2011/6/3 1

Legal Protection for Pharmaceutical Patents & Generic Drugs in Taiwan Sung-Mei Hsiung Judge, Intellectual Property Court, Taiwan J.S.D., U.C. Berkeley School of Law, U.S.

2011/6/3 2

Outline ／Topics

• The Role of Pharmaceutical Industries in Human Health

• The Role of Patents in Pharmaceutical Technology• The Challenges of Pharmaceutical Patents in

Taiwan• The Role of Generic Drugs in Human Health• A Tug of War between Pharmaceutical

Patents and Generic Drugs

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Outline ／ Topics

• The Competition of Pharmaceutical Patents and Generic Drugs in Taiwan

• The Protection of Pharmaceutical Patents in Taiwan

• The Measures of Facilitating Generic Drugs’ Entry in Taiwan

• The Judicial Role in Protecting Pharmaceutical Patents and Generic Drugs in Taiwan

• Case Study

2011/6/3 4

The Role of Pharmaceutical Industries in Human Health

• The pharmaceutical industries drive innovation of new drugs, including the contraceptive pills, penicillin, vaccines and other antibiotics that have saved millions of lives over years. Health Care Policy ： Prevention v.s. Prescription

2011/6/3 5

The Role of Pharmaceutical Industries in Human Health

• The pharmaceutical industries produce both patents drugs and generic drugs which are equivalent to pioneer drugs (patent drugs) containing same active ingredient as the patent drugs.• Independent Inventor v.s. Research Fund

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The Role of Patents in Pharmaceutical Technology

• Incentive for drug research: moneymaking product

• The importance of patent system in pharmaceutical technology field

• 30 yrs after the Chakrabarty Case (June 16, 1980, US Sup. Ct.)

Prof. Ananda M. Charkrabarty U. Illinois at Chicago College of Medicine

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The challenges of Pharmaceutical Patents in Taiwan

Generally, pharmaceutical patents are protected based on the same rules as other kinds of patents.

The challenges of patentable requirements: definiteness, enablement and non-obviousness

ATORVASTATIN (LIPITOR)

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The challenges of Pharmaceutical Patents in Taiwan

• The standard to decide the patentable requirements:

A person having ordinary skilled in the art (PHOSITA): a hypothetical person

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The challenges of Pharmaceutical Patents in Taiwan

• Factors that may be considered in determining level of ordinary skill in the art include: (1) the educational level of the inventor; (2) type of problems encountered in the art; (3) prior art solutions to those problems; (4) rapidity with which innovations are made; (5) sophistication of the technology; and (6) educational level of active workers in the field.

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The challenges of Pharmaceutical Patents in Taiwan

• “ A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton.”

• “In many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle.” (KSR v. Teleflex, 550 U.S. 398, 2007)

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The challenges of Pharmaceutical Patents in Taiwan

• Example:• A patent related to the creation of a

compound to treat ear infections without damaging a patient's hearing

• The PHOSITA shall be a pediatrician or an otologist ?

v.s.

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The challenges of Pharmaceutical Patents in Taiwan

Types of Pharmaceutical PatentsSubstance patentUse patentProcess patentFormulation patentCrystal form patentSalt hydrate patentMedical Procedures?

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The Role of Generic Drugs in Human Health

• The patent term that covered the pioneer drug’s active ingredient has expired.

• Market competition leads to substantially lower prices.

• public interest v.s. industries interest

2011/6/3 14

A Tug of War Between Pharmaceutical Patents &

Generic Drugs

want to extend patent protection

as long as possible

want to enter the market as early as

possible

Pioneer drugs Generic drugs

2011/6/3 15

The Competition of Pharmaceutical Patents and Generic Drugs in Taiwan

• Principle: Making a balance between patent protection & encouraging

generic entry • The Hatch-Maxman Act (1984, U.S.)• Extending the patent term of

pharmaceutical patents• Facilitating generic drugs to enter the market

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The Protection of Pharmaceutical Patents in Taiwan

• Ⅲ,Sec. 51, Patent Law (2010/8/25,Taiwan)• The term of an invention patent right shall ends with

20 years from the filing date of the patent application.

• Ⅰ,Sec. 52, Patent Law(2010/8/25,Taiwan)• Patents concerning pharmaceuticals, agrichemicals

and their processes• A patentee may apply for an extension of the patent

term for 2 to 5 years (effected on 2002. 1.1)

2011/6/3 17

The Measures to Facilitate Generic Drugs’ Entry in Taiwan

• Basically, application procedure for generic drugs is much simpler than for new drugs.

• Only three tests related to (1) standards and test methods, (2) stability, and (3) biological equivalence are required.

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• Experimental Use Exception Sec.Ⅰ, Art. 57, Patent Law (effected on2002/1/1)

The effect of an invention patent right shall not

extend to any of the following matters: 1. Where the invention is put into practice for

research, educational or experimental purposes only, with no profit-seeking acts involved therein. Of course, generic drugs company is not non-profit…

However, if the act is only for speeding up the generic

drug to enter the market…

The Measures to Facilitate Generic Drugs’ Entry in Taiwan

2011/6/3 19

The Measures to Facilitate Generic Drugs’ Entry in Taiwan

• Experimental Use Exception

• Sec. , Ⅴ Art. 40-2 Pharmaceutical Affairs Law (effected on 2006/5/30)

• The protection offered by this Article does not apply to data (of a new patent drug to apply for the approval to enter the market) collected by non-patent holders for educational and clinical research purposes.

2011/6/3 20

The Measures to Facilitate Generic Drugs’ Entry in Taiwan

• Experimental Use Exception The scope for experimental use is only

for generic drugs entering the market

sooner after the patent term expired.

Not permitted if the purpose is to manufacture or sell generics before the expiration of the patent term

Not permitted if the purpose is to manufacture

stocks for selling generics after the expiration

of the patent term

2011/6/3 21

The Measures to Facilitate Generic Drugs’ Entry in Taiwan

• Data Exclusivity Protection for Pharmaceutical Drugs Exception

Sec ,Ⅰ Art. 40-1, Pharmaceutical Affairs Law (effected on 2006/5/30)

For the purpose of protecting public interest, the central health competent authority may, where necessary, disclose the relevant information of a drug’s ingredients, instructions etc….

2011/6/3 22

The Measures to Facilitate Generic Drugs’ Entry in Taiwan

• The Same Instruction Requirement Art. 20,Guideline for Registration of Medicines (effected on 2005/1/7) The instructions of the generic drugs shall be the same as the pharmaceutical patents

• Article 26, Pharmaceutical Affairs Law The term "instructions" as used in this Act shall refer to the instruction sheets accompanied with pharmaceuticals or medical devices.

2011/6/3 23

Civil actions of the 1st & 2nd instancerelated to•Patent Act•Trademark Act •Copyright Act •Optical Disk Act•Trade Secrets Act•Fair Trade Act •Others

‧Criminal actions of the second instance related to IPR‧Excluding Juvenile criminal cases

•Administrative actions of the first instance related to IPR disputes

Administrative Action

Civil Action Criminal Action

IP Court Jurisdiction

The Judicial Role in Protecting Pharmaceutical

Patents and Generic Drugs in Taiwan

智慧財產法院

2011/6/3 24

Supreme CourtSupreme Court(Civil & Criminal)(Civil & Criminal)

The Judicial Role in Protecting Pharmaceutical

Patents and Generic Drugs in Taiwan

2nd Instance Civil Action

2nd InstanceCriminal Action

1st InstanceCivil Action

Supreme Supreme Administrative Administrative

CourtCourt

1st InstanceAdministrative Action

Intellectual Property Office

Intellectual Property Court

Administrative AppealAdministrative Appeal

1st InstanceCriminal

Action

District Court

2011/6/3 25

The Judicial Role in Protecting Pharmaceutical Patents and Generic Drugs in Taiwan

(statistics: July 1, 2008 to April 30, 2011)

)

Type of IP Case

Civil Action

Administrative Action

Criminal Action

Number

Patent 1,114 472 0 1,566

Trademark 219 717 232 1,168

Copyright 453 3 488 944

Trade Secret 36 0 0 36

Others 517 47 272 836

Total 2,319 1,239 992 4,550

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The Judicial Role in Protecting Pharmaceutical Patents and Generic Drugs in Taiwan

(statistics: July 1, 2008 to April 30, 2011)

Technical Fields Number

Electronic / Electrical Engineering 308

Computer Science 87

Mechanical Engineering 575

Civil engineering / Architecture 59

Chemistry / Chemical Engineering 113

Biotechnology Medicine 35

Industry Design 58

Total 1,235

2011/6/3 27

Case Study

• Case related to definiteness• Case related to enablement• Case related to non-obviousness• Case related to crystal form patent• Case related to experimental use exception• Case related to extension of the patent term

2011/6/3 28

Case Study

• Patent applicant： U.S. Agouron Pharmaceuticals Inc. & Japan Tabacco Inc.• Invention： HIV protease inhibitors• Independent Claim 1：

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Case Study

• TIPO ： lack of definiteness & enablement requirements

• TIPC ： only one example could not describe enough how “R” or “R’ ” works; undue experiment are needed

• Not patentable (decided on 2010/7/1, no appeal)

2011/6/3 30

Case Study

• Patent applicant： U.S. Shering Corporation• Invention ： Hydroxy-Substituted Azetidinone Compounds Useful As Hypocholesterlemic Agents• US 2002/0019409 A1 ： Treating Allergic and Inflammatory Conditions• In Taiwan, medical procedure is not patentable, so the applicant change the invention as a use patent and no priority right can be advanced in this case.

2011/6/3 31

Case Study

• TIPO ： lack of non-obviousness requirement

• TIPC ： The use of the compound has known to PHOSITA = obvious

• Not patentable (decided on 2010/6/17, affirmed by

the Supreme Administrative Court)

2011/6/3 32

Case Study

• Patentee： French Sanofi Aventis• Opposing Party ： TW PharmaStar• Invention： Polymorphic Form of Clopidogrel Hydrogen Sulfate

2011/6/3 33

Case Study

• The patentee is successful in defending Polymorphic Form 2 different from Form

1, and its effect at easier and more stable to make tablet is non-obviousness.

• TIPO ： Patent is valid.• TIPC ： Patent is valid. (decided on 2011/3/10, appeal withdrawn on 2011/5/27)

2011/6/3 34

Conclusion

• A balance between patent and competition policy will lead pharmaceutical patents and generic drugs become good friends in the market.

2011/6/3 35

Vielen Dank Für Ihre

Aufmerksamkeit!

Sung-Mei Hsiung

Judge, Intellectual Property Court, Taiwan

J.S.D., UC Berkeley School of Law, U.S.

Sung-Mei Hsiung

Judge, Intellectual Property Court, Taiwan

J.S.D., UC Berkeley School of Law, U.S.