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