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July 23, 2013



Judge Moore's opinion in Momenta Pharmaceuticals is really bad, and these two district court cases may be the "tip of iceberg" on how problematic the Momenta Pharmaceuticals opinion is with regard to applying the Hatch-Waxman "safe harbor" to post-FDA approval activity. As Chief Judge Rader correctly pointed out in his dissent in Momenta Pharmaceuticals, Judge Moore’s opinion reads 35 U.S.C. § 271(e)(1) in a manner contrary to the statutory language, and more importantly, completely inconsistent with the legislative intent for when this “safe harbor” provision was to apply. Even more troubling, Judge Moore’s opinion in Momenta Pharmaceuticals cannot be easily squared with the earlier Federal Circuit case of Classen Immunotherapies, Inc. v. Biogen IDEC (where Judge Moore dissented from the Federal Circuit’s majority opinion written by Judge Newman and joined by Chief Judge Rader). In other words, we've got jurisprudential "mess" in terms of the Hatch-Waxman "safe harbor" which only an en banc ruling by the Federal Circuit can fix.

It is not clear that an en banc CAFC will fix the mess. They have been sparring with the supreme court and themselves for years. This mess requires a congressional fix. To fix it, references to "congressional intent" have to go away and the statute replaced with language that, despite the court's finding that it is clear and unambiguous, is in fact clear and unambiguous.

Any time judges have to resort to reading legislative intent tea leaves, you know you are in real trouble. With clean language, congress (and the rest of us) will finally come to know what it is that they really did intend those many years ago.

Anyone out there any good at statute drafting? Seriously.


As other sections of the patent law have indicated (for example, 101), even direct and clear words are still amenable to tea-leaf reading and the finding of implicit language (if that is what the Court wants to do).

But you have a nice thought...


I disagree – if an en banc Court were to limit 271(e)(1) to pre-approval activity, I’m not sure the Supreme Court would disrupt that interpretation. But then again, I wouldn’t put it past them. Maybe a re-tooling of the safe-harbor provision language is necessary at this point. Thanks for the comment.


Andrew and Skeptical,

I think that your comments reflect at least some of the unease I feel about what has happened (and continues to happen) to patent law recently, especially since the KSR decision. Something feels very wrong with what has happened to sections 101, 103, 271(e)(1) and some others (maybe 112 and written description, which I have been watching with real dread for several years now - that one feels like it is about ready to blow up and we could then easily be in the absolutely hellish and irrational world of European Article 123(2)).

To me this stuff isn't just about arcane nuances in patent law. It is about what appears to me to be one of the key bulwarks that protects the American standard of living. America cannot maintain its standard of living by simply asking employees to flip hamburgers faster or by exporting more soybeans and coal. Those things should help (or not, depending on what one thinks, e.g., about coal and the environment), but they cannot sustain us. Patents cover innovation and innovation is where we have a real global edge in wealth creation. I don't think we can fully capitalize on that advantage if our laws are in disarray.

Maybe I am way off base here, but I suspect that certainty in patent law will ultimately lead to more wealth creation than less certainty, which unfortunately is the direction I suspect we are going. Absent intellectual property protections, how are we going to compete and at least maintain what we have? Just consider how some (not all) of our competitors compete - they can be absolutely ruthless, i.e., mass scale cheaters. When foreign governments step in and simply take (via, e.g., price controls or statutory subject matter limits) some or all of what is theoretically "protected" by intellectual property, they reap the benefit and we lose our ability to accumulate that lost wealth.

It is also worth note that the U.S. arguably has, for the most part, been very generous with most of the rest of the world over the last 60 years or so. Intellectual property has been one of America's gifts to the world. I am uncertain that we can sustain that generosity much longer. One reasonable and fair way to level playing fields is to get things in patent law straightened out. It won't fix everything, but it should help.

Maybe the English language will never be up to the task of being truly clear and unambiguous when it comes to patents. I just think that some of the wheels have come off the cart and some more are about ready to fly off. I very much hope that I am wrong and that everything is going in the right direction. My instinct just says otherwise.

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