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11th October 2004
From Warsaw Business Journal
by Michael Lars White
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 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.
The generic rush
"Whatever happens with generic Polish drugs based on so-called 'central products' before and after accession is very controversial as far as EU law," says Paulina Kieszkowska, a legal expert with international law firm Baker and McKenzie who is handling Pfizer's case against Polpharma.
As it turns out, Polish drugs that managed to get registered in Poland before accession could be granted a 'transitional period' in the new EU before having to upgrade their products. The result was rather interesting, with thousands of drugs suspiciously being registered in Poland on one single day in particular: April 30. Kieszkowska believes many of these were 'ghost' generics-where drug-makers sent in two-page 'instruction letters' on their dubious new drugs in order to get 'conditionally' registered, which allowed them to put off fulfilling all of the regulatory conditions until actual launch of the product.
"This rush to register all before accession was so obvious. From a public health perspective, it's really dodgy," she says.
"From the EU's point of view, this is cheating. They were 'conditionally' registered, and such conditionally registering is illegal. Such conditionality should result from the law," she says. "There is no tradition in Poland to challenge these decisions. Maybe they should start."
Although Kieszkowska prefers to describe the situation in general rather than discuss the Maxigra case in particular, she no doubt sees this discussion as relevant to the Maxigra case. To Polpharma's credit, however, they did register Maxigra as early as March. And Ministry of Health officials don't seem to have a problem with it.
"I think everything is correct with this drug," says Adam Kalinowski from the Ministry of Health. "It couldn't be put on the market now, but as far as I know it passed the registration process."
Talk to the chemist
The WBJ spoke to one of the scientists who helped discover the new synthesis that created Maxigra, Osman Achmatowicz, a chemistry professor with the Pharmacological Institute in Warsaw.
When asked whether his team used Pfizer's data, as Pfizer's lawyers will want to show, he replies: "It depends on what you mean. If you mean are we familiar with the molecular structure that was first developed by Pfizer, [yes] we have been familiar with their approach. Our route, [however], is different."
He points out that since Pfizer's Viagra is patented, it is, after all, in the public domain and open for anyone to see. "We have patented our approach as well," he says.
"I don't know what is meant by 'you used our data.' This is for the patent lawyers to discuss," he says. But he is adamant about the uniqueness of the synthesis they discovered: "Am I following their route? No, I am not. This is from the point of view of a chemist."
For the record, Achmatowicz says: "I am convinced that we have not infringed on the patent as far as the synthesis is concerned."
It would appear then that the question of patent infringement will hinge on whether it is an issue of process or of the end result.
Pfizer's Linka, not surprisingly, sees the latter: "The whole issue is about sildenafil," which he says is itself protected by the EU patent law, "and according to my knowledge, it doesn't discuss processes."
The worldwide anti-impotence front
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.
Generically yours
So where does this leave Polpharma's Maxigra, and Polish generics in general? Are these EU drug battles worth fighting over for anyone besides companies like Pfizer? It appears the lawyers as well as EU politicians will have a say.
"For me as a citizen, I feel cheated, because I don't know what these drugs are worth," says Kieszkowska of the overall drug registration process in Poland.
As to how court cases like these will turn out, she says: "You've got a registration valid in the Polish office, but ultimately the court may say it looks a bit fraudulent."
But as Polpharma's Jakubiak sees it: "You cannot sue somebody for registering a product."
And although some drugs registered in this country may lack effectiveness-or even be dangerous to one's health-it's a safe bet that erectile dysfunction sufferers across Poland will be rooting for the underdog, Polpharma, and its Viagra copy that, after all, has the same active ingredient as Viagra and will likely be cheaper than the original.
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. source :-http://www.wbj.pl/ | 
