Tom Blackwell National Post
A major pharmaceutical company has taken the unusual step of suing an Ontariohospital for patent infringement, alleging the institution effectively duplicated apatented Bayer Inc. antibiotic by diluting a more concentrated, generic version ofthe same drug.
The case is an extraordinary example of the lengths to which pharmaceuticalcompanies will go to defend their intellectual property - and is likely to succeed incourt, said medical and patent-law experts. However, the lawsuit may wellbackfire on the public relations front, they predicted.
"I think this is going to look, from Bayer's point of view, pretty petty," said JoelLexchin, an emergency doctor and health policy professor at Toronto's YorkUniversity.
"The hospital is probably doing this for a small number of patients, costing Bayeralmost zilch in terms of lost sales. If this drives up hospital costs, Bayer, I don'tthink, would look very good."
Bayer filed the lawsuit last week against the Thunder Bay Regional HealthSciences Centre, demanding the hospital stop producing and selling a dilutedversion of intravenous ciprofloxacin, give back any profits it made and pay"aggravated, punitive and exemplary" damages.
The company declined to discuss the action in detail, but defended it as necessaryto protect a product into which it has invested hundreds of millions of dollars inresearch and development. It had earlier tried, unsuccessfully, to get aninjunction against Sandoz Canada, which makes the much-cheaper generic productused by the hospital.
"We have always vigorously defended our patent rights and will continue to doso," said Emily Hanst, a Bayer spokeswoman. "We do defend our patent rights tothe end."
The health sciences centre refused to comment on the case.
Ciprofloxacin, the drug at the centre of the dispute, counters a variety of differentbacteria, including those causing urinary-tract and kidney infections. It becamefamous a few years ago as the chief treatment for anthrax victims in the UnitedStates.
While the patent on tablet versions of cipro expired in 2004, Bayer's IV form, soldto hospitals in pouches ready to be infused in patients, is protected until March,
http://www.canada.com/components/print.aspx?id=6060b53b-fc0a-4ba5-b50e-8174feae6696&k=0
2008. Bayer sold $24-million worth of cipro over the past year, according toresearch firm IMS Health Canada.
Sandoz received Health Canada approval last year to market a concentrated,generic version that must be diluted before use, prompting Bayer to sue thegeneric firm. In a decision in April, however, the Federal Court denied Bayer'srequest for a temporary injunction halting sales of the Sandoz cipro until the casecomes to trial.
That did not stop the German-based company from going after the Thunder Bayhospital. The statement of claim Bayer filed in Federal Court alleges the hospital took thecontentious Sandoz cipro and diluted it to the same concentration as the brand-name version.
No statement of defence has been filed and the allegations have not been provenin court.
The pharmaceutical industry accounts for the vast majority of patent lawsuits inCanada, which typically cost each side about $1-million in legal fees, said RichardGold, head of McGill University's Centre for Intellectual Property Policy.
Upholding and extending patents on existing drugs is increasingly important forbrand-name companies since so few new breakthrough, high-profit drugs havebeen brought to market lately, he said.
In most cases, though, the firm sues a competitor, usually a generic manufacturerlike Sandoz, not a public institution, noted Prof. Gold.
"They tend not to want to [sue hospitals] because, a) they are their customers,and b) it looks bad in the press," he said. "And it's not like the pharmaceuticalindustry is a well-loved industry."Bayer may fear that other hospitals will follow the Thunder Bay hospital's exampleand wants to set a precedent, he said.
The few cases where pharmaceutical companies have aggressively defended theirpatents against public-sector agencies have usually backfired, said Tina Piper,another McGill law professor.
She cited the case of Myriad Genetics, a U.S. company that was criticized afterthreatening court action against Canadian provinces for violating its patent over agene-based test for breast cancer.
Intravenous versions of antibiotics are typically given to patients when theycannot take a pill orally for some reason, said Dr. Michel Laverdière, president ofthe Association of medical microbiology and infectious disease Canada.
He said he is not aware of any other hospital diluting a generic version ofintravenous cipro.
Copyright 2007 CanWest Interactive, a division of CanWest MediaWorks Publications, Inc. All rights reserved.
http://www.canada.com/components/print.aspx?id=6060b53b-fc0a-4ba5-b50e-8174feae6696&k=0
INSTRUCTIONS FOR COLONOSCOPY USING HALFLYTELY Important – Please read this instruction sheet completely You have received a prescription for HalfLytely. Have your prescription filled at a pharmacy. 1. On the morning prior to the examination, mix HalfLytely with lukewarm tap water to the top of the line on the bottle, shake to dissolve powder, and refrigerate. Add flavoring packet o
Friday » August
2008. Bayer sold $24-million worth of cipro over the past year, according toresearch firm IMS Health Canada.