How far can Generics manufacturers rely on the Originators trial data in the ASEAN region?
Introduction
Data exclusivity is generally understood to mean generic drug makers may not rely on data submitted by the originator to obtain approval for the same drug. In other words, manufacturers will have to submit their own trial data for marketing authorization, even if there is already a prior approval for the same drug and indication.
In a sense, the originator clinical trial data held by the drug agency is not freely available to third parties. However, the obligation to keep trial data confidential should not be confused with the concept of data exclusivity.
In the absence of data exclusivity, the generic drug manufacturer will be free to request that the drug agency rely on the originator data to grant approval for the same drug. Such can be done without the generic maker having access to the data since it is the drug agency that is asked to refer to such data held by them. All the generic manufacturer needs to do is to submit evidence that the generic drug is bioequivalent to the originators’ drug.
The drug originator would, however, argue that such data is exclusive to them and no one else should be allowed to rely on the same data for subsequent marketing authorization to third parties.
Data exclusivity, if present, is a mechanism to prevent the drug agency from relying on the originator data in granting approval for the same drug. A number of countries have data exclusivity laws in place.
This article discusses the availability of data exclusivity as a protection in ASEAN countries.
Indonesia
Data exclusivity – nil
While the regulations provide that clinical trial data is protected as confidential information, the decision-maker at the National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan (BPOM) may still rely on originator trial data to issue marketing authorization for generic drugs, provided that the generic maker submits evidence of bioequivalence.
Provision on confidentiality of trial data – Article 27 (1) and (4) of the Head of BPOM Regulations No. 24 of 2017 on Criteria and Procedures for the Registration of Drugs:
Article 27
(1) Registration documents as referred to in Article 25 paragraph (2) consist of:
- part I : administrative documents, Product Information and Labels.
- part II : quality documents.
- part III : nonclinical documents.
- part IV : clinical documents.
…
(4) The registration documents as referred to in paragraph (1) are confidential documents which are used only for evaluation purposes by the authorities.
Myanmar
Data exclusivity – nil
Myanmar law on the protection of trade secrets and confidential information is not yet well developed, and there are currently no specific data protection laws or regulations.
The Department of Food and Drug Administration (FDA) under the Ministry of Health is responsible for evaluating pharmaceutical registrations. According to the Guidelines on Drug Registration Application by the FDA, the body applies ‘‘The ASEAN Common Technical Dossier for the Registration of Pharmaceuticals for Human Use’ as the Criteria and Procedures for drug registration. Thus, the documentary requirement is the same in other ASEAN countries as below,
Part I: Administrative data and product information
Part II: Quality
Part III: Nonclinical (for NCE/ New products for Myanmar)
Part IV: Clinical (for NCE/ New Product for Myanmar)
However, there is no express provision in National Drug Law or its related Rules for data exclusivity covering pharmaceutical products or the documents mentioned above as confidential. The FDA claims that they will not disclose the information of the respective drug applications except the name of the granted drug and the owner/manufacturer of the drug for publication purposes.
Vietnam
Data exclusivity – Yes, five years
Data exclusivity in Vietnam’s pharmaceutical andagrochemical sectors is governed by Article 128 of the Vietnam Intellectual Property Law (amended in 2009, 2019 and 2022) (‘the IP Law’). The IP Law obliges the competent authority to take necessary measures to prevent the unauthorized use or disclosure of trade secrets, including test results and data that are the product of substantial effort.
For pharmaceuticals, from the date the originator submits the secret data in an application for marketing authorization until five years after the date of grant marketing authorization to the originator, the IP Law prevents granting marketing authorization to subsequent applicants using the secret data submitted by the originator without the consent of the originator. Exceptions may apply if the data is independently obtained. In addition, the competent authority must publish information about the applications for marketing authorization of subsequent applicants using the secret data submitted by the originator on the competent authority’s website to ensure transparency and compliance with Article 18.53(1) of Progressive Agreement for Trans-Pacific Partnership (CPTPP).
Circular No. 05/2010/TT-BYT, which guides the implementation of Article 128 of the Law in the pharmaceutical sector, outlines the provisions for maintaining the confidentiality of trial data in the regulatory approval process (the Circular).
The Drug Administration of Vietnam (DAV) is the competent authority tasked with ensuring data confidentiality in the marketing authorization process. The data eligible for confidential treatment encompasses clinical trial data associated with medicines containing new active ingredients.
For data to qualify for confidential status, they must meet certain conditions as stipulated in the IP Law and Article 6 of the Circular:
- The data must constitute a trade secret that satisfies the protection criteria specified in relevant articles of the IP Law.
- They must be the result of significant labor investment.
- A formal request for data confidentiality must be submitted (to DAV in the application for marketing authorization of the medinies), as detailed in Clause 1, Article 7 of the Circular.
These regulations and provisions collectively create a framework that aims to protect the intellectual property of pharmaceutical companies, encourage innovation, and ensure data exclusivity in the Vietnamese pharmaceutical market, all while safeguarding public interests and access to essential medicines.
Philippines
Data exclusivity – nil
The Philippines’ current legal framework does not provide data exclusivity. It does provide, though for data protection against ‘‘unfair commercial use.’
The Philippines has been a member of the TRIPS Agreement since 1995. On 1 January 1998, the Republic Act (RA) No. 8293 or the Intellectual Property Code of the Philippines (‘‘the IP Code’)[1] was enacted for the Philippines to become TRIPS compliant, including Article 39.3 of the TRIPS Agreement on data protection, which provides that ‘‘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’. Accordingly, Section 72.4 of the IP Code (as amended by Republic Act No. 9502 (RA No. 9502) or the Universally Accessible Cheaper and Quality Medicines Act of 2008) provides:
‘SEC. 72. Limitations of Patent Rights. – The owner of a patent has no right to prevent third parties from performing, without his authorization, the acts referred to in Section 71 hereof in the following circumstances:
xxx
72.4. In the case of drugs and medicines, where the act includes testing, using, making or selling the invention including any data related thereto, solely for purposes reasonably related to the development and submission of information and issuance of approvals by government regulatory agencies required under any law of the Philippines or of another country that regulates the manufacture, construction, use or sale of any product: Provided, That, in order to protect the data submitted by the original patent holder from unfair commercial use provided in Article 39.3 of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), the Intellectual Property Office, in consultation with the appropriate government agencies, shall issue the appropriate rules and regulations necessary therein not later than one hundred twenty (120) days after the enactment of this law.” [Emphasis supplied]
Joint Administrative Order No. 2008-01 was subsequently issued to implement RA No. 9502. Rule 9 (iv) thereof on regulatory evaluation and approval of drugs and medicines merely restates the provision on the protection of data against unfair commercial use in Article 72.4 of the IP Code. However, it also provides that the regulatory agency (‘‘the BFAD’ or now the Food and Drug Administration (‘the ‘FDA’)) ‘‘shall not be precluded from using all data, including, but not limited to, pre-clinical and clinical trials, of an applicant when evaluating other applications’:
‘Rule 9. Limitations on Patent Rights. The owner of a patent has no right to prevent third parties from performing, without his authorization, the acts referred to in Section 71 of the IP Code as enumerated hereunder:
x x x
(iv) Regulatory Evaluation and Approval. In case of drugs and medicines, where the act includes testing, using, making or selling the invention, including any data related thereto, solely for purposes reasonably related to the development and submission of information and issuance of approvals by government regulatory agencies required under any law of the Philippines or of another country that regulates the manufacture, construction, use or sale of any product (72.4).
(iv.a) Use of Data by BFAD. The BFAD shall not be precluded from using all data, including, but not limited to, pre-clinical and clinical trials, of an applicant when evaluating other applications. (n)
(iv.b) Data Protection from Unfair Commercial Use. Data submitted by the original patent holder shall be protected against unfair commercial use as provided in Article 39.3 of the TRIPS. (72.4)
When required as a condition of approving the marketing of drugs and medicines that utilize new chemical entities, any submitted undisclosed test or other data, the origination of which involves a considerable effort, shall be protected against unfair commercial use. In addition, such data shall be protected 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. (39.3).” [Emphasis and underscoring supplied.]
It thus appears from the above rule that ‘protection against unfair commercial use” does not include data exclusivity.
In fact, the Food and Drugs Administration of the Philippines (FDA) released several FDA Circulars on the submission of bioequivalence studies in applying for marketing authorization, including FDA Circular No. 2013-014[2] , which requires the submission of satisfactory bioequivalent studies for ‘subsequent generic products to be marketed after the patent expiration of the innovator.” It cites the following ‘principle” for the requirement: ‘The ‘innovator drug has proven its safety and efficacy in view of available satisfactory clinical data/studies. When its patent expires, pharmaceutical manufacturers may produce generic versions of the innovator product, provided they can establish product interchangeability through BE Studies or BE Waiver, whichever is applicable.”
Thailand
Data exclusivity – nil
Thailand does not have specific laws regarding data exclusivity. Nevertheless, the Trade Secrets Act BEE 2545 (2002), as amended by the Trade Secrets Act (No.2) BEE 2558 (2015), does provide some level of protection for trade secrets (including in the form of testing results) submitted by the drug originator to the drug agency for drug approval, as outlined in Section 15 of Chapter 3 regarding the maintenance of trade secrets by state agencies.
Section 15 of this Act stipulates that any data qualifying as trade secrets, which involves substantial effort and is submitted to the Food and Drug Administration (FDA) to support marketing approval, will be safeguarded by the FDA upon the applicant’s request to maintain the trade secrets. The FDA will have duties to prevent the disclosure, deprivation or unfair use of such data in trading activities. This means that the drug originator has the right to data exclusivity under this provision.
Section 15 of the Trade Secret Act reads:
‘Section 15
In cases where the law requires the applicant for a permit to manufacture, import, export or sale of drugs or agricultural chemical products with new chemical substance to file information supporting the permit; and if such information, either wholly or in part is trade secrets in the form of testing result, or other information regarding its preparation, discovery or creation which has involved in a great deal of effort, and the applicant has requested the state agencies to maintain the trade secrets, the state agencies concerned shall have the duties to maintain the trade secrets from being disclosed, deprived of or used in unfair trading activities, in accordance with the regulations prescribed by the Minister
The regulations under paragraph one shall, as minimum requirements, contain the following provisions:
(1) Conditions of request submitted to state agencies for maintenance of trade secrets;
(2) Details of testing result and information that is qualified as trade secrets;
(3) Period of time for which trade secrets are to be maintained;
(4) Method for maintenance of the trade secrets, taking into consideration the type of technology and testing result or confidential information; and
(5) Duties and liabilities of state officials in the maintenance of trade secrets.”
The Public Health Ministerial Regulation Regarding the Protection of Trade Secrets, subsequently issued in 2007, stipulates that the applicant can record such data with the FDA. The FDA will issue a certificate of recordal and must maintain the data confidential for five years from the date of recordal, unless the data is no longer qualified as trade secrets.
In addition, the Official Information Act BEE 2540 (1997) allows a state agency or state official to issue an order prohibiting the disclosure of official information (which is defined as information in possession or control of a State agency, including the information relating to a private individual”) protected by law or information given by a person and intended to be kept undisclosed, as outlined in Section 15(6) of the Official Information Act.
‘Section 15
A State agency or State official may issue an order prohibiting the disclosure of official information falling under any of the following descriptions, having regard to the performance of duties of the State agency under the law, public interests and the interests of the private individuals concerned:
…
(6) an official information protected by law against disclosure or an information given by a person and intended to be kept undisclosed
…
An order prohibiting the disclosure of official information may be issued subject to any condition whatsoever, but there shall also be stated therein the type of information and the reasons for nondisclosure. It shall be deemed that the issuance of an order disclosing official information is the exclusive discretion of State officials in consecutive levels of command; provided that, a person who makes a request for the information may appeal to the Information Disclosure Tribunal as provided in this Act.”
The implication is that the FDA can issue an order prohibiting the disclosure of the data qualifying as trade secrets submitted by the drug originator and protected by law – which promotes data exclusivity.
However, none of the mentioned provisions explicitly prevents the FDA from referencing and relying on the originator’s registration data when considering subsequent generic applications. Regarding the FDA’s guidelines on submitting applications for new generic and generic drugs, it does not require the applicant to submit nonclinical and clinical documents, which is in contrast to the practice for new drugs. While the Trade Secret Act does offer limited protection for trade secrets, including testing results submitted by drug originators to the FDA for drug approval, the omission of specific document submission requirements for generic drugs implies a potential gap in safeguarding trade secrets and data exclusivity. Consequently, we can imply that generic drug applicants might indirectly benefit from the documentation related to new drugs due to the lack of specific document submission requirements for generic drugs.
In summary, Thailand currently lacks explicit data exclusivity protection laws, and the existing safeguards under the Trade Secret Act might not fully cover the documentation related to new drugs, leaving room for ambiguity and the need for further clarification within the regulatory framework.
Cambodia
Data exclusivity – nil
While the Cambodia Law on Management of Pharmaceuticals generally governs pharmaceutical-related regulations, there is no specific rule discussing data exclusivity or confidentiality of trial data in the marketing authorization of generic makers.
However, Article 128 of the Law on Patent, Utility Models and Industrial Designs provides some protection for undisclosed data.
Article 128: In requiring the production of evidence, the competent Court before which the proceedings referred to in Article 127 of this Law take place shall take into account the legitimate interests of the alleged infringer in not disclosing his manufacturing and business secrets.
According to the Report of The Working Party on TRIP Agreement Accession of Cambodia (2003 report) (Requirements on undisclosed information, including trade secrets and test data)[3], in the sense of implementing the accession of TRIP, comments from the working group on the commitment to protect against unfair commercial use of an undisclosed test is quoted as follows:
‘Cambodia would protect against unfair commercial use of undisclosed test or other data submitted in support of applications for marketing approval of pharmaceutical or of agricultural chemical products which utilize new chemical entities, by providing that no person other than the person who submitted such data may, without the permission of the latter person, rely on such data in support of an application for product approval for a period of at least five years from the date on which Cambodia granted marketing approval to the person that produced the data. Prior to the issuance of marketing approval of any pharmaceutical and agricultural chemical products, the relevant Ministries in Cambodia will determine the existence of a patent covering a product for which an application for marketing approval had been filed by a party other than the patentee, and will not approve such application for marketing approval until the date of the expiration of such patent.” (Paragraph 205 of the Report)
Concluding remarks
It would appear from above that data exclusivity as a means to ring fence originator drug is limited. Nevertheless, one should also consider the patent linkage system discussed in these Rouse articles on these links below:
- Patent Linkages in Southeast Asia
- Patent Linkage in Indonesia
- An overview of the protection of new medical use/indication patents in key Southeast Asian markets
List of authors:
- Indonesia – Kin Wah Chow, Evi Triana, Kintan Mayang Puspitadewi
- Thailand – Mind (Kannicha) Wungmuthitakul, Ning (Nontaya) Chulajata, and Kaew (Peeraya) Thammasujarit
- Vietnam – Duong Vu
- Myanmar – Thet Htar Aung
- Philippines – Charlene Calvelo
- Cambodia – Sreymao Mao
[1] https://www.ipophil.gov.ph/images/Patents/IRRs/RepublicAct8293.pdf
[2] https://www.fda.gov.ph/wp-content/uploads/2021/08/FDA-Circular-No.2013-014.pdf
[3] https://docs.wto.org/dol2fe/Pages/FE_Search/FE_S_S009-DP.aspx?language=E&CatalogueIdList=1715&CurrentCatalogueIdIndex=0&FullTextHash=#
