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« Alcon Research, Ltd. v. Apotex Inc. (Fed. Cir. 2012) | Main | In re Beineke (Fed. Cir. 2012) »

August 13, 2012

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Comments

It takes chutzpa to disagree with Judge Newman (almost never wrong) AND Judge Rader (a close second to Judge Newman). Judge Moore shows not only that she doesn't know patent law, she doesn't even know the rules governing the court she sits on: the question was already decided by an earlier panel (Classen), and until there's an en banc decision saying otherwise, subsequent panels are bound by the first panel's decision.

This is what happens when judges start worrying too much about being overruled. Hypothetically, a crusty old veteran can afford to figure "how to best decide this case." But if you're a young up-and-comer it's important to please the bosses upstairs, even if they're fools. So instead or writing the best possible opinion, you write an opinion that's least likely to trigger a cert grant.

What are the chances of a cert grant in a case that expansively construes the safe harbor and sticks it to the patentee? Nil. On the other hand, look at Classen - it's already attracting Supreme Court attention (CVSG is pending).

Personally, I think Judge Rader has a point though. We are now incredibly far removed from anything Congress was talking about when it created the safe harbor in '84.

Dear Moo:

True, but the inconsistency really springs from the Supreme Court injecting political/policy considerations into statutory construction. Judge Rader made the case in Merck on Congressional intent, and the Court rejected it based on their "plain meaning" standard - which just means they can say the statute means what they think it means, not what Congress intended. The reason - because generic drugs are good and patents are bad. As Chief Justice Roberts said in the healthcare case, that isn't the Court's proper role. But it seems to be what they are doing (Mayo being the latest example).

Which encourages advocacy groups to write amicus briefs loaded with conclusions not based on evidence to influence the court - which does not bode well for Myriad, and means that only strong countervailing amici are necessary. And even then, the magic microscope will no doubt arise.

Thanks for the comment.

"It takes chutzpa to disagree with Judge Newman (almost never wrong)"

Hilarious. Keep 'em coming.

"What are the chances of a cert grant in a case that expansively construes the safe harbor and sticks it to the patentee? Nil."

Indeed. And the chances that Congress will be so offended by this interpretation of its precious "intent"? Also nil.

In other words, Moore's result is the right result.

Classen's patent was one of the worst grants in USPTO history, by the way.

KIR,
nope, Judge Moore's result is the "safe" result - it's likely to stand even if it's wrong just short of triggering cert or corrective legislation. "Not wrong enough" isn't the same as "right."

"Classen's patent was one of the worst grants in USPTO history, by the way."

That could be true. There are like 100 things wrong with that patent - so why are people banging on the Supreme Court door screaming "safe harbor?" Is it so hard to invalidate the thing? Oh wait - that would require work.

Kevin - yes, let's put these cases under the magic microscope. Congress couldn't agree enough to write an unambiguous statute - these things happen when they pass something that's not fully baked. Well enough... it's happened before and it's happened since. So now we have judges doing with it whatever they please, to the point where it's unclear which activities are NOT in the safe harbor.

KIR, who said the Classen patent was good patent? If you'd read the decision you'd know that the issue of validity wasn't before the CAFC, only the question of patent-eligibility under 101 (and Newman and Rader explicitly recognized that it might be invalid under 102, 103 or 112 but that question wasn't before them) and whether or not the "safe harbor" applied to anything besides obtaining "pre-marketing approval of generic counterparts of patented inventions". The answer to the latter question was no, so Moore had no business ignoring that panel decision. As usual she follows precedent only when it suits her.

Kevin,

You're absolutely correct that Moore's majority opinion reads the phrase "solely for uses" completely out of the safe harbor provision.

Rader's reading of the legislative intent on when the safe harbor applies is absolutely correct. I was in practice when Hatch-Waxman was being considered and enacted, and to treat the safe harbor as applying to anything other than pre-FDA approval activity would have shocked those in Congress who enacted this piece of legislation. And Rader is also correct that Moore's opinion cannot be so easily reconciled with the prior Classen decision.

One key point that wasn't addressed by your summary was Rader’s contention that applying the safe harbor provision to Momenta’s patented analytical method created a “disequilibrium” between Section 201 of Hatch-Waxman (which permits patent extensions where there is regulatory delay in marketing the patented invention) and Section 202 (which permits/protects activities, such as those supporting ANDAs, prior to patent term expiration) because Momenta could not obtain patent term extension for its patent under Section 201 (now 35 U.S.C. § 156). In support of this “disequilibrium” argument, Rader cited the 2008 decision in Proveris Scientific Corp. v. Innovasystems, Inc. In response, Moore’s majority opinion tried to refute this “disequilibrium” argument by citing the 1997 decision in Abtox, Inc. v. Exitron Corp. (holding that “patented invention” of 35 U.S.C. § 271(e)(1) includes all medical devices, whether or not eligible for patent term extension under 35 U.S.C. § 156).

In my opinion, the holding in Proveris Scientific (rather than Abtox) is much more applicable to Amphastar’s use of Momenta’s patented analytical method, but not primarily based on Rader’s “disequilibrium” argument. While Proveris Scientific discusses this “disequilibrium” issue, that was not the primary basis for the holding in that case that the safe harbor provision did not apply. Instead, Proveris Scientific ruled that the term “patented invention” in the safe harbor provision did not include the alleged infringer’s analytical device because it was not subject to pre-market approval by the FDA. Similarly, it does not appear that Momenta’s patented analytical method was subject to pre-market FDA approval, and was thus outside the safe harbor provision, whether or not the information provided by that patented method was “reasonably related to the development and submission of information” required by the FDA. Put differently, it is very problematical that use of Momenta’s patented analytical method by Amphastar even qualifies as a “patented invention” subject to the safe harbor provision in view of the Federal Circuit’s holding in Proveris Scientific.

EG,

Great comment. The Solicitor General view on Classen seems to agree with you and that the lower courts erred in their interpretation with respect to Momenta.

http://www.justice.gov/osg/briefs/2012/2pet/6invit/2011-1078.pet.ami.inv.pdf

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