Below is a link to MNTA's full pettion for cert. I did not realize, but should have probably guessed, that the petition would be longer than a few paragraphs or pages. There are 33 pages of analysis, plus appendices containing the lower court opinions. The petition addressed the Soliciter General's recommendation to deny cert in Classen as follows:
This Court long has recognized the importance of the scope of Section 271(e)(1), having reviewed the Federal Circuit’s construction of this provision in Eli Lilly and Merck. Indeed, even before the Federal Circuit issued its conflicting decision in this case, this Court invited the views of the Solicitor General as to whether certiorari should be granted in Classen. GlaxoSmithKline v. Classen Immunotherapies, Inc., 133 S. Ct. 50 (2012). Although the decision below had issued by the time the Solicitor General recommended that this Court deny review in Classen, there were issues particular to Classen (and not present in this
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case) that led the Solicitor General to believe that Classen did not present a suitable context in which to address the scope of Section 271(e)(1). Brief for United States as Amicus Curiae at 10, 20-23, GlaxoSmithKline v. Classen Immunotherapies, Inc., No. 11-1078 (U.S. Dec. 13, 2012).
Moreover, the Solicitor General’s recommenda- tion was based on the fundamental misconception that the panel majority in this case could somehow overrule or limit Classen. Id. at 20. That simply is not so: under Federal Circuit law, a panel opinion “remains binding precedent until it is over-turned by the Supreme Court or by [the court of appeals] en banc.” Masias v. Secretary of Health & Human Servs., 634 F.3d 1283, 1288 (Fed. Cir. 2011). “Where there is direct conflict [between two decisions of the Federal Circuit], the precedential decision is the first.” Newell Cos. v. Kenney Mfg. Co., 864 F.2d 757, 765 (Fed. Cir. 1988).
Significantly, the Solicitor General neither defended the holding of Classen nor endorsed the breadth of the Federal Circuit’s holding in this case. As to Classen, he opined that the scope of the safe harbor is not confined categorically to pre-approval activities. Brief for United States, supra, at 11-18. As to the decision here, the Solicitor General explicitly expressed no view as to the “correctness” of the Federal Circuit’s conclusion that “information may be deemed ‘submitted’ to FDA if it is preserved in records that FDA regulations require a drug manufac- turer to make available for inspection by FDA on request.” Id. at 20 n.4.
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Until this Court steps in, the outcome of Section 271(e)(1) disputes will turn on which purportedly binding decision a district court decides to follow, and then on which judges happen to be on the reviewing Federal Circuit panel. This npredictability (and arbitrariness) flies in the face of the very purpose of the Federal Circuit—to ensure national uniformity in patent law. Markman v. Westview Instruments, Inc., 517 U.S. 370, 390 (1996). Companies will have no idea whether they are free to use patented inventions or whether such use will subject them to infringement liability, whether they should invest in various types of new technology, or what value, if any, their own patents have.
The petition advances good arguments for granting cert. (but no mention of my "takings" argument, which seems obvious to me and may mean that it cannot be raised here because it was not made at the lower court level). March 25th is the due date for Amphastar to submit its reply.
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