Data Exclusivity: Current overview and expectations

Mexican Data Exclusivity system is facing new challenges in light of current regulatory framework and reiterated holders’ concerns, as Anna Arroyo and Fernando Granados of Uhthoff Gómez Vega & Uhthoff report.

Recently, several queries have been raised regarding the precise manner in which Mexico brings protection to one of the elements that involves more effort, time and money in the commercialization of new chemical and biological molecules with therapeutic application: the invaluable clinical data. In this sense, we have noted that, for most pharma companies, it is not quite clear how prepared the Mexican Law is to offer Data Exclusivity.

In order to try to clarify this matter, we consider it important to mention that federal commission for protection against sanitary risks (COFEPRIS), which approves new drugs for marketing in Mexico, has been recognised as a National Regulatory Agency Level IV, for drugs and vaccines, by the PanAmerican Health Organisation (PAHO), since 2012 and 2014 respectively, becoming the first Latin American Regulatory Agency in obtaining both acknowledgements.
Due to these recognitions, sanitary registrations obtained in Mexico are valid in other Latin American countries such as Chile, Colombia, Panamá, Costa Rica, Ecuador, Belize and El Salvador, reason for which requesting a sanitary registration in Mexico has become more attractive for pharmaceutical companies aiming to have a strong presence in LATAM, by having a reach to the population of almost 100 million people.

Nonetheless, some companies have their reservations when it comes to clinical Data Exclusivity and the solidity of its enforcement, particularly for biological products, given that in Mexico Data Exclusivity is only available when the corresponding sanitary registration application is filed, and Mexican Industrial Property Law does not dictate a specific period of time for Data Exclusivity.

It is worth noting that Canada and the United States, which are part of the most important international free trade agreement of which Mexico takes part (NAFTA), include specific Data Exclusivity regulation in their Federal Law. In this sense, Canada currently provides eight years of data protection for an innovator drug, to both biologics and conventional small molecule pharmaceuticals, and that generic manufacturers are unable to file a drug submission referencing an innovator drug within six years of the initial authorization of the innovator drug (Section C.08.004.1 of Data Protection Regulation); while in the United States, biologics have an exclusivity term provided by the Biologics Price Competition and Innovation Act (BPCI Act) of 12 years from the date the reference product was first licensed, and a five-year Data Exclusivity period for conventional small-molecule generic drugs.

How did we get there?
In 2009, Mexican legislation underwent a critical reform on the subject of biological products when article 222 BIS was included the General Health Law; said article introduced the terms “biotechnological drug” and “biocomparable” and rejected the terms “biological product” and “biosimilar”.

Later in 2012, COFEPRIS issued an official communication dictating the guidelines for Data Exclusivity, which stated that this type of protection would exclusively apply to new chemical entities; biotechnological drugs were not explicitly mentioned, but what happened ever since, is that Data Exclusivity has been provided for both, new chemical entities and biotech drugs all the same. No further distinctions between these two classes of pharmaceuticals have been attempted.
Now then, regarding to the Mexican Industrial Property Law, since the Mexican Constitution considers international treaties at the same level as federal laws, the Mexican Congress was prompted to amend, in 1994, some laws to adjust them to the conditions stated in NAFTA. The amendments included the addition of Article 86 BIS into the Industrial Property Law, which states that “information regarding safety and efficacy of pharmaceutical and agricultural products that make use of new chemical components, shall be protected under the terms of the international treaties to which Mexico is part”.

For Mexico, the main international agreements considering Data Exclusivity are TRIPs, in its Article 39(3) which specifies that “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”; and NAFTA, in Articles 1771.5 and 1771.6, further specifying that “…the Party shall protect against disclosure of the data related to safety and effectiveness of the product, where the origination of such data involves considerable effort, … no person other than the person that submitted them may, without the latter’s permission, rely on such data during a reasonable period of time after their submission, which shall normally mean not less than five years from the date on which the Party granted approval to the person that produced the data for approval to market its product”.
Other international provisions regarding Data Exclusivity are the free trade agreement between Mexico, Colombia and Venezuela (G-3); however, most of the stipulations concerning Data Exclusivity stated in this free trade agreement are based in NAFTA or TRIPs.

There is no doubt in that the provisions as set forth in TRIPs and NAFTA, regarding Data Exclusivity, have been useful during these last decades; however, Mexico is reaching a point wherein Data Exclusivity will become a key role for pharmaceutical companies to consider.

Are there changes to be expected?
The current Data Exclusivity panorama could change sooner than expected, since negotiations for new NAFTA regulations are currently in process, in fact US, Canadian, and Mexican trade negotiators just concluded the seventh round of negotiations in Mexico City. However, intellectual property provisions remain unsolved, and a revision regarding Data Exclusivity seems mandatory in the remaining negotiations.

In Mexico, 45 % of sanitary registrations related to biotechnological drugs are filed by US based pharmaceutical, while MX based pharmaceuticals represent only 3 % of the sanitary registrations. Consequently, it could be expected that, in future rounds of negotiation, United States will seek for laws that are more Data Exclusivity friendly, where a 12-year Data Exclusivity for biologics and a 5-year for chemical entities could be reasonably asked for their part.
The negotiations of the new NAFTA regulations could face some obstacles due to internal political situation of each of the related countries, for example, in Mexico, elections will be held on July 1 to elect a new president; in Canada, several provincial elections will be held in upcoming months; and in the United States, congressional midterm elections could disrupt the current balance of power in Congress, which may result on an important delay in NAFTA interests and negotiations. This is prompting the actual administrations of each of the involved countries to seek a new deal on NAFTA quickly, where an agreement including most of the essential matter could be expected by June 2018 at the latest, with all the efforts put into having a new definitive treaty by the end of 2018.

Finally, seeing that an amendment to the Industrial Property Law defining the scope of rights and terms of Data Exclusivity in Mexico looks quite unlikely, pharma companies with Data Exclusivity concerns, should lookout for any near future NAFTA resolutions on this matter.

Anna Arroyo
Fernando Granados