[Ip-health] Patently absurd - article in Toronto Star (March 15/04)

[Richard Elliott]

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[ Picked text/plain from multipart/alternative ]

TORONTO STAR
Monday, March 15, 2004
http://www.thestar.com/NASApp/cs/ContentServer?pagename=3Dthestar/Layout/Ar=
ticle_PrintFriendly&c=3DArticle&cid=3D1079305810078&call_pageid=3D971358637=
177

>Patently absurd: Canada's copyright law
>Drug firms enjoy rights here others can only dream of
>
>But top court to hear a challenge to Mulroney-era law
>
>KEVIN LIBIN
>SPECIAL TO THE STAR

>With the power cut to save money and the place as well-heated as a meat
>locker, a walk through the empty, darkened hallways of Biolyse Pharma
>Corp. feels like you've stumbled on to a ghost ship. Tucked away in a
>sheltered valley, hidden from the busy highways that shoot through the
>town of St. Catharines, the only sounds are the howl of a biting wind and
>the roil of Twelve Mile Creek, which rushes just a few feet past the old
>building.
>
>The Biolyse plant was once home to Niagara College, and many of the
>classrooms and lockers are still here. Things seem like they're frozen in
>a state of suspended animation and, in a way, they are.
>
> From one week to the next, Brigitte Kiecken and her husband, Claude
> Mercure, have been locked in a battle over intellectual-property (IP)
> law, waiting to find out whether they'll suddenly be ordered to shut
> their doors.
>
>They moved here in 1999, leaving behind a home and a lab business in
>Quebec's Gasp=E9 region. They had plans to convert the empty college
>building into a bustling drug plant, churning out vats of their
>anti-cancer drug, Paclitaxel for Injection.
>
>Five years later, you have to know where to look if you want to find the
>barely half-dozen workers left shuffling quietly around Biolyse. Today,
>the scientists are spending most of their time outside, in the =AD30 degre=
e
>C chill. Mercure and others have been toiling through the frigid night to
>repair the two-storey structure of tanks and tubes needed to compress a
>tangled heap of prickly Canada yew trees into a few vials of potentially
>life-saving medicine.
>
>"We were actually in the process of having a roof installed over the whole
>installation, and ended up paying lawyer fees instead," sighs Kiecken,
>Biolyse's president and chief administrator, sitting in what was
>undoubtedly once the dean's office. "Some things get neglected. At least
>if they had a roof, they wouldn't be so cold."
>
>Biolyse has had to forgo a lot over the past year. Kiecken and Mercure
>developed a groundbreaking way of producing a critical cancer-fighting
>drug. But selling it has been a challenge, to say the least.
>
>That's because Bristol-Myers Squibb, which makes a similar drug called
>Taxol =AD based on a synthetic version of a compound called paclitaxel fou=
nd
>in a tree related to the Canada yew =AD has accused Biolyse of infringing =
on
>its patents. Squibb has yet to prove as much, but thanks to what critics
>claim is Canada's overprotective treatment of patent holders, Squibb
>merely has to accuse Biolyse of infringement and it can block Paclitaxel
>for Injection from the Canadian market for years.
>
>It's a perfectly legal manoeuvre that brand-name firms have been using
>since the mid-1990s to prevent generics from disturbing their monopolies
>on drugs after the original patents have lapsed. No other country gives
>big drug manufacturers this kind of unchecked power =AD and no other
>industry in Canada has it as good as the drug makers, either.
>
>Powerful pharma companies enjoy a dominance in Canada that they can only
>dream about elsewhere. The upshot is that smaller producers and generic
>manufacturers trying to bring cheaper products to the Canadian market face
>hurdles that just don't exist in the United States and Europe.
>
>"Imagine working on something for 14 years," says Mercure, who, though he
>is supposedly retired for health reasons, continues to show up to work
>almost daily to help out where he can. "You're down to the commercial side
>of it, and you're stretched out to the maximum, and you have contractual
>obligations, and then a judge can just say, `You guys are closing down
>tomorrow,' without demonstrating any patent violation on our part. No
>other business in the world is subject to this kind of harassment."
>
>Blocked from selling its paclitaxel drug, Biolyse laid off most of its
>employees last spring. It's tough to plan for the future, say Kiecken and
>Mercure, when they don't know whether they'll suddenly be ordered to shut
>their doors permanently or, on the other hand, win the right to supply
>every province in the country with badly needed treatments for breast,
>lung and ovarian cancers.
>
>A judge has given Biolyse permission to sell its paclitaxel, though it now
>has just one customer =AD British Columbia's cancer care agency. Other
>provincial agencies, spooked by the lawsuits, say they can't afford to
>commit to a drug whose supply could be cut off at any moment. When it came
>time to harvest the yew bushes this year, says Kiecken, she had no clue
>how much they would need.
>
>
>----------
>`We're wasting our time in court, and people are dying of cancer'
>
>Brigitte Keicken, president of Biolyse Pharma
>
>
>----------
>Usually, it doesn't even matter how defensible these sorts of
>patent-infringement claims are. By the time the accusations see the inside
>of a courtroom, the big pharma companies have either come up with an
>improved replacement drug, or the smaller, less resilient firms are
>consumed by monstrous legal fees.
>
>"They wear you out =AD that's what they like to do," says Kiecken. "And it
>works."
>
>In the crosshairs of one of the biggest pharmaceutical companies in the
>world, fighting over a drug worth nearly $1 billion (U.S.) in yearly
>revenue, that might have been the predictable end to Biolyse =AD if it
>hadn't been for a recent court victory that gave the company the right to
>take its case before the Supreme Court later this year.
>
>In theory, Canadians are sitting on a gold mine, something Kiecken and
>Mercure were the first to figure out, in 1988. Before that, the only known
>source of paclitaxel came from the bark of the Pacific yew (Taxus
>brevifolia), found in the Pacific Northwest =AD a discovery made by the U.=
S.
>government's National Cancer Institute in the 1960s.
>
>But getting the substance required killing the tall yews, and Pacific yews
>take nearly a 100 years to mature. In the late '80s, the NCI called for
>alternative solutions, and an army of scientists went to work to find it =
=AD
>including Kiecken and Mercure, who wondered if the yews growing in their
>backyard might not be hiding some of the same life-saving compounds as
>their cousins out west.
>
>They found the paclitaxel in the needles. But in 1991, the NCI partnered
>with Bristol-Myers Squibb to develop paclitaxel, marketing it as Taxol.
>When Kiecken and Mercure notified Health Canada about their discovery, the
>agency had to decide whether the paclitaxel in the Canada yew was a whole
>new drug, or should be considered a copy of the compound found by the NCI
>years earlier.
>
>Health Canada ruled that since Biolyse's product came from a different
>source, it was not a copycat of Squibb's Taxol. But that meant Biolyse
>couldn't rely on NCI clinical trials and would have to prove its drug's
>efficacy with their own trials. Seven years and $7 million later, Biolyse
>received Health Canada's notice of compliance =AD a formal approval for
>injectable paclitaxel to be sold to cancer patients.
>
>With that work behind them, Kiecken and Mercure geared up to supply the
>drug to Canadian hospitals. Underfunded provincial health authorities in
>British Columbia and Ontario rushed to sign exclusive contracts for
>Biolyse's drug, which is cheaper than Taxol.
>
>But a month later, Squibb's lawyers petitioned to have Health Canada's
>decision overturned, accusing Biolyse of selling a generic imitator and
>violating Canadian patents on Taxol. A Federal Court judge agreed and
>revoked the approval for Biolyse's drug in 2002. The company was
>immediately enjoined from marketing Paclitaxel for Injection for two
>years, until the matter got hashed out in a courtroom.
>
>Any other intellectual-property dispute in Canada would work the opposite
>way: the patent holder would first have to prove that the other company
>had infringed on its patent rights before blocking the sale of the product
>in question. If successful, the patent holder would be able to stop the
>violator, and demand compensation and damages for any money made using the
>patented technology without permission.
>
>Under rules created by Brian Mulroney's government and implemented in
>1993, only drug companies have the luxury of shutting down competitors'
>products before they even see the light of day. Since then, multinational
>pharmas have become increasingly sophisticated in their attempts to stop
>competing drugs =AD particularly generics =AD from reaching market.
>
>In Canada, in particular, certain drugs have kept challengers away long
>after original patents have lapsed, a process known in the industry as
>evergreening. According to Canada's Patented Medicine Prices Review Board,
>fewer than 1 per cent of ostensibly new drugs can accurately be considered
>the first drug to effectively treat a condition or represent a significant
>improvement over existing medicines. As brand-name companies make slight
>modifications to their drugs and continue to file new "later-listed"
>patents on top of existing ones, they can usually refresh their
>intellectual-property rights far beyond the 20-year exclusivities
>guaranteed to drug makers.
>
>In Canada, where drug spending increased by 13.9 per cent in 2002, you
>might expect legislators to bristle at anti-competitive behaviour in the
>high-stakes medicines market. In his 2002 report on Canada's health-care
>system, Roy Romanow specifically singled out evergreening as something
>that should be addressed immediately by a federal review. There have been
>Senate hearings on the matter, and an investigation is underway at the
>Competition Bureau. But the Liberal government has done nothing to change
>the federal regulations.
>
>"We're wasting our time in court, and people are dying of cancer," says
>Kiecken.
>
>Any decision that draws bright lines around what constitutes genuine
>intellectual property in Canada would carry far greater significance than
>just the case at hand =AD or for the drug marketplace in general. It could
>set the tone for how our society chooses to balance the interests of
>inventors with our respect for free competition.

Richard Elliott
Director, Legal Research & Policy / Directeur, politiques et recherche
juridique
Canadian HIV/AIDS Legal Network / R=E9seau juridique canadien VIH/sida
890 Yonge Street, Suite 700, Toronto, Canada M4W 3P4
Tel : +1 (416) 595-1666                 Fax +1 (416) 595-0094
E-mail: relliott@aidslaw.ca     Web: www.aidslaw.ca

The Canadian HIV/AIDS Legal Network is a partner organisation of the
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Le R=E9seau juridique canadien VIH/sida est un organisme partenaire  du AID=
S
Law Project
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du
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et social des Nations Unies.
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