The Protection of Data Submitted to Drug registration Authorities

1. Workshop for the GCC on the Protection of Invention in the Pharmaceutical Sector, Patents, Undisclosed Information and Health Policies The Protection of Data Submitted to Drug registration Authorities Riyadh, Saudi Arabia 15-16 October 2012 Marco Aleman, Deputy Director, Patent Law Division, and Head, Legislative and Policy Advice Section, WIPO, Giulia Ragonesi, Consultant, WIPO

2. Drug Discovery Process* compounds * Pharma 2008

3. LIFE CYCLE OF A DRUG* literature know-how education funding equipment time biological materials bioinformatics data Research Development Patentee Commercialization Generic Commercialization Basic research Applied research Applied research Pre-Clinical research Clinical trials Generic Testing 1st clinical trial positive 2nd clinical trial positive Generic drug available (patent expires or invalid) Reduction to practice (in vitro) Animal tests positive Regulatory approval (country by country) Biological model drug available Conception publication patent application sales safety efficiency bioequivalent 3-10 years New delivery system patent prosecution exclusive rights New method of use patent issuance (country by country) 20 years + * Generic Drugs, Compulsory Licensing, and other Intellectual Property Tools for Improving Access to Medicine, Michael A. Gollin, 2001

4. Test data for pharmaceuticals • Undisclosed • Expensive to produce • Necessary to prove safety and efficacy for a drug • Need to consider the originator’s efforts in developing this data (in terms of time, human resources and financial investment) Protection? Which kind of protection?

5. Test data Protection: sui generis system Article 39.3 TRIPS Agreement “Members, when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use. In addition, Members shall protect such data against disclosure, except where necessary to protect the public, or unless steps are taken to ensure that the data are protected against unfair commercial use”

6. Main aspects of data protection under TRIPS Agreement • Open provision of law Negotiation history • Insertion in the part dedicated to undisclosed information and unfair competition ( but not required evidence of fraud, deceit and dishonesty) • Main aspect: - test data obtained with a considerable effort - data related to pharmaceutical and agro-chemical products only - need of obtaining a marketing approval - new chemical entity (NCE) - protection against disclosure and unfair commercial use - No mentioned explicitly exclusivity data protection

8. Balance of two sets of interests - Protection of efforts to create data - Keep it secret - No! Need to reproduce data already available -disclosure to the public for reasons of transparency

9. Protection against unfair commercial use (1) • “Unfair”: meaning more extend in comparison to “unfair” competition embraces the notion of enrichment without a cause (free-riding situations) - free riding by competitors (not by everybody) - free-riding in the business world intrinsically dishonest • “Commercial”: usually refer to the “pertaining to commerce or trade” and “looking toward financial profit”  But: competitors are not in possession of this data, only Governments  Which is the commercial use they can make it?

10. Protection against unfair commercial use (2) • “Use”: The act of putting something to work, or employing or applying a thing, for any (esp. a beneficial or productive) purpose (Oxford English Dictionary)  something different from exploitation (use direct to profit) • Consequences: a theory argues that “unfair commercial use” possible under this provision might be constituted by relying on the test data by the RRA  But: this hasn’t been explicitly excluded by Article 39.3 TRIPS

11. Options to protect test data at legislative level • Obligation of the Regulatory Review Authority to keep secret the information. Other aspects to take into consideration are the possibility by the RRA to rely on the test data already in its possession in case of application for a generic drug and remuneration to the innovator in case of use by third parties. • Obligation to keep secret the information and determined period of time during which the data cannot be used by the RRA to grant authorization to a subsequent generic drug for a certain period (data exclusivity regime)

12. Data protection: remuneration • No! Provided in Article 39.3 TRIPS  left to Member states which decide to provide for it • Right of remuneration  intrinsic public nature of the interest involved (argued that originators are not philosophically or ethically endowed with the right to say no) • Argued in doctrine that it should take into account different values: - cost to create the data - opportunity costs - economic and scientific value - profit

13. Canadian Federal Court of Appeal, Bayer v. Canada (Attorney General) (1) • NAFTA Article 1711: data exclusivity for at least 5 years • Federal Court: • Filing of an Abbreviated New Drug Submission (ANDS) by a generic manufacturer  safety and effectiveness may be demonstrated by showing that the product is the pharmaceutical and bioequivalent of the innovator’s product  no! need to examine or rely upon the test data of the innovator • If safety and effectiveness of the product can be established only by, implicitly or explicitly, examining and relying upon the confidential data  yes! Data exclusivity • Bioequivalence and bioavailability studies safety and effectiveness are proved* *Critical to this decision: in any case a comparison with the innovator’s data has to be carried out so always data exclusivity protection

14. Undisclosed data • Test data: protectable as far as it is secret • Art. 39.2 TRIPS: undisclosed information (secret, measures to keep it secret, commercial value) • Nothing to do with the novelty of the chemical entity

15. New Chemical Entity (NCE) (1) • No definition in the TRIPS But: different from the novelty requirement for patentability Possible interpretations: - new application in the pharmaceutical sector of a product already known in another field; - « New »: first application in the world/in the country • “innovative drug” means a drug that contains a medicinal ingredient not previously approved in a drug by the Minister and that is not a variation of a previously approved medicinal ingredient such as a salt, ester, enantiomer, solvate or polymorph. (Canada, Data Protection Regulation (DPR), C.08.004.1) • « the designated therapeutic moiety, that has not been registered in a region or Member State (also referred to as a new molecule entity or new chemical entity). It may be a complex, simple ester, or salt of a previously approved substance. (US Department of Health and Human Services of the Food and Drug Administration, Federal Register, vol. 62 No. 227 of 25711/1997)

16. New Chemical Entity (NCE) (2) Productsincorporating a NCE: - a new pharmaceutical product is one that does not contain a chemical entity that has been previously approved in the Party for use in a pharmaceutical product(…) – Art. 14.9 .1 c) FTA USA-Baharain- - a new pharmaceutical product is one that does not contain a chemical entity that has been previously approved in the territory of the Party for use in a pharmaceutical product – Oman, Article 15.9 of the USA-OMAN FTA Old + new = old. - “pharmaceuticals or chemical agricultural products which contain new chemical substances” – Iraq, Coalition Provisional Authority Order Number 81-  old + new = new - «pharmaceutical or of agricultural chemical products that utilize new chemical entities” – Jordan, Article (8) Unfair Competition Law - old + new = new

17. Considerable effort • No definition in the TRIPS Agreement • purpose: protect the investment made in producing test data • Avoiding free-ride  no! Characteristics of IP rights (protection of human ingenium through exclusive rights) • Unfair competition not only fraudulent behavior, but also taking advantage of a given situation • Take into account both costs and intensity of the efforts • Decisions taken on a case by case basis by Member States

18. Approval of the relevant chemical entity • Data protected as far as the authorization for marketing is granted • Unapproved products no! Commercial interest • Astrazeneca A/S v. Laegemiddelstryrelsen, C- 223/01: • Danish Order No.165/95 on marketing authorizations for medicinal product “applicants do not need to submit toxological, pharmaceutical and clinical documentation referred to point 9 of Paragraph 3 if they show that one of the following conditions is satisfied: (…) The medicinal product in respect of which has been approved in the Community, under the legislation in force, for at least six years, and marketed in Denmark

19. Products: has to be put into the market? But: still actual market? If teh originator withdrew the marketing authorization? ECJ: it is necesary and sufficient that the marketing authorization of the reference medicinal product be ni force in the Member State concerned on the date of that application.

20. Exceptions and limitations to rights conferred (1) • Fair use of test data - avoid the repetition of test data that cause suffering on humans and animals - compulsory licensing - obtaining the data caused suffering on humans and animals - cases of extreme urgency -product not commercialized within a certian period of time - originator found liable of anticompetitive practices - test data necessary for the marketing approval of patented product subject to compulsory license

21. Exceptions and limitations to rights conferred (2) Example: Regulations for the protection of Confidential Commercial Information of May 5, 2005, Article 6 (Saudi Arabia) The competent registration authority – during the protection term of commercial secret – may permit third parties to use the undisclosed data of secret tests submitted by another applicant in the following cases: (1) If the product first registered in the Kingdom has not been subject to trading within a reasonable period of time determined by the registration authority, after approving its marketing (2) If this is required by a pressing necessity determined by the competent authority to protect public.

22. Thank you!