Biologic data exclusivity in Vietnam: change is on the horizon
Data exclusivity protection for biologics in Vietnam will soon undergo some welcome changes due to the enactment of a new pharmaceutical law at the beginning of 2017, and the country’s increased involvement in trade agreements such as the Trans-Pacific Partnership (TPP) and the EU-Vietnam Free Trade Agreement (EVFTA). While the changes are expected to be small, they could have a noticeable impact on manufacturers of biologics.
Biologics are composed of large, complex molecules, as opposed to the small molecules that make up conventional chemically derived drugs. Vietnamese legislation broadly defines biologics as medicinal products of biological origin used for the purposes of prophylaxis, therapy, and the diagnosis of human diseases. Biosimilars—the generic drug equivalent of biologics—also fall within this broad definition.
Clinical trials and data collection for conventional drugs and biologics are time-consuming and expensive to conduct, so it is necessary to offer, in addition to the protection provided by a patent, a period of data exclusivity protection to incentivise producers to continue research on new drugs.
Currently, Vietnam does not have any specific regulations on data exclusivity protection for biologics. Biologics, including biosimilars, are subject to the same data protection as small molecule drugs, as set out in the following two Vietnamese regulations:
(i) Article 128 of the Law on Intellectual Property: When an applicant for a licence 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 licences to subsequent applicants who use the secret data without the prior applicant’s consent; and
(ii) Circular No. 05/2010/TT-BYT: Applicants are given a five-year period of data exclusivity from the granting of marketing authorisation for drugs that are new chemical entities (NCEs). Parties who file their registration dossiers by referring to the data of a previous party that is protected under Circular 05 will be denied marketing authorisation by the Drug Administration of Vietnam (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 over whether article 128 of the IP Law and Circular 05 are in conflict. Circular 05 only prevents the DAV from granting marketing authorisation to parties who refer to data in the dossier of a previous party. To get around this regulation, however, subsequent parties can simply not refer to the previous party’s dossier and have marketing authorisation granted.
Under Circular 44/2015/TT-BYT, all biologics, including biosimilars, are required to have their trial data submitted in registration dossiers for marketing authorisation. In practice, however, the data protection regulations are of little help in protecting biologic reference products, because 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 required to have their own trial data for regulatory submissions. Consequently, there is no need to use the protected data of the originator, and the “data exclusivity” period granted in Circular 05 has limited effect.
New legislation
In April 2016, the National Assembly of Vietnam passed a new Law on Pharmacy, which will replace the current Law on Pharmacy on January 1, 2017. The new law provides different definitions and management measures for biologics and biosimilars. Consequently, biosimilar manufacturers will not be required to provide their own clinical trial data because they will be able to rely on the clinical trial data of innovative biologic producers to prove the safety and efficacy of their drugs.
While this will allow for biosimilar manufacturers to have access to the data of innovative biologic producers, it may serve as a deterrent for innovative biologic producers to continue to finance research for new biologics.
TPP changes
The TPP was signed in February 2016 and is currently awaiting ratification by its 12 member countries. If the ratification process proceeds smoothly, implementation of the deal could start by late 2017.
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 from 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.
Article 18.51 of the TPP applies the protection afforded by article 18.50 specifically to biologics. In particular, it provides an extended term of data protection of eight years, as opposed to the five years currently provided in Vietnam; or alternatively, five years combined with other additional measures.
To comply with the TPP, the IP Law and the Law on Pharmacy of Vietnam will probably be amended to provide measures to prevent generic drug producers from applying for marketing authorisation, instead of only maintaining confidentiality of the clinical data of innovators. The five-year duration of data protection will likely be preserved.
EVFTA impact
The bilateral EVFTA is expected to take effect in 2018. Article 9 requires Vietnam 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”. The DAV should consider amending domestic regulations to protect all data that applicants of new drugs submit to the DAV while requesting marketing authorisation, not just the submitted trial data.
Outlook
Overall, biologic manufacturers, internationally and domestically, can expect to see no increase in the term of data exclusivity protection that the DAV will grant for biologics. In comparison to data exclusivity protection in countries like the US, where exclusivity is granted for 12 years, biologic manufacturers are at a bit of a disadvantage in Vietnam due to the shorter time of protection.
However, if Vietnam ultimately decides not to grant biosimilar manufacturers marketing authorisation within the period of data exclusivity, biologic manufacturers will stand to benefit by being the sole producers of the biologics 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 trial data only to all types of data submitted.
Hien Thi Thu Vu is a patent executive at Tilleke & Gibbins. He can be contacted at: thuhien.v@tilleke.com
Huong Lan Nguyen is a regulatory affairs consultant at Tilleke & Gibbins. He can be contacted at: huong.n@tilleke.com
