I mentioned the other day that the Supreme Court had handed down a decision in Merck v. Integra. I also included in that post a link to Dennis Crouch's blog that invoked TypePad's "trackback" feature. The trackback put a link to my post on Crouch's blog. As a result I've had a lot of visitors who clicked over from Crouch's blog, and were probably disappointed to find that my post didn't actually say anything about the decision. So, now that I've had a chance to think about the decision a bit and discuss it with others, I thought I would offer something in the way of subtantive commentary.
An interesting aspect of the Supreme Court's decision is that it offers an actual test for whether the use of a patented compound is "reasonably related to the development and submission" of information to the FDA - that is, a test for whether a use is protected by the statutory safe harbor of 35 U.S.C. 271(e)(1). The Court ruled:
The use of patented compounds in preclinical studies is protected under §271(e)(1) as long as there is a reasonable basis for believing that the experiments will produce the types of information that are relevant to an IND or NDA.
Slip op. at 14. But this test is not without limits. The Court noted elsewhere in its opinion that
Basic scientific research on a particular compound, performed without the intent to develop a particular drug or a reasonable belief that the compound will cause the sort of physiological effect the researcher intends to induce, is surely not reasonably related to the development and submission of information. to the FDA. Slip op. at 12. And,
Basic scientific research on a particular compound, performed without the intent to develop a particular drug or a reasonable belief that the compound will cause the sort of physiological effect the researcher intends to induce, is surely not reasonably related to the development and submission of information. to the FDA.
Slip op. at 12. And,
At least where a drugmaker has a reasonable basis for believing that a patented compound may work, through a particular biological process, to produce a particular physiological effect, and uses the compound in research that, if successful, would be appropriate to include in a submission to the FDA, that use is "reasonably related" to the "development and submission of information under . . . Federal law."
Slip op. at 13-14. So, the Court enunciates the "reasonable basis for believing" test, but includes an overlay that requires the drugmaker to have a specific theory in mind as to why a particular compound might be a promising drug candidate. Shotgun or blind-guess early drug discovery research is not going to be exempted.
Even with that limitation, though, the Court's test is broadly articulated and will exempt a wide range of activities from patent infringement liability. One lawyer I talked with whose practice includes drafting and prosecuting drug claims for pharmaceutical companies, was troubled by the breadth of the Supreme Court's formulation. She wondered if the Court's decision would make it easier for competitors to design around her compound claims, because experiments that they do with the compound -while trying to develop a substitute compound for FDA approval - might fall with the Court's articulation of the statutory exemption.