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Drew L. Kershen Earl Sneed Centennial Professor of Law IEOSA at Whitetail, Idaho June 24, 2008 Copyright 2008, Drew L. Kershen – all rights reserved.

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Presentation on theme: "Drew L. Kershen Earl Sneed Centennial Professor of Law IEOSA at Whitetail, Idaho June 24, 2008 Copyright 2008, Drew L. Kershen – all rights reserved."— Presentation transcript:

1 Drew L. Kershen Earl Sneed Centennial Professor of Law IEOSA at Whitetail, Idaho June 24, 2008 Copyright 2008, Drew L. Kershen – all rights reserved

2  Patents  Antitrust  Brief comments  Liability  Some comments  Environmental/Administrative  Focus  Coexistence

3  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

4  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

5  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?

6  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

7  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

8 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.”

9 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

10 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

11 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

12 Labeling/First Amendment  International Dairy Foods Ass’n v. Amestoy, 92 F.3d 67 (2 nd 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

13 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

14 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

15 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

16 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

17 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

18 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

19 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

20 Coexistence  Good agronomic practices  Neighborly attitudes  Farmer choice  Review of the cases –  Their meaning  Their implications

21 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)

22 dkershen@ou.edu


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