1. 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

2. 2 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

3. 3 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.

4. 4 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. Thomas A Faunce et al., Linkage pharmaceutical evergreening in Canada and Australia, June 2007

5. 5 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.

6. 6 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 treatys 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.

7. 7 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.

8. 8 Example on Context: Data protection issues under the JORDAN-USFTA Article 4.22 Pursuant to Article 39.3 of TRIPS each Party, when requiring 1), as a condition of approving the marketing of pharmaceutical or of agricultural chemical products 2) that utilize new 3) chemical entities 4), the submission of undisclosed 5) test or other data, or evidence of approval in another country, the origination 6) of which involves a considerable effort 7), shall protect such information against unfair commercial use 8). In addition 9), Members shall protect such data against disclosure 10), except where necessary to protect the public, or unless steps are taken to ensure that the data are protected against unfair commercial use. 11)

9. 9 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.

10. 10 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 applicants diligence

11. 11 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.

12. 12 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.

13. 13 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…

14. 14 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.

15. 15 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