32 years ago, I wrote my first patent…
…the technology is now an overnight success.
If you dispute the notion that medical product development is a marathon, not a sprint, consider the attached article from MedTech Dive describing Boston Scientific's first-of-its-kind paclitaxel-coated balloon for the treatment of in-stent restenosis.
United States Utility Patent Number 5,716,981 authored by a medical student (Me), a young interventional radiologist (Lindsay Machan), my graduate supervisor (Larry Arsenault), a UBC professor (Helen M. Burt), and her jack-of-all-trades technician (John Jackson), first described pactlitaxel-coated stents and drug-eluting balloons in 1992. We started a company (Angiotech), partnered with the NIH (Alan Heldman and Jeff Frohlich) and BSC to develop what became the wildly successful TAXUS stent. James Barry, the technical lead at BSX, had deep experience in drug-eluting balloons and we had working prototypes as early as 1997, however, the balloon project was deemphasized because the race for DES supremacy became our singular focus.
Derived from pacific yew tree bark (taxus brevifolia), paclitaxel was hard to find and even harder to make. In those years, it was sourced from local tree farms, extracted, and purified through a lengthy and expensive semi-synthetic process; chemical synthesis was achieved years later. The drug is virtually insoluble in water, a characteristic that made it challenging as a billion-dollar breast cancer drug, but a curious advantage for a balloon delivery agent. Wanting nothing to do with the aqueous blood stream, the drug would preferentially seek refuge in the fatty lipid plaque of the diseased artery, serving as its own form of targeted drug delivery to the blood vessel wall.
By the time I left Angiotech to start Canary, paclitaxel was used in peripheral stents and in drug-eluting balloons for lower limb ischemia. The drug suffered a major setback when unknown Greek researchers gained international notoriety for claiming a meta-analysis showed higher death rates for vascular patients receiving paclitaxel. Competitors leapt on the news, which ultimately was proven to be false and arguably fraudulent, but the damage was done and paclitaxel use declined precipitously. Brilliant researchers at Boston Scientific (whom I have never met) clearly persevered and resurrected paclitaxel-eluting balloon technology. Managing the tough in-stent restenosis patients is an incredible accomplishment.
As for old US Patent 5,716,981? It survived validity challenges taken all the way to the English House of Lords; the resulting IP case law is still taught in most law schools. It has long expired, and I won’t be waiting by my mailbox for royalty cheques, but it served its intended purpose of spawning interest and investment in a new field of scientific exploration. Tonight, I will raise my glass to taxus brevifolia – proving once again, that in science, nothing beats a great molecule.
Field Reimbursement Manager, Pfizer Oncology
3moWhich hospitals currently have this technology? Thanks!