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« Senators Tillis and Cotton Propose Sequenced Examination Approach | Main | FCBA Remote Program on Protecting Technology »

March 25, 2021


Re the title of this otherwise informative post, Schadenfreude is, by definition, pleasurable for the one experiencing it. It is, literally, shameful joy. Thus the idea that Schadenfreude is not “always” unpleasant is something of an oxymoron. It is seldom unpleasant. Perhaps a more accurate title would have echoed Schiller as immortalized by Beethoven, “Freude! Freude! Schadenfreude! Sequence patents are no more!” :-)

Love it…

Since one can no longer obtain patent protection for biomarker diagnostic assays, R&D on diagnostic assays has significantly declined. Prior to Mayo, Myriad, and Alice, the majority of biomarker diagnostic assays for which patent protection was sought generally related to diagnostic assays that were not only easier to use and interpret, but more sensitive and more accurate than existing prior art/commercially available diagnostic assays. Such improved biomarker diagnostic assays were usually the result of a human-selected combination of a plurality of given/known biomarkers and then better so-called “correlations”—which are the expression levels of each biomarker with respect to the expression of the other biomarkers in the human-selected combination. Such “relative” expression levels and cutoffs are dependent on the human-selected combination of biomarkers.

The biochemical/metabolic pathways in humans are incredibly complex. See, for example, https://www.cc.gatech.edu/~turk/bio_sim/articles/metabolic_pathways.png. The simplest piece of one given biochemical pathway is like the most complex Rube Goldberg machine, with feedback loops, sensors, regulators, effectors, etc. Many do not realize and understand how the expression of one or more genes may or may not dramatically the expression of one or more other genes (because of the various feedback loops, sensors, regulators, and downstream effectors). The presence of one aberrant gene might not result in development of a given disease because other genes in the same specific pathway or another pathway may pick up the slack and cover for aberrant gene. Hence, biomarker diagnostic assays based on human-selected biomarker combinations that look at the multiple parts of a given biochemical pathway are far superior to commercially available single biomarker/gene assays in detecting disease and determining the likelihood that one might develop a disease without early preventative measures. Such multi-biomarker diagnostics also help determine whether one is likely going to respond to one therapeutic over another as two therapeutics for the same disease may target a different part of the biochemical pathway that leads to the given disease.

Unfortunately, current anti-patent views and prohibition against patenting biomarker diagnostic assays has essentially killed any incentive for one to spend the time and money needed for inventing such diagnostics and getting them FDA approved so that they are commercially available to the public. And, without the incentive of patent protection (which lasts for a limited time) that might help one recoup the enormous cost of the R&D required, we are unlikely to succeed in attaining truly personalized medicine. Instead, we will continue to be prescribed therapeutics according to what generally works for the majority and our height, weight, sex, and age rather than addressing/fixing the actual biochemical pathway that has gone amuck inside an individual.

Well, Jorge, perhaps the sentiment I was aiming at was the proper level of chagrin good-hearted people experience (or maybe should experience) when overcome by this feeling. But the post does illustrate that predictions based on what “everybody knows” (like, if course patents on isolated DNA is just wrong) can lead to unintended consequences, even for proponents of such a view.

With regard to “gene patents” specifically the decision was late enough in the game (and provided patent eligibility for the useful embodiments comprising cDNA) that there was little harm done. I’m not so sure about other natural products but that is evolving, and to the extent genetic information is relevant that will be sequestered in databases owned by large corporations. Not the Brave New World proponents envisioned but there we are.

Hope you are well. When is the book coming out?

Hi Kevin -- I like your focus on the problems caused by our healthcare reimbursement system. That is clearly a can of worms that bears little relation to the patent system, and really does need to be fixed.

My book on the Myriad case is scheduled for release in Nov. I'll send you a galley in the next couple of months -- comments, corrections and criticisms always welcome.

I learned that I prior to the 1970s patents were treated as evil anti-trust paper and then we had the 1980-2000 period when patent infringement was an effective use of patents.

I think US prosperity is related to this business cycle mentality which is of course politically manipulated.

I feel the narrowing of section 101 will come to haunt the US propensity and promote commercial invasions by other countries which will harm employment and companies of all sizes. Without IP we are fragile.

The trivialization of obviousness standards is another anti-patenting farce. I believed in the old 103 Stardard.

We are in a state of IP downward spiral and what Kevin reported is a tip of the iceberg.

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