28 generic versions ready to hit market but disputes remain

By Kim Tae-gyu

The patent for Viagra, the first prescription drug for erectile dysfunction, is set to expire today in Korea so a swarm of generic versions can hit the market beginning Friday.

Fourteen local pharmaceutical companies have received government approval for 28 generic versions including a couple made by CJ Cheil Jedang, a major affiliate of CJ Group.

``We plan to release our products this week in line with the patent expiration as initially planned, even though Pfizer is against the idea,’’ CJ spokesman Shin Seoung-pill said.

Pfizer, the drug’s creator, claims that sales of any Viagra copycats could be subject to lawsuits as the company should hold exclusive rights for the drug for an additional two years.

The company declared that the material patent of Viagra’s main component, sildenafil, will come to an end this week here but it holds a second method-of-treatment patent that runs through May 13, 2014.

In other words, Pfizer argues that anybody can take advantage of off-patented sildenafil but nobody can use the compound to market it as an erectile dysfunction treatment over the next two years.

The dispute is not new, as CJ brought the case to the Korean Intellectual Property Tribunal (KIPT) midway through last year, requesting it nullify the usage patent.

Against this backdrop, Pfizer has made no secret of its willingness to file damage suits against those who come up with Viagra imitators before the final court verdict.

``Companies that sell their generic versions of Viagra might face lawsuits if the court concludes that their sales are against our use patent,’’ a Pfizer insider said.

``We will wait for the court decision. But we can say this ― similar court action was taken in the United States last year and we won the case.’’

The compound patent of Viagra expired in late March this year so that sildenafil could be used by rival firmss. But the U.S. court has sided with Pfizer by acknowledging its method-of-treatment patent.

As a result, Viagra generics will not be available until April 2020 in the world’s leading economy when the second patent is scheduled to expire.

By contrast, CJ thinks that it has a shot at winning the court battle.

``As far as we know, Pfizer lost in similar cases in some European and South American countries. If we are destined to lose, why do you think that we filed a suit last year,’’ another CJ official said.

``This litigation is feared to continue for many years and we cannot remain as a sitting duck during that period.’’

Regulating blood flow in the penis to treat erectile dysfunction, Viagra became available in 1998 and it made its debut in Asia’s fourth-largest economy a year later to gain big popularity.

Global competitors like Cialis and Lvitra and locally-developed drugs including Zydena from Dong-A Pharmaceutical and Yaila by Chong Kun Dang compete in the market, whose size is around 100 billion won a year.

Viagra and Cialis each have about a third of the local market while Zydena is the No. 3 player.