October 3, 2016

Data Exclusivity for Biologics in Vietnam: Present and Future Regulations

Biologics are composed of complex, large molecules, as opposed to the small molecules that make up conventional chemically derived drugs. Because of the complex nature of biologics, clinical trials and data collections are expensive to produce and require a heightened level of data exclusivity protection beyond those of a patent to incentivize biologic producers to continue research on new biologics.

Vietnam has a period of data exclusivity for all drugs including biologics; however, this period does not consist of complete data exclusivity, rather only the protection of physical data from the assessment of other generic companies. In practice, such data protection periods do not help to prevent the granting of Marketing Authorization for generics, including biosimilars.

Under current legislation in Vietnam, biologics are broadly defined as medicinal products of biological origin used for the purposes of prophylaxis, therapy, and the diagnosis of human diseases. Consequently, both biologics and biosimilars are considered to be biologics and have the same data exclusivity management by competent authorities. Accordingly, both biologics and biosimilars must have clinical data to apply for a Marketing Authorization; therefore, biosimilar companies do not need to use the clinical data of biologics companies for regulatory submissions. Because of this, the “data exclusivity” period in Vietnam is not practical in practice.

The National Assembly of Vietnam passed the new Law on Pharmacy, which provides different definitions and management measurements for biologics and biosimilars. Consequently, biosimilars manufacturers may not be required to provide clinical data because they can rely on the clinical data of innovative biologics producers to prove the safety and efficacy of the drugs. Overall, Vietnam’s increased level of involvement in trade agreements, such as the Trans-Pacific Partnership (TPP) and the European Union-Vietnam Free Trade Agreement (EVFTA), and the new Law on Pharmacy will require slight (but important) changes  in Vietnam’s current data exclusivity protections of biologics.

Current Protections

Currently, Vietnam does not have any specific regulations enacted that protect data exclusivity for biologics; however, biologics are subjected to the same data protection as small molecule drugs. There are two different Vietnamese regulations that address data exclusivity for drugs:

  1. Article 128 of the Law on Intellectual Property (Art. 128 of the IP Law) requires that when applicants for a license for trading in or circulating pharmaceuticals is required to supply test results or other data that the applicant requests to be kept secret, the licensing body must not grant licenses to subsequent applicants who use the secret data without the prior applicant’s consent.
  2. Circular No. 05/2010/TT-BYT (Circular 05) allows for a five-year period of data exclusivity from the granting of marketing authorization for drugs that are new chemical entities (NCE). Parties who file their registration dossier by referring to the data of a previous party that is protected under Circular 05, will be denied marketing authorization by the DAV if they file the data without the permission of the previous party and without proof that the NCE was created independently of the previous party’s data.

There is some debate in Vietnam as to whether Art. 128 of the IP Law and Circular 05 are in conflict. Circular 05 only prevents the DAV from granting marketing authorization to parties who refer to the data in the dossier of a previous party. To get around this regulation, subsequent parties can simply not refer to the previous party’s dossier and have marketing authorization granted.

Under Circular 44/2015/TT-BYT, all biologics, including biosimilars, are required to have their trial data submitted in registration dossiers for marketing authorization. In practice, however, the data protection regulations are of little help in protecting biologic reference products for the following two reasons:

  1. By their nature, biosimilars are not identical copies of their originators. In addition to a thorough analytical assessment, head-to-head clinical studies against the originator are needed to establish comparability to the originator; therefore, biosimilars are often required to have their own trial data for regulatory submissions. Consequently, there is no need to use the protected data of the originator.

  2. Vietnam has no definition of biosimilars or specific regulations about requirements for trial data for biosimilars; therefore, some biosimilars with very limited trial data may be approved for marketing authorization.

Expected Challenges in Protection: TPP

Article 18.50 of the TPP protects undisclosed tests and other data submitted as a condition for granting marketing approval for a new pharmaceutical product. This is accomplished by not allowing third parties to submit the information in the undisclosed tests and other data, without the consent of the party that submitted the data, in order to market the same or similar product.  In the TPP there is a specific provision that applies the protection afforded by Article 18.50 to biologics. In particular, Article 18.51 of the TPP provides effective market protection for new biologics through either:

  1. Data protection as indicated in Article 18.50 for at least eight years from the date of first marketing authorization; or, alternatively
  2. Data protection as indicated in Article 18.50 for at least five years from the date of first marketing authorization, combined with other measures. 


The main difference between the TPP and Vietnam’s current regulations is that for biologic drugs, the TPP provides an extended term of data protection, eight years as opposed to five years, or alternatively, five years combined with other additional measures. It is anticipated that the corresponding provisions of the IP Law and the Pharmacy Law of Vietnam will likely be amended to provide measures to prevent generic drug producers from applying for marketing authorization, instead of only maintaining confidentiality of the clinical data of innovators. The five-year duration of data protection is likely to be preserved. Actually, the DAV had plan to build a legislation to provide measures to prevent generic drug producers from applying for marketing authorization.

Expected Challenges in Protection: EVFTA

In Article 9 of the EVFTA, the agreement requires the parties to issue the legal framework for protecting “undisclosed test[s] and other data” against unfair commercial use. The agreement also requires that the period for protection shall not be less than five years from the date on which the Party grants approval to the patent owner that produced the data. In Vietnam, only undisclosed tests and trade secrets are currently protected, while the EVFTA requires that the parties open their scope of protection to include not only undisclosed tests, but also “other data.”

In response to Article 9 of the EVFTA, the DAV should consider amending domestic regulations to protect all data that applicants of new drugs submit to the DAV while requesting marketing authorization, not just the submitted trial data.

Conclusion

Overall, biologics manufacturers, both internationally and domestically, can expect to see no increase in the amount of time the DAV will grant data exclusivity for biologics. In comparison to data exclusivity protections in countries like the U.S., where the period of exclusivity is granted for twelve years, biologic manufacturers are at a bit of a disadvantage in Vietnam due to the lessened time of protection; however, biosimilar producers will be able to release their products in much shorter periods of time, thus allowing for biologics to be available at lower prices.

If Vietnam does decide to not grant biosimilar manufacturers marketing authorization within the period of data exclusivity, biologic manufacturers will stand to benefit by being the sole producer of the biologic during that period. Biologic manufacturers will also benefit from the potential increase in the type of data protected under the EVFTA, as protections may extend from just trial data to all types of data submitted.

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