Friday, February 15, 2013

Myriad's BRCA Claims Held Patent Eligible in Australia

Today the Federal Court of Australia issued a decision in Cancer Voices Australia v. Myriad Genetics upholding the patent eligibility of three of Myriad's patent claims that recite isolated BRCA-encoding nucleic acids. Based on my understanding of the Australian court system (gleaned from Wikipedia) the decision seems to be analogous to a federal district court decision in the United States, i.e., the case was decided by a single judge, it can be appealed to the Full Court (a panel of 3 to 5 judges), and ultimately to the Australian High Court (the analog of the US Supreme Court). As in the case of the US challenge to Myriad’s BRCA patents, only patent eligibility is at issue, no other grounds of invalidity (including lack of novelty, lack of inventive step, lack of utility or lack of fair basis) were raised.

Looking to Australian precedent, the court held the claimed nucleic acids to be patent eligible “manner[s] of manufacture” within the meaning the Australian Statute of Monopolies, because the claimed nucleic acids constitute “an artificially created state of affairs which has economic significance.”

Although the Australian court came to the same conclusion as the Federal Circuit with respect to the patent eligibility of the claims, it declined to follow the reasoning of the Federal Circuit's Judge Lourie. In particular, the court rejected Judge Lourie’s conclusion that the isolated DNA claims are limited to DNA molecules that have been excised from the human chromosome in a way that requires covalent bonds to be broken. The Australian judge found that the claims are silent with respect to the length of the claimed nucleic acids, and that "there is nothing to suggest either in the claims themselves or in the body of the specification that the complete molecule of DNA as originally found on chromosome 17 that has been isolated . . . would be outside the scope of the disputed claims. . . . To interpret the disputed claims [so as to require that every isolated DNA sequence within the scope of the claims must have had at least some covalent bonds broken as a result the isolation process] would require me to impose an impermissible gloss upon the words of the claim.”  I entirely agree with the Australian court, and think that Judge Lourie was incorrect on this point.

In reaching its decision, the Australian court found it to be significant that:

(1) The Australian High Court had previously interpreted the scope of patent eligible subject matter expansively, and "made clear that metaphorical analysis may not be helpful in determining whether or not something constitutes patentable subject matter” [our US Supreme Court might benefit from this approach];

(2) “[I]n the absence of human intervention, naturally occurring nucleic acid does not exist outside the cell, and ‘isolated’ nucleic acid does not exist inside the cell;” and

(3)  "It would lead to very odd results if a person whose skill and effort culminated in the isolation of a micro-organism (a fortiori, an isolated DNA sequence) could not be independently rewarded by the grant of a patent because the isolated micro-organism, no matter how practically useful or economically significant, was held to be inherently non-patentable.”

 The court noted that it is “trite law that you cannot patent a discovery, but if on the basis of that discovery you can tell people how it can be usefully employed, then a patentable invention may result.”

The court made a number of other important observations:

(1) “The disputed claims are not to genetic information per se. They claim tangible materials. Much emphasis was placed by the [patent challengers] upon the informational character of DNA as a storehouse of genetic information. But the disputed claims are not to information as such. They could never be infringed by someone who merely reproduced a DNA sequence in written or digitised form.

(2) “Because each of the claims is to an isolated chemical composition, naturally occurring DNA and RNA as they exist in cell are not within the scope of any of the disputed claims and could never, at least not until they had been isolated, result in the infringement of any such claim."

(3) “ [Australian precedent] does not require the Court to ask whether a composition of matter is a “product of nature” for the purpose of deciding whether or not it constitutes patentable subject matter. [Precedent] recognises that it may be unhelpful to approach the problem in this way. I think this is especially so in the field of biotechnology in which micro-organisms play a critical role in the development, manufacture and use of diagnostic and therapeutic products and techniques.”

(4) “[Australian precedent] does not require the Court to ask whether a micro-organism is “markedly different” to something that already exists in nature for the purpose of deciding whether it constitutes patentable subject matter (cf. Chakrabarty at 310).”

(5) “In the context of biological material, an artificial state of affairs may manifest itself in different ways. The physical properties of the naturally occurring material may have changed as a result of it having been isolated. But even if the physical properties of the material have not changed, the removal of the material from its natural environment and its separation from other cellular components may still give rise to what might reasonably be described as an artificial state of affairs. “

(6) “In my opinion the patentability of the isolated nucleic acids referred to in the disputed claims does not turn upon what changes have been made to the chemical composition of such substances as a result of them having been isolated. In particular, the question of whether these substances constitute patentable subject matter does not depend upon the type of chemical bond that may have been broken in the process of isolating them.”

The court also found significant, although not determinative, the fact that the Australian Parliament had considered and rejected proposals to limit the patenting of isolated nucleic acids, as well as the long-standing practice of the Australian patent office to grant claims to isolated nucleic acids.

In short, the decision of the Australian court broadly supports the patent eligibility of not only isolated DNA, but more generally isolated naturally occurring molecules.  It is entirely consistent with the long-standing interpretation of the US patent office, and the general understanding in the US prior to the Myriad case, that isolation of a naturally occurring molecule can constitute sufficient human intervention to satisfy the requirement of patent eligibility. It rejects many of the arguments being raised in the US by ACLU/PubPat and their supporters.


Manohar Singh said...

I found lots of interesting information here. The post was professionally written and I feel like the author has extensive knowledge in this subject. Partywear suit

Anonymous said...

thanks for share.

Patricia Green said...

The substance you are penning blows out my nous.
no win no fee claims

Patricia Green said...

The substance you are penning blows out my nous.
no win no fee claims

zarash khan said...

I totally love this site! All of your posts make me smile! You had a great example this is apply to manifesting a relationship /marriage/anything intangible?

Elias Crowder said...

Cheap Paper Writing Service
Buy a Paper Online
Write My Paper
Custom Writing Services
Custom Academic Writing
Papers for Sale
Buy Pre Written Essays
Cheap Term paper for sale
Cheap Essay Writing Services

rejuve health clinics said...


The Post seems to be good I really Like your Post very much thanks For sharing this awesome Post

rejuve health clinics

sathya said...

Hi there, awesome site. I thought the topics you posted on were very interesting. I tried to add your RSS to my feed reader and it a few. take a look at it, hopefully

I can add you and follow.

No Win No Fee

Anonymous said...

Factor Quema Grasa
Factor Quema Grasa Pdf
Libro Factor Quema Grasa
Factor Quema Grasa Gratis
Factor Quema Grasa Descargar
Factor Quema Grasa Descargar Gratis
Factor Quema Grasa Libro
Factor Quema Grasa Libro Gratis
Factor Quema Grasa Pdf Gratis


This lawsuite stuff just goes on and on.

jack smith said...

Some solicitors will be promising for high quality service at rock bottom cost but they will charge many extra fees for their service while closing the case and some solicitor will yield zero result.Solicitors north Sydney

fifa 15 coins said...

What greater function to improve your wardrobe then an AH-MAZING customized bag? Our favourite ones this time of year are satchels, totes, and bucket handbags. Not merely buy fifa 15 coins did they have a significant presence around the Fall 2013 runways, but we're continuously obtaining them on a number of trendy cheap fifa 15 coins stars and bearing in thoughts they are remarkably functional and appealing who can blame them?

Apple Ibeacon said...

This is really awesome and i love that..Apple Ibeacon This is very unique thing you put on that post.. Thanks for sharing..

China heated battery manufacturer said...

This is a great post. I like this topic.This site has lots of advantage.I found many interesting things from this site. It helps me in many ways.Thanks for posting this again.China heated battery manufacturer

steve7876 said...

Pleasant a single, there is certainly absolutely several smart points about this internet site numerous my audience may possibly comprehend this kind of practical; i've got to send out a keyword rich link, a number of appreciate it.carpet cleaning

steve7876 said...

Thank you for some other informative website. The place else may just I get that kind of information written in such a perfect method? I have a venture that I am simply now running on, and I’ve been at the glance out for such info.sell courses online

descargar whatsapp gratis para android said...

Thanks for sharing this quality information with us. I really enjoyed reading.
apply baixar facebook and descargar whatsapp para android and apply baixar facebook movel

jaring safety said...

The article posted was very informative and useful
thanks for sharing..
jaring futsal | jaring golf | jaring kassa / jaring polynet | jaring pengaman proyek | jaring pengaman bangunan | jaring pengaman gedung | jaring gawang | jaring paranet / jaring tanaman | rumput sintetis / rumput futsal |
tangga darurat | jaring cargo | agen jaring | jaring outbound | jaring truk | tali tambang

Mac Topan said...

Thanks for Sharing That... Sucses for You












drs hd recuperacao de dados said...

I thoroughly enjoyed reading it in my lunch time. Will surely come and visit this blog more often. Thanks for sharing..drs hd recuperacao de dados

limo Brooklyn said...

You’ve got some interesting points in this article. I would have never considered any of these if I didn’t come across this. Thanks!.limo Brooklyn

facelift atlanta said...

OPY World School is promoted and managed by Rao Mohar Singh Education Society with the mission to provide quality education at school level.facelift atlanta

key west wrist injury attorney said...

I haven’t any word to appreciate this post…..Really i am impressed from this post….the person who create this post it was a great human..thanks for shared this with us.key west wrist injury attorney said...

You have a very inspiring way of exploring and sharing your thoughts. It is very uncommon nowadays, lots of sites and blogs having copy pasted or rewritten info

web icons said...

Regards for your reviewed arrangement! My admit admit mate along catalog arrangement in ordain to i obligatory status my hold guarantee in addition i favorite receive smaller that could, an appropriate atomic inception fabricate upwards an fabulous director.web icons said...

You are awesome!! I am loving your blog! Keep up the great work! said...

Not so they don't live homework however tailor gap doesn't wicked children can't education their determine plus trace talents to baffle them from

rent a yacht in maimi said...

I haven’t any word to appreciate this post.....Really i am impressed from this post....the person who create this post it was a great human..thanks for shared this with a yacht in maimi

fx compared said...

This is the best application on the drop today. There access to enjoy great moments of relaxation:fx compared

purpose of refinancing a home said...

I thought it was going to be some boring old post, but it really compensated for my time. I will post a link to this page on my blog.purpose of refinancing a home

legal reputation said...

I have already bookmarked this blog. This article is way better than the previous articles I've read.I really enjoyed reading this post and I totally agree with your opinion. Keep up the great work. Thanks a lot!legal reputation

combat training said...

Thanks for letting us know about the new update. Features seem up to date with the current technologies avail in the market. Addition of the serial stack seems a plus point to me.combat training

Lithium polymer battery said...

I was looking at some of your posts on this website and I conceive this web site is really instructive! Keep putting up.Lithium polymer battery

contract repository said...

Just like in brick and mortar stores you can also find discount shopping online as like anything else you can find anything you want with only a few clicks of the mouse. While the brick-and-mortar is a plus for getting outdoors it can also be inconvenient and stressful.contract repository

how does a construction loan work said...

This article gives the light in which we can observe the reality. This is very nice one and gives indepth information. Thanks for this nice does a construction loan work

shahbaz said...

You can buy from our large and diverse collection of salwar kameez, party wear suits, Bollywood collection, cotton Kurtis, Anarkali suits, Bollywood saree and many other products.50s fashion

Legal Herbal Online said...

It's unlikely that any on the photographs had been considered less than 6 days in the past.sexual harassment lawyer

Legal Herbal Online said...

Thank you so much for the post you do. I like your post and all you share with us is up to date and quite informative, i would like to bookmark the page so i can come here again to read you, as you have done a wonderful job.slotenmaker den haag