Replies to post #157434 on Biotech Values

[stockbettor]

Thanks, it appears the FDA blog author extracted the key portions of the petition, which I have reproduced below for convenient reference:

Whether the use of a patented invention in the course of post-approval manufacture of a drug for commercial sale, where the FDA requires that a record of that manufacturing activity be maintained, is exempted from liability for patent infringement under Section 271(e)(1) as “solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs.

[ ** According to Petitioners, the Federal Circuit’s Classen and Momenta decisions are irreconcilable and fundamentally wrong:** ]

Both Classen and the ruling below give the wrong scope to the safe harbor provision and together they leave its meaning in an intolerable state of uncertainty. The Federal Circuit has shown no willingness to correct its interpretation or to provide the needed certainty. In the absence of guidance from this Court, future panels will have two purportedly binding precedents from which to choose. District courts are left adrift with two conflicting compasses, each purporting to be definitive. Companies attempting to chart their own courses have no idea whether they are free to use patented inventions or whether such use will subject them to infringement liability. The pharmaceutical industry cannot wait for the Federal Circuit to get it right (or wrong) a third or fourth time.

Absent review, the ruling below will undermine pharmaceutical industry investment in life-saving and life-enhancing innovations. Each drug the pharmaceutical industry brings to market requires enormous investment. That investment is predicated on the protection provided by the patent laws: protection for innovators, during a patent’s term, from unlicensed, commercial competition from their own invention. The court of appeals’ sweeping interpretation of Section 271(e)(1) calls into question the value of a great many pharmaceutical patents.

No mention of a potential 5th amendment "uncompensated takings" argument to invalidate the Fed. Cir. majority opinion. I thought CJ Rader's dissent strongly suggested such an argument. It may be that MNTA's attorneys failed to raise this argument at the appellate level, and the argument is now foreclosed. (Recall Wheeler's rather idiotic statement in the recent 4Q call Q&A that MNTA could not raise the HW safe harobr argument to attack Teva's Copaxone manufacturing patent on appeal because it was not presented to the lower court.) This would be unfortunate, because as Chief Justice Roberts stated in his Obamacare opinion, the SCt will reach for any reasonable construction of a statute to save it from unconstitutionality.

FWIW, I still give the SCt a more-than 50% shot to grant cert in MNTA. If it does, I think it will reverse, but I would like the odds of this happening much more if the takings argument is still available. Of course, I assigned a 90% probabiltiy that Classen/MNTA would be granted cert jointly so I wouldn't base any decision to buy or sell MNTA on my prediction skills.