5. Data exclusivity under the European normative framework
5.1. Data exclusivity and patent protection: intersections
Data exclusivity protection can function as an alternative layer of legal defence for pharmaceutical products, in the cases where the patent system itself fails to provide adequate market predominance611.
Data exclusivity is indeed to be considered as an autonomous form of protection in respect of patents612, given the absence of any reference to the patent law notions of novelty and inventive step in pharmaceutical development613: data exclusivity is in fact solely based on the “fixed event”
of granting a marketing authorisation614. Indeed, the granting a marketing authorisation follows a very strict process, leaving “little room for any
“creative” approaches”615: in order to grant data exclusivity protection there are no requirements of evidence that the original drug symbolizes a technical or therapeutic advancements as regards the “prior pharmacological art”616.
The only precondition needed is that of pharmaceutical safety and efficacy.
Thus, the subjection of the data exclusivity on mechanical criteria, renders this kind of protection qualitatively stronger than a patent protection617, not being exposed to generic disputes618.
611 PUGATCH, Intellectual Property and pharmaceutical data exclusivity in the context of information and market access, supra, 13. See also JUNOD, Drug Marketing Exclusivity in the United States & European Union Law, supra, 480, quoting Greg Perry of the European Generic Medicines Association (EGA), stressing the relevance of non patent exclusivity: “for originator pharmaceutical companies, the expansion of data exclusivity provisions has become one of the main ways of extending market protection and blocking generic competition. Data exclusivity is seen now as the principal means of extending market protection for new indications, pharmaceutical forms and other variations, especially where these are not innovative enough to gain patent protection”.
612 Cf. EISENBERG, Patents, Product Exclusivity, and Information Dissemination: How law directs biopharmaceutical research and development, 72 Fordham Law Review 2003, 477 ss., 482. Literature has also been stressing the considerable less administrative and procedural burden of data exclusivity as confronted with the patent system, beimg “cheaper to obtain and to maintain”. JUNOD, Drug Marketing Exclusivity in the United States & European Union Law, supra, 484.
613 FACKELMAN, Clinical data, data exclusivity and private investment protection, supra, 167.
614 Ibid..
615 Ibid., 176.
616 LISMAN-SCHOONDERBEEK, An Introduction to EU Pharmaceutical Law, supra, 42.
617 CLIFT, Data protection and Data exclusivity in Pharmaceuticals and Agrochemicals, supra, 433. COOK, Regulatory Data Protection in Pharmaceuticals and Other Sectors in V.V. A.A., Intellectual Property Management in Health and Agriculture Innovation, supra, 438.
618 Cf. PUGATCH, Intellectual Property and pharmaceutical data exclusivity in the context of information and market access, supra, 13-14.
Moreover, it has been noticed that unlike in the patent system, under data exclusivity regimes there are no compulsory license mechanisms to be found619.
Indeed, most of the WTO Members have introduced provisions to override patent protection in cases of public health emergencies or for remedying anticompetitive behaviours620.
However, since data exclusivity regimes do not assure any form of exemption to protection, in the cas a compulsory license is granted, generic pharmaceutical companies intending to enter the market, would be still required to obtain marketing authorisation, with the effect of potentially blurring the effectiveness of the license itself621.
Literature has also been underlining a few other possible scenarios in which data exclusivity regimes interact with patent protection622.
According to the first scenario, in some circumstances data exclusivity works as a “gap filling alternative”623 for patent protection over pharmaceutical products624.
This can happen for example in those circumstances in which a patent for a pharmaceutical product is not recognized625- for example in the case of biopharmaceuticals626- or for which the patent term has long expired before the granting of a marketing license627.
619 CLIFT, Data protection and Data exclusivity in Pharmaceuticals and Agrochemicals, supra, 433.
620 Cf. ANDERMAN, The strategic uaw of Patent Enforcement and Acquisition Metgods and Competition Law, in GOVAERE-ULLRICH, Intellectual Property, Market Power and the Public Interests, supra, 171 ss..
621 Stressing this point WEISSMAN, Data Protection: Options for implementation, in ROOFE-TANSEY-VIVAS-EUGUI, Negotiating Health- Intellectual Property and access to Medicines, supra, 166.
622 COOK, Regulatory Data Protection in Pharmaceuticals and other Sectors, supra, 438-439.
623 REICHMAN, Rethinking the role of clinical trials data in international intellectual property law: the case for a public goods approach, supra, 38. See also FACKELMAN, Clinical data, data exclusivity and private investment protection, supra, 166.
624 CORREA, Protecting Test data for Pharmaceutical and Agrochemical Products, supra, 83. The American Congress has motivated the introduction of data exclusivity as a means of “enhancing the development and testing of unpatentable pharmaceuticals”, as is recalled by REICHMAN, Rethinking the role of clinical trials data in international intellectual property law: the case for a public goods approach, supra, 37.
625 Countries such as Spain and Portugal did not have a patent system until the definitive enforcement of the TRIPs Agreement on the 1st January 2005, requiring all countries that were bound to it to grant protection for inventions in “all areas of technology”. REICHMAN, Rethinking the role of clinical trials data in international intellectual property law: the case for a public goods approach, supra, 37.
In these cases data exclusivity has been a substitute for patent protection over the interested products. CORREA, Protecting Test data for Pharmaceutical and Agrochemical Products, supra, 83.
626 Indeed, patent protection for biopharmaceuticals was given only in 2006. According to the European Generic Association, “data exclusivity was created at a time where there were no patents for biotech products. This data exclusivity period therefore provided a form of market protection for
In some cases, patent protection for a product approved by regulatory authorities may be very difficult, or impossible to obtain, for instance as for new physical forms, new synthetic processes, or new uses of old substances, that would not satisfy the innovative patentability requirements628.
Data exclusivity can also have an important role in absence of patent protection, as a means of protection of studies for an additional medical use of a previously authorised original drug. Art. 10 (1)(4) and 10(5) of the Directive provides in fact an additional and separate year of data protection, covering each and every of the drug’s indications, and also those already authorised for marketing629. This provision grants therefore protection to new therapeutic indications, but mostly becomes a means for innovators to maintain the market predominance in respect of previously authorised therapeutic indication630.
When data exclusivity operates independently from the patent shield, literature has noticed how exclusive rights over test data have the effect of removing “from the public domain products that should be freely available”
631.
In other circumstances, data exclusivity has the function of “supplementary incentive” as regards the development of those pharmaceutical products that end up being protected by a shortened patent protection, due to the length of the regulatory approval procedure632, or because of the length of clinical trials processes, such as the ones needed for the testing of orphan
these products in the absence of patents, which was particularly important to those Member States with developing biotech industries. Patents now exist for biotech products”. EGA, Data exclusivity, a major obstacle for Innovation and Competition in the EU Pharmaceutical sector, Brussels, 2000, 4.
627 One of the most notorious cases is the one of Taxol-Bristol-Myers Squibb’s anti-cancer drug, discovered by the National Cancer Institute in 1962, and whose active substance was licensed for marketing only in 1991. Cf. PUGATCH, Intellectual Property and pharmaceutical data exclusivity in the context of information and market access, supra, 14.
628 Cf. COOK, Regulatory Data Protection in Pharmaceuticals and Other Sectors, supra, 438, talking about
“second generation patents”. See also JUNOD, Drug Marketing Exclusivity in the United States &
European Union Law, supra, 483, talking about product line extensions, such as “slow release versions of pre-existing drugs”.
629 FACKELMAN, Clinical data, data exclusivity and private investment protection, supra, 173 ss..
630 LISMAN-SCHOONDERBEEK, An Introduction to EU Pharma Law, supra, 56.
631 CORREA, Protecting Test data for Pharmaceutical and Agrochemical Products, supra, 95.
632 EISENBERG, The role of the FDA in Innovation Policy, supra, 374.
drugs, or biogenetic pharmaceuticals633. In these cases the effective term of patent protection is shorter than the term of protection provided by data exclusivity634.
Finally, if a generic manufacturer manages to produce a different but bioequivalent form of an already patented product, this generic drug could be patented, but due to the data exclusivity regime, it would not be granted a marketing license before the expiry of the exclusivity period. Indeed, according to art. 10.2 of the Directive, “the different salt, ester, ethers, isomers, mixture of isomers, complexes or derivatives of an active substance shall be considered to be the same active substance”635, and if the active substance thus falls in these categories, generic reference is not permitted, thus making the scope of the data exclusivity larger than that of patent protection636.
These scenarios directly reflect that data exclusivity is centred in the grey area of non-patentable, but still economically valuable, pharmaceutical developments, extending the area of protection from competition enjoyed by pharmaceutical products.