...Reproducibility is the cornerstone of peer-reviewed science.
Many moons ago in graduate school, I was introduced to The Journal of Irreproducible Results, a venerable science humor journal first published in 1955. The journal provides a respite to the daily grind of scientific research with jokes, and a mix of real and imagined science. In 2017, we may be facing a different type of merger between real and imagined science. This time it isn’t funny. While peer-reviewed science still remains the gold standard, it is under attack from all sides — junk science, political science, celebrity science, and assaults on funding.
The patent system is the middle child of peer reviewed science — it does not get the attention of its older sibling (the “cure” for a dread disease), or its younger sibling (the baby startup that will change the world). Patents are, in many respects, commercial documents designed to secure exclusivity to inventors and help fund its older and younger siblings. But when there are problems in the peer reviewed science family, the middle child will also feel the impact.
...a surprisingly high percentage of major studies across various scientific disciplines cannot be reproduced by other scientists.
Self-inflicted wounds for peer reviewed science have come from several quarters including highly public allegations of fraud and now a “crisis” in reproducibility. The crisis of reproducibility has been explained in detail elsewhere, but here is the short version: a surprisingly high percentage of major studies across various scientific disciplines cannot be reproduced by other scientists. There are many explanations for the crisis — some are sinister and many are not. Regardless, the crisis of reproducibility comes at a time when science is under attack from the highest levels of Government to the darkest recesses of the internet.
Reproducibility is the cornerstone of peer-reviewed science. Ideally, scientists and the public are assured by careful peer-review, that the results submitted to scientific journals are valid based on the provided data. It has been simply assumed that the data could be reproduced by other scientists. However, reproducibility is not necessarily assured by the peer review process. Unreliable science can have far reaching negative effects including jeopardizing patients and wasting resources that would be better spent on more promising avenues of study.
My focus in this post, however, is on the impact of crisis of reproducibility on the patent system. The patent system is one important benefactor of peer-reviewed science — especially in the life sciences. It is common for life science patents to be based in whole or in part on initial drafts of articles destined for peer-reviewed journals.
In addition, Patent Examiners rely a great deal on the published literature when rejecting patent applications. In view of the relatively high percentage of irreproducible published literature, one wonders whether an equivalent high percentage of rejections of patent claims are based on irreproducible science, and therefore, questionable rejections.
Patent Examiners, of course, have neither the facilities or time to check if the results used in rejections are reproducible and correct. They justifiably rely on the peer review system to referee the results for them. Thus, the burden shifts to patent applicants and their attorneys to consider whether or not rejections are valid and reproducible.
Patent Examiners should be open to the possibility that the basis for a rejection may, in fact, be incorrect...
In cases where the rejections are not valid, applicants should consider submitting a declaration demonstrating the results disclosed in the journal article are not reproducible, if applicable. In view of the “crisis of reproducibility,” Patent Examiners should be open to the possibility that the basis for a rejection may, in fact, be incorrect.
On the flip side, patent applicants should be aware that data described in their applications may likewise be questioned. It is important to note that data and conclusions in patent applications are not peer-reviewed. When challenging questionable peer-reviewed prior art, applicants may want to have their own results validated (under appropriate confidentiality precautions) to ensure that data and conclusions described in the patent applications are reproducible.
Fortunately, journals, universities, and the pharma/biotechnology industry are taking the “crisis of reproducibility” seriously. Until the issue has been fully addressed, we should all proceed with caution when relying on peer-reviewed science while recognizing that peer review is still the gold standard and should not be replaced with junk science that endangers our society and planet.
[Jeremy A. Cubert is a partner at VLP Law Group and is a member of the firm’s Intellectual Property practice group. He writes about strategies to simplify the way inventors and investors evaluate and protect biotechnology and pharmaceutical inventions.]