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Generic Viagra

Even thought there are many places to buy generic Sildenafil Citrate, the active ingredient in Viagra, a generic Viagra copy designed in Poland is set to hit the country's drugstores and take a slice out of Pfizer's Viagra sales. But Pfizer say it blatantly violates their EU patent and is filing suit. The situation reveals a deeper rift between this country's love of cheap generics and the EU's stricter stance on intellectual property.

Four years ago, a handful of chemistry professors at the Pharmacological Institute in Warsaw found an alternative way to synthesize sildenafil, the active ingredient found in Viagra, that world-famous little blue pill created by pharmaceutical giant Pfizer and used by men worldwide to fight erectile dysfunction (ED). Now Polpharma, the Polish pharmaceutical concern that bought the new recipe and even got it registered in Poland last March, is set to take it to market, providing a cheap viagra alternative to the sex drug once famously endorsed by Bob Dole on American TV.

But since Viagra has a central patent in the EU, and now that Poland is a member of that new EU, there's a bit of a problem. Well, make that a whole slew of problems, revealing a Polish attitude toward intellectual property that may well leave many EU enthusiasts limp with disappointment.

"According to our knowledge, it is perfectly legal," says Krzysztof Jakubiak, PR manager for Polpharma, which is the biggest pharmaceutical producer in Poland in terms of volume. Kubiak declines to comment on when they plan to launch Maxigra. When and if it does get cleared for launch, though, Polpharma stands to take a significant cut from the estimated $3 million yearly sales of Viagra in this country, and possibly even find a way into the $1 billion global market. Seems nice, but Viagra-inventor Pfizer won't stand for it. They say it blatantly violates EU law.

"We have instituted legal proceedings against Polpharma already," says Pfizer spokesperson Adam Linka. The lawsuit centers around the EU law of "data exclusivity." As Linka describes: "The EU law states that no generic drug may be launched in EU markets for 10 years following the drug's registration." And in this case that would mean not until 2008, since Viagra was registered back in 1998. And it would appear that this may be only the first in a long series of drug disputes, as new EU member Poland has to 'fess up to its deep love of generics, not to mention its relatively lax view of patent protection.

Of course, Poland is not the only place where Pfizer has had to fight for Viagra. China, for example, has been a particularly tough market for the company, as the country removed Viagra's patent protection earlier this year. And it appears that Pfizer's tremendous cash cow is doomed to fall before competition even in places where Viagra's patent protection still stands. Although Pfizer is still far and away the world's largest pharmaceutical maker, with a market value upwards of $225 billion, they have to watch out for GlaxoSmithKline, their nearest rival, who, in partnership with German Bayer, have been given the legal green light to debut an orange pill called Levitra that has similar effects to Viagra and will launch first in Germany and later in the rest of the EU. Levitra is already available in the USA and will launch in China by the end of the year.

A Croatian pharmaceutical concern, Pliva, has already brought its own Viagra knock-off to the market, called Dinamico, which is 15 percent cheaper than the original. But Dinamico appears to be legally scot-free, as Pfizer never filed for patent protection in Croatia and, what's more, Croatia has yet to join the EU and therefore shouldn't suffer an EU lawsuit like the one Pfizer has lodged against Polpharma.

This leads to the important question of whether Polpharma might be able to export Maxigra and significantly increase its revenue potential. The resounding answer is: Not likely. For one thing, the drug has to be registered and accepted in each of the countries it wants to sell in, and, as Kieszkowska says: "The EU is totally closed to those questions." And in large markets like China, where Pfizer has no patent protection anyway, one can easily envision a number of dirt-cheap Viagra copies of their own that would surely dominate.

When asked whether Maxigra would be offered at a substantially lower price than Viagra, Jakubiak says flatly: "No comments on that, but by definition generic drugs have a lower price than the originals." And even if Maxigra does weather the legal storm, clearly it will be some time before they start handing out free samples.

Sam Fields