Last month, the U.S. Patent and Trademark Office issued its interpretation of the standards for subject matter eligibility set forth in the Supreme Court's recent decisions in Mayo v. Prometheus and AMP v. Myriad. The guidelines comprise a wealth of flow charts, factors and factual inquiries an examiner should make in determining whether a “product of nature” has been sufficiently changed by human intervention to be patent eligible. The guidelines are much broader in their determination of what is patent ineligible than was mandated by the Supreme Court’s Myriad decision (which was limited to genomic DNA, albeit in a decision containing sufficient dicta that almost any interpretation is possible).
The most serious issue raised by the guidelines is its mandate that the following be categorically excluded from patent eligibility: [C]hemicals derived from natural sources (e.g., antibiotics, fats, oils, petroleum derivatives, resins, toxins, etc.); foods (e.g., fruits, grains, meats and vegetables); metals and metallic compounds that exist in nature; minerals; natural materials (e.g., rocks, sands, soils); nucleic acids; organisms (e.g., bacteria, plants and multicellular animals); proteins and peptides; and other substances found in or derived from nature ... regardless of whether particular words (e.g., "isolated", "recombinant", or "synthetic") are recited in the claim.
In other words, almost anything that is purified from nature, no matter its structure or source, is patent ineligible unless it has been chemically modified rather substantially; “mere” isolation will generally not be enough for a compound to be considered patent eligible.
When considering the impact of these guidelines there are a few considerations that should be kept in mind. The first is that these guidelines have no force of law; they are merely administrative tools for how the Patent Office will administer the law under its (mis)understanding of the Supreme Court's rubrics. Courts have consistently recognized that they are not bound by the office's understanding of how to apply the law. Thus, thousands of granted patents have not been lost or invalidated unless and until this interpretation of subject matter eligibility gets judicial imprimatur.
The office’s categorical, per se distinction between the types of inventions enumerated above and other types of inventions is not likely to pass judicial muster. The office has done this before, when it decided that patents would not be granted on "living things" (in the In re Bergy and Diamond v. Chakrabarty cases). These decisions led to the Supreme Court’s decision in Chakrabarty, affirming the appellate court decision that the office was wrong to make such a categorical distinctions on patent eligibility.
The Court has tried to be parsimonious in its recent patent eligibility decisions: in Bilski v. Kappos, Bowman v. Monsanto and even Myriad, the court has stated directly that its decisions should be limited to the case before it (and even Justice Breyer recently conceded that his Mayo decision was intended to set forth some general principles to be “filled in” later by the lower courts). By crafting the absolute, categorical prohibitions contained in the guidelines, the office has seriously overreacted to these decisions in ways both unnecessary and inconsistent with the Supreme Court's more measured approach.
That the Guidelines do not implement the Supreme Court's decisions in a reasonable and workable way to promote American innovation can be appreciated readily by noting that none of the inventions in the following list are now patent eligible:
• Isolated chemical compound from crude oil useful as a lubricant
• Isolated chemical compound from a plant useful as a drug
• Isolated antibiotic produced by bacteria
• Isolated protein from an animal useful to cure/ameliorate human disease
• Isolated cucumber gene that extends freshness
• Isolated human gene (erythropoietin) (unless, of course, either of the two genes are claimed as cDNA, or as part of a recombinant expression construct, for example).
Unless and until overturned by the judiciary or (less likely) by the U.S. Congress, these guidelines will work their mischief. Perhaps the extent of this mischief will inform members of Congress, their friends in the administration and the popular press about the outcome we can expect if these broad prohibitions stand against patenting subject matter that has been responsible for most progress in the life sciences over the past century (and that have fueled one of the drivers of the American economy since the 1980s). If life, health, better nutrition and independence from conventional sources of fossil fuels aren't enough to be convincing, then maybe stressing the effects on jobs and the economy will be.
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/.
(Opinions of the columnist do not necessarily reflect those of the publishers, editors or staff of DDNews)