Inventive Steps: the CRISPR Patent Dispute and Scientific Progress
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Science & Society Inventive steps: the CRISPR patent dispute and scientific progress The recent patent decisions about CRISPR tell us a lot about how advances in biology are actually made— and how they are not Jacob S Sherkow ecent decisions by patent offices in institutions—has been widely criticized by highlights a long-standing division between the USA and Europe concerning the scientists. One prominent researcher, science and patent law concerning how R revolutionary gene-editing technol- Michael Eisen from the University of Califor- biological research is actually conducted—a ogy, CRISPR/Cas9, have shed light on the nia, Berkeley, has taken particular issue division that is likely to widen as research in importance—and puzzles—of one particular with the PTAB’s articulation of the typical molecular biology advances. This article area of patent law: “nonobviousness”, as it manner in which molecular biologists adapt briefly explains these differences in patent known in the USA, or, in Europe, the discoveries to different cell systems. “[O]ne law, especially with respect to the law’s crit- “inventive step”. In February 2017, the US can believe that it was obvious that CRISPR ical “nonobviousness” or “inventive step” Patent Trial and Appeal Board (PTAB) found would work in eukaryotic cells, and still not requirements, and explains their importance that the work of Feng Zhang, a researcher at expect that it would work the first time to CRISPR researchers and molecular biolo- the Broad Institute in Cambridge, MA, USA, someone tried it or that the process would gists of all sorts. constituted a “nonobvious” advance over be free of frustration”, he wrote on his blog the celebrated work of Jennifer Doudna of several days after the US decision. “Because The importance and history the University of California, Berkeley (USA) that’s how science works!” of obviousness and Emmanuelle Charpentier, then at Umea˚ ...................................................... University, Sweden [1]. As a consequence, Since modern patents were first granted in the Broad Institute will be able to keep its “...both patent offices’ the 17th century, governments were faced US patents covering the technology irrespec- decisions are almost certainly with the conundrum of “drawing a line tive of how Doudna and Charpentier’s correct as a matter of law if not between the things which are worth to the patent application proceeds. By contrast, the public the embarrassment of an exclusive European Patent Office (EPO) announced the realities of scientific patent, and those which are not” [3]. that it had granted Doudna and Charpen- progress” Patents were established as incentives for tier’s European patent application covering ...................................................... inventors to spend time and money devel- broad uses of CRISPR/Cas9 in essentially But both patent offices’ decisions are oping new inventions. Without some rights any cell type, despite the US Patent Office’s almost certainly correct as a matter of law if to prevent others from copying their inven- decision to the contrary [2]. Other parties— not the realities of scientific progress. The tions once they were first sold—so the including the Broad Institute—will be able US opinion concerning nonobviousness— economic theory goes—developers would to challenge Doudna and Charpentier’s the sine qua non of patentability—is fairly not undertake the ardor of research in the European patent. But for now, the EPO’s accurate: Whether prior research “would first instance. But this right to exclude decision is an implicit recognition that have suggested to one of ordinary skill in others from practicing new and useful tech- Doudna and Charpentier’s work was, itself, the art that [the new] process should be nologies was considered to be a powerful a major “inventive step” over the work that carried out and would have a reasonable one, and determining which inventions came before it. likelihood of success” [1]. In Europe, one is merited the law’s security poised no short- Patent law does not always neatly align entitled to a broad patent on a new tech- age of administrative, legal, and philosophi- itself with the realities of biological research. nique, if it demonstrates an “inventive step” cal problems. But these competing decisions have put over prior methods—even if there no guar- In the USA, the courts took up the those differences on parade. The US decision antee that it will work for all of its claimed mantle of assessing the worth of new in particular—and even the nature of the applications. As noted by a number of intel- technology under the patent laws. Like controversy between the two US research lectual property scholars, this standard the technologies they were charged with Innovation Center for Law and Technology, New York Law School, New York, NY, USA. E-mail: [email protected] DOI 10.15252/embr.201744418 ª 2017 The Author EMBO reports 1 EMBO reports CRISPR patents and scientific progress Jacob S Sherkow investigating, their opinions consisted of conducted. They aspired to critically exam- for example, can surprisingly be regulated by various attempts—trials and errors—to ine prior papers to assess whether the developing otherwise similar constructs for make workable what was otherwise an patented invention was truly a significant controlling fucosylation pathways. Further- imperfect machine. In the early part of the advance, much in the same spirit as Isaac more, biology—unlike, say, physics—is not 19th century, courts required patented Newton’s reference to standing on the shoul- practiced in a sterile environment. Work inventions to be “of more ingenuity and ders of giants. It required a concrete compar- conducted in molecular biology often takes skill than that possessed by an ordinary ison between the elements of prior studies place within the medium of living cells or mechanic” [4]. Litigating genius, suffice it and the current one—the patent on examina- complex genetic environments. As a result, to say, proved less than fruitful, so courts tion. And it posed these questions to a hypo- translating a technique from one system to adopted a variety of standards, none of thetical scientist—an ordinary one in the another frequently proves difficult. And even which proved any easier. By the mid-20th same field—to assess what he or she where researchers seem capable of attaining century, things had deteriorated to the point thought. In an age when good government promising results, issues over experiments’ that US Supreme Court Justice Robert H. was widely perceived as being one that reproducibility abound. This has compli- Jackson remarked that “the only patent that ushered scientific research into the fore, cated the task of asking whether an average is valid is one which this Court has not been Federico and Rich’s invention of “nonobvi- molecular biologist—a “person of ordinary able to get its hands on” [5]. ousness” was a both a political and legal skill in the art” in patent law’s parlance— ...................................................... triumph. would think the invention to be “obvious” or Today, obviousness is by far the most lack an “inventive step” over what came “In an age when good crucial doctrine of the patenting process. It before it. government was widely is the primary source of patent offices’ ...................................................... rejection of patent applications. And it perceived as being one that “Unlike other fields, such as ushered scientific research into arises as a defense in virtually every patent case litigated in court. In addition, mechanical engineering, the fore, Federico and Rich’s many other procedures at patent offices in molecular biology is considered invention of “nonobviousness” the USA and throughout the world substantially more was a both a political and consider the potential obviousness of a “unpredictable”...” legal triumph.” patent even after it may have already been ...................................................... ...................................................... issued. For this reason, nonobviousness or an inventive step has become “the heart of This complication has only worsened In 1952, as part of a major overhaul of the patent law” [7]. recently. Prior to 2007, obviousness analy- the patent laws, Congress tasked two ses almost exclusively used documentary prominent patent attorneys, Pasquale The obviousness inquiry in evidence, such as patents and articles in Joseph Federico and Giles Sutherland Rich, molecular biology scientific journals. In 2007, however, the with giving form to this elusive “inventive- US Supreme Court took up the case of KSR ness” requirement. Their invention: what Despite the improvements of the obvious- International Co. v. Teleflex Inc., and deter- we call “nonobviousness” today, the prohi- ness doctrine in aligning patent law with mined whether such a narrow focus on bition on patents covering inventions for scientific research, it has presented unique patents and papers was appropriate. The which the “differences between the problems for molecular biology. Unlike Court concluded that, in addition to the claimed invention and the prior art are other fields, such as mechanical engineer- documents traditionally considered by the such that the claimed invention as a whole ing, molecular biology is considered Patent Office in determining obviousness, would have been obvious ... to a person substantially more “unpredictable”. Given it should now also look to factors such