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 thatare expected to have broad implications for the biotechnology andpharmaceutical industries: Bowman v.Monsanto and AMP v. Myriad Genetics.The cases involve different aspect of patent law and have different implicationsfor the future; what they share is an erosion of patent protection that hasbeen granted and depended upon by the biotech/pharma industries for more thanthree decades. These implications will surely be discussed at this year's BIOconference.

1. Bowman v. Monsanto: Self-replicatingtechnologies

The Bowman caseinvolves Monsanto's Roundup Ready recombinant, herbicide-resistant soybeans.This technology has provided the first increase in soybean yield in over ageneration, and dramatically reduces the labor-intensive aspect of weed removalthat traditionally has limited soybean cultivation. Monsanto sells its RoundupReady seed under contractual terms that prevent replanting of progeny soybeans,and has successfully protected its franchise using contract and patent law toprevent unauthorized replanting.

FarmerBowman attempted to avoid these restrictions by purchasing soybean seed fromgrain elevators, replanting that seed and treating the crop with Roundup herbicide.

Bowman relied on the high penetrance of Roundup Ready seedin the commercial soybean market, wherein more than 90 percent of seed has theherbicide-resistance trait.Bowman argues that Monsanto's rights to the seed wereexhausted upon the first sale of the first seed, and Monsanto argues that, evenif true, the seed produced by the soybean plants resulting from the firstplanting is a new seed, a remaking of the recombinant seed, the rights to whichhave not been exhausted. The Supreme Court heard oral argument on the issue inFebruary, and generally seemed to side with Monsanto. A decision is expected bythe end of the court's term in June.

While the question is limited to Monsanto's soybeans, thecase has broader implications for any self-replicating technology. Whether avaccine, a recombinant cell making a protein or any of the many research anddiagnostic tools (plasmids, cells, organisms) that have the capacity toself-replicate, a decision that a first sale exhausts patent rights wouldpermit a purchaser to essentially "set up shop" with the innovator's inventionand sell in competition with him. While such a result is unlikely, the courthas not been patent- (or patentee-) friendly over the past decade, so thepossibility exists that an adverse ruling (or one containing troublesome dicta)will inhibit further development of such technologies or encourage biologicallimits (like "terminator technology," which would prevent further replicationof the recombinant product) that, at best, would be wasteful—or, at worst, havetheir own set of negative consequences.

2. AMP v. Myriad Genetics: Patenting humangenes and 'products of nature'

The Myriad casehas received much more attention, in part due to the subject matter (humangenes and patent protection thereof) and the patient population (breast cancerpatients and women at familial risk for developing breast cancer). The questionis at once narrow and broad, being directed towards the patent eligibility ofhuman "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 geneticdiagnostic tests for BRCA1 and BRCA2 mutations associated with risk for breastand ovarian cancer (exclusivities that will expire over the next few years asthe patents expire), but the case is directed towards claims to isolated humanDNA that are not infringed by the practice of the genetic diagnostic methods.This aspect illustrates another way the Myriadand Bowman cases are similar:they are supported in part by political partisans endeavoring to weaken theU.S. patent system in the benighted hope that by doing so the cost of patentedtechnologies will be reduced (and failing to realize that the more likelycourse is that the existence of such technologies is what will decrease). TheMyriad case may be decided narrowly, along lines that are limited to humangenomic DNA, or may contain broad statements of patent eligibility that couldjeopardize patent protection for biologic drugs, bioagriculture and biofuels.That case will be argued on April 15, and will also be decided by the end ofthe court's term.

3. Biotechnology'sfuture depends on patent protection

The U.S. Supreme Court has exerted a negative influence onU.S. patent law for over a decade. Now, it has the opportunity to injure one ofthe few American technological success stories for the last generation, forreasons that are as arcane as they are unnecessary. With luck, they will resistthe urge and issue thousands of U.S. patents to companies to continue to protectexisting technology and provide the promise of the future protection needed tocontinue the development of biotechnology for the next 30 years.

Kevin Noonan is a partner with the law firm McDonnell Boehnen Hulbert & BerghoffLLP and represents biotechnology and pharmaceutical companies on a myriad ofissues. A former molecular biologist, he is also the founding author of thePatent Docs weblog, http://patentdocs.typepad.com/. His column appearsbi-monthly in the Government Watch section of ddn.