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Top Articles - Thinking Outside the Contract: Engaging with China on Cultural and Legal Fronts
China is well entrenched in the global marketplace, but with Chinese piracy reported at 90 percent, it's the third least friendly country for protecting intellectual property (IP).
China's accession into the World Trade Organization started four years ago. With this commitment to regulatory and economic restructuring, China has indeed been a country of economic opportunity for multinational corporations.
In theory, WTO accession means that WTO members can
China's accession into the World Trade Organization started four years ago. With this commitment to regulatory and economic restructuring, China has indeed been a country of economic opportunity for multinational corporations.
In theory, WTO accession means that WTO members can
According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
enjoy IP protections. In China, secure those patent protections carefully. Dot the i's, cross those t's and ‘watch your language.’ Also, anticipate litigation.
According to attorneys A. Jason Mirabito and Carol Peters, in a March 2005 article published in Chip Scale Review:
-- In the past there was little enforcement of IP in China. However, in 2002, Chinese courts litigated more than 6,000 civil cases involving IP issues. About 2,000 cases involved pate
According to attorneys A. Jason Mirabito and Carol Peters, in a March 2005 article published in Chip Scale Review:
-- In the past there was little enforcement of IP in China. However, in 2002, Chinese courts litigated more than 6,000 civil cases involving IP issues. About 2,000 cases involved pate
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
nt suits. The rest were trademark and copyright actions.
--Japan is the leading filer of patent applications in China, followed by the United States, Germany and South Korea, in that order. On the other hand, the United States is the largest filer of trademark applications, followed by the Japanese.
--Japanese companies have been the most litigious companies in China, filing a large number of trademark infringement and design infringement suits against Ch
--Japan is the leading filer of patent applications in China, followed by the United States, Germany and South Korea, in that order. On the other hand, the United States is the largest filer of trademark applications, followed by the Japanese.
--Japanese companies have been the most litigious companies in China, filing a large number of trademark infringement and design infringement suits against Ch
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
nese companies, largely in the automotive industry.
Those 2002 statistics pale compared to recent figures, reported by the International Herald Tribune: In 2005, "Chinese courts dealt with 12,205 civil intellectual property cases, an increase of 32 percent from 2003 and a few dozen two decades ago."
Consider one recent case, which demonstrates that China's legal savvy is climbing with its growing stake in US markets and the global economy. The case also d
Those 2002 statistics pale compared to recent figures, reported by the International Herald Tribune: In 2005, "Chinese courts dealt with 12,205 civil intellectual property cases, an increase of 32 percent from 2003 and a few dozen two decades ago."
Consider one recent case, which demonstrates that China's legal savvy is climbing with its growing stake in US markets and the global economy. The case also d
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
emonstrates the role of US courts in patent and IP protection, along with the perseverant or 'energized' stance required by US companies threatened by counterfeit goods or the prospect of piracy.
Energizer & Eveready vs. Just about Everybody
The dispute started in the spring of 2003, when Energizer Holdings, a US company, and its subsidiary Eveready filed a lawsuit with the International Trade Commission (ITC). The complaint addressed a signature p
Energizer & Eveready vs. Just about Everybody
The dispute started in the spring of 2003, when Energizer Holdings, a US company, and its subsidiary Eveready filed a lawsuit with the International Trade Commission (ITC). The complaint addressed a signature p
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
oduct, a long-lasting battery design—affecting in particular a line of zero mercury-added alkaline batteries that Energizer has held a patent on for three decades. Also mentioned in the suit are games, toys, and other products manufactured with batteries whose designs are protected.
Energizer asked the ITC to issue a cease-and-desist order and to ban US imports of these products, claiming the batteries exported to the United States by the 26 manufacturers,
Energizer asked the ITC to issue a cease-and-desist order and to ban US imports of these products, claiming the batteries exported to the United States by the 26 manufacturers,
ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
affiliates or distributors named in the suit had infringed on Energizer's US patent. Among the multiple respondents named in the complaint, nine were Chinese manufacturers, including Fujian Nanping Nanfu. Nanfu Battery is one of China’s largest alkaline battery manufacturers and suppliers. Energizer requested the ITC investigation under Section 337 of the US Tariff Act.
At the time of the original filing, China was considered the world's largest manufactu
At the time of the original filing, China was considered the world's largest manufactu
easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
rer and exporter of this specific battery with an estimated 75-80 percent of its goods being exported to overseas markets. According to a China press report, "Chinese batteries usually cost between a 10th and a third less than US-made ones, making them very popular in overseas markets."
The ITC handed down a preliminary ruling in 2004, deciding that nine manufacturers from the Chinese mainland and Hong Kong infringed upon Energizer's patent, and recommende
The ITC handed down a preliminary ruling in 2004, deciding that nine manufacturers from the Chinese mainland and Hong Kong infringed upon Energizer's patent, and recommende
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
banning imports of the batteries. But four months later, the ITC closed its investigation, and ruled that Energizer's patent was invalid because it was …"indefinite as a matter of law…." Or, in the legalese: "The Commission held that Eveready's "proffer of alternative constructions of 'said zinc anode' was an admission of indefiniteness."
In plain terms, the main patent claim, or its language, was incorrectly written. Attorneys Mirabito and Peters reporte
In plain terms, the main patent claim, or its language, was incorrectly written. Attorneys Mirabito and Peters reporte
and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
d that the Commission determined "there was no infringement of the Energizer Holdings patents, and the continued importation of Chinese batteries was permitted."
It Just Keeps on Going and Going…
True to the brand as "the battery that never quits," Energizer kept on "going and going," and appealed the ITC's final decision to the U.S. Court of Appeals for the Federal Circuit. In the suit, Energizer named the ITC as defendants. Energizer's main conte
It Just Keeps on Going and Going…
True to the brand as "the battery that never quits," Energizer kept on "going and going," and appealed the ITC's final decision to the U.S. Court of Appeals for the Federal Circuit. In the suit, Energizer named the ITC as defendants. Energizer's main conte
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
tion was that the issue regarding language was not substantial enough to invalidate the patent.
The Court's January 25, 2006 ruling, and a follow-up March 20 mandate reversed the earlier ITC opinion, finding that the ITC erred and the patent draft was written correctly enough.
"In that regard, we conclude that 'anode gel' is by implication the antecedent basis for 'said zinc anode.' The Commission's holding of invalidity on the ground of indefiniteness is
The Court's January 25, 2006 ruling, and a follow-up March 20 mandate reversed the earlier ITC opinion, finding that the ITC erred and the patent draft was written correctly enough.
"In that regard, we conclude that 'anode gel' is by implication the antecedent basis for 'said zinc anode.' The Commission's holding of invalidity on the ground of indefiniteness is
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
reversed."
In the unanimous ruling, the Court directed the Commission to proceed in accordance with the Administrative Law Judge's prior ruling that the Energizer patent is valid, according to Legal Times analyst, Emma Shwartz.
It was a happy day at Energizer headquarters in St. Louis. "We are pleased that this case has been sent back to the ITC for review," said Michael Pophal, Senior Patent Counsel at Energizer, quoted in a company press release. "By i
In the unanimous ruling, the Court directed the Commission to proceed in accordance with the Administrative Law Judge's prior ruling that the Energizer patent is valid, according to Legal Times analyst, Emma Shwartz.
It was a happy day at Energizer headquarters in St. Louis. "We are pleased that this case has been sent back to the ITC for review," said Michael Pophal, Senior Patent Counsel at Energizer, quoted in a company press release. "By i
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
ssuing this mandate, the appeals court has cleared the way for additional inquiry into whether those companies that import mercury-free alkaline batteries into the United States are doing so illegally. If it is indeed determined that they are doing so illegally, the ITC will then determine the appropriate remedy for that illegal activity."
As before, Energizer will seek the general exclusion remedy in the ITC. If the ITC upholds the company's claim, this r
As before, Energizer will seek the general exclusion remedy in the ITC. If the ITC upholds the company's claim, this r
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
medy will bar infringing batteries, including those made or sold by the remaining respondents from importation or sale in the US, and will permit sanction enforcement by US Customs.
What’s Next? A Changing Landscape?
Energizer expects a favorable outcome from the ITC. But even as they await the ITC review, the Internet-surfing public has been reading about the recent ITC mandate in starkly opposite terms: in China, recent press accounts erroneously
What’s Next? A Changing Landscape?
Energizer expects a favorable outcome from the ITC. But even as they await the ITC review, the Internet-surfing public has been reading about the recent ITC mandate in starkly opposite terms: in China, recent press accounts erroneously
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
have been reporting that the Court ruled in favor of Chinese manufacturers. They fail to report that the jury, with respect to the ITC, is still out.
It appears that a gentle, collaboratively toned communication between Energizer and China has helped the situation. Many of the erroneous reports have been pulled from news sites.
While Energizer seems to be battling questionable imports the longest and hardest, they aren't the only company doing battle wit
It appears that a gentle, collaboratively toned communication between Energizer and China has helped the situation. Many of the erroneous reports have been pulled from news sites.
While Energizer seems to be battling questionable imports the longest and hardest, they aren't the only company doing battle wit
t?
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
Chinese manufacturers and companies alleging technology violations of patents, trademarks and IP infringements. The litigious ranks include Hitachi-IBM and Cisco, who won its patent battle over the Shenzhen-based Huawei in 2003. Cisco eventually proved that Huawei, arguably the top Chinese provider of switches and wireless infrastructure, had copied the U.S. companies' firmware code line for line into its products. Huawei settled.
Still, other recent case
Still, other recent case
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
s are coming to favorable conclusions for plaintiffs defending goods in China courtrooms, an indicator that China is serious about its place in the WTO and in the global economy.
--In late 2005, java giant Starbucks Coffee won its two-year-old case against 'Xingbake' (translation Star Bucks), for trademark and logo infringement. The case was decided in Shanghai No. 2 Intermediate People's Court, and was considered a landmark judgment and litmus test of Chi
--In late 2005, java giant Starbucks Coffee won its two-year-old case against 'Xingbake' (translation Star Bucks), for trademark and logo infringement. The case was decided in Shanghai No. 2 Intermediate People's Court, and was considered a landmark judgment and litmus test of Chi
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
na's amended trademark laws. Xingbake has filed an appeal.
--In 2004, Swiss agribusiness and agricultural chemical maker Syngenta was awarded an apology and compensation after its patent infringement lawsuit was successfully concluded against a Chinese business group. The case was heard in a Nanjing court, one known for its expertise in intellectual property.
There is little doubt that China's government will quickly improve its IP stance, but this analys
--In 2004, Swiss agribusiness and agricultural chemical maker Syngenta was awarded an apology and compensation after its patent infringement lawsuit was successfully concluded against a Chinese business group. The case was heard in a Nanjing court, one known for its expertise in intellectual property.
There is little doubt that China's government will quickly improve its IP stance, but this analys
.
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
believes the most effective pressure will come from its own domestic companies, particularly as they evolve from a heavily manufacturing-depending economy to a service and integrated products economy. This more sophisticated economic profile makes IP rights even more critical, because more Chinese companies will have more at stake when IP is violated.
Recent positive announcements make it clear that rule of law increasingly will be guiding China's economy
Recent positive announcements make it clear that rule of law increasingly will be guiding China's economy
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
. In the meantime, keep your intellectual property under a close watch, and build trust with your Chinese partners. Good contracts, good guanxi, and good sense will prove invaluable.
Sources: Chip Scale Review, International Herald Tribune, China Daily, China.org, Legal Times, Syngenta, Energizer Holdings / Eveready Battery, Starbucks, Energizer Court of Appeals Ruling: http://www.ll.georgetown.edu/federal/judicial/fed/opinions/05opinions/05-1018.pd
Sources: Chip Scale Review, International Herald Tribune, China Daily, China.org, Legal Times, Syngenta, Energizer Holdings / Eveready Battery, Starbucks, Energizer Court of Appeals Ruling: http://www.ll.georgetown.edu/federal/judicial/fed/opinions/05opinions/05-1018.pd
tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
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