美 vs 中 "비아그라 특허전쟁"

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2004-07-09 03:36
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 특허분쟁에 관심있는 분들을 위해 퍼왔습니다. 상황이 아주 재밌게 돌아가네요.


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美 vs 中 "비아그라 특허전쟁"

中, 특허권 취소… 美, 무역보복 검토

김민구 기자 roadrunner@chosun.com

입력 : 2004.07.08 18:04 23'
 
남성 발기부전 치료제 ‘비아그라’에 대한 중국 정부의 특허권 취소 조치가 미국과 중국 간 무역 분쟁으로 비화할 조짐을 보이고 있다.
중국 국가지적재산권사무국(SIPO)은 비아그라를 개발한 미국 제약업체 화이자사에 2001년 부여했던 특허권을 지난 6일 돌연 취소했다. 이 조치는 비아그라 특허권에 대한 중국 제약업체들의 무효화 요구를 수용한 것으로, 당국이 비아그라 복제품의 유통을 합법화시킨 셈이다.

이에 대해 화이자사와 미국 정부는 즉각 반발했다. 미국 무역대표부의 리처드 밀스 대변인은 블룸버그통신과의 회견에서 “명백한 지적 재산권 침해 사례로 볼 수밖에 없다”며 “중국 정부와 이 문제를 논의할 것”이라고 말했다. 화이자사도 “(중국 정부의) 행동에 극도로 실망했다”며 즉각 항소할 것이라고 밝혔다. 또 중국 내 사업 확대 계획을 재검토할 것임을 시사했다.

영국 파이낸셜타임스(FT)는 베이징의 외교 소식통을 인용, 미국과 유럽연합이 보복조치를 검토할 가능성이 있다고 전했다. SIPO는 특허권 취소 사유를 즉각 공개하지 않고, 금주 중 해명서를 발표하겠다고만 밝혔다.

중국 내 비아그라 시장 규모는 1억2000만달러(약 1380억원)로 추산되며 해마다 급속히 성장하고 있다. 현지 제약업체 15곳은 이미 비아그라 제조기술을 확보, 시판을 준비 중인 것으로 알려졌다.


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July 8, 2004
Pfizer Reports China Has Lifted Its Viagra Patent
By GARDINER HARRIS
 
Regulators in China took away Pfizer's patent there on Viagra, the drug company said yesterday, in a case that the Bush administration considers an important test of China's commitment to international trade agreements.

But a consumer advocate said the Chinese decision was sensible and consistent with international rules.

Pfizer received a so-called use patent for Viagra from the Chinese in 2001, a decision that was challenged by producers of generic drugs. The challenge was considered by the patent re-examination board of China's State Intellectual Property Office, which ruled yesterday in favor of the generic drug makers, Pfizer said. The company indicated that it would appeal.

While the case may foreshadow future battles over patents and trade between the two countries, it may have little practical effect on sales in China. Pfizer said that sales of genuine Viagra there were minimal.

Viagra imitation drugs are widely available in much of Asia. Indeed, Viagra, the first drug approved for treating erectile dysfunction in men, has been one of the most widely pirated medications in the world. More recently, the Food and Drug Administration has approved two other impotence drugs, Levitra and Cialis.

But Viagra has also become the American counterpoint in a broad debate brought on by the AIDS epidemic over how and when poor nations should be allowed to seize patents on important medicines.

Most countries agreed in international negotiations that nations should be allowed to authorize or import cheap copies of any medicine deemed essential to the health of its people.

But the United States has argued for some time that this ability to seize patents should be limited to recognized public health crises like AIDS and malaria.

In this argument, American trade authorities often brought up the matter of Viagra. Should countries be allowed to seize the patent of a drug that does nothing more than make erections possible? To Washington, the answer was clearly no.

American officials have in the last two years repeatedly raised the issue of the Viagra patent challenge with the Chinese authorities, calling it a test of their commitment to international trade rules. China's agreement in 2001 to join the World Trade Organization requires that it adopt and enforce intellectual property laws.

Richard Mills, a spokesman for the United States trade representative, said, "It's difficult not to view this case within a pattern of intellectual property infringement." The United States, he said, will "be discussing this and other intellectual property issues with the Chinese."

But James Love, director of the Consumer Project on Technology in Washington, said the Viagra case was far from simple. Pfizer, after all, was seeking a use patent on Viagra in China, not a patent on the actual compound.

The distinction dates back to Pfizer's original work on the drug. When it was first discovered, Pfizer had hoped that Viagra would work as a heart drug and patented it for that. It did not work as hoped, but researchers noticed its effect on men during human testing. Pfizer patented this secondary use in the United States and Europe.

Mr. Love argued that not all countries recognized these later patents, and that international law did not require them to do so. He applauded the Chinese authorities for refusing to follow the American lead.

A Pfizer spokesman, Bryant Haskins, said the Chinese patent board disallowed Viagra's use patent because the application failed to provide information that was not required or requested when the company applied for the patent in the late 1990's. Mr. Haskins said he did not have a copy of the ruling.

Michael Kirk, executive director of the American Intellectual Property Law Association, a group of intellectual property lawyers, said the Chinese authorities had been fairly good about granting patents requested by Western companies.

But he noted that China's enforcement, particularly its willingness to crack down on piracy in music, movies, computer programs and the like, had been lacking.


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U.S. Officials to Ask China to Restore Pfizer Patent (Update1)

July 8 (Bloomberg) -- U.S. trade officials plan to ask China to restore Pfizer Inc.'s patent for Viagra, the world's best-selling impotence treatment, as part of talks aimed at stamping out piracy of drugs, software, music and movies.

The Chinese State Intellectual Property Office on Tuesday withdrew Viagra's patent, granted in September 2001, after a challenge by generic drugmakers, Pfizer spokesman Bryant Haskins said yesterday. The 20-year patent, first applied for in 1994, was due to expire in 2014.

``It's difficult not to view this case within a pattern of intellectual property infringement,'' U.S. Trade Representative spokesman Richard Mills told Bloomberg News in Washington. ``We will be discussing this and other issues with the Chinese.''

U.S. Democratic presidential candidate John Kerry says the Bush administration hasn't done enough to crack down on what he called China's illegal trading practices. Annual counterfeit medicines may be worth more than $32 billion worldwide, according to the International Federation of Pharmaceutical Manufacturers Associations, a non-governmental organization.

Pfizer signed an agreement in May to train regulators in Shanghai in how to ``detect and deter'' the illicit production of the company's products in and around China's major business city, the China Daily reported in May.

Chinese police working with investigators for Eli Lilly & Co. discovered 40,000 fake Viagra pills after raiding a warehouse in the southern Chinese province of Guangdong in May, Time Magazine reported in June, citing Eli Lilly officials. Also seized were 750,000 tablets that were imitations of sexual- dysfunction drugs Eli Lilly's Cialis and Levitra, marketed by Bayer AG and GlaxoSmithKline Plc.

Piracy Talks

The owner of a Beijing-based company arrested for selling fake Viagra and exporting it to the U.S. was sentenced to one year in prison and a $12,000 fine, Time magazine said.

``This decision concerns us because we think our patent is a strong one,'' Pfizer's Haskins said. ``The decision that was made yesterday was absolutely wrong. This is not the end of the ballgame.''

The topic will be one of several intellectual property issues on the agenda during a U.S. trade delegation visit to Beijing, according to a U.S. government official, who asked not to be identified. A date for the visit hasn't been set.

Last month, U.S. Commerce Secretary Donald Evans said talks he held with Premier Wen Jiabao in Beijing at the time were to ensure intellectual property rights are better protected. Copyright infringement has strained trade relations, Evans said.

Chinese sales of Viagra, the world's best-selling medicine for erectile dysfunction, are small because the company is only able to sell the medicine in hospitals, Haskins said. Viagra generated $1.88 billion in sales for New York-based Pfizer last year, with $776 million coming from outside of the U.S.

Pfizer shares fell 15 cents to $33.72 at 4:01 p.m. in New York Stock Exchange composite trading. They have declined 4.6 percent this year.
 


To contact the reporter on this story:
Rob Delaney in Beijing at  robdelaney@bloomberg.net

To contact the editor responsible for this story:
Peter Langan at  plangan@bloomberg.net
Last Updated: July 8, 2004 01:35 EDT 
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Pfizer: China Overturns Viagra Patent
Pfizer Says China Has Overturned Its Viagra Patent; Company Plans to Appeal Decision

The Associated Press

 

BEIJING July 7, 2004 — Pfizer Inc. said Wednesday that its Chinese patent for Viagra had been overturned and that it would appeal.

Pfizer "is extremely disheartened by this recent action," the company said in a statement. It said its China patent for the anti-impotence drug would remain in effect while it appeals.
 
Experts said it appeared to be the first time the Chinese government had overturned a pharmaceutical patent.

Foreign drug companies have been watching the case as a test of China's commitment to intellectual property rights. Deputy U.S. Trade Representative Josette Shiner in November called the Viagra patent challenge a "particularly troubling" example of a questionable Chinese commitment to intellectual property rights.

Patent protection for drugs is relatively new in China only about 10 years old, according to Joseph M. Damond, associate vice president for Japan and Asia Pacific at the Pharmaceutical Research and Manufacturers Association. Damond said he wasn't aware of China ever taking this action before and believed it was a first.

Nonetheless, Damond didn't want to attach too much significance to the event. He said the industry's main concern in China is counterfeiting.

Viagra was introduced in China in 2000, and after six months on the market, the official Xinhua News Agency reported that some 90 percent of Viagra pills sold in Shanghai, the country's largest city, were fake.

Damond said counterfeit drugs are a very lucrative business and that fakes from China are sold throughout Asia and have also showed up in Canada. He believes it is only a matter of time before they find their way to the U.S. market.

"No one is put in jail for counterfeiting," said Damond. "There is no deterrent."

The patent re-examination board of China's State Intellectual Property Office overturned Pfizer's 2001 patent on the use of sildenafil citrate, Viagra's main ingredient, the statement said. It didn't say when the board issued its ruling.

Phone calls to the SIPO weren't answered Wednesday afternoon and there was no reference to the ruling on the agency's Web site.

A group of Chinese drug companies had petitioned the office to nullify Pfizer's patent for sildenafil citrate, saying it failed to fulfill the "novelty requirement" of Chinese law.

Under that requirement, a patent can only be granted if no identical invention has been published or used within the country.

New York-based Pfizer has already lost patent protection for Viagra through similar challenges in Colombia and Venezuela.

"This is just another example of spotty intellectual property rights in the developing world," said Richard Evans, an analyst at Sanford C. Bernstein.

Shares of Pfizer traded at $33.92, up 5 cents, Wednesday afternoon on the New York Stock Exchange.
 

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