genetics Archives - IPOsgoode /osgoode/iposgoode/tag/genetics/ An Authoritive Leader in IP Mon, 18 Mar 2013 17:15:51 +0000 en-CA hourly 1 https://wordpress.org/?v=6.9.4 Bowman v. Monsanto and Patent Exhaustion: To Be, or Ought to Be? /osgoode/iposgoode/2013/03/18/bowman-v-monsanto-and-patent-exhaustion-to-be-or-ought-to-be/ Mon, 18 Mar 2013 17:15:51 +0000 http://www.iposgoode.ca/?p=20439 More of a cautionary winter's tale than a midsummer night's dream, an Indiana farmer facing legal action from a certain biotech and chemical multinational behemoth recently reached the U.S. Supreme Court. The case is called Bowman v. Monsanto, and with all that hangs in the balance, a herbicide-resistant rose by any other name would, in […]

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More of a cautionary winter's tale than a midsummer night's dream, an Indiana farmer facing legal action from a certain biotech and chemical multinational behemoth recently reached the U.S. Supreme Court. The case is called , and with all that hangs in the balance, a herbicide-resistant rose by any other name would, in fact, smell as sweet (to the victor).

By most if not all - ()()(), the Court showed little sympathy for Bowman's position, appearing prepared to uphold in favour of Monsanto and patent rights-holders. While one could not contradict the Court on applying current law, there seemed to be an unacknowledged tension running through the hearing, between applying the law as it is and questioning what it ought to be in the face of unprecedented situations in patent law and related intellectual property issues.

I. Prologue: “Two parties, unalike in privity...”

Enter the facts. Monsanto sells certain types of soybean (and other) seeds with a patented gene that makes them resistant to Roundup, a Monsanto herbicide. Farmers who buy seeds from Monsanto must sign a contract binding them to using the seeds only once; they cannot plant seeds descended from the bought seeds. However, Monsanto allows farmers to sell, under no special conditions, descendant seeds to grain elevator mixtures. Bowman bought and planted such a mixture and harvested seeds from the plants that survived Roundup spraying, which indicated they were resistant.

The central issue of the case is whether or not Bowman planting descendants of the original seeds he bought constitutes patent exhaustion. Does Monsanto's patent reside only in the first generation of seeds sold to farmers, or does it reside in all seeds with the Roundup-resistant gene, including those grown into existence after sale?

II. Submission for Monsanto: “Justice! the law! my dockets, and my patents!”

Monsanto argues that if withers with the first sale of seeds alone, then the patent would quickly cease to have effect as all buyers could easily grow their own seeds from saved ones every year, instead of having to buy more from Monsanto. This, Monsanto contends, would “devastate innovation in biotechnology”. According to Monsanto, patent exhaustion does not include a right for the buyer to make unlimited copies of the sold item. Intervenors such as the added that patent exhaustion does not apply at all, as the new seeds are “new articles of manufacture”.

At the hearing, the justices raised challenges such as whether a Monsanto-favouring decision would have “the capacity to make infringers out of everybody”, due to the fact that Monsanto holds a near-total monopoly over soybean seeds, and due to events such as patented seeds into the fields of other farmers. The latter issue is particularly in light of .

III. Submission for Bowman: “Fare you well; your suit is cold.”

According to Bowman, Monsanto's first sale of the seeds exhausts the patent, and that's all there is to it; the buyer may do anything they like with the item after that. In perhaps a patent version of the thin-skull rule (obvious foreseeability notwithstanding), Bowman's argument implies that it's simply unfortunate Monsanto's patent happens to reside in something that is self-replicating and thus patent-undermining ; that is the liability one assumes with living organisms. Both Bowman and Monsanto claim that the other is asking the Court to carve out an exception in their favour.

Counsel for Bowman received a , with the justices actively putting him on the defensive regarding issues such as: the potential destruction of Monsanto's and similar patents flowing from a decision for Bowman; the inadequacy of contracts to replace patent protection; farmers' rights (or lack thereof) to exploit the self-replicating nature of seeds to go around Monsanto's patent; how frequent a practice it is for farmers to use grain elevator seeds for crops (and thus how severely an adverse decision would impact them); and whether or not counsel was mischaracterizing Monsanto's claim.

IV. Epilogue: “The course of true law never did run smooth.”

As mentioned, this case has the potential to set off trajectories in IP law far beyond what farmers may do with soybean seeds, and perhaps calls for more than straightforward application of existing law. First, the tellingly acted as intervenor for Monsanto, fearing a decision for Bowman could set a precedent applicable to and copyright. Multiple parties strengthened this nexus by citing (about making disk copies in a jurisdiction abroad),and some have extended this connection to include cell lines and DNA used in medical research, not to mention .

Second, Monsanto argued that “size has never been thought to affect the contour of patent rights”. With anti-competition concerns such as and , however, the Court might consider whether size should, in fact, matter. Urgency arises in view of the fact that 93 percent of American-farmed soybeans (along with nearly 90 percent of both cotton and corn) were genetically engineered in 2010, according to a by , intervenor for Bowman.

Third, the justices consistently challenged Bowman on the idea that biotechnology patents should be exhausted on first sale in the case of . Justice Ginsburg asked, “Where is that in the law?” The problem here is that with the biotechnology in question, self-replication is the biology, not the technology; Monsanto did not invent photosynthesis. Current patent law as the Court seems poised to interpret it, however, treats the seeds and buyers as if Monsanto did.

Justice Ginsburg is correct in that Bowman's position is not in the law—and perhaps it . We can only hope that after having the various high stakes involved, the Court will hand down a decision that more fully speaks to the of whether or not, and how, it ought to be.

Cynthia Khoo is a JD Candidate at the University of Victoria.

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The Patentability of Gene Sequences: Myriad Genetics’ Day in the United States Supreme Court /osgoode/iposgoode/2012/07/02/the-patentability-of-gene-sequences-myriad-genetics-day-in-the-united-states-supreme-court/ Tue, 03 Jul 2012 02:21:29 +0000 http://www.iposgoode.ca/?p=17244 In late March, The United States Supreme Court ordered the U.S Court of Appeal for the Federal Circuit to reconsider Myriad Genetics’ existing patent on two genes associated with a high risk of breast and ovarian cancer, in light of the judgement rendered in Mayo Collaborative Services v Prometheus Labs (Prometheus). A unanimous Supreme Court […]

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In late March, The United States Supreme Court the U.S Court of Appeal for the Federal Circuit to reconsider Myriad Genetics’ existing patent on two genes associated with a high risk of breast and ovarian cancer, in light of the judgement rendered in (Prometheus). A unanimous Supreme Court in Prometheus held that the patent sought by Prometheus for the personalized medicine dosing process was ineligible for patent protection since it was a .

In the , the Association for Molecular Pathology v Myriad Genetics (Myriad), Myriad Genetics alongside the University of Utah, isolated two genes, BRCA 1 and BRCA 2, which are associated with breast and ovarian cancers. Furthermore, it developed a test that examines the DNA extracted from the genes for mutations that signify risk of developing breast or ovarian cancer. The patent of the two genes grants Myriad Genetics a monopoly on testing for mutations and thus prevents other laboratories from performing such tests.

An action brought by the American Civil Liberties Union and the Public Patent Foundation on behalf of various medical groups, patients and researchers that Prometheus’ patent on the human genes were invalid as they were products of nature, and the ensuing monopoly granted prevented women from garnering confirmatory tests. A United States District judge in New 91ɫ conceded and the patents in 2010. Nonetheless, this victory for the American Civil Liberties Union and association was short lived, as the Court of Appeal for the Federal Circuit the ruling, holding that the DNA isolated from the body was patentable since it was “markedly different” in a chemical structure from the DNA within the body. On appeal to the Supreme Court, the case was remanded to the Court of Appeal for the Federal Circuit for review.

On review, the Federal Court will be required to resolve whether isolating genes BRCA 1 and BRCA 2 merely describes a law of nature or whether it is “.”As mentioned earlier, and pursuant to Section 101 of the , laws of nature, natural phenomena, and an abstract idea are not patentable. This provision is one that is seemingly simple to grasp, however, upon further interpretation, becomes complicated and abstract. Patents sought by individuals who are able to demonstrate that their particular invention involves a of an abstract idea or law of nature are entitled to patent protection. Therefore, Section 101 patent analysis is oriented towards what constitutes an application. In Prometheus, patent protection for the diagnostic test that looked for chemicals formed when drugs used to treat gastrointestinal diseases were broken down in the body was since the test merely recited and applied a law of nature. The future success or failure of Myriad Genetics’ patent may be foreshadowed utilizing the lesson learned from Prometheus, with greater accuracy depending on the degree of alignment between both cases.

Perspectives on whether the fate of the Prometheus patent foretells a grim tale for Myriad are rather varied and stratified. lawyers and patent experts believe that the ruling in Prometheus is not easily transferable to the present case since Myriad’s patents are compositions of matter while Prometheus’ were methods of testing. Dr. Robert Cook-Deegan, director of the program on genome ethics, law and policy at Duke University the logic to be different since the present case is about a thing, as opposed to a method. believe that the ruling in Prometheus is opposed to the rationale used by the appellate court to uphold Myriad’s patents. Daniel Ravicher of the Public Patent Foundation opined, “the isolation of DNA is a trivial, well-understood step…A unanimous Supreme Court has now undeniably declared that a trivial noninventive transformation” is not sufficient to obtain patent protection.

Irrespective of outcome, both Prometheus and Myriad have generated useful dialogue about the ethical and economic challenges facing the Unites States patent system in an age of biotechnology and the increasing monetization and exploitation of genetics.

Tracy Ayodele is a JD Candidate at Osgoode Hall Law School.

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