Saturday, October 26, 2013

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)

Friday, September 20, 2013

"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.

                                                                ...

Thursday, September 19, 2013

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.

Thursday, July 18, 2013

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." 

Friday, July 12, 2013

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