Interesting piece, which I took the liberty of posting on SI. To me, Guttag is off base in his second to last paragraph, however.
"In my opinion, the holding in Proveris Scientific (rather than Abtox) is much more applicable to Amphastar’s use of Momenta’s patented analytical method, but not primarily based on Rader’s “disequilibrium” argument. While Proveris Scientific discusses this “disequilibrium” issue, that was not the primary basis for the holding in that case that the “safe harbor” provision did not apply. Instead, Proveris Scientific ruled that the term “patented invention” in the “safe harbor” provision did not include the alleged infringer’s analytical device because it was not subject to pre-market approval by the FDA. Similarly, it does not appear that Momenta’s patented analytical method was subject to pre-market FDA approval, and was thus outside the “safe harbor” provision, whether or not the information provided by that patented method was “reasonably related to the development and submission of information” required by the FDA."
Emphasis mine. The analytical process wasn't subject to pre-market approval by the FDA? Really? Does he mean separately from the ANDA approval process for M-enox (in which case I get it)? I'm having trouble parsing this interpretation, and currently like Rader's disequilibrium tack much better.
Tasteless aside: Imagine if the three justices formed their own law firm: Moore, Dyk,'n' Rader. Offices one floor below Dewy, Cheatem, & Howe, I suppose.
Regards, RockRat
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