Unpredictability in Patent Law and its Effect on Pharmaceutical Innovation

Part II of this Article summarizes the current R&D crisis confronting the pharmaceutical industry and the accompanying drop-off in innovative output from this important technological sector. Part III explains Mr. Armitage's "view from industry," which attributes a significant causative effect to unpredictability in the patent system. Part IV provides two Lilly case studies involving generic challenges to two of the company's important drugs, Gemzar and Strattera, in which the company has suffered as a result of this unpredictability. Part V identifies three distinct forms of unpredictability in patent law: unpredictability caused by the proliferation of loosely defined standards rather than bright line rules; unpredictability associated with long-delayed clarification of critical and identifiable ambiguities in patent law; and perhaps worst of all, unpredictability that occurs when courts adopt a new interpretation of legal doctrine and apply it retroactively, to the detriment of the investment-backed expectations of patent owners.

Part VI discusses how Congress and the United States Patent and Trademark Office (PTO) can ameliorate problems of unpredictability by taking a more active role in instituting changes in patent law.