It must be the most thankless job on the bench.
A core group of Federal Court of Canada judges toil away in virtual anonymity, juggling an ever-growing backlog of numbingly technical cases involving hundreds of millions of dollars of corporate profits.
The big money is about as close to drama as these cases get. Witnesses never appear in court to testify. Instead, judges must wade through knee-high stacks of conflicting affidavits and scientific testimony that are about as dull as an accountant's daybook.
Welcome to the tangled world of pharmaceutical patent litigation. When the federal government introduced a tortuous bit of rule-making known as the Patented Medicines (Notice of Compliance) Regulations in 1993, its goal was to strike a balance between the rights of drug manufacturers to protect their patented inventions and the ability of generic producers to bring cheaper drugs to the market.
Instead of balance, however, the regulations have given way to what can only be described as a judicial nightmare. Federal Court judges are swamped with a rising tide of complex litigation and law firms are scrambling for talent to keep up with one of the country's fastest-growing practice areas.
Currently, there is a team of approximately 30 Federal Court judges devoting some or all of their time to about 350 separate drug patent cases. It is a staggering load of files, involving arcane scientific disputes about what may or may not be protected by patents.
On the one side of the great legal divide are giant drug companies that keep a small army of specialists at such firms such as Gowling Henderson LLP busy fighting generic companies seeking to introduce drugs that they believe are no longer protected by patents. Fighting back are a handful of aggressive generic manufacturers such as Apotex Inc. and NovoPharm Ltd. that are prepared to wage expensive courtroom battles with the help of high-priced talent from such firms Goodmans LLP and Heenan Blaikie LLP, respectively.
"The system is overwhelmed. It is a very unsatisfactory regime," said Ron Dimock, a Toronto lawyer with Dimock Stratton LLP, who has represented both traditional and generic drug manufacturers.
The need for specialized talent is so great that Heenan Blaikie LLP recently struck a preliminary agreement to hire all 12 lawyers and 23 staff at the Toronto-based patent specialist firm Ivor M. Hughes.
"The pace, intensity and proliferation of patent litigation has put enormous pressure on firms to add expertise and capacity just to keep up," said Jonathan Stainsby, who heads Heenan's patent litigation group.
Depending on who you talk to, the flood of litigation can be attributed to the flawed structure of the Patented Medicine rules. Drug manufacturers with deep litigation pockets have been able to use the rules as a stalling device that is so powerful that the Supreme Court of Canada called it "Draconian."
Every time a prescription drug manufacturer challenges a generic company's plan to introduce a new product to the market, the rules typically require the generics to shelve plans for as much as 24 months until, typically, a Federal Court judge hands down a decision on the dispute. With that kind of stalling power, it is little wonder that drug companies are eager to drag generic competitors into court.
Once the cases land in Federal Court, arriving at justice is no easy matter.
Unlike the United States, which has installed a specialized network of patent courts to resolve disputes, Canada has shifted the burden to Federal Court judges who have little or no scientific expertise to bring to the drug litigation.
"Judges are human, not computers," an exasperated Mr. Justice Roger Hughes of the Federal Court told battling lawyers in court last summer after he was deluged with written and conflicting expert opinions during a drug patent case.
In a widely quoted drug patent decision in 1993, former Federal Court judge Francis Muldoon complained that an "unschooled judge cannot perceive the truth ... among all the chemical or other scientific baffle-gab."
Reform is badly needed, Mr. Muldoon complained, to stop what he called "a solemn exercise in silliness."
With little hope for reform in sight, drug companies are focusing their energies on a kind of scientific one-upmanship. The more scientists that big drug companies throw at their cases, the more resources are needed by generic competitors such as Apotex and NovoPharm.
"You are not much use to your client unless you understand the scientific issues," said Norm Bacal, Heenan's national co-managing partner, who led the discussions with Ivor M. Hughes.
"This gives us the opportunity to expand our pharmaceutical practice and branch out broadly across the patent law."
For patent watchers, the most interesting thing about the deal is that Ivor M. Hughes agreed to close shop and move in with Heenan. The small Thornhill, Ont.-based firm was founded more than 30 years ago by Ivor Hughes and has built a reputation as a leading patent expert.
For years, the firm has worked closely with Goodmans and its client Apotex, so more than a few industry players were surprised when word began circulating that Mr. Hughes was joining Heenan.
Mr. Hughes was not available to comment. But according to Galileo Search Ltd.'s Michael Cooper, who initiated the talks with Heenan, Mr. Hughes' priority was to find a firm that would hire all of his staff and had the potential to expand into new areas of patent work.
"We made a short list and Heenan was at the top," Mr. Cooper said.
Patent specialist firm Ivor M. Hughes has a staff of 30 in which three are lawyers. Incorrect information was published Wednesday.