While political pundits might consider 2013 the year of the “no,” biotechies might think about it as the year of the “know.”  Who can know what, what knowledge is patentable, and knowing how it can be used were all issues which found a newly devoted audience, including seven people in long robes.

In AMP v. Myraid, the Supreme Court ruled that some DNA can be patented, and some cannot, allowing clarity second place behind confusion.  Genes are now officially not patentable (which surprised few), however the biochemically trivial change of making “a cDNA” (a biochemical casting, such as a foot leaves in mud) is patentable.  While Myriadmay not stop others from detecting the BRCA genes by sequencing, at least some other methods (those that use cDNAs) may be able to be protected.  Clear. As. Mud.

Similarly obscure but potentially having even greater impact on diagnostics was the Supreme’s 2012 decision in Mayo v. Prometheus.  The court ruled that detecting a pattern that occurs (such as one in the blood) — essentially the essence of lab diagnostics — is not patentable.  Moreover, next generation tests are anticipated to be based on unexpected, non-intuitive, novel patterns and algorithms that “know” if a person has cancer, Alzheimer’s, depression or other disease. Needless to say, not everyone was happy with the decision.

The rub here is whether that information and algorithm can be used in a way that is inventive AND that doesn’t stop others from using the pattern or the algorithm.  Including the application of a known method in a new setting has allowed petitioner’s claims.  Official “guidance” has been issued but clarity still awaits her day. For these patents, you pay your money, disclose your secrets, and await rulings by junior examiners, courts and potentially an act of Congress to know if they will be protected.  Thus proprietary algorithms and methods, which never expire, never legally become public, and cost many tens of thousands of dollars less than patents may become more frequent methods of IP protection. Who knew?

What the FDA knows and discloses has also been a big issue.  Many trials, and most of the knowledge the FDA receives are never disclosed.  A key motivation for the initial existence of the FDA was a lack of information.  Back in the 19th century, it was common that neither patients nor physicians knew what was in “Patent Medicines” (for example Mrs. Winslow’s Soothing Syrup, promoted as effective in the NY Times in 1860’s contained enough morphine that it killed infants via respiratory depression).

In early 20th century congress acted to create the FDA.  At the time no effective information sharing system existed. The FDA came into existence to collect information and to remove from the market unsafe foods and medicines. Latter the FDA was authorized to both remove products that were not effective and pre-determine — even prior to the available of adequate information — both safety and efficacy.  Over time its job has evolved to determine the subtle and often unknowable balance of risk vs. benefit before sufficient general use has occurred to allow either risks or benefits to be known.

But the essence of personalized medicine is that this precise balance is different for each patient.  Thus the information and knowledge disparity is now flipped.  While the FDA, at best, has generalized sub-population (clinical trial) statistics, physicians have extensive individual information (which will only increase with electronic medical records, gene sequencing, protemic profiling, etc.).  Physicians can already order detailed information on individual patient metabolism pathways (which effect drug metabolism and thus dosage).

While the FDA has successfully pressured 23andMe, which provided additional gene information, future generations of such services (which will have biomedical software, manuals and people to increase recipients understanding of individual results) are likely to flourish.  So long as the FDA plays nice — or is pushed to increase disclosures — the information imbalance is irrevocably switched: doctors and patients can be more in the “know” than the FDA.  But the tension here remains: to what extent will a patient be permitted to know themselves?