The U.S. Patent and Trademark Office recently issued (without public notice or opportunity to comment) its interpretation of the standards for subject matter eligibility in view of the Supreme Court's recent decisions in Mayo v. Prometheus and AMP v. Myriad. The framework of the Office's issued Guidelines has been discussed previously (see "USPTO Issues Guidance for Analyzing Subject Matter Eligibility of Claims Reciting Laws of Nature/Natural Principles, Natural Phenomena or Natural Products"). Stripped of the Guidelines' flow charts, factors, and factual inquiries, the Guidelines in large part mandate the following exclusion 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.
The response from the patenting and biotech communities has been appropriately Apocalyptic; however, 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 Office will administer the law under its (mis)understanding of the Supreme Court's rubrics. Such Guidelines have been issued before -- involving how the Office would apply the law relating the utility and written description (in 2001), for example. While the Federal Circuit has occasionally referenced such Guidelines (see, for example, the first, vacated decision in Enzo v. GenProbe), courts have consistently recognized that they are not bound by the Office's understanding of how to apply the law. Thus, bemoaning the loss of thousands of granted patents is at best premature; until this interpretation of subject matter eligibility gets judicial imprimatur these Guidelines have no effect on existing patents.
It is also important to recognize that the Office made a categorical, per se distinction between the types of inventions enumerated above and other types of inventions. The last time the Office made such a distinction was when it decided that patents would not be granted on "living things" in the Bergy and Chakrabarty cases. The CCPA (and Judge Rich) made short work of this distinction (for many reasons the Judge's opinion in the In re Bergy case is delightful reading), and the Supreme Court also found that whether something is alive is not a categorical distinction supporting patent ineligibility. The Supreme Court has spent over a decade reversing the Federal Circuit's bright line, per se rules on everything from the standards for granting an injunction to those for non-obviousness, and the window dressing of flow charts and the other parts of the Office's analytical framework does not disguise the per se nature of the Office's Guidelines for determining patent ineligibility. While it is possible the Supreme Court (or certain members thereof) might welcome this PTO action, if this is what the Court wanted to mandate it would have done so.
It is also important to understand how far the Office's Guidelines have gone beyond what the Supreme Court actually ruled in the recent spate of patent eligibility cases. The Court has tried to be parsimonious in these decisions (even in the Mayo case, although it is more difficult to recognize the Court's restraint in view of Justice Breyer's tendency to include copious dicta). But in Bilski v. Kappos, Bowman v. Monsanto, and even Myriad, the Court has been direct in limiting the scope of its decisions to the cases at hand, and to caution against over-interpreting its holdings. 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.
This inconsistency is evident by a cursory perusal of the Office's prior practices and behavior, specifically with regard to isolated species in the chemical and biochemical arts. In the Bergy case itself, Judge Rich noted that no one, including the Office, disputed the patent eligibility of lincomycin, the antibiotic produced by the bacterial species (Streptomyces vellosus) whose patent eligibility was at issue. Mere inspection of Patent Office records will reveal numerous patents on isolated enzymes, chemicals, and other "products of nature" whose distinction was that they had been isolated from nature by the hand of man into a form not found in nature and thus that were patent eligible. And the cases to the contrary -- of vanadium, lithium and other minerals, for example -- were the exceptions perhaps because of their more fundamental nature as elements as opposed to complex molecules having beneficial utilities. It is nothing more than pedantic absolutism to ignore these distinctions just because antibiotics and other important molecules come from "nature"; as Chief Judge Rader has noted, all we have is nature and the Office's Guidelines ignore these well-established distinctions.
It is perhaps not a surprise that the Office issued these Guidelines, in view of the hostility to patents evinced almost weekly by the Obama administration. Whether the result of undue influence from companies themselves hostile to patenting due to the impact patents can have on their industries, or from academics having their own reasons for taking an anti-patent stance, or simply because administration officials believe that patents make drugs and other products more expensive, it has consistently been the case that in its public statements and policy initiatives the Executive Branch has acted in ways not supportive of patenting and frequently seemingly naïve about the issues and the effects of the positions that have been taken (recall the "magic microscope," for example). Former Director Kappos seemed to be a buffer between the Office and the rest of the administration in this regard, consistent with his broad experience. His absence (and the consequences of not naming a permanent Director since Mr. Kappos left) is evident in the substance of these Guidelines.
The Guidelines also remind us of the foolishness of the idea that courts should give greater deference to Patent Office determinations, or worse, that the Office should be given substantive rulemaking authority. The Guidelines illustrate a policy heavily influenced by politics, and politics change from administration to administration. This is the case even without direct influence on the Office by higher ups in the Executive; there is no evidence that the infamous "claims and continuation" rule changes under Director Dudas were part of a patent-unfriendly effort by the Bush administration rather than the Office's response to criticism from agencies like the Federal Trade Commission, bodies like the National Academies of Science, and (again) academic critics making specious arguments about an applicant's ability to "wear down" an examiner to grant a patent improperly. But such politicking does not benefit innovation or promote progress.
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).
These Guidelines will work their mischief until they are appealed to the Federal Circuit, or until the Supreme Court has the opportunity to clarify its thinking on subject matter eligibility. Perhaps the extent of this mischief will convince those companies and professional organizations that have sat on the sidelines to get involved in informing 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 1980's). 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.