Sequenom Goes to CAFC

As expected the Sequenom case has been appealed to the CAFC, the high patent court. The docket entry appears below:

"USCA Case Number 14-1142 USCA for the Federal Circuit for 153 Notice of Appeal filed by Sequenom, Inc.. (ysS, COURT STAFF) (Filed on 12/5/2013) (Entered: 12/06/2013)."

I am 85% certain the lower court's decision will be overturned by the pro-patent CAFC despite the decision in the Myriad case.  The only question I have is whether the Supreme Court will grant cert once the Sequenom case is decided.  Stay tuned for more on this case.

Footnote on Ariosa

According to the complaint in one of the cases now styled Ariosa v Sequenom, the original plaintiff was a company called Aria.  According to the March 28, 2012 edition of a web based journal, Clinical Sequencing News:

"Aria Changes Name to Ariosa Diagnostics; Completes Clinical Validation of Prenatal Trisomy Test."

Sequenom agaonst Ariosa

Sequenom and Ariosa are the two parties named in the NYT article in the previous post.  As usual, it is not that simple.  There are several parties on both sides and a lot of cross suing going on.  But my research has revealed one of the patents (there may be more) involved in the case.  USPN 6,258,540 is directed to:

"Non-invasive prenatal diagnosis."

The Abstract of the Patent: "The invention relates to a detection method performed on a maternal serum or plasma sample from a pregnant female, which method comprises detecting the presence of a nucleic acid of foetal origin in the sample. 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."
Talk about ethics!  This one's a beaut.

Here's a link to the patent:

http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=6258540.PN.&OS=PN/6258540&RS=PN/6258540

Judge Invalidates Patent for a Down Syndrome Test

http://www.nytimes.com/2013/11/01/business/judge-invalidates-patent-for-a-down-syndrome-test.html?emc=edit_tnt_20131031&tntemail0=y&_r=0

KosherGoldfish to speak on Nov. 3

Celebrate Jewish Book Month

with Beth El Writers

Jewish Book Month is the month prior to Chanukah and this year it occurs between October 26 and November 26.

The Beth El Media Center will celebrate with three Coffee and Bagel with Beth El Writers events in the Dimond Library on Sundays, November 3, 10 and 17

at 10 AM. There is no charge for the Coffee and Bagel with Beth El Writers.

Questions? Call Gilah Goldsmith, 703-528-1629.

Speakers for the Coffee and Bagel with Beth El Writers include:

Art Gershman, author of Other People's Bodies, will speak on November 3. 

Art's book deals with the new frontier of biological patents.

The Latest in Empire (GenebyGene)

You do not have access to this transcript.

**RESTRICTED DOCUMENT** NOTICE OF FILING OF OFFICIAL TRANSCRIPT of FINAL ARGUMENT IN PLAINTIFFS' MOTION FOR PRELIMINARY INJUNCTION held on OCTOBER 7, 2013 before Judge ROBERT J. SHELBY. Court Reporter/Transcriber RAYMOND P. FENLON, Telephone number (801) 809-4634.NOTICE RE REDACTION OF TRANSCRIPTS: Within 7 business days of this filing, each party shall inform the Court, by filing a Notice of Intent to Redact, of the parties intent to redact personal data identifiers from the electronic transcript of the court proceeding. The policy and forms are located on the court's website at www.utd.uscourts.gov. Please read this policy carefully. If no Notice of Intent to Redact is filed within the allotted time, this transcript will be made electronically available on the date set forth below.
Transcript may be viewed at the court public terminal or purchased through the Court Reporter/Transcriber before the deadline for Release of Tr anscript Restriction. After that date it may be obtained through PACER. Redaction Request due 11/4/2013. Redacted Transcript Deadline set for 11/14/2013. Release of Transcript Restriction set for 1/13/2014. (asp)

The latest in Empire (Ambry)

You do not have access to this transcript.

**RESTRICTED DOCUMENT** NOTICE OF FILING OF OFFICIAL TRANSCRIPT of FINAL ARGUMENT IN PLAINTIFFS' MOTION FOR PRELIMINARY INJUNCTION held on OCTOBER 7, 2013 before Judge ROBERT J. SHELBY. Court Reporter/Transcriber RAYMOND P. FENLON, Telephone number (801) 809-4634.NOTICE RE REDACTION OF TRANSCRIPTS: Within 7 business days of this filing, each party shall inform the Court, by filing a Notice of Intent to Redact, of the parties intent to redact personal data identifiers from the electronic transcript of the court proceeding. The policy and forms are located on the court's website at www.utd.uscourts.gov. Please read this policy carefully. If no Notice of Intent to Redact is filed within the allotted time, this transcript will be made electronically available on the date set forth below.
Transcript may be viewed at the court public terminal or purchased through the Court Reporter/Transcriber before the deadline for Release of Tr anscript Restriction. After that date it may be obtained through PACER. Redaction Request due 11/4/2013. Redacted Transcript Deadline set for 11/14/2013. Release of Transcript Restriction set for 1/13/2014. (asp)

"The Empire Strikes Back (Gene By Gene)" complaint

Excerpts from "The Empire Strikes Back (Gene By Gene):" or shorthand: "Empire IIB" complaint:

US District Court Electronic Case Filing System
District of Utah (Central)
CIVIL DOCKET FOR CASE #: 2:13-cv-00643-RJS

University of Utah Research Foundation et al v. Gene by Gene Assigned to: Judge Robert J. Shelby Cause: 35:0271 Patent Infringement

Date Filed: 07/10/2013 Jury Demand: Plaintiff Nature of Suit: 830 Patent Jurisdiction: Federal Question

IN THE UNITED STATES DISTRICT COURT FOR THE

DISTRICT OF UTAH, CENTRAL DIVISION

UNIVERSITY OF UTAH RESEARCH

FOUNDATION, a Utah nonprofit corporation; the

TRUSTEES OF THE UNIVERSITY OF

PENNSYLVANIA, a Pennsylvania nonprofit

corporation; HSC RESEARCH AND

DEVELOPMENT LIMITED PARTNERSHIP, a

Canadian limited partnership organized under the laws

of the Province of Ontario; ENDORECHERCHE,

INC., a Canadian corporation organized under the laws

of the Province of Quebec; and MYRIAD

GENETICS, INC., a Delaware corporation;

Plaintiffs,

vs.

GENE BY GENE LTD,

Defendant.

COMPLAINT

DEMAND FOR JURY TRIAL

Case No. 2:13-cv-00643-EJF

Magistrate Judge Evelyn J. Furse

Case 2:13-cv-00643-RJS Document 2 Filed 07/10/13 Page 1 of 16

2

4822-5161-8324.1

                          COMPLAINT FOR PATENT INFRINGEMENT

1. Plaintiffs, University of Utah Research Foundation (“University of Utah”), The

Trustees of the University of Pennsylvania (“University of Pennsylvania”), HSC Research and

Development Limited Partnership (“Hospital for Sick Children”), Endorecherche, Inc.

(“Endorecherche”), and Myriad Genetics, Inc. (“Myriad”), complain against Defendant Gene By

Gene, Ltd. (“Defendant”) as follows:

                                       JURISDICTION AND VENUE

2. This civil action for patent infringement arises under the patent laws of the United

States, specifically under Title 35 of the United States Code, Sections 271, et seq. Subject matter

jurisdiction in this Court is founded upon 28 U.S.C. §§ 1331 and 1338(a).

3. This Court has personal jurisdiction over the Defendant because it regularly conducts

business in this district and has committed acts in this judicial district which give rise to this

action. On information and belief, Defendant sells, offers for sale, and has sold genetic testing

products to residents of this jurisdiction. On information and belief, Defendant has attended,

advertised, and or presented at conferences and/or meetings held in this jurisdiction in which it

sells, offers for sale, has sold, and advertises its genetic testing products. On information

and belief,Defendant has attended,

advertised, and or presented at conferences and/or meetings held in this jurisdiction in which it

sells, offers for sale, has sold, and advertises its genetic testing products. On information and

belief, Defendant has business relationships and/or has collaborated with multiple business

and/or research entities in this district to which it sells, offers for sale, has sold, and/or advertises

its genetic testing products.

                                                       ...

                                     GENERAL ALLEGATIONS

11. Myriad is a molecular diagnostic company that develops and uses proprietary

technologies that permit doctors and patients to understand the genetic basis of human disease

and the role that genes play in the onset, progression and treatment of disease. Myriad’s

technologies result in, and guide the development of, new molecular diagnostic products that

assess an individual's risk for developing disease, identify a patient’s likely response to drug

therapy, and assess a patient’s risk of disease progression and recurrence.

12. For healthcare providers, Myriad offers an array of genetic tests, prognostic tests and

personalized medicine tests to help healthcare providers assess a patient’s increased cancer risk,

disease aggressiveness and optimize efficacy of chemotherapy. Myriad’s testing products

provide healthcare providers with information to help make medical management decisions to

reduce cancer risk and help make sure specific treatments are tailored for each individual patient.

13. For patients, Myriad offers tests that provide important clinical information to assist

patients and their healthcare providers in assessing cancer risk so the patient can take

preventative action to reduce the risk of disease and in making treatment decisions if the patient

is diagnosed with cancer. Myriad improves patient care through the development of new

products across multiple medical specialties.

14. In the early-to-mid 1990s, Plaintiffs discovered the genetic sequences of the BRCA1

and BRCA2 genes and mutations that increase a woman’s risk of developing breast and ovarian

cancer. Since that time, Myriad has invested over $500 million to implement this discovery and

create a molecular diagnostic test for hereditary breast and ovarian cancer related to the BRCA1

and BRCA2 genes. Plaintiffs’ efforts have revolutionized patient care and provided medical

diagnosis and treatment options never thought possible.

15. Defendant offers laboratory services, including clinical diagnostic and genomic

services, including testing and analysis of BRCA1 and BRCA2 genes.

16. Defendant, through its DNA Traits division, began offering its BRCA1 and BRCA2

analysis as part of its testing menu on June 13, 2013. Defendant offers stand-alone tests

comprising full gene sequencing and analyses for the BRCA 1 and BRCA 2 genes.

                                                                ...

Empire IIA (Ambry)

District of Utah (Central)
CIVIL DOCKET FOR CASE #: 2:13-cv-00640-RJS

The captioned case above is Myriad's latest suit, together with other suits against other defendants, against Ambry Genetics, which I call "The Empire Strikes Back (A)", or shorthand: "Empire IIA."

I will report more on this later.

Sen. Leahy Requests Compulsory License of Myriad Patents

From a press release on Senator Patrick Leahy's website:

"July 12, 2013

WASHINGTON – Senate Judiciary Committee Chairman Patrick Leahy (D-Vt.) on Friday sent a letter to the National Institutes of Health (NIH) urging the agency to consider using its authority to ensure greater access to life-saving genetic testing that was developed with federal research dollars."

The letter urges NIH Director Francis Collins to exercise "march-in rights" to either force Myriad to license its patents at a reasonable royalty rate, or, if Myriad refuses, to license the patents directly.  This is precisely the type of situation which was envisioned when this provision of the Leahy-Smith Act (permitting the licensing of government funded research) was promulgated.  A link to the letter follows:

http://www.leahy.senate.gov/download/07-12-13-pjl-to-nih-re_-myriad-march-in

One thing I don't like about the Leahy letter is the following statement;  "...As a result, Myriad may continue to be the only company able to provide women with the genetic testing they need..."  That "may" doesn't make clear that there are presently at least two cases pending challenging Myriad's genetic testing program.  But these two labs being sued by Myriad are not the only ones offering the tests.  According to one source:
http://www.genomeweb.com/clinical-genomics/warning-would-be-competitors-myriad-and-brca-test-patent-holders-sue-ambry-gene
" Emory Genetics Lab, GeneDx, Pathway Genomics, Ethigen, and the University of Washington announced they would offer BRCA testing after the Supreme Court's ruling in AMP v. Myriad." 

Human Rights and the Genome

The following is excerpted from a very lengthy and prolix statement.

Universal Declaration on the Human Genome and Human Rights

The Universal Declaration on the Human Genome and Human Rights was adopted unanimously and by acclamation at UNESCO's 29th General Conference on 11 November 1997. The following year, the United Nations General Assembly endorsed the Declaration.

Universal Declaration on the Human Genome and Human Rights 11 November 1997

The General Conference,

Proclaims the principles that follow and adopts the present Declaration. 


A. Human dignity and the human genome

Article 1 

The human genome underlies the fundamental unity of all members of the human family, as well as the recognition of their inherent dignity and diversity. In a symbolic sense, it is the heritage of humanity. 

Article 2 

(a) Everyone has a right to respect for their dignity and for their rights regardless of their genetic characteristics. 

(b) That dignity makes it imperative not to reduce individuals to their genetic characteristics and to respect their uniqueness and diversity. 

Article 3 

The human genome, which by its nature evolves, is subject to mutations. It contains potentialities that are expressed differently according to each individual’s natural and social environment, including the individual’s state of health, living conditions, nutrition and education. 

Article 4 

The human genome in its natural state shall not give rise to financial gains. 

Washington Post's Pessimistic View of "Emipre II"

Here is the Washington Post's pessimistic view of Myriad chances in overcoming AMP v Myriad's holding of invalidity of gene patents.  I am not so pessimistic.  I think Myriad's claims can be overcome or designed around.
http://www.washingtonpost.com/blogs/wonkblog/wp/2013/07/12/you-cant-patent-human-genes-so-why-are-genetic-testing-companies-getting-sued/

The Empire Strikes Back

The NYT reports that Myriad Genetics has sued two competitors for infringing its patents, citing the numerous claims of the patents which were not declared invalid by thee Supreme Court.  Here is a link to the article.
http://www.nytimes.com/2013/07/11/business/2-competitors-sued-by-genetics-company-for-patent-infringement.html?emc=tnt&tntemail0=y&_r=0

Twenty Thoughts on Myriad

A very interesting post on the blog "PatentlyO" by IP attorney Dennis Crouch gives the thoughts of twenty of his colleagues, mostly law professors.
Each is asked to comment, with the limitation to a 40 word statement, on the effect of the Myriad decision.  The professors include Gregory Dulin of the University of Baltimore, Jorge Contreras of American University, John Duffy of the University of Virginia, Jeffrey Lefstin of the Unviersity of California, Hastings, David Berry of the University of Michigan, Timothy Holbrook of Emory University, Mark Lemley of Stanford University, Jonathan Masur of the University of Chicago, Thomas Cotter of the University of Minnesota, Andrew Chin of the University of North Carolina, Christal Sheppard of the University of Nebraska, Eileen Kane of Pennsylvania State University, Dan Burk of the University of California, Irvine, Brenda Simon of Thomas Jefferson School of Law in San Diego, and Andrew Torrance of the University of Kansas.  A link to the post follows.
http://www.patentlyo.com/patent/2013/06/myriad.html

Interview with Randoph Clower, PhD, JD

Below is a link to an interview in Metropolitan Corporate Counsel with Randolph Clower, PhD, JD, a biotech IP attorney in Buffalo, NY.
Why Buffalo?
Starting with a December 2012 announcement that New York State will spend $50 million to build a life-sciences innovation center on the Buffalo Niagara Medical Campus, the state aims to incubate a biotech cluster in Buffalo, fueled by University at Buffalo innovation, local medical expertise and private investment. 
In the interview Clower distinguishes between Big Pharma and Bio.
However, I would point to pages 65-67 of "Other Peoples Bodies" for a view of Pharma's penetration into the biotech sector.
http://www.metrocorpcounsel.com/articles/24396/landmark-case-comes-down?goback=%2Egde_36507_member_252351304

AMP Celebrates

Here's a link to the AMP press release (pdf) celebrating the Myriad decision:

http://www.amp.org/about/press_releases/documents/20131306_SCOTUSAMPvMYRIAD.pdf

More Fallout From Myriad

The following is an email exchange between myself and and Dr. Roger Klein.

Dr Klein, MD JD FASC, is associated with the Association for Molecular Pathology, the lead plaintiff in the Myriad gene patenting case decided June 13, 2024.  The exchange took place on Linkin and Outlook email.  To read the post scroll down to the bottom of the post and up.

---------------------------------------------------------------------------------------------

We were very pleased with it. Roger On 06/22/13 3:12 PM, Arthur Gershman wrote: -------------------- What is your opinion of the Myriad decision? On 07/24/12 5:37 AM, Arthur Gershman wrote: -------------------- Matthew Dowd, of Wiley Rein. For details please visit my nascent blog: http://koshergoldfish.blogspot.com/ The brief is also on the blog. On 07/24/12 5:21 AM, Roger D. Klein MD, JD, FCAP wrote: -------------------- I was there as well. I haven't yet had an opportunity to read Watson's brief. Who is representing him? Roger

Myried Chuef Eats Crow

Here's what it's like to eat crow by the chief of Myriad:

http://www.nytimes.com/2013/06/21/opinion/a-ruling-on-gene-patents.html?emc=tnt&tntemail0=y&_r=0

big BIO on Myriad

Here's big BIO's statement on the Myriad decision.
This statement is posted on an official blog of BIO titled BIOtechNOW.

http://www.biotech-now.org/public-policy/patently-biotech/2013/06/myriad-supreme-court-decision-bios-statement#

The Forward's Take on Myriad

The Jewish Daily Forward's take on the Myriad decision:

http://forward.com/articles/178638/jewish-women-declare-victory-on-supreme-court-brca/

Myriad Fallout

Here's the start of the fallout from the Myriad decision,  Citing the first paragraph of a NYT article and a link to the article:
http://www.nytimes.com/2013/06/19/opinion/our-genes-their-secrets.html?emc=tnt&tntemail0=y&_r=0

Our Genes, Their Secrets

By ELEONORE PAUWELS

Published: June 18, 2013

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WASHINGTON — THE Supreme Court’s unanimous ruling last Thursday, barring patents on human genes, was a wise and balanced decision that clears away a major barrier to innovation in the areas of biotechnology, drug development and medical diagnostics. But the decision is just a first step toward finding the right balance between protecting legitimate intellectual property and securing an open future for personalized medicine.

Historic Decision

The Supreme Court of the United States has now ruled that claims for human DNA are ineligible for patent.
Here's a link to the decision:
http://www.cnn.com/2013/pdf/12-398_8njq.pdf

The Outrageous Cost of a Gene Test

Here's an opinion piece in the New York Times by David Agus, a medical oncologist and a professor of medicine and engineering at USC.  It is titled "The Outrageous Cost of a Gene Test," and it is about the Myriad test for the BRCA1 and 2 gene mutations. 
http://www.nytimes.com/2013/05/21/opinion/the-outrageous-cost-of-a-gene-test.html?_r=0
He says the tests could be done in the $100 range, instead of the $4,000+ Myriad Genetics charges.

Second Opinions

According to Nina Totenberg of NPR:

http://www.npr.org/blogs/health/2013/04/15/177035299/supreme-court-asks-can-human-genes-be-patented

"Patients are also outraged that they can't get a second opinion on Myriad's test results."

Washington Post Writer Ruth Marcus

Washington Post writer Ruth Marcus offers her opinion that genes should be free from patent restrictions:
http://www.washingtonpost.com/opinions/ruth-marcus-angelina-jolie-shows-why-brca-testing-access-is-needed/2013/05/21/9ab51a98-c24c-11e2-8c3b-0b5e9247e8ca_story.html

Marcus asserts that Myriad has allowed second opinions.  I challenge this assertion.  It seems to me that this is a half truth at best.
I am going to scour the SCOTUS transcript of the recent hearing to verify this assertion of to debunk it.  I will get back to you on this.

Angelina Jolie

Angelina Jolie's courageous and moving statement about her double mastectomy:
http://www.nytimes.com/2013/05/14/opinion/my-medical-choice.html?_r=1&

Jolie's,statement includes the following:
"Breast cancer alone kills some 458,000 people each year, according to the World Health Organization, mainly in low- and middle-income countries. It has got to be a priority to ensure that more women can access gene testing and lifesaving preventive treatment, whatever their means and background, wherever they live. The cost of testing for BRCA1 and BRCA2, at more than $3,000 in the United States, remains an obstacle for many women."

Dramatic Testimony of Congresswoman Debbie Wasserman Schultz

In a provision of the America Invents Act, the U.S. Patent Office was instructed to report to Congress on genetic diagnostic testing patents, in the wake of the Supreme Court decision in Prometheus.  Several hearings were held including one in Alexandria, Virginia on February 16, 2012.  The record included dramatic video testimony by Congresswoman Debbie Wasserman Schultz:

CONGRESSWOMAN WASSERMAN SCHULTZ: Good morning, and thank you to everyone at the U.S. Patent and Trademark Office for working so hard to coordinate this public hearing today. Thank you in advance to Therese Stanek Rea, Janet Gongola, Stuart Graham, and the entire USPTO legislative team for the incredible work on which you are about to embark. I am so grateful for your attention and dedication to these vital 

questions of genetic testing, exclusive licensing, and how that affects patient outcomes. 

For all of the advocates attending today's hearing, we are so grateful for the devotion you've given to patients undergoing genetic testing throughout your careers. Your insight and commitment have been vital to developing, nurturing, and realizing the potential of genetic tests for improving medical outcomes. 

It is such a pleasure to speak with you all for the first public hearing on this important provision from the America Invents Act. I'm truly delighted that you've all dedicated yourselves to this goal, and I look forward to what the results of this study will bring. 

I'm thrilled that this study is among the first wave of America Invents Act provisions to be implemented, and that process begins with you, the USPTO, and all of the advocates and organizations participating in this hearing. Over the next several months, you have the incredible opportunity to investigate this complicated aspect of patent law in need of a 

thoughtful remedy. 

As you know, this study is the result of a provision in the patent reform law Congress passed last summer that will help engender much-needed patient protection and choice for patients undergoing genetic diagnostic tests. My hope is that this study will illuminate ways to remove patient access barriers to second opinions on genetic testing on patented genes. 

With the passage of this law, Congress is primarily interested in several important questions. For example, what impact does the current lack of independent second opinion testing have on the ability to provide the highest level of medical care to patients and recipients of genetic tests, and how does this inhibit innovation for existing tests? What would be the effect of providing an independent second opinion genetic test on existing patent and license holders of an exclusive genetic test? What impact does the current exclusive licensing and patents on genetic testing have on the practice of medicine, including but not limited to the interpretation of testing results and 

performance of testing procedures. And what is the role that cost and insurance coverage have on access to and provision of genetic diagnostic tests? 

These vital questions must be answered because of the complicated reality that we're facing today. Tests are now available for a majority of genetic disorders, such as colon cancer, Parkinson's disease, Alzheimer's disease, stroke, and many others. But in approximately 20 percent of all cases, only one laboratory can perform the tests due to patent exclusivity for the diagnostic testing, and often the actual human gene being tested. Genetic disorders that fall into this patent exclusivity area include breast cancer, Long QT, and certain neurological diseases, such as muscular dystrophy. 

I believe that the availability of a second testing procedure in these areas would have several benefits, the most important of which is that it would allow people making life-altering medical decisions based on these genetic tests to seek out an independent second 

opinion. By allowing clinical laboratories to confirm the presence or absence of a gene mutation found in a diagnostic test, we can help Americans access the second opinions they truly deserve. 

As you may know, I know firsthand the stress of wanting a second opinion but being unable to get it. Several years ago, just after my 41st birthday, I found a lump while doing a routine breast self-exam. It was cancer. Luckily, I found my tumor early and my treatment options initially were fairly straightforward. I was supposed to have a lumpectomy and radiation, and that would have been the end of the story, but an incredibly wise and thoughtful nurse educator asked the right questions about my family's health history that threw my story for a loop. 

I never would have known that as an Ashkenazi Jewish woman, a Jew of Eastern European descent, with two paternal great-aunts who had had breast cancer, that there were some significant red flags in my genetic file. I did not know that as an Ashkenazi Jew I was five times more likely to have the BRCA1 or BRCA2 genetic mutation. I did not know that carriers of that 

mutation have up to an 85 percent lifetime chance of getting breast cancer and up to a 60 percent chance of getting ovarian cancer. 

My nurse suggested that I take the BRCA test, and I could not be more grateful for her knowledge and advice. This process, however, presented a new set of challenges and questions for which no woman could ever be prepared. 

Now, as many of you know, there is only one test on the market for the BRCA mutations. The maker of this test not only has a patent on the gene itself, they also have an exclusive license for their laboratories to administer the tests. So, there is absolutely no way for someone who is questioning her genetic risk for breast or ovarian cancer to get a second opinion. 

This is intensified by the fact that for many women, the test results are inconclusive. Imagine being faced with this decision: Your genes hold the key to your survival, having major body-altering surgery could save your life, but the test results failed to give you any answers. What would you do in that situation? 

You know, you might say that I was 

lucky. My tests clearly showed that I had the BRCA2 mutation, but there was absolutely nothing I could do to question these results or receive an independent confirmatory test. So, I had no choice but to make the life-altering decision to have seven major surgeries, including a double-mastectomy and an oophorectomy from a single administration of a single test. 

Unfortunately, many women have to face this decision with even less reliable information than I had. No one should ever have to go through this experience without the comfort and the confidence of a second opinion. With so much at stake, it is incredibly important that we give everyone in this situation as much certainty as we possibly can. 

I can assure you it was devastating to me to have to make a decision that was as life-altering as a double- mastectomy and six other major surgeries without being able to confirm the results of that genetic test. We owe that much to those whose lives hang in the balance. Many of you helped shape this legislation, and now it is your task to make sure 

that your knowledge and experience can be put into practice to help save lives. 

I wish you all the best of luck in this important endeavor, and I look forward to hearing all of your ideas and suggestions. Thank you so much, again, for being here today and for your dedication to the health and wellbeing of others. Thank you. 

Gene Patenting on the Radio

On the Kojo Nnamdi Show, WAMU 88.50, yesterday, the topic was "Patenting Your DNA." discussing the Myriad case.

The following is a quote from the Kojo Show website:

"Last week, the Supreme Court heard Association for Molecular Pathology v. Myriad Genetics, Inc., a case with questions about the legality of patenting human DNA at its center. Some medical professionals say the bigger issue is Myriad Genetics' lock on a vast database of test results, essential for analyzing mutations in two sections of genetic code that can indicate increased risk of breast and ovarian cancer. A number of groups are working to replicate that and other genetic testing information in a public database. We explore the legal and ethical issues around patenting DNA.

Guests

Robert Nussbaum

Holly Smith Professor of Medicine, Chief of the Division of Genomic Medicine, and Member of the Institute of Human Genetics UCSF School of Medicine

Jorge Contreras

Associate Professor of Law, Washington College of Law, American University

Lisa Schlager

Vice President, Community Affairs for Facing Our Risk of Cancer Empowered (FORCE)"

Here is a link to the show:

http://thekojonnamdishow.org/shows/2013-04-23/patenting-your-dna

I called in to present the "kosher goldfish" position.  You may hear me about half way into the hour long broadcast.

I was answered by Ms Schlager, who agreed with my general proposition, but had a little trouble when the Holocaust was mentioned.  This is the reason why I tell the parable of the kosher goldfish.  Apparently it's "Too much salt" for many people, even Jewish people.

Article Predicts 8-1 SCOTUS will invalidate the Myriad Patents

The article in WestLawInsider predicts the SCOTUS will invalidate the Myriad patents by and 8-1 decision, with only Justice Alito dissenting:


http://westlawinsider.com/top-legal-news/fantasyscotus-are-human-genes-patentable/?action=rpx_register&rpx_collect=email&rpx_session=rpx_5176deb23ea0d8.56873958&rpx_provider=LinkedIn&redirect_to=http%253A%252F%252Fwestlawinsider.com%252Ftop-legal-news%252Ffantasyscotus-are-human-genes-patentable%252F%2523respond&rpx_username=Arthur%2BGershman&rpx_email=art.gershman%40live.com

Wall Street Journal Article

http://online.wsj.com/article/SB10001424127887324485004578424782830965300.html

Who Owns You?: Other people's bodies: a fresh perspective

Who Owns You?: Other people's bodies: a fresh perspective

The Jewish Daily Forward weighs in

The Jewish Daily Forward, which reports on all thing Jewish  has as article about gene patents in general and the Myriad case as well.  The Forward's Jewish angle is that Jewish ethics clash with gene patenting.  Anne Cohen, the author of the article, interviewed Rabbi David Teutsch, director of the Levin-Lieber Program in Jewish Ethics at the Reconstructionist Rabbinical College.  The rabbi said, “How do we provide enough profits to researchers while guaranteeing open access to the results of that research?”  Cohen's interview revealed the rabbi's analysis: "The two goals should be weighed against each other. But ultimately, Teutsch asserted, access to healing should trump private profit".  As the rabbi said: “If a very narrow interpretation of patented property rights is applied here, we’re not going to fulfill the value of maximizing healing. The desire to maximize profits should not be allowed to trump maximizing healing." The article went on to quote Arthur Caplan, perennial academic ethicist, who has apparently moved from U Penn to NYU.
Also quoted were William A. Haseltine, who is a former CEO of Human Genome Sciences, and Rebecca Eisenberg, Professor of Law at the University of Michigan, leaving us to wonder, is Hazeltine a Jewish name?

Washington Post Barrage

In what can only be called a barrage, the Washington Post trained its guns on the Myriad case and gene patents.  The shock and awe campaign's opening salvo was an Op Ed piece  titled "Who owns your DNA? Not who you think." in the print edition, and more directly on line as "The Supreme Court should invalidate the patent on human DNA." Jeffrey Rosenfeld and Christopher Mason, holding PhD's from NYU and Yale, respectively, who are professors of genomics at New Jersey and Cornell Medical Schools, respectively. were the authors.  They conclude, "It is imperative that the Supreme Court invalidate Myriad’s patent, defend genomic liberty and make clear that one’s genes belong to that person alone."
Then, in an editorial timed to coincide with the oral arguments in the case on April 15, 2013, the Post fired, "Patents on Human DNA need Congress's input."
The next day, two thirds of A2 rang out with commentary by Dana Milbank and straight reportage by Robert Barnes.  I have only one comment to make, and it's addressed to Dana Milbank: While I agree with your conclusion wholeheartedly, shame on you for making fun of Justice Sotomayor - we need the vote!

Transcript

Myriad Supreme Court Transcript:

http://www.supremecourt.gov/oral_arguments/argument_transcripts/12-398-amc7.pdf

Interesting Poll:

In anticipation of the Myriad hearing tomorrow the IPO (see pages 69-72 of my book "Other Peoples Bodies.") is having a webinar on the case on Wednesday, April 17.  On the panel will be be our own, Prof. Joshua Sarnoff, along with two bio-patent techies.
A previous webinar was held on the Prometheus case, in which the SCOTUS unanimously struck down a patent on so-called "personalized medicine."  The Myriad and Prometheus cases are closely linked.
In the wake of the previous webinar, the guiding hand behind it, Pamela Sherrid, conducted a poll with some not so surprising results: 75% of the patent professionals responding said the SCOTUS got the law wrong; 66% said they could get around the decision by clever claim drafting.  Finally, the poll asked several questions about the Myriad case.  Here's the surprise: 44% said the decision would be the same, with 41% saying the Court would take the DOJ position (See page 57 of "OPB") and, not surprisingly, only 15% saying all claims would be invalidated.  The poll is located at:
http://ipchat.biz/prometheuspoll.html

ALDF Revisited

A new opportunity has arisen to overturn ALDF v Quigg, the case testing the validity of  patents on all non-human animals.

Prolume v Gentarget et al.is outlined below:

Infringement	Court : U.S. District Court for the Southern District of California
Presided by: William Q. Hayes	Civil Action No: 3:13-cv-00130-WQH-BLM
Defendant(s) : 1. Gentarget, Inc. 2. Genprice, Inc. 3. Amsbio LLC 4. BST Scientific PTE LTD 5. Gentaur Molecular Products BVBA 6. Filgen Biosciences, Inc. 7. Does 1 through 10, Inclusive	Plaintiff(s) : Prolume, LTD. — represented by Law Offices of Philip J Kaplan; Los Angeles, CA Attorneys: Philip Jeremy Kaplan
Patent(s) in Suit :
6,232,107	Luciferases, fluorescent proteins, nucleic acids encoding the luciferases and fluorescent by Bryan et. al.
7,109,315	Renilla reniformis fluorescent proteins, nucleic acids encoding the fluorescent proteins by Bryan et. al.

The lawsuit reeks of the the "indicia of extortion."

Additionally since the patents claim animal genes (aquatic life) a defense might be the invalidity of patents for the reasons argued by ALDF against then-Commissioner Donald Quigg, supporting the Patent Office.  For details see the post on my blog: (http://www.koshergoldfish.com/ethics_of_biotechnology.html)

"Other Peoples Bodies."

http://www.lulu.com/shop/arthur-gershman/other-peoples-bodies/hardcover/product-20292057.html

GenTarget Inc, 6640 Lusk Blvd. Suite A107, San Diego, USA(858)678-8683

Interesting SCOTUS Blog post

http://www.scotusblog.com/2013/02/nothing-under-the-sun-that-is-made-of-man/

The author concludes:

" In any case, if the law’s prior treatment of human-related inventions is a reliable guide, it is likely that human gene patents will soon be history."

Watson Brief before the Supreme Court

http://www.wileyrein.com/newsroom.cfm?sp=newsreleases&id=810

The brief is at the end of the article.

Oral Argument set for Monday, April 15, 2013

     

No. 12-398 Title: Association for Molecular Pathology, et al., Petitioners v. Myriad Genetics, Inc., et al. Docketed: October 1, 2012 Lower Ct: United States Court of Appeals for the Federal Circuit   Case Nos.: (2010-1406)   Decision Date: August 16, 2012 Questions Presented ~~~Date~~~  ~~~~~~~Proceedings  and  Orders~~~~~~~~~~~~~~~~~~~~~ Sep 25 2012 Petition for a writ of certiorari filed. (Response due October 31, 2012) Oct 3 2012 Consent to the filing of amicus curiae briefs, in support of either party or of neither party, received from counsel for the petitioners. Oct 24 2012 Brief amici curiae of National Women's Health Network, et al filed. Oct 26 2012 Brief amicus curiae of Academics in Law, Medicine, Health Policy and Clinical Genetics filed. Oct 30 2012 Brief amicus curiae of AARP filed. Oct 30 2012 Brief amici curiae of Cancer Council Australia, et al. filed. Oct 31 2012 Brief of respondents Myriad Genetics, Inc., et al. in opposition filed. Oct 31 2012 Brief amici curiae of Kali N. Murray and Erika R. George filed. Oct 31 2012 Brief amici curiae of Canavan Foundation, et al. filed. Oct 31 2012 Brief amici curiae of American Medical Association, et al. filed. Nov 9 2012 Reply of petitioners Association for Molecular Pathology, et al. filed. Nov 13 2012 DISTRIBUTED for Conference of November 30, 2012. Nov 30 2012 Petition GRANTED limited to Question 1 presented by the petition. Jan 2 2013 Consent to the filing of amicus curiae briefs, in support of either party or of neither party, received from counsel for the petitioners. Jan 3 2013 The time to file the joint appendix and petitioners' brief on the merits is extended to and including January 24, 2013. Jan 3 2013 The time to file respondents' brief on the merits is extended to and including March 7, 2013. Jan 24 2013 Joint appendix filed. (2 volumes) Jan 24 2013 Brief of petitioners Association for Molecular Pathology, et al. filed. Jan 28 2013 Brief amicus curiae of Juhasz Law Firm, P.C. in support of neither party filed. Jan 29 2013 Brief amici curiae of American Medical Association, et al. filed. Jan 30 2013 Brief amici curiae of GeneDx and Law Professors filed. Jan 30 2013 Brief amici curiae of National Women's Health Network, et al. filed. Jan 30 2013 Brief amicus curiae of Federation Internationale Des Conseils En Propriete Intellectuelle in support of neither party filed. Jan 31 2013 Brief amicus curiae of CLS Bank International in support of neither party filed. Jan 31 2013 Brief amicus curiae of United States in support of neither party filed. Jan 31 2013 Brief amici curiae of International Center for Technology Assessment, et al. filed. Jan 31 2013 Brief amicus curiae of Genformatic LLC filed. Jan 31 2013 Brief amici curiae of Academics in Law, Medicine, Health Policy and Clinical Genetics in support of neither party filed. Jan 31 2013 Brief amicus curiae of James D. Watson, Ph.D. in support of neither party filed. Jan 31 2013 Brief amici curiae of Fifteen Law professors filed. Jan 31 2013 Brief amicus curiae of Sigram Schindler Beteiligungsgesellschaft mbH in support of neither party filed. Jan 31 2013 Brief amicus curiae of AARP filed. Jan 31 2013 Brief amici curiae of Kali N. Murray and Erika R. George filed. Jan 31 2013 Brief amicus curiae of Institute of Professional Representatives Before the European Patent Office (EPI) in support of neither party filed. Jan 31 2013 Brief amici curiae of Ethics & Religious Liberty Commission of the Southern Baptist Convention and Prof. D. Brian Scarnecchia filed. Jan 31 2013 Brief amicus curiae of Eric S. Lander in support of neither party filed. Jan 31 2013 Brief amicus curiae of American Intellectual Property Law Association in support of neither party filed. Jan 31 2013 Brief amici curiae of Canavan Foundation, et al. filed. Jan 31 2013 Brief amicus curiae of Professor Eileen M. Kane filed. Jan 31 2013 Brief amicus curiae of Knowledge Ecology International filed. Jan 31 2013 Brief amicus curiae of InVitae Corporation filed. Feb 11 2013 SET FOR ARGUMENT ON Monday, April 15, 2013 Feb 14 2013 CIRCULATED