13 June 2005

Mercky Waters

As promised—or threatened—here are a few comments on Merck. This case involved use of a patented compound during development of an anticancer drug, described in more than sufficient detail in Justice Scalia's opinion. One aspect to which he didn't give sufficient weight (although, in the end, it would only reinforce his conclusion) and reveals that Justice Scalia is not a scientist is the use of the patented compound as a control, against which other potential drugs were tested. Merck KGGaA v. Integra Lifesciences I, Ltd., No. 03–1237 (Jun. 13, 2005), slip op. at 5.

In any event, one extended comment bears some consideration for what it implies about intellectual property law in general, not just patent law.

In respondents' view, preclinical studies related to a drugs efficacy, mechanism of action, pharmacokinetics and pharmacology are not reasonably included in an IND or an NDA, and are therefore outside the scope of the exemption. We do not understand the FDAs interest in information gathered in preclinical studies to be so constrained. To be sure, its regulations provide that the agency's "primary objectives in reviewing an IND are… to assure the safety and rights of subjects," but it does not follow that the FDA is not interested in reviewing information related to other characteristic of a drug. To the contrary, the FDA requires that applicants include in an IND summaries of the pharmacological, toxicological, pharmacokinetic, and biological qualities of the drug in animals. The primary (and, in some cases, only) way in which a drugmaker may obtain such information is through preclinical in vitro and in vivo studies.

Id., slip op. at 9–10 (ellipses in original; citations omitted). This has some interesting implications for copyright, in the context of fair use under § 107 and the various library exemptions in § 108. However, it would have been much more persuasive had Justice Scalia tied these functions directly to use of the patented compound as a control. If nothing else, this would enable young scientists who have little or no sophistication in intellectual property to understand both the breadth and limitations of the opinion. Instead, now we're going to see litigation that tries to discern the limits of this "preclinical exception" that will no doubt be extracted from this case. I'd make a snide remark about prevention being better than a cure (I think I just did), but that might be in poor taste in an opinion ultimately founded on searching for a cure and not on prevention.