Protection for Genetically Modified Organisms
If a patent holder has the right to stop someone who “[m]akes, uses, offers to sell, or sells”1 her product, what happens when her product runs away and starts making itself?
In 1980, the Supreme Court of the United States contemplated in Diamond v. Chakrabarty2 whether genetically modified organisms (GMOs) constitute patentable subject matter under 35 U.S.C.A. § 101. Plaintiff’s developed microorganism was able to decompose crude oil (good for oil spills); plaintiff filed patents for method, inoculum and bacteria. The patent examiner approved the first two claims, but denied the third on the rationale that micro-organisms are products of nature which, as living things, are not patentable under §101. In a landmark decision, the Chakrabarty Court ruled that products of human ingenuity “having a distinctive name, character [and] use” were deemed patentable subject matter and proper subjects of utility patents. Previously, only natural substances purified from non-plant life were patentable, like insulin.3
Chakrabarty inherently demonstrates that the controversy around the patentability of living organisms. Many people find it immoral to own life-forms. More recently, some worry that in the future a patentee will own other people’s genetic code.4 But, the real wonder is about the feasibility of patenting self-reproductive life. What happens when, for example, Chakrabarty’s organisms get loose in the environment and start eating up oil spills all over the world? Does his right to exclusion stay intact after he loses control of his patented product? Now that patents on living organisms are commonplace in the U.S., what is the scope of ownership and how do we deal with infringement? Specifically, does it make sense to, under strict liability, punish people who accidentally infringe when the patented subject matter is itself self-reproducing and does not have the mental capacity to refrain from reproduction?
Predictably, the last decade has already seen this problem beginning in the plant world: “genetic drift” is the contamination of one farmer’s crops by the genetically modified seeds of another farmer’s crops, most likely the result of pollination via wind, insects or animals. For instance, in 2001, a Minnesota farming couple, the Fitzgeralds, was impacted by genetic drift when a neighbor’s corn crop grew in their own field despite a plethora of precautions. The Fitzgeralds had hoped to increase profits by growing organic, non-GMO corn. When their neighbors’ genetically modified corn showed up in 800 bushels, they lost close to $2,000 in organic profits.5
It is notable that the plant world is facing this problem because the Chakrabarty court partially came to its decision by inferring that Congress understood living things to be patentable from the 1930 Plant Patent Act (PPA) and the 1970 Plant Variety Protection Act (PVPA). Both acts afford patent-like protection to certain kinds of plants; the PPA is confined to asexually reproduced plants, and the PVPA to sexually reproduced plants. Though the Board of Patent Appeals finally extended patentability from micro-organims to plants in 1985,6 and to organisms, or non-human animals, in 1987,7 the PVPA still exists and is used. Protection under the PVPA is easier to obtain because there are no nonobviousness or enablement requirements as in the Patent Act. The downside to the PPVA, however, is that it grants several exceptions to infringement actions including a farmer’s exemption.8 This exemption acknowledges the fact that plants are self-reproducing, and that once a breeder has sold her protected seed, the farmer never need buy the seed from her again. The exemption allows farmers to continue using the new seeds he has farmed for his own planting purposes, but he may not sell the seeds for further planting. (He could, for example, sell them as feed.)9
Thus, under the patent act and under the PVPA, the Fitzgeralds could have been sued for infringement for the “use” of these genetic seeds. The only completed case so far on such an issue was in Canada: in 1998, Monsanto, the licensee and owner of a “patent that discloses the invention of chimeric genes that confer tolerance to glyphosate herbicides such as Roundup,” sued Schmeiser, a seventy year old Canadian farmer, for infringement because while hehad never purchased nor licensed Roundup Ready canola, his 1998 canola crop was 95-98% Roundup Ready Canola.10 In March 2001, the Supreme Court of Canada ruled that Schmeiser violated Monsanto’s patent because he “used” the patented cell and gene by growing the canola. Schmeiser argued that “‘propagation of Roundup Ready Canola without a license cannot be a ‘use’ by them because plants are living things that grow by themselves,’ rather than through human intervention…. [but the Court] rejected this interpretation because farming involves abundant human intervention.”11 In an unexpected twist, the subsequent appeal overruled the infringement in light of a more recent case that had deemed higher life forms, including plants, non-patentable subject matter; the court followed that no one can “acquire patent protection over whole plants,” and confined the scope of Monsanto’s patent to the engineered genes and cells outside of an organism that contain those genes.12
However, the Canadian court’s new ruling is not the consensus the United States. Patents protect inventions, and anything embodying that invention without consent infringes the inventor’s protection. So it seems that right now, strict liability holds, and the growth of a non-licensed GMO is inherently infringement. For example, an animal made up of cells containing patented engineered genes, like a a cow engineered to produce sweeter milk – and all of its offspring that have (not necessarily express) the sweet-milk gene, is covered by the patent.
Many commentators have called on Congress to more clearly define what constitutes infringement when reproduction can occur. Some suggest a rule regulating the reproduction of animals, along with an exemption similar to the PPVA’s exemption for farmers.13 Yet in all of this, it seems that hardly anyone is asking why a patent-holder should continue to hold onto a patent or protection that he has lost complete control over. What happens when genetically modified animals go wild, or engineered crops take over entire geographical regions? Perhaps when GMOs are “lost,” adverse possession should kick in. Congress should clarify infringement for self-reproductive organisms, but they should revisit patent policies. They should keep in mind that patents are meant to encourage development and competition, but this process is unfairly skewed towards large corporations when their GMOs take over small farmer’s crops, as in the Monsanto case described above.
What’s next? Could a patent owner start suing states, or even countries, for constructive possession over his self-reproducing genetically modified animals?
1 35 U.S.C. § 271(a) (2003).
2 447 U.S. 303 (1980).
3 See Parke-Davis v. H.K. Mulford, 196 F. 496 (2d Circ 1912) (holding that both the process of purifying and the actual purified chemical substance of adrenaline are patentable).
4 Donna M. Gitter, Led Astray by the Moral Compass: Incorporating Morality into European Union Biotechnology Patent Law, 19 Berkeley J. Int’l L. 1 (2001). See also, Daniel R. Heimbach, Religious, Philosophical, And Ethical Perspectives On Cloning: Cloning Humans: Dangerous, Unjustifiable, And Genuinely Immoral, 32 Val. U.L. Rev. 633, (1998); Rev. Phillip C. Cato, Ph.D., Engineering Eden: Investigating The Legal And Ethical Dilemmas Of Modern Biotechnology: The Hidden Costs Of Fertility, 20 St. John’s J.L. Comm. 45 (2005).
5 See Anthony Shadid, Genetic Drift Threatens US Organic Farmers, BOSTON GLOBE, April 8, 2001, at G1.
6 See Ex parte Hibberd, 227 U.S.P.Q. 443 (1985).
7 See Ex Parte Allen, 2 U.S.P.Q.2d 1425 (1987).
8 Jim Chen, The Parable Of The Seeds: Interpreting The Plant Variety Protection Act In Furtherance Of Innovation Policy, 81 Notre Dame L. Rev. 105, 125 (2005).
9 Thomas Zeleny, Property Rights In Living Things: Difficulties With Reproduction And Infringement, 2 San Diego Justice J. 209, 212 (1994).
10 Monsanto Canada Inc. v. Schmeiser,  1 S.C.R. 902, 2004 SCC 34, para. 58 (Can.)
11 Dr. Andrew W. Torrance, Metaphysics And Patenting Life, 76 UMKC L. Rev. 363, 401 (2007).
12 Monsanto Canada Inc. v. Schmeiser,  1 S.C.R. 902, 2004 SCC 34.
13 Zeleny, supra note 9, at 231-36.
14 Id. at 236 (acknowledging the inevitability of genetically modified animals gone wild, but lacking a solution).