Editorial Revisado por pares

On patenting time and other natural phenomena

2013; Elsevier BV; Volume: 27; Issue: 2 Linguagem: Inglês

10.1016/j.rbmo.2013.05.001

ISSN

1472-6491

Autores

Jacques Cohen,

Tópico(s)

Genetics, Aging, and Longevity in Model Organisms

Resumo

Claiming cell cycle timing or duration as an invention that merits a patent would strike most students of developmental biology as an unlikely proposition but researchers at Stanford University have successfully done exactly that! The first three cell cycles in the human embryo developing in vitro are now owned by a corporation, thanks to patents issued to Stanford University and exclusively licensed to Auxogyn – a time-lapse embryo evaluation startup company (Wong et al., 2011Wong, C.C., Loewke, K.E., Baer, T.M., Reijo-Pera, R.A., Behr, B., 2011. Imaging and evaluating embryos, oocytes, and, stem cells. US20110092762.Google Scholar, Wong et al., 2012Wong, C.C., Loewke, K.E., Baer, T.M., Reijo-Pera, R.A., Behr, B., 2012. Imaging and Evaluating Embryos, Oocytes, and Stem Cells [Imagerie Et Évaluation D’embryons, D’ovocytes Et De Cellules Souches/Abbildung Und Evaluierung Von Embryos, Oozyten Und Stammzellen]. Trustees of the University of the Leland Stanford Junior University Board. Ep2430454 A1.Google Scholar, Chavez et al., 2012Chavez, S.L., Loewke, K.E., Behr, B., Reijo-Pera, R.A., 2012. Methods of Detecting Aneuploidy in Human Embryos [Procédés de détection de l’aneuploïdie dans des embryons humains]. The Board of Trustees of the Leland Stanford Junior University. Wo/2012/116185.Google Scholar). Yet there is little debate that time is not an invention but a conceptual dimension that can be quantified. It is a fundamental element of the universe and as obvious as a point or a line in terms of its mathematical probability. Development in embryos proceeds in dimensions of space and time, which is why timekeeping mechanisms have evolved in eggs and embryos (Johnson and Day, 2000Johnson M.H. Day M.L. Egg timers: how is developmental time measured in the early vertebrate embryo?.Bioessays. 2000; 22: 57-63Crossref PubMed Scopus (57) Google Scholar, Pratt, 1989Pratt H.P. Marking time and making space: chronology and topography in the early mouse embryo.Int. Rev. Cytol. 1989; 117: 99-130Crossref PubMed Scopus (15) Google Scholar). It therefore comes as a surprise that the duration of the human embryonic cell cycle can be patented. The length of the cell cycle is not an invention and its key role in development is not a new observation; it is an indisputable and well-known fact of nature described and pondered by the likes of Theodor Boveri since the discovery in the late 19th century that eggs are fertilized by spermatozoa and that the early zygote undergoes rather precise cell divisions or cleavage (Boveri, 1912Boveri T. Anton Dohrn.Science. 1912; 36: 453-468Crossref PubMed Google Scholar, Johnson, 2002Johnson M.H. Time and development.Reprod. Biomed. Online. 2002; 4: 39-45Abstract Full Text PDF PubMed Scopus (16) Google Scholar). Periodic events and length of time in any cell should not be the subject of some legal definition or patenting. The Stanford patents set a poor precedent in the emerging field of embryo kinetics, a field which provides embryologists with a more precise accounting of the timing of events during embryo development and the possibility of using this information to predict developmental potential. Patents are government-endorsed titles or rights granted to an individual or corporation, particularly the rights to manufacture, sell or use an invention. It is hard to consider the length of a cell cycle, no matter what the definition of its periodic length is, as a patent right. It begs the larger question, should naturally occurring phenomena inherent to life be patented? The US Patent and Trademark Office (USPTO) decided nearly 30 years ago, when it issued the first gene sequence patent, that naturally occurring genes can be owned (Goodman et al., 1984Goodman, H.M., Shine, J., Seeburg, P.H., 1984. Microorganism containing gene for human chorionic somatomammotropin. US4447538.Google Scholar). Although it is likely that those patent examiners did not fully realize the consequences of their decision, once the first patent was approved, many others followed. The outpouring of gene patent applications that followed became uncontrollable as thousands of gene sequences were discovered and patented. A later requirement by the USPTO to describe the gene in addition to providing the sequence did not stop the flood of applications. Once the USPTO is set on a course of action, it rarely reverses an earlier policy, hence gene sequence patents were here to stay with dire consequences. Most legal systems base policy on precedents, so once one type of patent is allowed it may not be reversible until either a court decision or law reverses or alters the policy. This can take a long time. A US federal judge overturned two infamous gene patents in 2010 owned by Myriad on the BRCA1 and BRCA2 genes, which predispose individuals to breast, ovarian and other cancers. Previously Myriad had been charging a fee to anyone who wanted to have their own genes read. The Myriad court decision was overturned by a higher court based on the argument that a gene sequence in vitro is somehow different from the naturally occurring variant. A dissenting judge went further, argueing that a natural gene sequence that induces a cell to express BRCA is not a human-made invention. In a recent commentary on this very topic Salzberg, 2012Salzberg S.L. The perils of gene patenting.Clin. Pharmacol. Ther. 2012; 91: 969-970Crossref PubMed Scopus (6) Google Scholar argued that the concealment of knowledge during the patent application process is in direct contrast to the progress of science, since scientists should disseminate their work publicly and openly so others can either broaden the findings or dispute them. This goes against the essence of patenting and I do not agree with such generalizations. Patenting can play a role in innovations in engineering and other tangible areas of discovery, so that inventors and their sponsors are protected and can continue their work while remaining financially secure. A patent can extend and protect a line of research without being suffocating. Nothing stops the authors of a patent from publishing their research as long as the patent application precedes the submitted paper by a day. The issue at hand is not patenting itself but whether one can or should patent a naturally occurring phenomenon. Salzberg argues further that patented genes discourage ongoing research on the genes and stifle scientific progress. This is not true. Once an invention or discovery – in the case of genes – is patented, researchers are allowed to continue to conduct studies in the protected area as long as the study is not conducted for financial profit. Patents do not prevent research, they exclude others from competing economically. Researchers focused on embryo kinetics should ignore the time patents claimed by Stanford. They are free to research the biological events described in the patents. In the meantime responsible reproductive specialists should protest against the precedent set by Stanford and argue in favour of patents that protect original inventions and not those that claim natural phenomena as property.

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