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