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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
2011/6/3 3
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
2011/6/3 6
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
2011/6/3 7
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)
2011/6/3 8
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
2011/6/3 9
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.
2011/6/3 10
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)
2011/6/3 11
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.
2011/6/3 12
The challenges of Pharmaceutical Patents in Taiwan
Types of Pharmaceutical PatentsSubstance patentUse patentProcess patentFormulation patentCrystal form patentSalt hydrate patentMedical Procedures?
2011/6/3 13
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
2011/6/3 16
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.
2011/6/3 18
• 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
2011/6/3 26
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:
2011/6/3 29
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.