In the future, there is likely to be an increasing number of therapeutics derived from both single-ingredient and combination-ingredient
herbal formulations. International alliances in the R&D and commercialization/modernization of TCM may well reap big dividends.
The Patent Question
When companies consider venturing into China, their greatest concern typically involves intellectual property protection.
Historically, most Chinese pharma companies lacked R&D capabilities and produced undifferentiated generic drugs, competing
primarily on price. Before 1993, China did not grant drug patents. New drugs were quickly copied, often by several local companies,
causing price erosion and loss of profits. For this reason, multinational pharma companies have hesitated to introduce innovative
drugs for fear of losing control and not getting proper protection for valuable assets.
China's entry into the World Trade Organization in December 2001, however, coupled with the Chinese government's desire to
attract foreign investment and its mandate to protect the country's own "high technology content" industries, has definitively
improved IP protection and enforcement in the past few years.
The WTO agreement requires China to:
- enhance protection of intellectual property rights by enforcing foreign and international patents in accordance with the
Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), which mandates at least 20 years of drug patent
- increase foreign companies' participation in the Chinese pharmaceutical distribution industry. By the end of 2004, China's
entire retail and wholesale drug markets will be open to overseas entities, after an initial opening in selected cities.
- comply fully with international regulatory standards. This includes making China's regulatory agencies transparent in their
decisions on drug approval.
- reduce tariffs on imported pharmaceuticals from 9.6 percent to 4.2 percent on average.
Says Doug Olson, an IP lawyer with the firm of Paul, Hastings, Janofsky & Walker: "China is working hard to make patent protection
in China the functional equivalent of Western patent systems. Although the Chinese court system does not yet appear to grant
damages on the same scale as in the US, injunctions to stop infringement are routinely granted."
For example, several Chinese citizens were fined and sentenced to up to two years in prison for counterfeiting three GSK products—the
antimalarial Halfan (halofantrine) and the antibiotics Ampiclox (ampicillin and cloxacillin) and Amoxil (amoxicillin). One
violator who sold counterfeits of J&J's Band-Aid adhesive bandages was sentenced to six years in jail. The counterfeit products
There are still challenges ahead. In July, the Chinese Patent Re-examination Board decided that a patent for Pfizer's Viagra
(sildenafil) was invalid, stating that Pfizer's application failed to accurately explain the use of the drug's key ingredients.
The news sent shock waves through the industry, causing some critics to doubt the progress China has made in protecting IP.
However, a closer examination reveals a more complex picture. In fact, long before the Chinese court intervention, Eli Lilly,
Icos, and Bayer, whose drugs for erectile dysfunction compete with Viagra, successfully overturned Pfizer's patent in Europe,
using the same strategy that was later used in China. (The UK court and the European Patent Office revoked the Viagra patent
in 1999 and 2001, respectively.)
To Tony Chen, head of the China IP Practice Group at Paul Hastings and a returnee from the US, the Chinese court decision
"demonstrates the evolution of the Chinese intellectual property dispute resolution system, which is quickly following its
Western counterparts." He has observed an increasing number of IP disputes in China. In part this is because a growing number
of Chinese companies are incorporating litigation into their strategy, but it is also because of the increasing number of
Chinese patents. The China Patent Office received 105,318 applications for inventions in 2003—about the same number filed
in the United States. Forty-six percent were foreign, representing a growth of more than 30 percent since 2002.