CD: What key trends are you seeing in patent litigation in the pharma and biotech sector? How are these developments leading firms to re-think and adjust their patent litigation strategies?

Bell: In the past, the classic situation has been one in which a litigated patent read on an entire pharmaceutical product. With increased patenting of product features, methods of use, and manufacturing technologies, that type of circumstance has become less common. Instead, companies are routinely faced with complex considerations bearing on how an allegedly infringing product is manufactured, marketed or used. In this context, issues relating to the availability of non-infringing alternatives are more prominent than ever. Challenges in proving damages also arise, for instance in showing that a patented feature was the basis for demand of the product, or that consumers attributed significant value to a feature relative to technologies that may have been used previously.

Schüssler-Langeheine: Traditionally, litigation in the pharma and biotech sector has been widely dominated by disputes between originators and generics companies concerning the generics’ strategies of entering the market for established drugs earlier than their competitors – for example, either by challenging patents protecting profitable products or entering the market at their risk or by premature marketing activities which the generics believe are either difficult for the proprietors to become aware of or can be argued as not infringing. We still see a lot of these actions. Actions against parallel traders and counterfeiters are another part of ongoing litigation activities in this sector. Infringement actions of that kind focus on legal rather than technical questions, on the interpretation of the law rather than on claim construction: what kind of preparatory steps for market entry result in an imminent threat of infringement and justify a preliminary injunction? Does an offer for delivery after patent expiry infringe the patent before its expiry? Can API suppliers rely on their customers’ Bolar exemption? Also, intelligence, fact finding and securing evidence are key. However, the pharma and biotech sector is slowly undergoing a fundamental change. The low hanging fruit has been harvested. The patent cliff has been left behind. Fewer blockbuster drugs will be approved. As a result, litigation strategies will have to reflect the legal uncertainties associated with claims, the construal of which by a court is not reliably predictable. In our experience, litigation strategies in the pharmaceutical and biotech sector increasingly require a broader perspective, more creativity, and a mechanism to ensure tight and effective coordination.

Apr-Jun 2014 issue

Charles River Associates (CRA)

Hoffmann • Eitle

Skadden, Arps, Slate, Meagher & Flom LLP