patents introduction and international regime victor h. bouganim wcl, american university

PATENTSPATENTSIntroduction and International RegimeIntroduction and International Regime

Victor H. Bouganim

WCL, American University

Victor H. Bouganim, WCL, American University, Spring 2001

U.S. ConstitutionU.S. ConstitutionThe United States Constitution provides Congress with the following power:

“to promote the Progress of Science and useful Arts, by securing for limited Times to…Inventors the exclusive Right to their…Discoveries.”Article I, section 8, clause 8


Historical BackgroundHistorical Background 1790: First U.S. patent

statute passed 1793: The 1793 Act

instituted a registration system

1836: The 1836 Act introduced formal examination and examiners

1952: The Patent Act of 1952, inter alia, replaced the subjective invention test with an objective test for non-obviousness

1970: The Paris Convention

1978: Patent Cooperation Treaty in force

1982: Congress passed the Federal Courts Improvement Act, creating the Court of Appeals for the Federal Circuit (C.A.F.C.)

1999: American Inventors Act of 1999


TRIPS Amendments to the US TRIPS Amendments to the US Patents Act, 1994Patents Act, 1994

The patent term is now 20 years from the date of filing.

35 U.S.C. Sec. 154 WTO members may

introduce evidence of pre-patent filing in their home country when requesting a U.S. patent. 35 U.S.C. Sec. 104

Definition of infringement expanded to include the acts of unauthorized offering for sale or importing. 35 U.S.C. Sec. 271

Provisional applications permitted. 35 U.S.C. Sec. 111


Theory of PatentsTheory of Patents

Incentives Disclosure

Legal Protection for limited periodLegal Protection for limited period


Types of PatentsTypes of Patents

Utility PatentsDesign PatentsPlant Patents


Obtaining a PatentObtaining a PatentRequirements

Patentable Subject Matter

UtilityNoveltyNonobviousnessEnablement

RightsThe right to exclude others from:

making using selling offering for sale importing


Patent Protection - InternationalPatent Protection - International Patents are granted to inventors according to

national law Patents represent territorial grants of exclusive rights Each jurisdiction provides varying patent protections

– Example – many developing nations refuse to grant patents on pharmaceuticals

– Countries like South Africa introduces ‘compulsory licensing’ of certain drugs, e.g. for treatment of AIDS. Currently, a lawsuit is discussed in Pretoria.


International Patent RegimeInternational Patent Regime

TRIPS, Art. 27-34– Reference to the Paris Convention [TRIPS, Art. 2]

Paris Convention, 1883 as amended in 1967. Patent Cooperation Treaty, 1970. European Patent Convention

– Designed to permit a single office at Munich and The Hague to issue patents of all countries party to the treaty

European Union Patent Convention– Designed to create a single patent

valid throughout the EU


Paris Convention - OverviewParis Convention - Overview 160 States are members (The Paris Union), including: EU, USA

and Japan (as in January 2001) Concluded in 1883. Amended and revised several times, last in

1979. Governed by WIPO - World Intellectual Property Organization Subject matters covered:

– Patents and Utility Models– Trademarks, Service and Collective Marks– Industrial Designs– Trade Names and Geographical Indications– Unfair Competition


Paris Convention - PrinciplesParis Convention - Principles

National Treatment

Right of PriorityCommon Rules


PCT - Patent Cooperation TreatyPCT - Patent Cooperation Treaty

Established in 1970, Amended in 1979, modified 1984.

Open to members of the Paris Union.Facilitates international patent search

and registration.


Patent ConventionsPatent Conventions

Paris Convention– “right of national

treatment”– “rights of

priority”patent applications in foreign jurisdictions are not dependent upon success in home country

– Does not reduce the need for individual patent applications

Patent Cooperation Treaty (PCT)– 40 countries including U.S. – Designed for greater uniformity and

less cost in the international patent filing process

– Filings can be done in selected countries instead of in each individual country

– International Searching Authorities (ISA)

– Allows applicant to have an international preliminary examination


Drugs & Health PatentsDrugs & Health Patents

North v. South debate: Do drug patents unfairly keep needed medications out of the hands of indigent populations?

Should the duration of patent protection be reduced for prescription drugs, so more affordable generic versions can be produced in less than 20 years?

Should health procedures, e.g., a surgical technique be patentable?

What is the relationship between drug patents and the health and well-being of individuals?


Patents - ExclusionsPatents - Exclusions

Members may exclude from patentability inventions … necessary to protect ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment …

TRIPS, Art. 27.2

Members may also exclude from patentability:

(a) diagnostic, therapeutic and surgical methods for the treatment of humans or animals;

(b) plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals …

TRIPS, Art. 27.3


Class DiscussionClass Discussion Should drug patents receive the same protection in

developing countries? Compulsory licensing of drugs - is it justified? In

what conditions? South African AIDS drugs example

– The Pharmaceutical Manufacturers' Association (PMA) challenged the Medicines and Related Substances Control Amendment Act in a bid to stop the South African government from making cheaper generic drugs available.


South African Patent CaseSouth African Patent Case

The trial in Pretoria, South Africa which opened on 5 March, 2001 was adjourned to 18 April, 2001.

Parties ultimately settled out of court.

What role does TRIPS play in this dispute?


Patents - Compulsory LicensingPatents - Compulsory Licensing

Article 31 of the TRIPS sets outs the framework for national laws on use without authorization of the patent owner.

Article 31 gives countries broad discretion on government use of compulsory licensing.– For example, there are no limitations on the

grounds upon which a government can authorize use of a patent by third parties, only a set of procedures to follow.


Compulsory LicensingCompulsory Licensing TRIPS Rules - 1 TRIPS Rules - 1

Governments consider cases on their individual merits

Prior to authorizing third party use, there should be an effort to negotiate a voluntary license on reasonable commercial terms

Government must provide for "adequate remuneration . . . taking into account the economic value of the authorization."


Compulsory LicensingCompulsory Licensing TRIPS Rules - 2 TRIPS Rules - 2

”Use shall be authorized predominantly for the supply of the domestic market." [ TRIPS, Art. 31(f)]

There are many exceptions to the general rules. [ TRIPS, Art. 31]– For example, the requirements for negotiation for a

voluntary license on reasonable commercial terms may be waived:

in the case of a national emergency or other circumstances of extreme urgency or in cases of public non-commercial use.


CIPRO PatentCIPRO Patent

The need for generic Cipro antibiotics for Anthrax infection depends upon --

– Can terrorists deliver Anthrax to large numbers of people?

– Could an attack take place before Bayer could deliver large quantities of Cipro?

The probability of any of the above happening is unknown.

Scientists presume that 100 kilos of Anthrax could kill 1 to 3 million persons.


The Need for Generic CiproThe Need for Generic Cipro The Health Authorities presume a need for

medications for 10 million persons. – At the 120 pill recommended course of treatment for

Cipro, this is 1.2 billion pills. – Bayer says it can produce 2 million per day. At this

rate it would take 600 days to supply 1.2 billion pills. – 5 generic companies have already received US FDA

clearance for the quality of their generic Cipro, and could immediately be asked to manufacture the drug.


U.S. Legal FrameworkU.S. Legal Framework The US government already has the right to use

patents without a license, under 28 US 1498, an authority which is often used for other patents.

HR 1708: Affordable Prescription Drugs and Medical Inventions Act

– Amends the Patents Act to provide for compulsory licensing of certain patented inventions relating to health.

– Introduced in the House on May 3, 2001


28 USC 149828 USC 1498 Deals with uses of patents or copyrights, when the use is

by or for the US government.

– Under this statute the US government does not have to seek a license or negotiate for use of a patent or copyright in certain circumstances.

– Any federal employee can use or authorize the use of a patent or a copyright.

– The right owner is entitled to compensation, but cannot enjoin the government or a third party authorized by the government, to prevent the use.

patents introduction and international regime victor h. bouganim wcl, american university

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