The Protection of Data Submitted to Drug registration Authorities

Riyadh, Saudi Arabia15-16 October2012

Marco Aleman,

Deputy Director, Patent Law Division, and Head, Legislative and Policy Advice Section, WIPO,

Giulia Ragonesi, Consultant, WIPO

Workshop for the GCC on the Protection of Invention in the Pharmaceutical Sector, Patents, Undisclosed Information and Health Policies

Drug Discovery Process*Drug Discovery

Pre

Clinical

5000-10000 compounds 250

3-6 years

CLINICAL TRIALS

5 -3

Phase1

Phase 2

Phase 3

VOLUNTEERS

20-100 100-500 1000-5000

6-7 years

NDA Post-marketing surveillance

One approved drug

0,5-2 years

compounds

* Pharma 2008

LIFE CYCLE OF A DRUG*

* Generic Drugs, Compulsory Licensing, and other Intellectual Property Tools for Improving Access to Medicine, Michael A. Gollin, 2001

drug available

safety

literature

know-how

education

funding

equipment

time

biological materials

bioinformatics data

Basicresearch

Appliedresearch

Appliedresearch

Pre-Clinicalresearch

Clinicaltrials

Biologicalmodel

ConceptionReductionto practice(in vitro)

Animaltestspositive

1stclinicaltrialpositive

2ndclinicaltrialpositive

Regulatoryapproval(country bycountry)

Research Development

GenericTesting

Genericdrugavailable(patent expiresor invalid)

PatenteeCommercialization

publication

Generic Commercialization

patentapplication efficiency sales bioequivalent

3-10 years

patentprosecution

exclusive rights

patent issuance(country by country)

20 years +

New delivery system

New method of use

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?

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”

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

Patents Trade Secrets

Data protection Data exclusivity

Protects Products and processes

Undisclosed information

Data related to pharmaceutical or agro-chemical products NCE

Data related to pharmaceutical or agro-chemical products NCE

Against Not authorized use by third parties

- Disclosure

- Unfair competition

- unfair commercial use

- disclosure

grant of an authorization to a second applicant based on the same, previous data

Period 20 years no limit No limit 5 to 10 years

Requirements

Novelty, inventive step, industrial applicability

- Secret

- Measures to keep it secret

- Economic value

- Undisclosed

- Considerable efforts

- NCE

Authorization to market

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

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?

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

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)

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

Canadian Federal Court of Appeal, Bayer v. Canada (Attorney General) (1)

NAFTA Article 1711: data exclusivity for at least 5 yearsFederal 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 innovatorIf safety and effectiveness of the product can be established only by, implicitly or explicitly, examining and relying upon the confidential data yes! Data exclusivityBioequivalence 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

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

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)

New Chemical Entity (NCE) (2)

Products incorporating 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

Considerable effort

No definition in the TRIPS Agreementpurpose: protect the investment made in producing test dataAvoiding 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 situationTake into account both costs and intensity of the effortsDecisions taken on a case by case basis by Member States

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

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.

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

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.

Thank you!