drew l. kershen earl sneed centennial professor of law ieosa at whitetail, idaho june 24, 2008...
TRANSCRIPT
Drew L. KershenEarl Sneed Centennial Professor of LawIEOSA at Whitetail, IdahoJune 24, 2008Copyright 2008, Drew L. Kershen – all rights reserved
Patents Antitrust
Brief comments Liability
Some comments Environmental/Administrative
Focus Coexistence
Patents: two strands Company v
Company Patent validity Licensing
Company v Farmer Infringement Saved seed issue Monsanto Canada v.
Schmeiser
Antitrust: two strands Direct allegations of
actions in restrain of trade
price fixing Defense in
infringement cases Technology use
agreements Pricing in other
countries Unsuccessful
In re StarLink Corn Prods. Liab. Litig., 212 F. Supp.2d 828 (N.D. Ill. 2002) Corn approved for feed not food Physical intermingling – adulterated food EPA refused exemption or tolerance
Concerns about allergic reactions None confirmed Administrative failure
Settlement of $ 110 million; $ 2 billion total
Sample v. Monsanto, 283 F. Supp.2d 1088 (E.D. Mo. 2003) Unapproved in EU export market corn &
soybean traits – fully approved in the U.S. and other export markets
Claim for “pure” economic loss No proof of physical intermingling Did not reach issue: if physical
intermingling, is loss of an export market “damages” in law?
Hoffman & Beaudoin v. Monsanto Canada, 2005 SKQB 225, aff’d on appeal 2007 SKCA 47, leave for appeal dismissed Sup. Ct. Canada Loss of EU market; Loss of opportunity to grow
organic canola Broad range of common law (trespass, nuisance,
negligence) – dismissed Economic loss doctrine precludes claims One provincial environmental claim allowed Class action rejected – appeal on the class action
issue, case is now final
In re LL601 Rice litigation (2007) Approved field trials of transgenic rice Intermingled into seed supply – two varieties
14 month USDA investigation – undetermined Economic losses arising from
Disruptions to export market (EU, Mexico, Philippines) Loss of seed varieties
Still in preliminary, procedural stages; no substantive rulings
Strikingly similar to claims made in Sample v. Monsanto and Hoffman & Beaudoin v. Monstanto Canada
Environmental/Administrative
Foundation on Economic Trends v. Heckler, 756 F.2d 143 (D.C. Cir. 1985) Against NIH approval of “frost-minus” transgenic
bacteria National Environmental Protection Act (NEPA)
challenge Rigorous Environmental Assessment (EA) required for
this particular experiment – possible dispersion Refused request for Programmatic Environmental Impact
Statement (EIS) on all transgenic experiments Concurring Judge – the NIH had done three EAs but
should put them altogether so as to “not only ease lay concerns, but facilitate [judicial] review as well.”
Environmental/Administrative
Foundation on Economic Trends v. Block, 1986 WL 5156 (D.D.C. 1986) USDA basic research in
animal productivity NEPA – adverse impact of
genetic engineering and industrial agriculture
Judge Richey wrote, “NEPA requires predictions but not prophecy, and impact statements ought not to be modeled upon the works of Jules Vernes or H.G. Wells.”
Foundation on Economic Trends v. Johnson 661 F. Supp. 107 (D.D.C. 1986) Coordinated Framework for
Regulation of Biotechnology from Office of Science and Technology
NEPA and Administrative Procedures Act (APA)
Abstract speculation about what federal agencies may do in the future – no case or controversy
Environmental/Administrative
Foundation on Economic Trends v. Lyng, 680 F. Supp. 10 (D.D.C. 1988) USDA license for pseudorabies vaccine
containing genetically altered virus Virus-Serum-Toxin Act and NEPA USDA prepared EA, not EIS – not an
arbitrary and capricious major action
Environmental/Administrative
Stauber v. Shalala, 859 F. Supp. 1179 (W.D. Wisc. 1995) Recombinant bovine growth hormone (rBGH) FDA decision to allow and to not require label –
FDA prepared EA, not EIS – NEPA challenge Second look under NEPA after FDCA approval – not
required Laws “do not contemplate an independent
consideration of socioeconomic effects when there is no determination that the proposed agency activity will significantly effect the environment.”
FDA had not acted arbitrarily and capriciously
Labeling/First Amendment
International Dairy Foods Ass’n v. Amestoy, 92 F.3d 67 (2nd Cir. 1996) Challenge by Monsanto of Vermont statute
requiring warning label on milk from cows treated with rBGH
Mandatory state label violates First Amendment – freedom from being forced to speak
No health or safety concerns – consumer fears (alleged) insufficient reason to support the law
Environmental/Administrative
Alliance for Bio-Integrity v. Shalala, 116 F. Supp.2d 166 (D.D.C. 2000) FDA policy on food improved by modern
biotechnology (genetically modified food) Presumption of substantial equivalence (GRAS) Use same procedures as for all other foods No label needed or allowed under FDCA statute
NEPA challenge – FDA did not prepare EA or EIS Ruled that NEPA does not apply to policy; applies
only to “major federal action” Process by which a food is made is not a “material
fact” for statutory requirements related to labeling
Environmental/Administrative
International Center for Technology Assessment v. Leavitt, 468 F. Supp.2d 200 (D.D.C. 2007) (actually third decision) FDA decision not to regulate transgenic
zebra fish for recreational aquariums – Glofish
NEPA and ESA challenges FDA policy (inaction) is not major action FDA did not act arbitrarily and capriciously
Environmental/Administrative
Center for Food Safety v. Johanns, 451 F. Supp.2d 1165 (D. Haw. 2006) APHIS permit to conduct field trials for genetically-
engineered pharmaceutical-producing plant varieties NEPA and ESA challenge – APHIS did not prepare either an
EA or an EIS Programmatic study of GEPPV Ruled that granting a permit is a major federal action
requiring EA or EIS for specific permits NEPA and ESA do not apply to GEPPV policy development –
APA applies as developed Declaratory relief – the permits had already expired
Court had ruled in an earlier judgment that the issues were not moot
Environmental/Administrative
International Center for Technology Assessment v. Johanns, 473 F. Supp.2d 9 (D.D.C. 2007) APHIS permits for field trials of RR creeping bent grass – test
completed in 2003 [Scotts Miracle-Gro Company has petition to deregulate (not
at issue in this case)] Plant Pest Act (noxious weed) and NEPA Remanded for noxious weed determination; species level,
not variety level, is appropriate Notification and acknowledgment -- Categorical exclusions,
but regulatory exceptions to the categorical exclusions Ruled APHIS acted arbitrarily and capriciously by not
explaining exceptions to field trial permits – permanent injunction as to permits for field trials until exceptions addressed that could lead to EA or EIS
Environmental/Administrative
Geertson Seed Farms v. Johanns, 2007 WL 518624 (N.D. Cal. 2007) APHIS used EA in determination of deregulation of
RR alfalfa NEPA challenge to EA Ruled APHIS acted arbitrarily and capriciously by
not considering in the EA Economic and social impacts, particularly organic
farming Cumulative effect of glyphosate-resistant weeds
Reversed deregulation; granted permanent injunction against future planting
On appeal
Environmental/Administrative
Center for Food Safety v. Connor, pleadings filed N.D. Calif. Jan. 23, 2008 RR sugar beets – 50% planted this year; estimate for 2009
of 90% in the field for processing Lawsuit is very similar to Geertson Seeds case about RR
alfalfa – same claims and same relief sought Focus not on fields, but on sugarbeet seed production –
claims related to seed purity of table beets and chard, particularly organic
Preliminary procedural stages Scheduling conference on August 8 Motions to Intervene by Forage Genetics, Monsanto, American
Sugarbeet Growers Ass’n, and other industry groups to support APHIS decision to deregulate
Coexistence
Scientific studies about pollen flow, volunteers, and seed purity
Willamette Valley Specialty Seed Crop Association
Zero tolerance Organic Standards Consumer demands Export Markets Boulder Colorado Coexistence guidelines
Coexistence
Good agronomic practices Neighborly attitudes Farmer choice
Review of the cases – Their meaning Their implications
Concluding Quotation
In 1985, Senior Circuit Judge MacKinnon wrote in a concurring opinion in the Heckler case :
“The Foundation’s conduct also has delayed this vital experiment … The use of delaying tactics by those who fear and oppose scientific progress is nothing new. It would, however, be a national catastrophe if the development of this promising new science of genetic engineering were crippled by the unconscionable delays that have been brought about by litigation using [NEPA] and other environmental legislation …” Foundation on Economic Trends v. Heckler, 756 F.2d 143, 161 (D.C. Cir. 1985)