Digital Theses Archive


Tesi etd-08312017-115131

Type of thesis
The Value of Pharmaceutical Patents in Cumulative Settings - Access to Novel Medicines in Europe
Scientific disciplinary sector
SCIENZE GIURIDICHE - Individual Person and Legal Protections
relatore Prof. COMANDE', GIOVANNI
Membro Prof.ssa PALMERINI, ERICA
  • cumulative patenting
  • intellectual property
  • licensing
  • patents
  • pharmaceuticals
Exam session start date
It is common practice of the pharmaceutical industry, that operates with significant risks and uncertainty regarding the prospective of the research activity, to apply for patent protection early in the R&amp;D process in order to set the technical level. As a result, it is common to file many broad initial applications and then later surround them with secondary applications which inevitably leads to the construction of wide-scope patent portfolios that are difficult to invent around without the risk of infringing the IP rights of the original patent owner. Such patenting strategy, consisting of overlapping claims, could be used for the purposes of extending the market exclusivity period beyond the term of the basic patent and as a means of creating legal uncertainty among competitors. This is possible mainly due to applying the economic patent valuation method that focuses on the portfolio value ex post when patents are ripe for licensing than focussing on the ex ante valuation that would be more adapt to reflect the patent value. <br>Thus, although it is not possible to prolong the patent protection period for the subject matter of the basic claim, it is possible to extend the overall life-cycle of the patent portfolio and extend its breadth that indirectly encompasses the initial invention by claiming follow-on patents. These patents, although possibly carrying little individual value within the patent portfolio, in the overall context, could have a significant value for the patent owner from the legal as well as economic point of view. Thus, it would be accurate to say that the value of the basic patent tends to be probabilistic while, in the later stage, patent strength does not necessarily equal the patent value.Even if these individual patents, after fulfilling the patentability criteria, don´t reflect the actual contribution of the patent owner, could be used as strategic means to negotiate beneficial licensing agreements or as tools of excluding competition in the marketplace.<br>The research project analyzes current patenting practices in the European pharmaceutical industry settings pre-grant and the effects of cumulative patenting practices to effective competition post-grant. The main argument of the thesis is that although strategic patenting practices is common in the pharmaceutical sector and there is nothing illegal in these practices within the context of the patent law that does not take into account the intentional aspect applicants but relies on the assessment of the technical criteria, when these practices make a negative effect to effective competition in the Community post-grant, norms and practices applicable to patent law may come into conflict with legal norms of the antitrust. Finally the research suggests licensing as possible solutions to the strategic patenting practices.<br>