Transcript Slide 1

Towards equitable and affordable
medicine prices policies in Jordan
Interpretation of Jordanian Patent Law and
JUSFTA to improve access to medicines
Dead Sea 4-5 December 2007
Presented by:
Hiba A. Zarour, Esq.
*BSc. Pharmacy, Master of Intellectual Property, Juris Doctor
* Admitted in New York and Massachusetts
Intellectual Property Counsel
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What should the Government do
to ensure access?
• Do not close the door on interpreting or even
challenging IP laws, this is what courts are for,
laws and agreements are not gospel.
• Listen and give equal credibility to all parties
• Legislate wisely.
• Do not provide an overkill, balance rights with
exceptions.
• Insist on flexibilities and make use of them
• Learn and Consult with other governments who
underwent the experience
• Contact NGOs, WIPO and ask for experts’ help
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In Pharmaceuticals the Need for a
Balanced Legal System is Essential
• Rules are important to ensure
Intellectual Property protection of the
new medicines so they would be
created to alleviate human suffering.
• Limitations on these rules are equally
important to have medicines that are
readily available and affordable.
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What is Ever-greening?
• Ever-greening : is not a formal concept of
patent law. It is best understood as a social idea
used to refer to the innumerable ways in which a
pharmaceutical patent owners utilize the law and
related regulatory processes to extend their high
rent earning intellectual property privileges
particularly over highly profitable “blockbuster”
drugs.
• We have to interpret agreements in a way to
prevent ever-greening.
• Australia, Canada enacted anti-ever-greening
legislation to battle provisions of the FTA that
could delay introduction of generics.
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Thomas A Faunce et al., ‘Linkage’ pharmaceutical evergreening in Canada
and Australia, June 2007
How to achieve the balance?
• Interpretation of treaties to give rights to right
holders but also to prevent abuse of patent rights
that leads to dangerous ever-greening practices
that cost governments billions of dollars due to
delays in introducing cost saving generics.
(According to a 1998 study by the Congressional
Budget office, generic drugs save consumers
between $8-$10 billion each year).
• Enacting anti-ever-greening laws if need be (the
Australian experience post AUS-USFTA).
• Analysts agree that the most dangerous type of
ever-greening is linkage between marketing
approval and patent protection. Unlike later signed
FTAs which has this language Jordan FTA does not
have such a linkage.
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Interpretation of treaties under International
Law : General Rules
1. Good faith and ordinary meaning of text (Plain
meaning rule/civil and common law) within the
treaty’s context. (Context includes preamble and
annexes and agreement in conclusion of treaty or
instrument accepted as part of treaty)
2. In addition to Context subsequent agreement
regarding interpretation. Subsequent practice in
application establishing agreement on
interpretation.
3. A special meaning shall be given to a term if so
intended.
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Interpretation of Treaties: Supplementary
• Preparatory work and circumstances of
conclusion should be consulted if the
interpretation under the general rules:
– Leaves the meaning ambiguous
– Leads to a result which is manifestly absurd
or unreasonable.
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Example on Context: Data protection
issues under the JORDAN-USFTA
Article 4.22 Pursuant to Article 39.3 of TRIPS each Party,
when requiring1), as a condition of approving the marketing of
pharmaceutical or of agricultural chemical products2) that utilize
new3) chemical entities4), the submission of undisclosed5) test or
other data, or evidence of approval in another country, the
origination6) of which involves a considerable effort7), shall
protect such information against unfair commercial use8). In
addition9), Members shall protect such data against
disclosure10), except where necessary to protect the public, or
unless steps are taken to ensure that the data are protected
against unfair commercial use.11)
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Data Protection: Context
The FTA accepts TRIPS Article 39.3 as the
basis for the data exclusivity article.
Therefore, any meaning given to the terms
in this article that legal scholars or lawyers
deem as consistent with the TRIPS
agreement is consistent with the context of
this agreement.
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Example on Ordinary Meaning
Jordan US FTA provisions related to pharmaceutical Products
Article 4.23 (a) Each Party shall make available an
extension of the patent term to compensate the patent
owner for unreasonable curtailment of the patent term as a
result of the marketing approval process.
•
Make available: mechanism for inducing the applicant to
ask for extension and cap on extension e.g. the US gives
the patent holder 60 days post approval to inform the
patent office, otherwise, the holder is not granted
extension. The extension cannot exceed five years and
the total term of a patent plus extension cannot exceed 14
years
•
Unreasonable; what does unreasonable mean? There
should be a timeline that takes into consideration many
factors including the applicant’s diligence
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Example 2 on Ordinary meaning;
Hint at Linkage-Ever-greening?
Article 4.23.(b)
The patent owner shall be notified of the
identity of any third party requesting marketing
approval effective during the term of the patent.
NO. Ordinary meaning rule requires only
that patent owner be notified and it does
not require the generic to notify.
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Example on Subsequent Practice
US practice post agreement is different than
Jordan. Application of a generic is an act of
infringement in the US but in Jordan it is not.
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Example on Subsequent Practice
Infringement of a patent under US patent law
35 USC 271: Infringement of a patent
(e)
(1) It shall not be an act of infringement to make, use,
offer to sell, or sell within the United States or import
into the United States a patented invention solely for
uses reasonably related to the development and
submission of information under a Federal law which
regulates the manufacture, use, or sale of drugs or
veterinary biological products. (Regulatory Exception)
(2) It shall be an act of infringement to submit (A) an application under section 505(j) of the Federal Food,
Drug, and Cosmetic Act or described in section 505(b)(2)
of such Act for a drug claimed in a patent or the use of
which is claimed in a patent…
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Example on Subsequent Practice: Patent
Holder Rights Under Jordanian Patent Law
Article 21
C. Notwithstanding any conflicting provision
in this law or any other law, all types of
scientific research and development
(Regulatory Exception) and filing
applications for obtaining marketing
permits carried out before the elapse of
the patent protection period shall not be
regarded as infringement neither civil nor
criminal .
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Access to medicines: A Stable Legal
Environment
The government should ensure:
• Transparency of laws and balance between rule
and exception.
• Not assuming role of legislator by reading into the
law what is not written.
• Not assuming a role reserved for courts by
becoming the enforcer of private IP rights.
• Keeping a record of the negotiating history of any
agreement that affects access to medicines.
• Learning the field.
• Making teams of international as well as national
lawyers. Seeking lawyers to prevent problems as
well as to solve them
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