In the pharmaceutical world, often times a method of use patent is used to sue competitors, such as generic drug companies, for patent infringement. The standard that is supposed to be used in evaluating a method of use patent infringement is the inducement to infringe test. Under this test, there is supposed to be a "mental" state of mind factor and the direct infringement factor. What we see often times, though, is a court's reluctance to actually measure or evaluate the mental state of the competitor and resort to strict liability instead. This is wrong.
A brand company (patentee) may point to the generic company's proposed label to assert the required mental state. But pointing there is not the end-result. Sure it is expedient to simply point at some verbiage in a label and then declare without more investigation that culpable mental state exists. But that is not the law. Whereas the main focal point of the inquiry is in the "Dosage and Administration" section of the label, a patentee may not be able to make the case by just pointing there. Worse, the patentee may not be able to point there at all and must point to other sections of the label, such as the Warnings or Contraindications sections. And even then, a patentee may need to contort the stated language from benign or permissive language into more mandatory or explicit language, usually by use of the hired gun expert.
A brand company may argue that any language in the label is an "instruction" on use and point to the Grokster (Supreme Court copyright) case for legal support. Inducement to infringe is not a game of "gotcha" though. Inducement requires a real, honest to goodness evaluation of the mental state of the defendant.
Aside from the obvious problem: a hired gun expert can take any language, as loose and ambiguous as it is, and make it into more explicit language. For example, suppose the patented method of use claims using Drug X, but using less of Drug X if the patient also Drug Y. [I am ignoring at the moment whether such as claim is even patentable.] Now in the proposed generic label, the verbiage may only state or suggest that "if" the patient is taking Drug Y also, the Doctor "may" consider reducing the amount of Drug X or that the Doctor may want to monitor the patient for any drug interactions. A patentee's expert may testify that even with loose language like "may" consider reducing Drug X, this is really an express instruction. The generic company's expert may testify the opposite, that such language is only permissive, not mandatory or explicit. What else can be done?
In my law review article from 2014 published in the William Mitchell law review (link embedded here or available on my LinkedIn profile in publications), I discuss why inducement to infringe requires a higher level of inquiry. I debunk Grokster's application to patent inducement. I also show where generic companies could avoid certain inducement claims (or at least try to mitigate against them) by having certain procedures in place.
In my practice, I have also successfully conducted training seminars and coached clients in an effort to minimize inducement claims.
In any case, it is always important for Generic companies to be vigilant in how method of use patent claims are being asserted and get quality legal advice timely.
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