Data Protection for Innovator Biologic Drugs in South America: the Case of Mexico
By Moeller IP Advisors
Until 2016, 35,480 applications for patenting biological drugs were filed in Mexico, according to data provided by Innography, an IP consulting company. It seems clear that Mexico constitutes a highly valued market for biologics. However, at this date, Mexico doesn’t have a law or another regulatory instrument that guarantees personal data exclusivity to pharmaceutical companies that produce and market biologic drugs, although this protection has been granted, in some cases, via case law. This is particularly critical, especially when compared to other jurisdictions: the US legal system provides for 12 years of DPE, while Canada grants a protection that lasts 8 years.
Why is DPE important for Biologics
Biologics are drugs that, because of their complexity, are particularly expensive to manufacture compared to the traditional pharmaceuticals. On the other hand, it is possible to synthesize a generic biologic agent that is structurally different enough from the original without infringing a patent on the original biologic. In other words, it’s relatively easy to manufacture a “copycat” biologic without breaching a patent. This copycat biologics are called biosimilars, they have the same therapeutic effect of the original biologic and, in fact, they can reduce the effectiveness of patent exclusivity.
Hence the necessity to protect the original producer through another tool: granting the exclusivity of the personal data used in the clinical trial. This way, other companies would not be allowed to leverage the clinical data that supports the effectiveness and safety of the biosimilar – but would need to produce their own data, which is clearly more costly and time-consuming.
DPE Protection in Mexico
On June 19, 2012, Cofepris, the Mexican Commission for Health Risks (Comisión Federal para la Protección contra Riesgos Sanitarios) published an internal decree providing guidelines to grant protection to DPE in Mexico, but only with regard to traditional pharmaceuticals.
The protection has a duration of 5 years: during this period, competitors are not allowed to use clinical trials and other information provided by the producing company to prove the drug’s safety and efficacy.
The DPE established by the Cofepris, however, didn’t include biological pharmaceuticals.
On the other hand, in the last few years pharmaceutical companies asked and obtained, through legal actions, a sort of de facto DPE protection for biological pharmaceuticals, on the basis of the interpretation of international treaties (namely, NAFTA and TRIPS). The protection granted by the Courts has been established in 5 years – which is the term NAFTA refers to- although in 2015, after a trial initiated by the company Janssen Cilag, a Federal Circuit Court determined that the duration could be longer than 5 years if gathering the clinical data involved considerable efforts and time.
The Trans Pacific Partnership and the future of DPE
The Trans Pacific Partnership (TPP), a free trade agreement between twelve Pacific rim countries, was initiated to encourage commerce among 40% of the world’s economy, including Mexico, Australia, Canada and, until January 2017, the US. Some parts of the TPP deal with Intellectual Property Rights: one of them aims at uniforming the term for data exclusivity between all the member countries. Mexico signed the TPP in 2012, but so far, hasn’t issued any normative act referring to DPE.
Implementing the TPP would mean a safer, normative scene for warranting DPE to producers of biologics in Mexico.