Much controversy has arisen surrounding the implementation of this provision over the past two decades, mostly involving generic applicants competing among themselves for the 180-day period.
Thus, disputes have arisen about which among the involved generic companies should obtain the exclusivity, including but not limited to whether it should be the first to certify that a patent was invalid or did not infringe (the paragraph IV certification), the first to be sued by the innovator, whether a suit was necessary, the first to win such a suit (whether necessary or not), or some combination of the above.
A myriad of fact patterns has emerged over the years, accompanied by changes in FDA positions and inconsistent court cases, precluding the semblance of a single, understandable rule. But all bear testament to the importance of the 180-exclusivity period to generic drug makers, and the degree to which the availability of that period acts as an incentive to the introduction of new generic drugs.
What then in the law compelled the FDA, and then the Courts, to permit innovator companies to compete during the 180-day period with their own authorized generics, while precluding such activity by generic products themselves?
In creating the 180-day exclusivity period, Congress drafted the statutory language so as to prohibit the FDA from approving only additional section 505(j) applications, or ANDAs, the applications routinely filed by generic companies. The statute did not refer in this context to the possibility that additional, identical versions of branded products might be introduced through NDA supplements, which are regulated under different statutory sections, sections 505(a) through (e).
This is quite easily explainable; it is doubtful Congress even considered plausible the practice of innovator manufacturers introducing their own products as generics to compete immediately with the very first marketed generic. Had Congress thought about it, it is much better than an even bet that such products would have been treated similarly to products approved under ANDAs in order to preserve the incentive to challenge innovator patents.
Given the rules of construction applicable to statutory language viewed as unambiguous, however, neither the FDA nor the courts were willing to delve into Congress intent but, rather, simply applied the legislative language literally to limit the 180-day exclusivity to only 505(j) (i.e., ANDA) applications.
Indeed, relying completely on the literal statutory language, neither the FDA nor either of the two courts even spent much time discussing the obvious underlying policy question, or the possibility of an unexpressed intent of Congress. And though the Court of Appeals accepts the common nomenclature of the 180-day period as an exclusivity, it fails to recognize that the term shared exclusivity is an inherent contradiction.
It is not clear whether this decision is the final word on the subject, but it is likely to be the operating word for at least a significant period of time. While seeking Supreme Court review is a possibility, review must first be granted, and even a different decision will not come soon, while the present policy becomes more entrenched.
Will the decision change generic product practices in challenging innovator product patents? It is incontrovertible that a one-generic-drug exclusivity provides far more economic benefit to the exclusivity holder than an exclusivity shared with an authorized generic.
Some have referred to permitting authorized generic competition during the 180 days as crippling. On the other hand, others have pointed out that even a shared exclusivity can provide significant financial rewards for the exclusive real generic.
When coupled with the satisfaction of demonstrating the invalidity of an innovator patent, it is likely that patent challenges by generic companies will continue to some, though perhaps a lesser, extent, and requiring perhaps more exacting analyses over the prospective benefits.
That not everyone is convinced that the FDAs action comports with the overall statutory purpose, however, is quietly suggested in a bipartisan request from certain members of Congress (sent after the trial court had ruled, but before the appellate court decision) requesting the Federal Trade Commission to review the competitive effects of authorized generics. Ultimately, if a change is to be made, it is likely to emanate from Congress.
For some time, there has been debate on whether the compromises of Hatch-Waxman need a further look, an effort that has been largely forestalled by, as some view it, an innovator industry that is concerned over a potential shift in revised legislation against its interests. It will be somewhat ironic, but not entirely unusual, were this case to promote the taking of that further look.