Claim Construction Strategies For Trial And Appeal In Pharma Litigation

Claim construction is the single most important event in the course of a patent litigation. It defines the scope of the property right being enforced, and is often the difference between infringement and non-infringement, or validity and invalidity. – Circuit Judge Kimberly Moore (dissenting from the denial of a petition for rehearing en banc of Retractable Technologies v. Becton, Dickinson and Co., No. 2010-1402, 2011 WL 2652448 (Fed. Cir. 2011). The importance of claim construction to patent litigation results in a tremendous amount of time, effort, and resources devoted to obtaining a favorable claim construction at the district court level. The Markman (claim construction) hearing is a pivotal—and often dispositive—event in the progress of a patent infringement case. Despite the time and effort spent by litigators, experts, and judges in construing claims at the district court level, claim constructions are also the most likely aspects of a case to be reversed on appeal. See Jeffrey A. Lefstin, The Measure of the Doubt: Dissent, Indeterminacy, and Interpretation at the Federal Circuit, 58 HASTINGS L.J. 1025, 1026 (2007). The high reversal rate is due in part to inconsistencies in the law (and application of the law) governing claim construction, as well as to the de novo standard under which claim constructions are reviewed on appeal. See Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc).

Nowhere is the paradoxical relationship between the effort expended at trial on claim construction and the certainty of the result on appeal more dramatic than in the pharmaceutical and biotechnology fields. There are two main reasons why the paradox is so keenly felt in the life sciences. First, patent claims in the life sciences tend to use sophisticated and art-specific nomenclature that has no plain meaning to a layman, and that requires extensive tutorial and background information for the district court to make sense of the terms disputed. Second, claims terms are to be construed according to the understanding of one of ordinary skill in the art, and the level of ordinary skill in the life sciences tends to be higher than in most other industries.

For instance, the level of ordinary skill in the pharmaceutical or biotechnology arts may require a Ph.D. in organic chemistry, molecular biology, or immunology, with experience in drug design, antibody technology, or other highly skilled disciplines. The same analysis in other mechanical or Internet technologies may only require a bachelor's degree and experience in the relevant...