Raj Bawa on Nanomedicine Patents

“Although the full potential of nanomedicine is years or decades away, recent advances in nano-related drug delivery, diagnosis and drug development are beginning to change the landscape of medicine,” says Raj Bawa in an essay for Small Times. Raj is the President and Founder of Bawa Biotechnology Consulting LLC (bawabio@aol.com), as well as an adjunct professor at Rensselaer Polytechnic. He also has a habit of organizing nanotech conferences in exotic locations, like India, Thailand or Troy, NY.

Raj is also a friend of mine. Every few months I get a care package containing copies of articles he has written. On top of the most recent stack was his essay, Patenting nanomedicine: a catalyst for commercialization? Raj is a former patent examiner and a current patent agent, so he knows a thing or two about the U.S. Patent and Trademark Office (PTO). Raj is a little worried about the “confusion” at PTO over a glut of patent applications coming in relating to nanomedicine. The land grab is on, as companies try to write patent claims regarding everything their nanowidget could possibly be used for, now and in the future. “The race to hurriedly patent anything “nano” has produced a pile of unduly broad patents,” says Raj. “This proliferation will ultimately produce a web of overlapping patent thickets requiring litigation to sort out, especially if sectors of nanomedicine become financially lucrative.”

So far nanotech has been devoid of the savage patent fights that biotechnology is famous for. In previous articles, Raj has compared the current state of nanotech patents with the early days of the biotechnology industry. The patent office, besieged with patents of technology it did not understand, granted a lot of overly broad patents that later had to be whittled down by litigation. History is set to repeat. The reason we have yet to see a lot of litigation with respect to nanotechnology is because nanotech companies are not making much money yet. Not too many companies sue solely for bragging rights, given the hourly rates of patent attorneys.

According to Raj, PTO’s definition of nanotechnology, essentially copied from the National Nanotech Initiative, is flawed, as far as nanomedicine is concerned. “…this sub-100 nanometer size limitation is not critical to a drug company from a formulation, pharmacokinetic or efficacy perspective since the desired property (improved bioavailability, reduced toxicity, etc.) may be achieved in a size outside of this range.” The sub 100 nanometer range has always been kind of arbitrary—it was selected because it is about the range where quantum effects become either a feature or a problem for the design of a given device or material. But for medicine, quantum effects are not much of an issue and the differences in behavior between a particle that is 100 nanometers in diameter up to one that is a micron in diameter are not substantial. The critical part of the scale for nanomedicine is actually smaller; below 50 nanometers there are real scale differences in the ability of particles to leave the blood stream, for instance.

Like any concerned alumnus, Raj worries about the institution he left. “The increase in the volume of patent application and technological advancement has created additional challenges for the PTO: workforce issues like high attrition; budgetary/revenue problems with Congress; lack of collaborative or interdisciplinary patent examination; poor automation and patent search tools; and lack of focused expertise in nanomedicine,” says Raj, in one long breath. Its enough to make someone leave and start up their own consulting firm.

But it’s not a laughing matter— “the patent thicket problem in nanomedicine may prove to be the major bottleneck to viable commercialization, negatively affecting the whole nanomedicine enterprise,” Raj concludes. Bummer.

I hope that Raj is wrong, but he’s probably right; the man knows whereof he speaks. All the wonderful hype about nanomedicine, like Ray Kurzweil’s improbable mantra—“Live long enough to live forever”—may go up in smoke, at least while litigants grind through patent issues.

Cancel my membership in the Immortality Institute.