In the fall of 1992, a relatively unknown pharmaceutical company based in Pickering, Ont., filed a 47-page document with the Canadian Intellectual Property Office, seeking to patent a new invention it said could transform the way doctors treat pain.
Like the millions of patent applications before it, the one filed in Gatineau, Que., by the Canadian subsidiary of U.S. drug giant Purdue Pharma promised remarkable things.
The company’s researchers had “surprisingly” discovered a new way to treat pain. Purdue’s innovative pill would substantially improve the “efficiency and quality of pain management,” because it didn’t need to be taken as often as other medications.
Most importantly, it was safer. In a section of the application called “Summary of the Invention,” where the benefits of the innovation are recorded, Purdue said its new pill could treat pain “without unacceptable side effects.”
The drug was awarded Canadian Patent No. 2,098,738. Its official title in the paperwork was listed as: controlled release oxycodone compositions. But Purdue called it OxyContin.
It would go on to become a blockbuster drug – the most popular long-acting prescription painkiller in Canada for more than a decade, and one of the most lucrative pharmaceutical inventions to hit the market.
When asked in 2014 how much money the company had made from the drug, Purdue Canada chief executive officer Craig Landau struggled to say.
“I’m honestly not certain. I don’t know. It’s in the billions of dollars for sure,” he told a House of Commons committee examining prescription-drug abuse.
In fact, the profits from OxyContin were massive, and growing every year. In Canada and the United States, where the drug was also patented, Purdue has made more than $30-billion (U.S.) from OxyContin since the mid-1990s.
Seeing this trend, other Canadian drug makers wanted a piece of those profits, and a series of patent wars broke out. Unwilling to wait the standard 20 years for the patent to expire in 2012, at least three pharmaceutical manufacturers went to federal court starting in 2005, seeking to produce their own versions of OxyContin.
In thousands of pages of court filings detailing those cases, which had not been made public until now, Patent 2,098,738 soon became shortened to the more manageable “Patent ‘738,” which became short form for one of the biggest backroom battles in Canadian pharmaceutical history, though few outside the business knew it was going on.
But as the drug makers fought over OxyContin’s spoils, deadly problems were emerging with the drug, and the industry knew it.
OxyContin wasn’t merely a commercial success because it was effective at killing pain – it was also highly addictive. Patients who were prescribed the seemingly benign pills for everyday conditions, such as back pain, were becoming hopelessly dependent upon them, unable to break their habit and requiring stronger and stronger doses as time went on. Increasingly, people were dying.
Canada’s opioid epidemic, which traces its roots back to the introduction of OxyContin and Patent ‘738, has now killed thousands.
Some of the biggest concerns about OxyContin, though, were raised by the drug industry itself, within numerous patent battles from 2005 to 2012 that never attracted any publicity.
Ranbaxy Pharmaceuticals Canada Inc. accused Purdue of “material misrepresentation,” alleging that Purdue knew from its own clinical research that the claims listed in Patent ‘738, which said OxyContin was safer and more effective than other prescription painkillers, could not be supported. “Such statements were added intentionally to mislead the Patent Office into believing that an invention existed,” Ranbaxy said.
Purdue disputed these allegations, and others, even as further lawsuits insisted the drug was far more addictive than its creator suggested.
But the attacks on Patent ‘738 weren’t designed to warn the public about problems with OxyContin. Instead, their purpose was to have the courts declare the patent invalid, so that other companies could move in and manufacture their own versions of the enormously profitable pill. In doing so, they hoped to claim some of the billions of dollars being made from controlled-release oxycodone.
This is the story of how Patent ‘738 sparked the opioid crisis in Canada, with OxyContin serving as the gateway to an epidemic of addiction that has since spread to other, more hazardous substances such as fentanyl. It has left many dead, and many more ravaged by the drug and its implications.
It is also a tale of how marketing – not necessarily sound medicine – helped turn Patent ‘738 into one of the most profitable drugs the industry has seen in recent memory, and how careful Purdue has been to protect that empire, even as the damage spread.
In 2014, Purdue Canada’s CEO acknowledged Canada had a problem with overprescribing opioids.
“We have a lot of work to do,” Dr. Landau, an anesthesiologist and pain doctor, told the House of Commons committee.
“That said, and to state the obvious, I do represent a company and I can’t remove my affiliation. We’re a company, and like any other business, we need the ink on our ledger to be black and not red.”