Korea's Supreme Court Upholds Lower Courts' Ruling against Pfizer's Lipitor Patent Extension

SEOUL - Ending nearly two years of court battles over the patent extension of Pfizer's cholesterol drug Lipitor , South Korea's Supreme Court upheld the lower courts' rulings in favor of six local Korean pharmaceutical companies that have been selling generics of Lipitor (atorvastatin).

The Supreme Court ruled on March 25 that Pfizer's Lipitor patent "was not being infringed," upholding the rulings by two lower courts that had dismissed claims by the multinational company that the local Korean firms breached its patent for the hypercholesterolemia drug.

The local Korean companies have been offering Lipitor generics at prices that are 60-70 percent of the original product.

"We are very disappointed with the court's decision as it disregards the value of innovative drugs and discourages the patent protection environment in Korea," Lee Dong-Soo, representative director of Pfizer Pharmaceuticals Korea Ltd. said in an emailed statement to PharmAsia News.

Despite the Supreme Court final ruling, Lee noted that Pfizer remains committed to protecting its intellectual property rights to ensure long-term viability of its research and development programs apart from the Supreme Court decision.

In June 2008, South Korea's patent court ruled in favor of the five local companies involved in the dispute with Pfizer (Also see "Sanofi-Aventis Loses Patent Lawsuit In Korea Over Oxaliplatin" - Scrip, 6 Nov, 2008.).

Immediately after Pfizer extended the original Lipitor patent for five more years in May 2007, local Korean pharmas including Dong-A demanded the court ruling, claiming that the patent extension was "invalid."

The Lipitor patent was originally held by Warner Lambert, which Pfizer acquired in 2004.

Pfizer has also been involved in patent disputes over Lipitor in other countries such as the Philippines with United Laboratories (Unilab) drug branded as Avamax (Also see "Pfizer, Unilab Prepare For Battle Over Lipitor Patent In The Philippines" - Scrip, 30 Nov, 2009.).

Saturation Of Lipitor Generics Already?

Chung Bo-Ra, healthcare analyst at Daishin Securities, said she expects the recent Supreme Court ruling will not really affect the local Lipitor market because it is already swamped with so many generics.

"There are already 70-80 types of Lipitor generics on the [Korean] market now, and the Supreme Court's ruling only upheld the previous rulings by two lower courts," Chung told PharmAsia News. "The ruling will not serve as a boost for increased sales for local pharmas because the Lipitor market is somewhat oversupplied now."

Generics have traditionally served as the main profit pipeline for South Korea's nearly 300 local companies, but the Korean government is now taking steps to switch that focus to developing globally competitive innovative products.

To that end, the government is moving to create a KRW2 trillion ($1.7 billion) R&D fund to help Korean companies develop globally competitive new drugs (Also see "Korean Government Announces Joint Fund To Beef Up Local Pharma Industry" - Scrip, 10 Feb, 2010.).

The government-led fund, which will be formed over the next five years, could help boost sluggish investment into research and development, which averages only about 5 percent of annual sales. Local Korean companies, known as "little pharmas in a pond," number about 900 small and large companies.

The Korean government is also moving to draw the participation by South Korea's leading conglomerates including Samsung Electronics.

The recent bid by Samsung Electronics to lay a firm foundation in the biosimilar business has been in part accelerated by a set of friendly gestures from the government, which sees the potential for the local biosimilar industry to grow faster and stronger if led by the country's financially-strong big companies such as Samsung (Also see "Korea's Samsung Electronics On Manhunt For Biosimilar Talent As Local Companies Keep Wary Eye On Competition" - Scrip, 26 Mar, 2010.).

- Peter Chang ([email protected])