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Copyright Law in China
Easily understood statute Difficult policy choice
11
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
Background Information: What Package Insert Is?
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, folded up sheets of paper placed inside the box your prescription bottle comes in.
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 DrugsCopy or abbreviate:
CopyShanxi 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 DrugsCopy 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/
20121218/1194609.shtml
Statute: FDA Regulations vs Copyright Act
FDA Regulations Require content and
format of the package insert
Require generic drug to be bioequivalent to pioneer drug
Copyright
Copyrightability Originality
Infringement Exceptions
Generic drug manufacturers either Generic drug manufacturers either copy or abbreviate the package insert copy or abbreviate the package insert of the pioneer drug of the pioneer drug
Generic drug manufacturers inevitably Generic drug manufacturers inevitably infringe, unless infringe, unless (a)(a)the package inserts are not copyrightable , the package inserts are not copyrightable , or or (b)(b)(b) legally excepted (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-infringementReasoning: 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