Friday, November 1, 2013

Aria Diagnostics v. Sequenom: Genetic Diagnostic Claims Patent Ineligible


 
A recent decision out of the ND of California portends poorly for the patent eligibility of genetic diagnostic testing methods.

Sequenom is the exclusive licensee of US patent 6,258,540, which Sequenom licensed from Isis
Innovation Limited.  The patent relates to prenatal detection methods performed on a maternal serum or plasma sample from a pregnant female, which methods comprise detecting the presence of a paternally inherited nucleic acid of fetal origin in the sample, and is based on the discovery that cell-free fetal DNA (sometimes referred to as “cffDNA”) is detectable in maternal serum or plasma samples. The “invention enables non-invasive prenatal diagnosis, including for example sex determination, blood typing and other genotyping, and detection of pre-eclampsia in the mother.”


Ariosa, formerly known as Aria Diagnostics, sued Sequonom in the Northern District of California seeking a declaratory judgment that it does not infringe the ‘540 patent. On October 30, the court granted summary judgment in favor of Arioso, declaring a number of claims of the ‘540 patent invalid for being directed towards patent ineligible subject matter under 35 USC 101. The decision is available here.


Claim 1 is representative of the invalidated claims. It recites:

 
1. A method for detecting a paternally inherited nucleic acid of fetal origin performed on a maternal serum or plasma sample from a pregnant female, which method comprises:

amplifying a paternally inherited nucleic acid from the serum or plasma sample and

detecting the presence of a paternally inherited nucleic acid of fetal origin in the sample.

 
Recent Supreme Court decisions addressing patent eligibility, particularly Mayo v. Prometheus, have emphasized two criteria for assessing patent eligibility of method claims directed towards a practical application of the discovery of a “natural phenomenon.” First, does the claimed method add something to the natural phenomenon beyond what is already “well-understood, routine, or conventional.” Second, does the claimed method “preempt” the natural phenomenon.

 
With regard to the first criterion, the District Court interpreted the requirement of something more than well understood, routine and conventional activity as imposing a requirement that the claimed method must constitute an “inventive” application of the natural phenomenon. The court held that “use of a newly discovered natural phenomenon [] will not render a claim patentable if the use of that natural phenomenon, [] is the only innovation contained in the patent.”  The court found that the only inventive aspect of the method was the discovery of the presence of cffDNA in maternal plasma, and that the detection of cffDNA using conventional techniques for DNA detection was not sufficiently inventive to render the claim patent eligible.

 
One way of looking at it is that the court essentially conducted a nonobviousness analysis, usually the province of Section 103, under the guise of Section 101 patent eligibility, treating the newly discovered natural phenomenon which formed the basis for the claim method as something akin to prior art, and concluding that it was not inventive (i.e., it was obvious) to combine the natural phenomenon with prior art methods for DNA detection. It will be interesting to see how the Federal Circuit responds to this interpretation of the “well understood, routine and conventional” language the Supreme Court used in Mayo.  Unfortunately, it seems to comport with a literal reading of Mayo. However, in the Federal Circuit’s recent fractured en banc decision in CLS Bank Int’l v. Alice Chief Judge Rader authored an opinion explicitly stating that, in his view, the Supreme Court’s use of the language “well-understood, routine and conventional” does not inject a requirement of inventiveness into the section 101 patent eligibility analysis.  Other Federal Circuit judges offered different interpretations, and there appear to be some that are much more receptive to that the Supreme Court has injected an “inventiveness” criterion in the test for patent eligibility.

 
Regarding the second criterion, the District Court found that the claim would cover all “commercially viable” means of testing for paternal cffDNA and thus preempted use of the natural phenomenon.  Sequenom presented evidence that there are alternate methods available for detecting cffDNA  that are not covered by the claim, but the court characterized these methods as not “commercially viable,” and hence not relevant to its preemption analysis, which focused on the practical impact of the patent claims.  The decision suggests that a method claim such as this is patent ineligible unless, “at the time of the invention or at the time of issuance of the patent,” there are available commercially viable alternatives for applying the claimed natural phenomenon.

 
If the approach used by this court is upheld by the Federal Circuit and applied generally to diagnostic claims, it would seem to severely limit the availability of patent protection for diagnostics.   One well-known patent that immediately comes to mind is Genetic Technology Ltd’s so-called “junk DNA” diagnostic patent, US Patent No. 5,612,179, which involves diagnostic analysis of non-coding DNA and has been asserted against numerous alleged infringers. But even if this approach is adopted, there remains some reason to be optimistic with respect to personalized medicine claims, particularly if the claim includes a step actually applying diagnostic information, for example by administering a drug to a patient. I think the Federal Circuit’s recent decision in Classen Immunotherapies, Inc. v. Biogen IDEC would support that position.

67 comments:

Vikas Dhama said...

Pacific BPO provides end to end bpo outsourcing solutions for medical healthcare including medical coding in India.

For more info : Diagnostic Coding India

Anonymous said...

1.Stanford reserachers discovered in 1970 that fetal cells and DNA circulated in a mother's blood (Fetal cells in the blood of pregnant women: detection and enrichment by fluorescence-activated cell sorting
L A Herzenberg, D W Bianchi, J Schröder, H M Cann, and G M Iverson).

2. PCR and amplification invented in 1983.

Call this not obvious; call it unpatentable subject matter--whichever. It's obvious that Prometheus v. Mayo was designed to stop exactly this sort of patent regardless of which "industry" (diagnostics) it affects.

Anu Hastha said...

There are many sites which expresses about biotech information. But your blog is looking good with very nice article. thanks for sharing.

Tamil movies

AlizeKendal said...

Very informative blog. you are updating regularly. thanks for sharing.

get instagram followers

Peter pearl said...

Hi

call it unpatentable subject matter--whichever. It's obvious that Prometheus v. Mayo was designed to stop exactly this sort of patent regardless of which "industry"

buy real youtube views

PENNY STOCK INVESTMENTS said...

Great biotech stocks.

belinda said...

Hi

The Label seems to be more impressive

more instagram followers

Jenny Rose said...

Hi,
Its very nice to see...
I would like to comment your post...
You done a great work here...

Arte Digital

SEO Expert said...

Glad to read your post :). It is very informative!

Radiator Covers UK said...

I appreciate your blog post, beautifully expressed and well written.

Free Online Games said...

Very value able post, I read the whole story when I start reading it.

Anonymous said...

the first criterion can used more than well muzik shqip

Anonymous said...

I see you've stopped blogging, which is well given you've been wrong about nearly everything for years from Mayo to Myriad and everything in between.. dead wrong each time.

fifa 14 coins said...

Dress up games is among the most common girl games online. There are numerous things which you could do with these dress up games. Be a celebrity stylist and produce a brand new style for your idol for example Miley Cyrus, Anne Hathaway,fifa 14 coins Selena Gomez and others. Dress up a celebrity, cartoon character and also other icons. You are able cheap fifa 14 coins to do their hair, make up and give them a completely different appear. Mix and match almost everything that you will discover inside the virtual closet. It is fifa 14 coins for sale possible to be as wild as you wish to or just be fashionable and elegant.

Emily Ratajkowski said...

Wonderful Post, I highly appreciate those people who share some good information, because I like those people who actually share :).
Laundry Service Richmond

Toby McGuire said...

Your article is very useful and have good knowledge, thanks for the post.
Debt Management Plan

Christina Aguilera said...

Very value able post, I read the whole story when I start reading it.
FOG

Bipasha said...

I appreciate your blog post, beautifully expressed and well written.
Radiator Covers UK

Bipasha said...
This comment has been removed by the author.
syed.mehdi said...

Unistem Bioscience offer stem-cell therapy. Replacing central nervous system. Find out everything you need to know about stem cell transplant india.

Rabica said...

Good and informative Post, I highly appreciate those people who share some good information, because I like those people who actually share :).

Jay Philip said...

Great Post, I highly appreciate those people who share some good information, because I like those people who actually share :).

Chang bui thi said...

I am very happy to read this. Appreciate your sharing
Signature:
i like play games friv online and play games2girls Download baixar facebook

baixar facebook movel said...

Thank you for sharing information.
----
descargar mobogenie and apply baixar facebook | mobogenie

tranbaongoc said...

Thanks for sharing the information. It is very useful for my future. keep sharing
Games for girls|
Kizi 1|
Kizi 2

thị hậu nguyễn said...

It is the best time to make plans for the future and it's time to be happy. I have read this post and if I could I wish to suggest you few interesting things or advice. Maybe you could write next articles referring to this article. I want to read even more things about it!
happy wheels
super mario bros
pacman
agario

pubsquash John said...

Thanks for sharing the information. It is very useful for my future. keep sharing
Kizi 123|
Friv 234|
Friv

bibikafu said...

Thanks for your great article friend, i get new information, new ideas to do somethings, i hope you will share again, i keep waiting for next post, thanks.
Kizi 3
Friv 4

ka maz said...

I like the flash and free games. Here is one of my favorite games today.
Friv 10

XUKA said...

Thank you for sharing a great information and useful. it really necessary and timely for me at this time. I wanted to share this information with my friends on the social network facebook.!
Friv 10000
Friv

An Giang said...

What a wonderfull post! thank you... read with pleasure!
Friv 1

Yepi said...

You need to kill time, you need entertainment. Refer to our website. hope you get the most comfort.
Thanks you for sharing!
Yepi
Kizi
Friv
Friv Games

Hieu Nguyen said...

you'd have time to look these kids active. Please visit our website and let us play the game interesting.
Thanks for sharing !
Friv 10
Kizi 10
Yepi 2

tranbaongoc said...

You are stressed and tired, you need entertainment. Refer to our website. hope you get the most comfortable.
Kizi 4

Online Friv said...

You need to kill time, you'd have time to look these kids active. Refer to our website. Hope you get the most comfort.
Thanks for sharing !
Friv 5
Kizi 1
Yepi 3

Friv 100 said...

Thanks for the best blog.it was very useful for me.keep sharing such ideas in the future as well.this was actually what i was looking for,and i am glad to came here!

tranthuphuong said...

thank you for your interest in welcome visit
Friv 4

Anonymous said...

New attractive game . I will play it every day
Friv|
Friv 2

Kizi said...

Kizi1000.in is a great place to play the best free online Kizi games, juegos Kizi, jogos Kizi, jeux de Kizi from the top game developers all over the world. Play free online at Kizi1000.in. Kizi

Friv4 said...

When you're tired, you want to relax after a stressful working hours, you need to have time to take care of the kids active.
Please visit our website and play exciting flash games.Thanks you for sharing!
Friv 4

Ki Moon said...

Thanks for posting this useful info. It really helped me!!!
Friv
Friv.com
Friv 2016

Kizi200 said...

Play the Best Free Games! We've picked out the racing games, cooking games, candy crush, games shooting, fashion games, ...
Thanks for sharing !
Kizi 200
Friv 1
Y88
Y9

Friv100 said...

You want to relax after a stressful working hours. Refer to our website. hope you get the most comfort.
Thanks for sharing !
Friv 100
Friv 8
Friv 2

Jenny Daring said...

slitherio
Tank trouble| happy wheels| Strike Force Heroes
This is an evolutionary strategy game that pits you against alien invaders. You begin the game in the Stone Age, with just a base and some money. Select your base to view the available building options and spend your money wisely. Buy buildings that will spawn offensive units and gatherers, as well as turrets to bolster your defenses. You can upgrade your buildings so that they produce more effective units and spawn them at a faster rate.
We are really grateful for your blog post. You will find a lot of approaches after visiting your post. Great work.
happy wheels|
strike force heroes | tank trouble 2

Fireboy and Watergirl arrived again to the temple in the forest. 2 players together can help them to find their way out.
fireboy and watergirl| fireboyandwatergirl| fireboy and watergirl 2
goodgame empire

Johnson Tonya E. said...

This is the game so players feel very fierce , adventurous . You try to join and play this game , you will feel great like.
age of war | tank trouble 2 |earn to die
gun mayhem | gun mayhem 2
slitherio | slither.io | slither io
can your pet | Red Ball | | duck life
Gmail.com by Google is one of the most popular email services nowadays which lets you send emails to your friends, relatives, business partners wherever they are (the only thing they need is the Internet)
gmail sign in | create a gmail account
Gmail login

GirlsGoGames Dressup said...

You want to relax after a stressful working hours. Refer to our website. Hope you get the most comfort.
Thanks for sharing !
GirlsGoGames
Kizi 100
Frvi


lee anh nuooi said...

invites you to play games for a chance to win cars Corolla Altis car

Friv Games
Kizi 100
Games2Win
Kizi 5

Pijat / Massage Panggilan Jakarta - Anies Massage said...

What a nice blog, it has very professional and creative content that i find really helpful. If every page that one opens has such great content, i would say that browsing could be the order of the day. History dissertation paper rewriting help offered by well trained experts that guarantee the best.

https://goo.gl/GAAFa9 Pijat Panggilan Jakarta www.aniesmassage.blogspot.com Pijat Panggilan Jakarta - https://goo.gl/t0UNUZ Pijat Panggilan Bandung www.massage-di-bandung.blogspot.com Pijat Panggilan Bandung - http://goo.gl/qpcb6j

GirlsGoGames Dressup said...

You want to relax after a stressful working hours. Refer to our website. Hope you get the most comfort.
Thanks for sharing !
GirlsGoGames
Kizi 100
Frvi

Kizi 3 said...

To flee war, to protect the lives of themselves and their families.
Mario Games
Friv 1000 | Doraemon Games | Kizi 1000 | Yoob

games2girls said...

You need to have time to take care of the kids active. Please visit our website and play exciting flash games.
Thanks you for sharing!
Games2Girls
Kizi 1000
Frin
Friv 3

Giải Trí Tổng Hợp said...

I was working and suddenly I visits your site frequently and recommended it to me to read also. Age Of War 2
Big Farm | Slitherio
Tank Trouble | Happy Wheels
Goodgeme Empire | Slither.io

yoob games said...

You need to have time to take care of the kids active. Please visit our website and play exciting flash games.
Thanks you for sharing!
العاب تلبيس
العاب طبخ 2017

Anonymous said...


العاب فلاش جديدة جدا استمتع بأفضل العاب الاونلاين 2016 مجانا من موقع العاب وشارك كل الالعاب الجميله مع كل اصدقائك
العاب
العاب سيارات
العاب تلبيس
العاب حرب
العاب
العاب بن تن
العاب طبخ
العاب غامبول
العاب سبونج بوب
العاب كرة القدم

العاب مكياج

لعبة الفراخ

لعبة زوما


لعبة من سيربح المليون

لعبة الفراخ

لعبة ماريو

العاب قص شعر

العاب باربي

العاب دورا


لعبة من سيربح المليون

Sk Awna said...

العاب بنات
العاب بنات كبار

Tdt 3535 said...

Thanks for sharing the information. It is very useful for my future. keep sharing. Can you play more games at: Friv.com | Kizi | happy wheels game

gun mayhem said...

You go to our Web page you can play online games for free.
Our Web page selection is the biggest collection so you can play entirely for free
gun mayhem 3 | can your pet 2
learn to fly 3 | happywheels
tank trouble 3

حسام داود said...

شركة تسليك مجاري بالرياض
شركة تسليك مجارى بالرياض
level تسليك المجاري بالرياض
افضل شركة تنظيف بالرياض
تنظيف شقق بالرياض
شركة تنظيف منازل بالرياض
شركة غسيل خزنات بالرياض
افضل شركة مكافحة حشرات بالرياض
رش مبيدات بالرياض
شركة تخزين عفش بالرياض
شركة تنظيف مجالس بالرياض
تنظيف فلل بالرياض
ابى شركة تنظيف بالرياض

Eric Trump said...

really amazing post .... keep it up
Friv 100

nguyen thanh truc said...

Games are games of human intelligence.
Join experienced talent with me yet! What are you waiting for?
age of war 2
gold Miner 2
unfair Mario 2
cubefield 2
tanki Online 2

Friv Games
Y2
Friv 200

amira said...




شجّع نفسك لأننا اليوم سنقوم بعرض لعبة جوال جديدة من نمط معارك الممالك لك!

إذا كنت مهتما بتلك الأنواع من الألعاب فربما قد سمعت بـClash of Clans ونسخ العناوين المشابهة. جميعا تبدوا متشابهة لبعضهم البعض وليس لديهم أي سمات متميزة ولكن هذا سيتغير اليوم لأننا نريد أن نقدم لك فجر الأسطورة ونعرض ميزاتها!



فجر الأسطورة
تعطيك أنماط وحرية أكثر. إنها أحد تلك الألعاب التي يمكنك الإلمام بها في أقل من 5 دقائق ولكن بعد ما يقارب الساعة من اللعب ستدرك أن بها المزيد

النقطة الأساسية باللعبة هي بناء جيش والهجوم على ممالك اخرى أصغر أو أكبر! بالطبع عليك تكوين قاعدتك وتوسيعها. إذا ما الذي يجعل فجر الأسطورة مختلفة عن العناوين المشابهة؟ في البداية اللعبة تطلب منك إختيار شخصيتك الرئيسية في فريقك - البطل! هنالك أكثر من 150 لتختار منهم! يمكن رفع مستواهم جميعا وتطويرهم لذا قم بجمع الميزد والمزيد من الأبطال الذين يمكن أن تقوم بدمجهم معا لتجعلهم يظهرون قدرات فريدة أكثر!

كيف توسع مملكتك! إنه سهل! بإستثناء الهجوم على ممالك اخرى للحصول على المواد يمكنك الإنضمام إلى فعالياتنا اليومية والأسبوعية الرائعة التي قمنا بتجهيزها لجميع اللاعبين! حاول أن تحارب بالحلبة أو التحالف وإحصل على جوائز رائعة!


فجر الأسطورة
تنتظرك بالفعل في الاب ستور وجوجل بلاي









amira said...




من المعروف أن أفضل ألعاب الجوال دائما تعمل على إيجاد التوازن بين ان تكون معقدة و بسيطة فى آن واحد.
يمكنك أن تمسك بكل شئ في خلال 5 دقائق ولكن بعد ساعة من اللعب سوف تدرك أنها توفر لك أكثر بكثير مما كنت تتوقع في البداية.

إذا ما هي لعبة فجر الأسطورة ؟ إذا كانت لديك حتى خبرة صغيرة في نمط ألعاب تشابك-الممالك، فستكون لديك فكرة جيدة عن ما هي فجر الأسطورة.
تبدأ أساسا مثل معظم الألعاب المشابهة.
أنت تستيقظ على أرض فارغة واللعبة تطلب منك أن تبني أول مباني إستراتيجية لك مثل الثكنة العسكرية أو أرض التدريب.
الان يمكنك البدء في تدريب جيشك! يمكنك أن تبدأ من الأقزام الأساسيين.
سيتاح أنواع أخرى من الجنود فور وصولك للمستويات التالية!

ولكن ما الذي يجعل فجر الأسطورة مختلفة عن باقي الألعاب المشابهة؟ قوتك الأساسية هي البطل وهو قائد جيشك.
أنت تختار أول بطل لك في بداية اللعبة ولكن بعد الميزد من المعارك المنتصرة سيتم مكافأتك بإمكانية إختيار أكثر وأكثر.
من السهل أيضا رفع مستواهم وحتى تطويرهم! كلما كان بطلك قويا، كلما إستطعت الفوز بالمعارك الصعبة!

وبالطبع فجر الأسطورة تقدم لك أنواع مختلفة من الفعاليات، يومية وأسبوعية،
حيث يمكنك الحصول على المكافات يوميا وأسبوعيا! لا تنسى إستخدامها لتحسين مملكتك!

تحميل لعبة فجر الأسطورة متاح الآن بالفعل في الاب ستور و سوق الأندرويد!











amira said...



هل بدأت تشعر بالملل من Clash of Clans، هل تشعر بأن مراحل اللعبة أصبحت مكررة ولا جديد فيها؟،
هل تريد القيام بتحدٍ جديد؟، جهّز نفسك لأننا نريد أن نقدم لكم المنافس الجديد لها والتي ستتيح لك أنماط لعب أكثر وحرية أكثر!

فجر الأسطورة هي لعبة إستراتيجية مجانية وبسيطة والتي تسمح لك ببناء مملكة خاصة بك وتدريب جيوش كبيرة تحت سيطرة الابطال.
اللعبة تقدم أكثر من 150 بطل لتختار من بينهم، كل واحد منهم يستطيع أن يظهر لك قدرة خاصة.
يمكن أيضا أن ترفع من مستواهم، بل ويمكنك أيضا دمجهم لتطويرهم، والذي يمكن أن يعطيك أبطال غير عاديين بقدرات غير مألوفة!
الأبطال هم دائما قادة فريقك وجعلهم أقوى يساعدك في بناء فريق أقوى.

تعطيك اللعبة مهام خاصة كل يوم، والتي تسمح لك بالحصول على سلع ومواد محدودة.
الحصول على الموارد الأساسية مثل الذهب والفاكهة السحرية أمر سهل للغاية، يمكنك سرقتها من الممالك التي قمت بتدميرها في المعارك.
اللعبة تقدم بعض الإضافات المدفوعة أيضا ولكنها إختيارية تماما. العملة المدفوعة - الشهب،
تتيح للاعبين الحصول على أشياء رائعة مثل الدروع والتي تساعدهم في بناء بطل أكثر قوة!

لعبة فجر الأسطورة تحاول ببساطة أن لا تكون مجرد نسخة من "Clash of Clans" فاللعبة تقدم لك حرية أكثر، خاصة من خلال توفير الأبطال.
إختلاف اخر هو أن فجر الأسطورة تظهر لك المزيد من إمكانيات المعركة. يمكنك الإنضمام إلى الحلبة أو حرب التحالف.
الحلبة بها معارك يومية قصيرة بينما التحالف فعالية اسبوعية أكبر.
الأصعب لها جوائز أفضل. فجر الأسطورة متاحة بالفعل في متجر الاب للـiOS و Google Play للأندرويد. جربها الان!











amira said...



منتديات أسامر
اسلاميات,عامه,ادبيه,اسرة مجتمع,حياه,صوتيات,ديكور,ترفيهي,انمي,العاب,game,منتديات اسامر افضل منتدي عربي و فيه عدة اقسام و هي اتصلات وتقنيه
منتدي أسامر

amira said...



منتديات أسامر
اسلاميات,عامه,ادبيه,اسرة مجتمع,حياه,صوتيات,ديكور,ترفيهي,انمي,العاب,game,اتصلات وتقنيه.
منتدي أسامر

amira said...


العاب برق

ttt4
g9g
hguhf ttt4
hguhf g9g

hguhf sdhvhj
car games

العاب فلاش برق

jjang said...

really amazing post .... keep it up
Juegos Friv 4
Kizi 1000