Court Opinion

ID: 8408355
Source: CourtListenerOpinion
Date Created: 2022-11-02 16:42:18.447901+00
Date Added: 2024-06-11T16:47:34.064732
License: Public Domain

PLAGER, Senior Circuit Judge,
concurring.
I join Judge Bryson’s carefully-crafted and well written opinion and the conclusions he reaches: (1) despite the somewhat unorthodox manner and circumstance in which the issues in the case reach us, we have jurisdiction over them; (2) the issue regarding the FDA’s practice of allowing multiple 30-month stays has been rendered moot in this case by the FDA’s action, at the request of SmithKline, terminating the stays associated with the patents that applied to Apotex’s ANDA, and Apotex’s failure, for obvious reasons, to challenge that action, resulting in the subsequent approval of the ANDA; (3) there remain other issues that were not rendered moot, and that require addressing by this court.
Among those other issues is the question of whether the Hatch-Waxman Act obligates the FDA to police the listing, by NDA holders, of patents in the Orange Book. The majority opinion analyzes the relevant statutory provisions, and concludes that Congress did not explicitly impose such a duty on the FDA. From this the opinion concludes that the FDA’s regulation, 21 C.F.R. § 314.53(f), which in effect denies any duty on the FDA to screen Orange Book listings, is reasonable.
Reluctantly, I concur that the statute does not explicitly place a duty on the FDA to administer the Act in this regard, but I find that conclusion fundamentally at odds with my notion of proper administra*1353tion of the law. The listing in the Orange Book of multiple patents related to a single approved NDA has significant legal consequences, as the majority opinion points out in the discussion of the issues before the court. The fact that the FDA’s revised rule finally1 outlawing multiple 30-month stays removes the legal consequence that was most subject to abuse, does not mean that these listings no longer have important consequences. Indeed, in this case itself, even though SmithKline requested delisting of its multiple patents along with the lifting of the stays, the FDA declined to delist the patents, pending its review to determine who else might be affected by its action.
It is the position of the FDA that it has no duty to screen the listing of patents in a publication it maintains as required by law, which publication is not simply a source of information but, as required by statute and FDA rules, imposes various legal duties on applicants for an ANDA, and has consequences for other ANDA applicants as well (see the discussion of the shared exclusivity rule). The power to impose those duties in any given situation is thus in the hands of the party, the NDA holder, most interested in imposing them as a way to discourage, or at a minimum delay, applied-for ANDAs. Under current FDA practice, if a person disputes an Orange Book listing, the FDA asks the NDA holder to confirm the correctness of the listing, and will not modify the listing unless the NDA holder agrees. See 21 C.F.R. § 314.53(f).
If this is not improper delegation of government power, it strikes me that it is at least poorly conceived administration of the laws. I am not impressed with the argument that the problem is cured because ultimately the validity of any listed patent will be determined by a court. The legal consequences, not the least of which is the chilling effect of the ANDA applicant having to file the paragraph IV certifications inviting such law suits, are immediate. The ultimate judicial vindication, if such there be, comes much later, and at considerable additional cost.
It does not seem to me to be an unreasonable expectation that the FDA have on its staff a handful of competent patent analysts, along with its multitude of scientific specialists, who, at a minimum, could make an initial judgment about the propriety of a fisting, consistent with the statutory requirement that the NDA holder file required patent information. See 21 U.S.C. § 355(c)(2). The FDA claims the power to police the fisting process to the extent of ensuring that patents that should be fisted are fisted; it is a relatively straightforward step to ensure that those patents that obviously should not be fisted are not. This would provide a neutral arbiter between the NDA holder and the ANDA applicant regarding an important matter of process, and would provide some balance between these competing interests, a balance that the Hatch-Waxman Act was intended to establish in the first place.
The need for the FDA to properly police the administration of the Act in this regard was made even more acute by our decision in Mylan Pharmaceuticals, Inc. v. Thompson, 268 F.3d 1323 (Fed.Cir.2001), in which we held that an ANDA applicant has no private cause of action against an NDA holder to require the NDA holder to re*1354move improperly listed patents from the Orange Book. If neither the Administration nor the courts see fit to make clear FDA’s obligation to administer the Act in a responsible way, Congress should consider doing so.

. The FDA argues it is reasonable to have multiple 30-month stays (the old rule), and equally reasonable not to allow them (the new rule). See 68 Fed.Reg. 36,675 (June 18, 2003). The new rule is clearly designed to foreclose an area of known abuses under the law; whether the old rule, should it be re-proposed, could ever be considered reasonable is a question not before us.