“OMG - It’s the GMOs!”
A Year of Breaking News in Biotech Controversies
November 18, 2014
Presenter: Panda Kroll, Chair, Ventura County Bar Association Bioethics Section
Sponsors: Intellectual Property/Technology Business Section
and In-House Counsel & Corporate Law Section of the SBCBA
Other VCBA Ethics, Culture & Biotechnology Presentations:
11/8, Saturday 3 pm, OJAI LIBRARY "Culture, Food, & Biotechnology - An Anthropological
Perspective on the GMO Controversy” (Angela Kirwin, MA Anthropology)
11/9 Sunday 3 pm, E.P. FOSTER LIBRARY (Ventura) “Are GMOs Kosher? - A Biblical
Perspective " (Rabbi Elihu Gevirtz)
11/16 Sunday 3 pm, E.P. FOSTER LIBRARY (Ventura) "Our Innate Cognitive Biases - How
Emotion and Tribalism Divide Us and How to Avoid Bias, Prejudice and Hype"
(Tom Krause, PhD Psychology)
12/13 Saturday 3 pm, OJAI LIBRARY "What Do We Mean When We Talk About 'Nature'?
A Catholic Perspective” (Karen Zedlick, PhD Theology)
12/14 Sunday 3 pm, E.P. FOSTER LIBRARY (Ventura) "GMO Label Legislation and the Court
of Public Opinion" (Panda Kroll, JD / MFA Media)
Let’s Romp Through A Year of Headlines
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April 2013 FDA Tentatively Approves First GE Animal For Food
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AquaBounty’s AquaAdvantage Salmon: “Frankenfish” or Food for the Masses?
Trader Joes, Whole Foods, Kroger’s Responds: We Won’t Carry It
May 2013 SCOTUS: Farmer Bowman Can’t Replant GE Seeds
June 2013 SCOTUS: “Is DNA Patentable? Yes, and No.”
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Angelina Jolie, Steven Colbert on ACLU v. Myriad
Progeny of Diamond v. Chakrabarty: “Are Life Forms Patentable?”
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Sep 2014
Nov 2013
Jan 2014
Monsanto settles “GE drift” litigation (wheat farmers)
FDA x’s 23andMe Direct-to-Consumer DNA Kits
OSGATA v. Monsanto - SCOTUS denies review of Non-GMO Farmers
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May 2014
Vermont 1st to Pass “Right to Know” GMO Label Law
unsuccessful suit for Declaratory Relief re: patent enforcement (Organic Seed Growers v. Monsanto)
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Grocers/dairy farmers sue to invalidate (unconstitutional compelled speech, etc.)
Nov 2014
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Maui County passes GMO cultivation ban (referendum)
Monsanto/Dow sue to invalidate (preemption, dormant commerce clause)
Also: Aug 2013 - Pepsi (Naked Juice) Pays $9M in “All-Natural,” “GMO-Free”
Label Fraud Class Action Settlement - FDA refuses to define “natural”
A Closer Look
 Part I Biomedical Controversies
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Public Policy re: Patentability of Our DNA - ACLU v. Myriad (SCOTUS)
Direct to Consumer DNA Diagnostic Test – FDA halts “23andMe” DNA Kit
 Part II Farm Wars – Agricultural Biotech
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No Patent Exhaustion re: GE Seeds – Bowman v. Monsanto (SCOTUS)
No Dec Relief re Non-Infringement – OSGATO v. Monsanto (CAFC)
Big $$$ Class Action Gene Drift Cases – “Tractor-Chasing Lawyers”
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(based on cost to test for GE contamination, conventional/GMO co-existence issues)
 Part III Food Fight – The Year of the Label
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GE label law passed in VT (and in CT, ME – with a hitch): EXPECT A FIGHT
AquaBounty’s Struggle to Commercialize GE Salmon (FDA tentative “ok”)
“All Natural” class action label litigation – FDA refuses to opine on “natural”
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Consumers will pay for organic, non-GMO; “ingredients you can see and pronounce”
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First Edgy Video - Colbert Report
Formula 01 Liquid Genetic Material
3:14
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“My chances dropped from 87% to
under 5%.”
ACLU v. Myriad
US Supreme Ct (2013)
April 2013 – Oral
argument: Both sides
play “promote
research” card
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May 2013 - Jolie
announces
prophylactic double
mastectomy, after
taking Myriad’s $3,000
test.
(12% carry gene)
June 2013 – SCOTUS
ruling: No, unless …
Both sides most likely agree with ACLU statement in cert petition:
 “The question of whether human genes and the information they
convey are patentable is of paramount importance to the future of
patent law, the advancement of medical science, and the health of
patients.”
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The Court focused on Diamond v. Chakrabarty, 447 U.S. 303 (1980):
“[p]roducts of nature are not created, and manifestations…of nature
[are] free to all men and reserved exclusively to none”
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Justice Thomas (SCOTUS unanimous opinion): “As the first party with
knowledge of the [BRCA1 and BRCA2] sequences, Myriad was in an
excellent position to claim applications of that knowledge.”“
Presentation by Panda Kroll, Esq.
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In the Beginning:
Diamond v. Chakrabarty (1980)
5-4: Patent Granted. C.J. Burger: Congress intended patentable subject
matter to "include anything under the sun that is made by man,“
even living things (GE bacterium capable of breaking down crude oil)
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Diamond v. Chakrabarty (1980)
first SCOTUS biotech patent case
“Grave risks … a gruesome parade of horribles. Scientists, among
them Nobel laureates, are quoted suggesting that genetic research
may pose a serious threat to the human race or, at the very least,
that the dangers are far too substantial to permit such research to
proceed apace at this time.
We are told that genetic research and related technological
developments
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may spread pollution and disease,
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may result in a loss of genetic diversity, and
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may tend to depreciate the value of human life.
These arguments are forcefully, even passionately, presented; they
remind us that, at times, human ingenuity seems unable to control
fully the forces it creates - that, with Hamlet, it is sometimes better
"to bear those ills we have than fly to others that we know not of.”…
It is argued that this Court should weigh these potential hazards in
considering whether respondent's invention is patentable subject
matter under 101. We disagree.
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[L]egislative or judicial fiat as to patentability will not deter the
scientific mind from probing into the unknown any more than
Canute could command the tides.”
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Part II: Farm Wars
Second Edgy Video: anti-GMO cartoon
Urban myths v.
Armani lobbyists
Where are citations to peerreviewed studies?
Get ready to be a social pariah,
regardless of how you roll
Biotech is controversial!
6:12
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DNA Drift = $.75B “Nuisance”
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2011 – $750M settlement to 11,000 farmers in class action
v. Bayer CropScience (extensive rice contamination)
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Damages: trade partners (Japan, EU) refuse to purchase; zero tolerance for GMO
Cost of testing; destruction of crops; containment – regain export customer trust
“What caused the loss of the market? The contamination … (Bayers lawyers) said everybody to
blame except Bayer…even a duck. I don’t know if it was the same duck, but he sure was busy.”
2013 – “tractor-chasing lawyers” file class actions (KS/ID/WA/OR) (MT ?!)
v. Monsanto (isolated wheat contamination - no GE wheat in commerce)
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Single plot in a single farm in OR exhibiting GE trait (RoundUp Ready) – TODAY, Montana farm
Abandoned wheat experiment, Monsanto “closed out” in 2001
Farmers seek compensatory and punitive money damages and an order that Monsanto
decontaminate all real estate, buildings and equipment;
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Negligence per se for violating federal crop protection laws;
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Negligence in breaching the duty to keep its GMO seeds isolated;
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Public and private nuisance;
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Strict liability for releasing a
"defective & unreasonably dangerous product;“ and
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Conversion or willfully interfering with the property of others.
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Bowman v. Monsanto
 Vern Bowman is ADORABLE
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Farmer Bowman: “75-year old eccentric bachelor,” “loyal Monsanto customer”
Bought commodity seeds from silo, late harvest, not under license
SCOTUS (May 13, 2013 - Kagan) – rejects patent exhaustion defense
seeds are self-replicating tech; Can’t save and replant; must repurchase
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Part III
Food Fight: “Right to Know?”
May
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8, 2014:
Vermont 1st to pass GMO label law
CT, ME: adoption conditional
Fight brewing re: preemption,
1st Amendment “right not to speak”
GMA has sued, VT AG: “Bring It.”
2013-2014:
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$4M settles Kashi class action
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$9M Naked Juice (Pepsi)
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Dozens of “All-Natural,” “GMO-Free”
label fraud actions - FDA declines to
define “natural”
Consumers will pay more for nonGMO “ingredients you can see and
pronounce”
Booming organic industry – but only
few can afford. Note organics don’t
love “non-GMO” labels – not poor
man’s organic.
Aquabounty AquaAdvantage
GE Salmon
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April 2013 – FDA Notice & Comment period concluded, “tentative approval”
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Application pending since 1995
Revolutionary: first GE animal for human consumption
Safeway, Target, Whole Foods, Kroger and Trader Joe's WILL NOT STOCK
Political hot potato – Jurassic Park, “Frankenfish”
Sept 2014– Gov. Brown signed law protecting CA’s native steelhead trout and salmon
populations by banning commercial spawning of GE salmon
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Take Home Messages
 The Year of the Label
 Right to Know v. Right Not to Speak
 GE fish could mobilize US consumers v. GE foods
 Biomedical Innovation – ACLU v Myriad
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SCOTUS: must add inventive steps, not merely isolate DNA
“Previvors,” public health community activism
 Ag Biotechnology - liability re: DNA drift
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Global markets are divergent:
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EU/Japan/Korea demand GE/GMO-FREE, zero tolerance
FDA, WHO, AMA & 1,000’s of studies suggest GE food is safe
Precautionary Principle: burden of proof
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Can’t get enough?
 Best Bio Book for Non-Nerds
 The Immortal Life of Henrietta Lacks (HeLa)
 For Nerds:
 subscribe to listserv GENET-news
 http://www.genet-info.org
 Challenge yourself:

The Double Helix: Dr. Watson’s intimate first-person
account of the race to discovery of DNA’s structure
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