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Top 3 reasons the Supreme Court is sure to be a hot topic at BIO 2013
Patent Docs by Kevin Noonan
The U.S. Supreme Court will decide two cases this term that are expected to have broad implications for the biotechnology and pharmaceutical industries: Bowman v. Monsanto and AMP v. Myriad Genetics. The cases involve different aspect of patent law and have different implications for the future; what they share is an erosion of patent protection that has been granted and depended upon by the biotech/pharma industries for more than three decades. These implications will surely be discussed at this year's BIO conference.
1. Bowman v. Monsanto: Self-replicating technologies
The Bowman case involves Monsanto's Roundup Ready recombinant, herbicide-resistant soybeans. This technology has provided the first increase in soybean yield in over a generation, and dramatically reduces the labor-intensive aspect of weed removal that traditionally has limited soybean cultivation. Monsanto sells its Roundup Ready seed under contractual terms that prevent replanting of progeny soybeans, and has successfully protected its franchise using contract and patent law to prevent unauthorized replanting.
Farmer Bowman attempted to avoid these restrictions by purchasing soybean seed from grain elevators, replanting that seed and treating the crop with Roundup herbicide.
Bowman relied on the high penetrance of Roundup Ready seed in the commercial soybean market, wherein more than 90 percent of seed has the herbicide-resistance trait. Bowman argues that Monsanto's rights to the seed were exhausted upon the first sale of the first seed, and Monsanto argues that, even if true, the seed produced by the soybean plants resulting from the first planting is a new seed, a remaking of the recombinant seed, the rights to which have not been exhausted. The Supreme Court heard oral argument on the issue in February, and generally seemed to side with Monsanto. A decision is expected by the end of the court's term in June.
While the question is limited to Monsanto's soybeans, the case has broader implications for any self-replicating technology. Whether a vaccine, a recombinant cell making a protein or any of the many research and diagnostic tools (plasmids, cells, organisms) that have the capacity to self-replicate, a decision that a first sale exhausts patent rights would permit a purchaser to essentially "set up shop" with the innovator's invention and sell in competition with him. While such a result is unlikely, the court has not been patent- (or patentee-) friendly over the past decade, so the possibility exists that an adverse ruling (or one containing troublesome dicta) will inhibit further development of such technologies or encourage biological limits (like "terminator technology," which would prevent further replication of the recombinant product) that, at best, would be wasteful—or, at worst, have their own set of negative consequences.
2. AMP v. Myriad Genetics: Patenting human genes and 'products of nature'
The Myriad case has received much more attention, in part due to the subject matter (human genes and patent protection thereof) and the patient population (breast cancer patients and women at familial risk for developing breast cancer). The question is at once narrow and broad, being directed towards the patent eligibility of human "genes," but more broadly involving the extent to which "products of nature" can be patented. The case has focused on Myriad's exclusive sourcing of genetic diagnostic tests for BRCA1 and BRCA2 mutations associated with risk for breast and ovarian cancer (exclusivities that will expire over the next few years as the patents expire), but the case is directed towards claims to isolated human DNA that are not infringed by the practice of the genetic diagnostic methods. This aspect illustrates another way the Myriad and Bowman cases are similar: they are supported in part by political partisans endeavoring to weaken the U.S. patent system in the benighted hope that by doing so the cost of patented technologies will be reduced (and failing to realize that the more likely course is that the existence of such technologies is what will decrease). The Myriad case may be decided narrowly, along lines that are limited to human genomic DNA, or may contain broad statements of patent eligibility that could jeopardize patent protection for biologic drugs, bioagriculture and biofuels. That case will be argued on April 15, and will also be decided by the end of the court's term.
3. Biotechnology's future depends on patent protection
The U.S. Supreme Court has exerted a negative influence on U.S. patent law for over a decade. Now, it has the opportunity to injure one of the few American technological success stories for the last generation, for reasons that are as arcane as they are unnecessary. With luck, they will resist the urge and issue thousands of U.S. patents to companies to continue to protect existing technology and provide the promise of the future protection needed to continue the development of biotechnology for the next 30 years.
Kevin Noonan is a partner with the law firm McDonnell Boehnen Hulbert & Berghoff LLP and represents biotechnology and pharmaceutical companies on a myriad of issues. A former molecular biologist, he is also the founding author of the Patent Docs weblog, http://patentdocs.typepad.com/. His column appears bi-monthly in the Government Watch section of ddn.