Leaders in Pharmaceutical Business Intelligence (LPBI) Group

A Personal View on IP: Larry H Bernstein, MD, FCAP

Author: Larry H Bernstein, MD, FCAP

I comment made on 12/9/2013

I have 3 patents, and I flew to Washington to the Patent Office with my now deceased patent attorney who had degrees in law and engineering, and both his sons were in Patent Law. I didn’t have the income to spend on my test for neonatal hyperbilirubinemia done by spectrophotometry. I spent about $100,000 dollars on patents, and only 1 submission out of 10 pass. The next step is harder. Getting it to the market. The market is blind to science. It is driven by market drivers. Perry Seamonds got his start as Medical Director of a Computer company owned by Rolls Royce, installed at Mayo and at Buffalo General. He is not only an outstanding physician (ophthalmology), but also knows the laboratory, trained under a Nobel nominated biochemist at Columbia, and had the patent on the bicarbonate enzymatic assay used on all instruments today.

He solved an automation problem that Technicon took for it’s own in creating the SMAC – removing the timing coils and using carryover correction. A decade before this, David Seligson had a falling out with Technicon because he had invented the multiphasic system. Yale became known for making it’s own instruments and reagents. But Michael Lehrer, one of the best, told him that their time had come and gone. There was a cost to developing the tests, a cost for quality control, and the problem of how to participate in a proficiency testing program. The regulation of the laboratory operations, already very good, became more cumbersome, but was helped by advances in manufacturing.

He was a visionary a decade ahead of his time. When every laboratory manager was attending user group meetings and the blackboard was filled with instruments coming on-line that needed interfaces, he saw and understood the problem. His engineer produced a “black-box” for each instrument. Each instrument was tied into a desktop “middleware” interface because the configuration then had physicians competing with the laboratory that was putting out 2 million tests a year. He was funded significantly by the medical staff. I visited his first installation, and I was told that the support was as good as he expected. His system was copied by a well put together company that preceded the one developed by Harvard. Arthur Karmen, one of the great clinical chemists, had experience with the system and then had it taken away and replaced by the vastly inferior system out of Kansas City that Mas Chiga and I discussed. Mas had already linked his computer to all the physicians on the medical staff.

I also had a long association with some of the leaders who had good knowledge of the computer that NIH built using a special language, that became a Boston-based company – MediTech. The history of the laboratory experience with informatics is a good 40 years old. Many of the EHR staff came out of the laboratory, and amazingly, the Blood Bank. I spent maybe 10 years with the AACC Laboratory Information Systems Division. It is established that 80% of the information a physician uses comes from the laboratory.

I recently filed a provisional patent for the “Second Opinion” that we developed – Gil David from Technion and RR Coifman, at Yale. It was validated and had a 30,000 patient database.

Kodak told me that I was always ahead of the market. The best representative, whose father was a computer scientist, came to my laboratory and showed me a program that would page the doctor on a critical value. We paged the surgeon who was in charge of the burn unit with a transthyretin value of 8. He loved it. Nursing had a stack of cellphones in a closet! It wouldn’t fly for security reasons. Four years later I was contacted by a company that had done the job completely.