Biotech Values

[stockbettor]

The Chief Judge's statement in his dissent about his role in Hatch Waxman was far more muted than his statements made near the conclusion of oral argument (which I just listened to again).

From his dissent:

The authors of this section (and I hesitate to add that I was present through this legislative process) did not imagine that § 271(e)(1) would allow continuous, commercial infringing sales during any portion of the life of the patent.

At oral argument, in questioning Amphastar's counsel as to whether Amphastar's interpretation of the Hatch Waxman exception would render all manufacturing control patents worthless, he said (about H-W's purpose):

I was there. I wrote that, so I know what it's meant to do.

The Chief Judge served as a legislative counsel in the Senate during the period H-W was enacted so there is no reason to doubt that he actively participated in drafting the statute. Note also that he vigorously complained about the majority's failure to review H-W's legislative history, culminating with this statement:

In fact, this court makes no attempt to examine the legislative history of this section at all — a very telling silence.

Even without a MNTA investment, this would be a fascinating case to follow from a legal perspective, assuming the Fed Circuit agrees to reconsider it en banc, and I find it difficult to imagine that the FC will not agree. I wonder if a case has ever arisen where a sitting judge was called upon to interpret a statute that the judge helped to draft.

If I were MNTA/Sandoz, I would be retaining well-connected lobbyists before the day is out to explore the possibibility of securing a legislative "technical correction" to the H-W exception to make it absoulutely clear that it reads as Congress originally intended it to read, as explained by the Chief Judge.