between ‘senior’ and ‘junior’ parties in an interference, and what it means to be ‘first-to-invent’.

Kevin Noonan has now written about the CRISPR interference over at the Patent Docs blog.  Being both a US patent attorney, and having a background in molecular biology, Kevin is far better qualified than I to write about this topic!  Obviously, therefore, you should read his article in full, if this subject is of particular interest to you. 

I was also recently contacted by Lee McGuire, who is the Chief Communications Officer at the Broad Institute, drawing my attention to a CRISPR IP information page that is being maintained on the Broad’s website.  You will appreciate, of course, that this is not a source of unbiased information.  It is, however, a useful resource with a lot of interesting content and links covering the CRISPR ‘story’ from Broad’s perspective.  As far as I have been able to determine, Berkeley is not (at this stage) providing any similar resource.

So, what will you learn if you take the time to read these additional sources?

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

Who Will Get the CRISPR Patent?

As has been widely reported, the US Patent and Trademark Office (USPTO) has instituted interference proceedings to determine who is entitled to own foundational patent rights in relation to CRISPR/Cas9 ‘gene editing’ technology.  I wrote about this brewing dispute back in July 2015, when I predicted that this would be ‘the last great US patent interference’, given that the US patent system changed from first-to-invent to first-inventor-to-file on 16 March 2013. 

As the number of applications filed under the former first-to-invent system dwindles, the opportunities for new interference proceedings – which are all about figuring out who invented first when separate applications with competing claims are filed – are becoming scarce.  Even less likely is another interference over a genuinely groundbreaking and immensely valuable invention.

For the full story, you should really go back and read my earlier article.  But if you lack the time or stamina, here is the TL;DR recap:

1. Berkeley Professor of Chemistry Jennifer Doudna and her collaborator Emmanuelle Charpentier were the lead researchers on a team that, in around 2012, developed so-called CRISPR/Cas9 – a biotechnology system consisting of an engineered RNA and a ‘cutting’ protein that can be used for highly-targeted gene editing;
2. Doudna, Charpentier and their co-workers have a US patent application pending (serial no. 13/842,859), which is based on a series of filings beginning in May 2012;
3. Doudna and Charpentier’s original work related to the discovery of the CRISPR system in relatively simple bacterial cells, but in January 2013 they were successful in applying the technology to human cells;
4. roughly in parallel, however, a team led by Feng Zhang at the Broad Institute, Inc and MIT reported similar success using CRISPR to edit human genes;
5. Zhang and his team also filed a US patent application, based on a series of their own filings beginning in December 2012 (i.e. more than six months later than Doudna’s earliest filing);
6. to complicate matters, Zhang requested prioritised examination under the USPTO’s Track One program and, as a result, was awarded the first patent on the basic CRISPR technology – US Patent No. 8,697,359, ‘CRISPR-Cas systems and methods for altering expression of gene products’, issued on 15 April 2015, even though Doudna’s group had been the first-to-file;
7. Doundna and Charpentier subsequently requested the USPTO to institute interference proceedings, in order to determine who is really entitled to own the patent rights to the CRISPR/Cas9 technology.

That request has now been granted.  So who will get the CRISPR patent?  Well, if I knew that I could save the USPTO a whole lot of work, and the parties a great deal of time and money.  Ultimately, only time and the evidence will tell.  But what I can do is to outline the basics of interference proceedings, and make a few tentative predictions.

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

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

Patented ‘Frankenfish’ Finally Granted FDA Approval

On 19 November 2015, the US Food and Drug Administration (FDA) approved, for the first time, a genetically engineered food animal.  Of course, there have previously been many genetically engineered food plants approved for production and consumption, such as Monsanto’s ‘Roundup Ready’ crops.  And animals have been genetically engineered and commercialised for other purposes, such as the Harvard OncoMouse for use in cancer research.

The animal in question is a fish.  More precisely, it is a genetically engineered salmon, developed by a company called AquaBounty Technologies under the brand name AquAdvantage.  AquaBounty claims that its salmon grow to full size in half the time of ‘regular’ salmon (18 months, as opposed to three years), are larger, require 25% less feed, and grow at a 1:1 ratio of feed mass to body weight. 

Of course, the positive spin on this is that farming AquAdvantage fish is more sustainable than other forms of salmon production.  However, the primary beneficiaries, at least initially, would be the producers who are able to grow and bring to market more fish in less time at lower cost.  If, that is, they can convince the consuming public to buy a product that has been emotively labelled ‘frankenfish’ by its detractors.

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Tags: Genetic technology, Patentable subject matter

Proposed Australian Examination Practice Gives Narrow Interpretation to High Court’s Myriad Ruling

IP Australia has opened a consultation on proposed changes in examination practice in light of the High Court’s ruling in D'Arcy v Myriad Genetics Inc [2015] HCA 35.  Although many people had feared (or hoped, depending upon their particular predilections) that the Australian Patent Office would follow the lead of the USPTO, and take a broad view of the High Court’s judgment, it is clear from the proposed examination practice that this will not be the case.

Indeed, it would be difficult for IP Australia to take any narrower view of the implications of the Myriad decision than the one it is proposing (except, perhaps, in relation to cDNA).  The Patent Office accepts that the High Court’s judgment establishes that ‘a claim to an isolated nucleic acid that merely represents information coding for a polypeptide is not patent eligible’, and has therefore concluded that the following are not patent-eligible:

1. naturally occurring human and non-human nucleic acid sequences encoding polypeptides or functional fragments thereof - either isolated or synthesised;
2. cDNA; and
3. naturally occurring human and non-human coding RNA - either isolated or synthesised.

However, the Patent Office proposes that it will continue to treat claims directed to pretty much everything else, not addressed directly by the High Court’s decision, as patent-eligible.  This includes other forms of isolated, naturally-occurring DNA such as regulatory DNA and non-coding DNA.

This is in stark contrast to the USPTO’s response to the corresponding decision of the US Supreme Court in Association for Molecular Pathology v. Myriad Genetics, Inc, which the US Office treated as affecting the patent-eligibility of all claims directed or relating to natural products.  Initial guidance from the USPTO suggested that this would even include new and useful combinations of natural substances (using gunpowder as an example).  Updated guidance issued in December 2014 improved the situation somewhat, by clarifying the process by which claims ‘directed to’ excluded subject matter should not be subject to rejection if they recite additional elements that amount to ‘significantly more’ than the exclusion.  Even so, it remains clear that a claim which recites ‘nothing more’ than an isolated natural product generally cannot be patented at the USPTO, whereas many such claims will continue to pass muster under the proposed Australian practice.

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Tags: Australia, Biotechnology, Genetic technology, Patent Office, Patentable subject matter

Australian High Court Nukes Biotech Industry from Orbit: “It’s the Only Way to be Sure”

The High Court of Australia has followed the US Supreme Court in unanimously declaring that naturally-occurring DNA sequences – even when extracted from the cell nucleus and isolated by human intervention – cannot, in themselves, be validly the subject of patent protection.  In particular, all seven High Court judges found that claims 1-3 of Myriad Genetics’ Australian patent no. 686004, each of which is directed to isolated nucleic acid molecules corresponding with the BRCA mutation associated with increased breast cancer risk, are invalid because they do not define a patent-eligible ‘manner of manufacture’ under Australian law: D'Arcy v Myriad Genetics Inc [2015] HCA 35.

In arriving at this ruling, the High Court has reversed the decisions of six Federal Court judges – one at first instance (Cancer Voices Australia v Myriad Genetics Inc [2013] FCA 65), and five more on appeal to a full bench of the Federal Court (D’Arcy v Myriad Genetics Inc [2014] FCAFC 115) – all of whom found that nucleic acids, once extracted from a cell and isolated from a complete DNA molecule, are artificially-created products that are chemically, structurally and functionally different from their natural counterparts, and thus patent-eligible.

Furthermore, in reversing last year’s decision of the Full Federal Court, the High Court has (retroactively) made a liar of Australia’s Trade Minister, Andrew Robb.  For months, Mr Robb has been telling anyone who will listen that Australia does not need to extend ‘data exclusivity’ for biologic drugs, because this country provides more extensive patent protection for biological materials than some others.  This line has been followed primarily for the benefit of the US negotiators of the Trans-Pacific Partnership Agreement (TPP), who initially wanted the agreement to mandate a minimum 12 years’ data exclusivity. 

As recently as 6 October 2015, following finalisation of the TPP after seven years of negotiations, Mr Robb was talking up Australia’s patent system as a key factor in reaching agreement on the contentious issue of data exclusivity for biologics.  Yet, the very next day, the High Court dropped its nuclear bombshell on that argument, by not only replicating the action of the US Supreme Court in declaring isolated naturally-occurring DNA to be unpatentable, but going further in extending this to synthesised biologics – including cDNA – that essentially embody the same ‘information’ existing in the naturally-occurring biological molecule.

Just to be clear, nobody – not even Myriad Genetics – cares that three Australian patent claims directed to the isolated DNA comprising the BRCA mutations have specifically been declared invalid.  Quite aside from anything else, the patent has expired, having reached the end of its 20-year term on 11 August 2015.  There are also probably very few people who would be greatly concerned that isolated naturally-occurring DNA sequences are not patentable in Australia.  It is now widely regarded that the completion of the human genome project, along with the relative ease, speed and low-cost of gene sequencing nowadays, has largely rendered such claims unpatentable for lack of novelty or inventive step anyway.

The larger concern with the Australian High Court’s decision for the entire biotechnology industry is likely to be its focus on the information content of the naturally-occurring DNA as ‘an essential element of the invention as claimed’.  This reasoning will create significant uncertainty as to the circumstances under which any product – whether wholly, or partially, synthesised, and including cDNA – which essentially exists to provide a ‘medium’ for naturally-occurring information, may continue to be regarded as patent-eligible in Australia.

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Tags: Australia, Biotechnology, Genetic technology, Innovation, Patentable subject matter, Public policy, Trans-Pacific Partnership

CRISPR – Will This Be the Last Great US Patent Interference?

On 9 November 2014, Berkeley Professor of Chemistry Jennifer Doudna and her collaborator Emmanuelle Charpentier, currently at the Helmholtz Center for Infection Research in Germany, attended an awards ceremony at NASA’s Ames Research Center in Mountain View, California.

Not only did Doudna and Charpentier – dressed to the nines, and looking more like glamour queens than the usual white-coated scientist stereotype – mingle with celebrities including Benedict Cumberbatch, Cameron Diaz and Jon Hamm, while enjoying a live performance by Christina Aguilera, they also received the 2015 Breakthrough Prize in the life sciences category.  The award, which was sponsored by Facebook’s Mark Zuckerberg and other tech billionaires, included prize money of US$3 million apiece.

To put that in perspective, had the two scientists received a Nobel Prize last year, they would have shared 8,000,000 Swedish Kronor, or about US$1 million, between them.  Of course, it is not all – or even mostly – about the money, and the prestige attached to a Nobel prize is undoubtedly greater.  And it seems to be odds-on that the discovery for which Doudna and Charpentier received the 2015 Breakthrough Prize – and which has been called ‘the biggest biotech discovery of the century’ – will one day be the subject of a Nobel Prize as well.

All of this fuss is about a technology called CRISPR/Cas9, which is essentially a DNA ‘editing’ tool that Doudna and Charpentier developed in (around) 2012, as a result of their research into a system used by bacteria to defend themselves against viruses.  Doudna has described the CRISPR/Cas9 (which stands for Clustered Regularly Interspaced Short Palindromic Repeats/CRISPR associated protein 9) tool as a ‘molecular scalpel for genomes’.  She and Charpentier demonstrated how it is possible to synthesise molecules, consisting of an engineered RNA and a ‘cutting’ protein, that can precisely target a short gene sequence within a genome, and slice the DNA open at that exact point.

Bacterial cells – in which the mechanism was first discovered – are simpler than the cells of higher organisms (known as ‘eukaryotic cells’).  However, in January 2013, Doudna and Charpentier took the next step, successfully cutting out and replacing a selected section of DNA in human cells.  In the same month, a team led by Feng Zhang at the Broad Institute, Inc and MIT reported similar success using CRISPR to edit human genes.

Which brings me to the main topic of this post.  Because, while Doudna and Charpentier have been collecting the public accolades, rubbing shoulders with the rich and famous, and banking the – doubtless well-deserved – proceeds of their success, it is Zhang who has been awarded the first patent on the basic CRISPR technology – US Patent No. 8,697,359, ‘CRISPR-Cas systems and methods for altering expression of gene products’, issued on 15 April 2015.  And that could ultimately be worth much more than $3 million!

This is now shaping up as a major battle over who will own the most basic, and potentially valuable, patent rights in relation to the CRISPR technology, and possibly the last great priority dispute of the ‘first-to-invent’ era of US patent law.

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Tags: Biotechnology, Genetic technology, Interference, US

Patentability of Genes May Turn on Claim Construction

A Full Bench of all seven judges of the High Court of Australia heard oral arguments in the appeal by Yvonne D’Arcy in the Myriad Genetics BRCA gene patent case starting on Tuesday 16 June 2015, and continuing through the morning of Wednesday 17 June 2015.  Transcripts of the first day and the second day of the proceedings are available.

As a preliminary matter, the High Court determined on Monday 15 June 2015 that it would not allow the application by the Institute of Patent and Trade Mark Attorneys of Australia (IPTA) to intervene in the case as amicus curiae.  I wrote previously about IPTA’s application, and subsequently about the opposition by the Commonwealth, and I am not at all surprised that the High Court turned IPTA down.

Based on the transcripts, it appears that there are up to four key issues that may determine the outcome of the appeal, i.e. whether or not Myriad’s claims to the isolated BRCA genes (and, by extension, all other patent claims directed to naturally-occurring genes that have been isolated from their natural environment) are proper subject matter for a patent under Australia’s ‘manner of manufacture’ test for patent-eligibility.

Those four issues are:

1. the proper construction (i.e. interpretation) of Myriad’s claims – more particularly whether they are, in substance, directed to a molecule or to ‘information’;
2. whether or not the test for ‘manner of manufacture’ requires a nexus between what is ‘artificial’ in an invention, and its economic value (and, if so, whether such a nexus exists in the case of isolated genes);
3. the desirability of consistency with the laws of Australia’s major trading partners and, if this is desirable, which of these other countries we should follow; and
4. the significance of the Australian Parliament’s repeated decisions not to introduce an express exclusion from patentability for ‘products of nature’ when the opportunity has arisen.

Reading the transcripts, it is not at all clear to me which way the seven judges (individually, or as a group) are likely to rule in this case.  While they certainly interrogated David Shavin QC (Queen’s Counsel appearing for Myriad) far more vigorously than David Catterns QC (Queen’s Counsel appearing for Ms D’Arcy), my impression is that Mr Shavin had answers for all of the judges’ questions and that, on balance, Myriad’s case is more consistent with the Australian authorities on patent-eligibility.  At the same time, however, it appears that at least some of the judges are disposed to rule against the patentability of isolated genes.

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Tags: Australia, Genetic technology, High Court, Patent law, Patentable subject matter

Myriad Hearing Date Set, Commonwealth Opposes IPTA Intervention

Oral arguments in the High Court appeal by Yvonne D’Arcy in the Myriad Genetics BRCA gene patent case will be heard in Canberra on Tuesday, 16 June 2015.

In the latest development in the case, on 26 May 2015, the Solicitor General of the Commonwealth of Australia filed an application to intervene in the Myriad proceedings.  The Commonwealth intervention will be triggered in the event that the High Court grants the request by the Institute of Patent and Trade Mark Attorneys of Australia (IPTA) (which I wrote about back in May) to intervene in the High Court proceedings as amicus curiae.

IPTA is seeking to raise a constitutional question, namely whether the concept of ‘invention’ within the Patents Act 1990 should be interpreted as extending to the full limit of the power granted to the Commonwealth to make laws ‘with respect to … patents of inventions’ under section 51(xviii) of the Commonwealth of Australia Constitution Act (the Constitution), in the absence of any express contrary intention.

As an Australian taxpayer, I find this development intensely irritating, and my annoyance is not directed at the Government, but at IPTA.  In effect, the Australian people are now footing the bill for Commonwealth intervention in High Court proceedings between two private parties as a direct result of IPTA’s decision to introduce a constitutional issue into the case.  With interpretation of the Constitution potentially at stake, the Government has not really had any choice in the matter.

The Commonwealth is opposing IPTA’s application to intervene.  However, in the event that the High Court grants the application, the Commonwealth will make submissions urging the Court to reject IPTA’s interpretation of the scope of the constitutional power to make laws with respect to patents.

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Tags: Australia, Constitution, Genetic technology, Patentable subject matter

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

Patent Attorneys Invoke Constitution in Myriad Gene Case

The Institute of Patent and Trade Mark Attorneys of Australia (IPTA) has applied to intervene as amicus curiae (i.e. ‘a friend of the court’) in the High Court appeal by Yvonne D’Arcy in the Myriad Genetics BRCA gene patent case.  In doing so, IPTA is seeking to raise a Constitutional matter, namely ‘whether the concept of “patents of inventions” in section 51(xviii) of the Commonwealth of Australia Constitution Act (the Constitution) encompasses isolated genetic material and other materials isolated from nature.’

The publicly-available documents filed in the appeal, including IPTA’s written submissions in support of its application for leave to intervene, can be viewed on the High Court’s page for the case, no. S28/2015.

It probably goes without saying that IPTA’s overriding objective is to ensure that the High Court does not overturn the decision of the five-judge panel of the Federal Court of Australia which found unanimously that Myriad’s claims directed to the isolated BRCA genes were patentable.

Historically, the High Court of Australia has been reluctant to entertain amici curiae in civil disputes between private parties.  The Constitutional matter being raised by IPTA is one which has not arisen in arguments before the lower courts, and appears to be unnecessary in order to decide the specific question of whether or not Myriad’s claims directed to isolated BRCA genes are patentable.  Furthermore, in my opinion IPTA’s argument is misconceived, although I am obviously not an expert on constitutional law, so there could be something I am missing. 

Overall, I think it unlikely that the court will allow IPTA’s application, but it could make things more interesting if I am wrong!

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Tags: Amicus curiae, Australia, Constitution, Genetic technology, Patentable subject matter

High Court Will Hear Appeal in Myriad BRCA Gene Patent Case

On Friday, 13 February 2015, the High Court of Australia granted ‘special leave’ to appeal a decision of five judges of the Federal Court of Australia that upheld the patent-eligibility of isolated genetic material. 

The original (unsuccessful) challenge to the patent, owned by Myriad Genetics, Inc along with two co-patentees, was launched by cancer-survivor and ‘gene patent’ opponent Yvonne D’Arcy, along with advocacy group Cancer Voices Australia (which has since disbanded and withdrawn from the case).  Ms D’Arcy is seeking revocation of claims 1 to 3 of Australian Patent no. 686004, each of which is directed to ‘an isolated nucleic acid coding for a mutant or polymorphic BRCA1 polypeptide…’.  Mutations in the BRCA1 gene are correlated with increased breast cancer risk, and can therefore be used as a basis for early detection of a predisposition towards development of cancer.

Corresponding claims in Myriad’s US patent have been found to be ineligible for patent protection by the US Supreme Court.  However, the unanimous decision of the five judges sitting as a Full Bench of the Federal Court, which was issued in September last year, made it very clear that the ‘manner of manufacture’ test for patent-eligibility under Australian law is different from the test that applies in the US under 35 USC 101.

According to a media statement issued by Maurice Blackburn – the lawyers representing Ms D’Arcy – a hearing will take place in April.  I would therefore expect that a final judgment will issue later in the year.

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Tags: Australia, Genetic technology, Patent law, Patentable subject matter

2015 in Preview – Predictions for the Year Ahead

Last week I looked at the year just passed, and compared my predictions with reality.  This week I want to look at the coming year in patents, to preview some anticipated developments, and to make new predictions for 2015.

Here, in brief, are some of the developments that I will be watching this year:

1. the application to the High Court by Yvonne D’Arcy, for special leave to appeal the Full Federal Court’s decision in the Myriad gene patents case;
2. the appeal to the Full Federal Court by the Commissioner of Patents in the RPL Central case, in relation to the patent-eligibility of computer-implemented inventions;
3. the two Australian patent infringement cases involving non-practising entities Upaid and Vringo;
4. the High Court has also been asked to review the Full Federal Court’s decision in AstroZeneca v Apotex [2014] FCAFC 99, including the analysis of the ‘starting point’ for assessing inventive step; and
5. in the US, the Patent and Trademarks Office will continue ‘refine’ its guidelines for the examination of patent-eligibility, while there will doubtless be further attempts to pass new patent law reforms.

Read on for my further thoughts and predictions on these issues.

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Tags: Australia, Computer programs, Genetic technology, Law reform, News, Obviousness, Patent law, Patent litigation, Patentology admin, Trolls, US