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CASE STUDIES

The First IP Lesson

By the end of 1980s and the beginning of 1990s, Tuberculosis, which was on decline in the United States suddenly started coming back creating a new scare amongst the healthcare professionals. This resurfacing of TB problem in the West was principally because of the AIDS epidemic. My research in TB diagnosis brought me to a US startup biotechnology company incorporated in Delaware in 1989. This Company was focusing on TB because of the new TB scare all across North America, and they picked me up literally looking for me half the world across.

While our focus was diagnostics at the time, two very famous research groups, one from a University in Northeast and another from Midwest claimed to have developed a magic prevention of TB requiring just one injection per month. They were widely covered by all the major news channels of US. They were often interviewed on TV about their once-a-month magic bullet injection to contain TB. One of them got in touch with us to offer his technology for clinical development. He was a very high profile scientist who had been continuously funded by National Institutes of Health (NIH). My boss, the CEO of my company who had almost made up his mind to invest in the technology asked me to review the technology, essentially because I was the only MD in the company. Well it was a privilege for a biotechnology company at the time to have an in-house physician.

I was relatively new in the US drug development industry and completely naïve to how science is actually played out in academia and industry. The technology was simply to use one of the most common ant-tuberculosis drugs INH (isoniazide) and load it in a biodegradable polymer to affect a slow release over long periods of time as the polymer degrades. I was neither a polymer chemist nor a pharmacologist. But common sense cannot be defeated even by rocket science. All I had to do was look into the half life of INH and its water solubility. This was because common sense told me firstly, that the more a drug is water soluble the faster it will elute out of the polymer, even before the polymer itself was completely degraded; and secondly, the shorter the half life the faster the drug will disappear from circulation. INH is highly water soluble and has relatively short half life of between 1 and 3 hours. Both these factors made it impossible that INH loaded slow release polymer formation can maintain sufficient therapeutic levels even for a week forget about a month. My boss was a pharmacologist still he could not believe my opinion because this guy was like God of tuberculosis. He even had a drug named after him. And also because how can the prestigious NIH go on funding if the concept was frivolous. And, more importantly because I was very new to the industry and obviously an underdog.

Well, I told my boss, “You got two choices. Either invest a million bucks in the guy’s proposal, or just spend a few thousand dollars in my protocol and I will show in less than two weeks that this is all non-sense. You don’t have to invest all that time and money to develop the INH polymer. INH is an approved prescription drug widely available all over the world. I have my physician colleagues in practice who can recruit about 10 healthy individuals and administer them INH infusion simulating the slow release pattern of the INH-polymer formulation. We will blind the blood samples and let this gentlemen’s own lab measure the INH levels in those blood samples. I bet my life you will not find even a trace of INH even if you infuse twice this guy’s estimated dose.”

A few weeks later my boss ended up saving millions potentially wasted in a publication-driven academic research, and I ended up learning my first lesson on the art and science of seeing the unseen of the Intellectual Properties. All that glitters indeed is not Gold, even if the God of the glitter says so.