1. Copyright Law in China  Easily understood statute  Difficult policy choice 1

2. 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 ?

3. 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?

4. 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

5. 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.

6. 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.

7. 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

8. 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)

9. 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

10. 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 copy or abbreviate the package insert of the pioneer drug Generic drug manufacturers inevitably infringe, unless (a)the package inserts are not copyrightable, or (b)(b) legally excepted

11. Copyright Act- the holder’s rights  The copyright holder has the exclusive rights to prevent the others from:  Copying  Making derivative work  etc

12. 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)

13. 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

14. 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)

15. 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)

16. 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)

17. 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

18. 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)

19. 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)

20. 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

21. 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