By Benjamin Bai and Helen Cheng
Viagra generated about US$1.7 billion in worldwide sales
last year. Pfizer has patented the use of Viagra's active
ingredient around the world, including in China, where the
State Intellectual Property Office (SIPO) granted its patent on
September 19 2001. Immediately after the grant, a dozen Chinese
pharmaceutical companies and individuals filed petitions to
invalidate the Viagra patent. Recently, SIPO issued a decision
to revoke the patent on the grounds that the patent had failed
to provide enough information on exactly how the active
ingredient was manufactured. In addition, GlaxoSmithKline,
Europe's largest drug maker, recently had to abandon its patent
on a popular anti-diabetic drug, which was under attack by a
group of Chinese drug companies. This article takes a closer
look at Chinese patent invalidation proceedings.
Grounds for Invalidation
Under Article 45 of the
any entity or individual who considers the grant of a patent to
be contrary to relevant provisions of the law may request the
Chinese Patent Re-examination Board (PRB), which has sole
jurisdiction over patent validity issues, to declare the patent
invalid. The grounds for filing a petition for invalidation of
a patent are the following: unprotectable subject matter;
double patenting; unpatentability; insufficient disclosure;
lack of support; indefiniteness; lack of essential technical
features; and amendment going beyond original scope of
While it is possible to file an invalidation petition based
upon any one of these grounds, it is most common that a
petition is filed on the grounds of unpatentability,
insufficient disclosure, and/or amendment going beyond the
original scope of disclosure. The likelihood of a petition
being accepted by the PRB based on such grounds is
substantially higher than that based on other grounds.
Overview of Proceedings
After an invalidation petition is filed, the PRB conducts a
formal examination. The PRB then forwards a copy of the
petition to the patentee and invites the patentee to respond
within a prescribed time limit. After the expiration of the
responding period, the PRB may arrive at a decision of the
invalidation based on the petition, as well as the response
filed by the patentee, if any.
Nevertheless, in most cases an oral hearing will be set,
either by a written request of the interested party or by the
ex officio determination of the PRB. During the oral
hearing, the PRB may question the interested parties and
witnesses and ask them to explain any evidence or fact at
issue, and each interested party may present its arguments.
After the conclusion of the oral hearing, the PRB begins
deliberation. The PRB may declare the patent invalid in whole
or in part or uphold its validity in its entirety.
The decision of the PRB is subject to judicial review.
Appeal of the PRB decision can be taken to the first
Intermediate People's Court of Beijing, which has jurisdiction
over lawsuits against the PRB and is entitled to review the
decision of the PRB de novo.
During invalidation proceedings, the patentee of an
invention or utility model patent, i.e., the respondent, cannot
amend the specification of the patent but has an opportunity to
make voluntary amendments to the claims. However, permissible
amendments in invalidation proceedings for an invention or
utility model patent are limited to: (a) cancelling one or more
claims; (b) combining one or more claims; and (c) deletion of
one or more members in a Markush group (a chemical structure
formula comprising of multiple selectable elements / members).
Moreover, amendment by combining claims is permissible only
when the combination results in a narrower scope. In contrast
to an invention or utility model patent, the patentee of a
design patent is not permitted to make any amendments to the
Permissible evidence in an invalidation proceeding includes
documentary, physical or audiovisual evidence, oral testimony
of a witness, statements of interested parties, conclusions of
experts, and records of on-site investigations and
examinations. In practice, the PRB relies almost exclusively on
documentary evidence in deciding invalidation cases. Oral
evidence is rarely relied upon. In addition, all evidence must
be verified and authenticated by the PRB before it can be
relied upon in the validity determination.
Evidence in a foreign language may be used in invalidation
proceedings. A Chinese translation should be filed when the
foreign language evidence is submitted or within a time limit
prescribed by the PRB.
With the recent success of Chinese domestic companies
against multinationals in patent invalidation proceedings, one
can expect patent challenges to intensify. Notwithstanding the
political rhetoric about China's lack of IP protection, it has
strengthened its patent system significantly in recent years.
Therefore, multinational companies facing patent challenges in
China should not operate under the mistaken assumption that
foreign companies cannot win in Chinese courts and agencies.
However, winning a legal battle in China requires more than the
will to succeed. As Sun Tzu, the master of the art of war in
ancient China, taught: "Know your enemy, know yourself, fight a
hundred battles, win a hundred battles."