Tuesday 11 December, 2007

Viagra canada

In the case related to the famous drug Viagra, the patent covered the use of sildenafil (the active ingredient in Viagra) for the treatment of erectile dysfunction. Apotex had alleged that the claims were invalid as being obvious, anticipated, broader than the invention, and were not claims to the use of the medicine.
Corresponding patents in the United Kingdom and other jurisdictions had been found invalid on the basis of obviousness, and the Canadian case turned on this very issue. Justice Mosley rejected the obviousness attack. He reinforced the value of inventions to society and reaffirmed that obviousness is a difficult test to satisfy. He considered all the relevant factors, including the teaching of the prior art as well as secondary indicia such as the surprise that accompanied sildenafil?s launch, its subsequent wide use and acceptance, and commercial success. The Court concluded that the most that could be said was that the prior art suggested that the class of drugs to which sildenafil belonged might have benefit in treating impotence (i.e., that the class of compounds might be ?worth a try?).
Justice Mosley recognized that inventions do not come out of the blue, but are based on the body of work in the prior art and on incremental progress; that is, they are part ?deductive science and part luck,? a standard consistent with Canadian case law, which holds that invention can arise equally through empirical research or lucky chance and inspiration.
Under Canadian law, a solution to a problem that might be ?worth a try? is not obvious. This is particularly so when, as in this case, all the experts who were working in closely related fields could not answer the question, ?If it was so obvious, why didn?t you do it??
Another notable aspect of Justice Mosley?s decision is the way he treated the so-called Swiss-type claims. While typical-use claims are often drafted to read ?the use of compound A for the treatment of condition B,? Swiss-type claims read ?the use of compound A for the manufacture of a medicament for the treatment of condition B.? Whether or not these are ?claims for the use of the medicine,? which entitles a patentee to assert these claims in Patented Medicines (Notice of Compliance) Regulations litigation, had been an unsettled question under Canadian law. Justice Mosley had no difficulty concluding that, ?taking a practical approach to [claim] interpretation,? the Swiss-type claims were ?claims for the use of the medicine? and entitled to the benefit of the protection of the Regulations .
The other validity allegations were also found not to be justified. As a result, Apotex is prohibited from obtaining marketing approval for its generic version of Viagra until after the patent expires in 2014. The decision is subject to appeal.

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Disclaimer: "IP Pharma Doc" blog is published for information purpose only. "IP Pharma Doc" blog contains no legal advice. I assume no legal responsibility for the views/information expressed here. “IP Pharma Doc” blog is my personal website and not edited by my employer, accordingly, no part of my blog should be attributed to my employer. All information on the present blog should be double checked for its accuracy and applicability. © Dr. Sarwal (2007)
 
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