The impact of the controversial Myriad gene patent litigation is not yet fully known, despite Friday’s Federal Circuit panel ruling which is being covered extensively in the general and legal media. Quite possibly, the full Federal Circuit and the Supreme Court will weigh in on the case, so we must wait and see for what the full impact will be. For now, however, in this most recent appellate decision, the Federal Circuit panel upheld the ability to consider isolated gene types of composition claims as potentially patentable subject matter. The Court rejected the notion that such claims were, per se, not eligible for patent protection. In forming its opinion, the Federal Circuit panel also recognized the settled property rights of the biotechnology industry formed over the past several decades. Other aspects of the opinion such as the Myriad method claims and the so-called Bilski test are beyond the scope of this short blog. Rather, this blog notes a nanotech angle to these controversies.
This Myriad litigation has many implications for and connections to nanotechnology, nano biotechnology, and nanomedicine. One of the central themes of nanotechnology has been borrowing concepts and materials from nature. This shows up in patenting. For example, among the current crop of 977 nanotech patents (there are 7,113 of them as of today), 4.5% of them refer to sequence ID information for DNA sequences (317). Hence, much innovation is occurring in the nanotech space related to DNA sequences of one form or another. Nanotechnologists can use nucleic acid sequences to build nanostructures, diagnose issues early and at low analyte levels, and in general create and control useful processes. So-called "DNA nanotechnology" was recently featured in Science Magazine. In DNA nanotechnology, the DNA (or other nucleic acids) is used as a structural, building material more than an informational material. Also, in Congressional testimony just several weeks ago re funding of nanotechnology, early diagnostic tests using nucleic acid nanotechnology were stressed as "blockbluster" applications of nanotech. Hence, the nanotechnology community should monitor the Myriad litigation for possible impact on nanotech commercialization.
While time is needed to fully digest this Myriad ruling, some preliminary comments are offered. For example, I appreciated, in particular, Judge Moore’s concurrence in the Friday opinions. For context, my technical background includes polymer chemistry. This Moore opinion quickly cuts to the heart of the matter: "DNA is a chemical polymer. In principle, a polymeric DNA sequence is no different than any other well known polymer, for example, nylon" Correct: polymer chemists have been tinkering with the nuances of polymeric microstructure for many decades and gaining patents on the innovations. Technologists have long looked to materials of nature for inspiration and guidance to solve practical problems and patent the solutions. So Man can make a material inspired by nature such as building a DNA molecule from scratch. Alternatively, Man can take nature’s materials and purify, isolate, and otherwise chemically modify them. Both are fair game for patenting compositions. In particular, Judge Moore noted the role of the polymer’s terminal groups in giving the DNA composition useful utility and differences over the nature-made material. For the polymer chemist, for example, the nature of the terminal or "end groups" can impact the polymer properties heavily and be a source of innovation. So it was good to see one of the judge’s getting to the essence of things from a polymer chemistry perspective.
The larger themes at stake in this Myriad litigation also relate to issues where nanomaterials may be found in nature, albeit in a different form from a commercially useful form. Some nanomaterials might be (well, are) found in space or in the earth, for example. The courts are looking to see if there is a difference between the natural form and the commercially useful form. Is one merely purifying something found in nature? Also important, however, is how the claim is drafted. The word selection in claim drafting might determine if the patentee wins or loses. The Myriad litigation flows from a specific set of claims, and other context at the PTO or in court litigation may provide alternative claim language strategies used by patentees to navigate the patent system.
In sum, a per se exclusion from patenting of isolated DNA materials which have unique structural aspects such as end groups would seem inconsistent with the larger body of chemical patent law. If the composition is new, whether it is isolated from nature or man-made, then the seminal issue becomes whether it is non-obvious. A composition which is man-made and a composition isolated or derived from nature can be the same and both can be patented. To hedge their bets, patentees may do well to include alternative claims which are free from the product-by-process types of words like "isolated."
We wait with keen interest as this Myriad litigation continues to play out and as patent claim strategies evolve over the months, years, and decades.