| Summary: | <p>This thesis argues that actors use the patent system as part of a ‘delay-and-pay’ strategy to preserve drug prices for as long as possible by delaying generic/biosimilar market entry – and that they have a significant incentive to do so. This strategy is based on the notion that it is significantly more profitable for patentees to delay generic/biosimilar market entry by way of a patent infringement claim and ensuing injunction, then pay damages to the enjoined party should the infringement claim be defeated. Patentees have much to gain and little to lose under ‘delay-and-pay’. My doctrinal analysis establishes that the generic/biosimilar defendants’ loss is likely undercompensated and the money that national health authorities spent purchasing the more expensive, patented drug whilst the interim injunction remained in effect is not usually compensated following a patent revocation and discharged injunction. Taken together this provides a significant financial incentive to delay generic/biosimilar market entry for as long as possible, even if patentees ultimately lose at trial.</p>
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<p>After discussing the incentives behind the delay-and-pay strategy, the thesis turns to the ‘how’. It starts by showing how actors now protect medicines with large patent portfolios comprising several different patents, which lays the basis for the structure of subsequent chapters. Following the traditional patent filing timeline of pharmaceutical patent portfolios, each chapter shows the relevant patent and/or ensuing procedural right forms one part of the delay-and-pay strategy and proposes targeted solutions. The thesis then proposes that the courts should require patentees to disgorge the additional profits made during the interim injunction to generic/biosimilar manufacturers and national health authorities to neutralise any benefits gained from the delay-and-pay strategy. With strained health budges and rising drug prices, it is imperative that underserved wealth transfers are reversed so patentees do not benefit from a windfall when enforcing invalid rights.</p>
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