Copyright Law in China
Easily understood statute
Difficult policy choice
1
A Controversial Copyright Case
When FDA Regulations and Copyright
Act Collide
Do generic drug manufacturers
infringe a copyright by copying the
package insert of the pioneer drug ?
Issue
 A controversy between FDA Regulations and
Copyright Act
 The package insert used on a generic drug product is the same
as the one of the pioneer drug. The pioneer drug company
sued the generic drug company for copyright infringement
 Shandong High People’s Court: no
infringement
 Shanxi Jinfang Pharmaceuticals vs. Sanyou Li Company (2004)
 Changsha Intermediate Court: infringement
 Shanxi Jinfang Pharmaceuticals vs. Sanyou Li Company (2004)
 How would the Supreme People’s Court
respond to this split?
Outline
I. Background Information
II. Statute in China: FDA Regulations
and Copyright Act
II. Court Decisions in China
IV. Comparison: The U.S. Law
III. Comments
 A package insert is information provided
with a prescription drug that tells you:
 What the drug is
 How it should be used
 How it works
 Safety concerns to be aware of and precautions to take
 In China, they are usually literally be thin,
Information:
foldedBackground
up sheets of paper
placed inside the
box your
prescription
bottle Insert
comes in. Is?
What
Package
FDA Regulations—Package
Insert
 What information the package insert
contains?
 Drug Administration Law of the People's Republic of China,
2001. : The insert package shall be indicated
 the adopted name of the drug in China,
 its ingredients,
 strength,
 manufacturer, approval number, product batch number,
 production date, date of expiry,
 indications or functions,
 usage, dosage,
 contraindications, adverse drug reactions, and precautions.
FDA Regulations— Generic
Drug
 Provisions for Drug Registration
 Article 74 The generic drug shall have the
identical active ingredients, route of
administration, dosage form, strength and
therapeutic effects with the registered drug.
Where a drug has been produced by more
than one manufacturer, the selection of
registered drugs for comparative study shall
be in accordance with relevant technical
guidelines
Practice in China:
 The Package Insert for Generic Drugs
 Copy or abbreviate:
 Copy
 Shanxi Jinfang Pharmaceuticals vs. Sanyou Li Company
(Shangdong High People’s Court, 2004)
 Hubei Welman Pharmaceuticals vs. Suzhou Erye
Pharmaceuticals (Chuangsha Intermediate People’s Court,
2009)
Practice in China:
 The Package Insert for Generic Drugs
 Copy or abbreviate:
 Abbreviate:
 A Journalist's survey: comparing the package inserts of the same drug
products (AMLODIPINE BESYLATE)
 manufactured by different companies:
 The text of package inserts varies among a pioneer drug
product and a couple of generic drug products
 Difference: The information is partially omitted in some
 usage, dosage, contraindications, adverse drug reactions,
and the consequences of overdose
 http://finance.china.com.cn/industry/medicine/yygc/20121
218/1194609.shtml
Statute: FDA Regulations vs
Copyright Act
FDA Regulations
Copyright
 Require content and
format of the
package insert
 Copyrightability
 Require generic
drug to be
bioequivalent to
pioneer drug
Generic drug manufacturers either
copy or abbreviate the package insert
of the pioneer drug
 Originality
 Infringement
 Exceptions
Generic drug manufacturers inevitably infringe,
unless
(a)the package inserts are not copyrightable ,
or
(b)(b) legally excepted
Copyright Act- the holder’s
rights
The copyright holder has the
exclusive rights to prevent the others
from:
Copying
Making derivative work
etc
Copyright Act—Possible
Defense
Possible Defense for the generic drug
manufacturers
 The package inserts are not copyrightable
• No originality
• China case: Shanxi Jinfang Pharmaceuticals vs. Sanyou Li
Company (Shangdong High People’s Court, 2004)
Copyright Act –
Copyrightability
Copyrightability requirement:
originality
Article 2 The term “works” used in
the Law shall mean original
intellectual creations in the literary,
artistic and scientific domain,
insofar as they are capable of being
reproduced in a certain tangible
form.
Implementing Regulations of The
Copyright
Copyright Act –
Copyrightability (con’t)
 Copyrightability requirement: originality
 Copyrightable:
 Novels, poems, biography, exam questions
 Textbooks, dictionaries, patent specification
 ……
 Uncopyrightable
 The term “Cloud Intelligence”
• Beijing Yuanjian Culture Dissemination Co. v. Alibaba Co. (Beijing
Chaoyang District People’s Court, 2011)
 Generic term “exercise book”
• Sheng Huanhua v. Jiling Publishing House (Shanghai Huangpu District
People’s Court, 2012)
 Phone number books
• Wang Jiming v. Wang Huaqiang & China Encyclopedia Publishing
House (1993)
Split Court Decisions: Case I
 Non-infringement
 Reasoning: not copyrightable, b/c no
originality
 The plaintiff's package insert is merely “an objective
description” of the drug
 There is no originality in the way of putting words together
Shanxi Jinfang Pharmaceuticals vs. Sanyou Li Company
(Shangdong High People’s Court, 2004)
Split Court Decisions: Case II
Infringement
Reasoning: Copyrightable, b/c
originality
 The package insert has originality, because it include
the experiment process and experiment data
Hubei Welman Pharmaceuticals vs. Suzhou Erye
Pharmaceuticals (Chuangsha Intermediate People’s
Court, 2009)
Response from Supreme
People’s Court?
FDA has filed a request to Supreme
People’s Court to clarify
Supreme People’s Court has been
doing focused group discussion to
collect comments from:
 Pharmaceutical industry
 Scientists
 Attorneys
 Law professors
U.S. Law
The package inserts are copyrighted
works
Using the package inserts on generic
drugs are legally exempted from
infringement
 SmithKline Beecham Consumer Healthcare, L.P. v.
Watson Pharmaceuticals, Inc., 211 F.3d 21 (2nd Cir.
2000)
Statute in China:
Copyright Act –Statutory Exceptions
None of the statutory exceptions
apply to generic drug package insert
cases
 Governmental documents are not copyrightable
(article 5)
 Fair Use . an exclusive list of 12 situations (article 22)
 Compulsory license for use in textbook (article 23)
What the law shall be?
Infringement or non-infringement?
 The possibility of using different expressions
• The scientific facts
• The format required by FDA
 The function of package insert
• Instructions for doctors and patients
Originality vs Legal Exception
No originality
 Cannot be enforced against generic drug
manufacturers
 Cannot ben enforced against other copiers
Legal Exception:
 Out of what the court can do
 Requires action by the congress