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AIPLA President’s blog: The Supreme Biotech



Jeffrey I. D. Lewis


Two cases currently before the Supreme Court highlight the Court's recent interest in biotechnology and patent law



Over the history of the Court, patent cases were typically considered on simpler technologies – such as how to distribute weight in a train car for coal and the process recipe for opening a mold shaping rubber products – but in the last few decades the Court has increasingly begun to delve into more complex technologies.

This started in many ways with the Supreme Court’s 1980 Diamond v. Chakrabarty decision, where the Supreme Court grappled with the general issue of whether a living thing – specifically a human-made bacterium – could be patentable subject matter under 35 U.S.C. § 101 (the gatekeeper definition of what subject matters can be patented). In the last few years the Court has expanded to more and more complex analyses, looking at a series of cases about the patentability of computer algorithms and so-called "business method patents." Last year it decided the biotechnology case of Mayo v. Prometheus, where the Court held that claims covering a method of measuring the metabolite levels from a particular treatment and then comparing them to an expected range of values – but not specifying how to respond if the results were outside the expected range – were not patentable under § 101 because they covered a law of nature.

Two currently pending cases this term, however, present stark attacks to the patent system and its ability to cover biotechnology advances, and these cases put the entire field of biotechnology – from agriculture to personalized medicine – at risk. The first case is Bowman v. Monsanto. The issue in that case is whether a patent protects subsequent generations of genetically engineered seed. Monsanto sells soy beans that have been modified so they will not be killed by Monsanto's well-known Round-Up herbicide. These Round-Up-Ready soy beans are sold to farmers with the agreement that the resulting "second generation" soy bean crop cannot be replanted to create a third generation of soy bean. There are no limitations, however, on using the second generation soy beans for any other purpose, including as animal feed or as food for humans.

Bowman bought soy beans as seed from a grain elevator and suspected that second generation Round-Up-Ready seed was included in his purchase. He planted those seeds and treated them with Round-Up, confirming his suspicion when third generation Round-Up-Ready soy beans survived the herbicide treatment. Monsanto argues that Bowman infringed its patents. Bowman counters that Monsanto should not control his freedom to use seed bought elsewhere as he sees fit; in other words, Bowman says Monsanto can control the use of Round-Up-Ready seed by contract for those who buy from Monsanto but not by patents for those who buy seed elsewhere.

As a matter of economics, Bowman asserts that Monsanto is trying to control farming. These arguments ignore the simple, specific fact that Bowman can always use seed other than Round-Up-Ready soy beans as many farmers do. On a macro-economic scale, Bowman cannot explain why anyone would conduct research to improve seed if the first sale of that improved seed to farmers meant they would be able to generate as much of that improved seed as they want by harvesting the crop and replanting a portion of it.

In effect, Bowman argues patent exhaustion – that the first time an item is sold the purchaser is free to use it for its intended purpose. That argument works for eye glass inserts (which can only be used for making eye glasses) and for computer parts (when they have a specific use) but this case is different. Here, planting seed can have a number of purposes, making food or generating more seed. You can read more about this in AIPLA’s amicus brief to the Supreme Court. This is the first time the Supreme Court has grappled with the issue of naturally self-reproducing inventions, where the patentee has made clear that some uses are licensed but another – making seed – is not.

It's fairly clear that if a company sells a machine you cannot then use that machine as a template for making new machines, i.e. by copying the purchased machine, without infringing, but in this instance the soy beans replicate themselves by the shear act of using them as intended. The Federal Circuit analyzed this argument by looking at the concept of "making," as found in the patent infringement statute, and indicated that making new third generation seed was different from using the second generation seed for other purposes. (The Federal Circuit also considered a conditional sale doctrine that went beyond what the Supreme Court has previously held, which may be subject to some attack at the Supreme Court.) If Bowman is allowed to succeed, it will choke off most biotechnological farming investments.

The second case is Association for Molecular Pathology v. Myriad. The essence of the dispute is whether isolated DNA is a product of nature and therefore not patent eligible under section 101, or instead has been isolated by man in such a way as is never found in nature and therefore can be patented.

The question asked by the Supreme Court, however, is actually much broader than the issue raised by the case. The Supreme Court has asked the more general question, "are human genes patentable?" But that is the wrongly positioned question for two reasons. First, the concept of patentable includes lots of statutory tests including whether an invention is new – human genes exist in the body and therefore generally are not new (i.e., they are not novel and nonobvious). Second, the facts of the case are much narrower than an attempt to patent human genes, the genes as found in the human body.

The question that the facts of the Myriad case actually present is whether a specific subset of the human gene, namely a particular segment of coding DNA, is patent eligible under Section 101. The patent claims involved in this case are for man-made strands of DNA. These claimed DNA sequences are not genes as found in humans, i.e. "human genes." They are instead disparate but related strands of DNA that the inventors isolated and arranged into adjacent coding regions without the naturally-occurring, non-coding intervening strands. The inventors then correlated certain strand anomalies or mutations with an increased risk of breast and ovarian cancer, an expensive and time-consuming correlation. Patents on these sorts of inventions are exactly what the Constitution hoped to incentivize by creating patents to promote "the progress of science and the useful arts."

The Association of Molecular Pathology and its supporters make broad sweeping statements that the ability to patent coding segments of DNA stifles innovation. Such hysterical assertions, that biotechnology patents preempt all scientific research, are simply wrong and are inconsistent with the existing law. For instance, 35 U.S.C. § 271(e)(1) generally exempts medical research development work from infringement, and there are also are common law exceptions to infringement for certain types of experimentation. Congress also has already exempted certain groups conducting medical processes from being liable for patent infringement, 35 U.S.C. § 287(c), and in doing so recognized that genetic material can be subject of patent protection. Read more about this in AIPLA’s amicus brief to the Supreme Court .

Both the Bowman and Monsanto cases involve important social and ethical questions, in terms of public access to new technologies as well as in terms of incentivizing scientific advances. Hopefully the Supreme Court will get it right and continue to protect the economic incentives and the importance of the U.S. biotechnology industry. AIPLA’s briefs in both cases emphasize how important protecting innovation is and the central themes of incentivizing the next generation of scientific advance. It should be interesting to see whether what the Court says, but until then thanks for reading.

Jeff

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