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« Carnegie Mellon University v. Hoffman-La Roche Inc. (Fed. Cir. 2008) | Main | USPTO News: Patent Office Posts Comments on New Appeals Rules »

September 10, 2008

Comments

Something is clearly amiss in this opinion. The distinction over Caraco makes absolutely no sense at all. The key mistake in this opinion is the following passage:

“Hence, if Caraco was successful, Ivax would get its 180-day exclusivity period sooner and Caraco would be able to obtain FDA approval earlier—resulting in greater competition at an earlier time. Without a declaratory judgment, Caraco could be excluded from selling a noninfringing product even if the asserted patent was proven to be invalid. See id. at 1287, 1296 n.14. Therefore, Caraco could have been blocked from entering the market by an invalid patent.”

The phrase “if Caraco was successful” assumingly means that both patents are invalidated. Ivax gets its 180 days because it can now launch as the first patent was invalidated. Ivax was blocked from selling because it lost on the first patent, but now that the first patent is out of the way it gets 180 days based on its successful maintenance of P-IV for the second patent (Ivax wasn’t sued on the second).

But then the court says “Without a declaratory judgment, Caraco could be excluded from selling a noninfringing product even if the asserted patent was proven to be invalid.” This makes no sense. If Caraco invalidates the first patent, then Ivax can launch and it gets 180 days, and immediately afterwards Caraco can launch.

Of course, the only difference is that in the second scenario Ivax can delay entry and thus deny Caraco entry for an indefinite period. But isn’t that the same as in this case. Ultimately, the objective in both cases is to trigger the exclusivity period for the second patent. So what’s the difference?

Dear Josh:

I think the problem is in the "proven to be invalid" language. In order for the opinion to make sense, the court must have meant something like "even if the patent was in fact invalid," which would also make sense of the language a few sentences later to the effect of Caraco being precluded from entering the market by an invalid patent.

This interpretation is consistent with the distinction the court seems to be making - that the '663 patent was not invalid, because Apotex had stipulated to the earlier judgment of validity and enforceability.

Or at least that's how I read it. Feel free to let me know if you can find a flaw in this interpretation; I admit this isn't the most clearly-written opinion.

Thanks for the comment.

"the proven to be valid" relates to the "asserted patent" not the second patent that they did not assert for which Caraco wanted a DJ.

My point is. If Caraco successfully invalidated the "asserted patent", then they would no longer be blocked entry by that patent, rather they would be blocked entry by Ivax's 180 days. Ivax could of course delay the 180 days by delaying marketing - and that's prceisely the reason Caraco brought the DJ - to trigger the 180 days by "court judgment".

So there really is no difference in the "injury" in Caraco and the injury in this case. In both cases the second filer wanted to trigger the 180 days by "court judgment".

I think the Caraco case was wrongly decided (see J Freidman's dissent), but this opinion doesn't reconcile.

Judge Moore is a newbie. But what about Michel and Rader? They are well respected.

I don't mean to sound nit-picky at all, but I think you overlooked an important fact that creates a major distinction in one of the cases you cite: the Prasco case was NOT an ANDA/Orange Book case.

For the DJ plaintiff to try to have the court exercise jurisdiction there was a real stretch beyond the limits of the "case or controversy" requirement. Basically the patentee had marked its product and had not responded to a demand for a covenant not to sue, and that's pretty much it.

The rest of the cases, including Carasco, have an Orange-Book/ANDA tie. An argument could be made that the listing of patents and the filing of an ANDA is sufficient to create DJ jurisdiction, especially in light of Congress' provision for DJ jurisdiction to the extent allowed by the Constitution.

The Prasco case simply didn't have the Orange Book/ANDA angle, and accordingly it was really a slam dunk for the patentee.

Dear Sean:

Nice catch. Prasco was inadvertently put into the wrong list of cases (it was originally in a list of Article III cases that was deleted in editing, and we incorrectly included it in the ANDA list).

We appreciate the correction.

Dear Josh:

According to the court, Apotex needed to prevail against both of the non-asserted, Orange Book-listed patents in order to trigger Teva's 180-day exclusivity period. So I don't think the distinction you draw about asserted and non-asserted patents in Caraco is the one the court was considering. The relevant passage from the Caraco case is as follows:

"Only by obtaining a judgment of noninfringement on BOTH the '712 and '941 patents can Caraco trigger Ivax's 180-day exclusivity period, which currently prevents the FDA from approving Caraco's ANDA." (emphasis added)


I think the point is that here, the court judgment would NOT have permitted Teva to market, due to the Paragraph III Certification on the '663 patent. This, coupled with the fact that Apotex had stipulated that the '663 patent was not invalid or unenforceable and infringed, may be the distinction the court was trying to reach. Sometimes the court thinks there is an equity (like Apotex trying to burn Teva's 180 days with a judgment) and crafts an opinion directed to that goal. Maybe this is such a case.

Thanks for the comment.

Kevin,

I read your response, but I couldn't make sense of what you're trying to say about "both" needed for triggering the 180 days. That's true and undisputed and in my previous comments I didn't write any different.

The point is like this:
1. Caraco was required to kill only the first (asserted) patent in order for Ivax to be able to start marketing (after which Caraco could start.
2. Caraco was required to kill BOTH patents in order to trigger Ivax's 180 days.
3. Thus the reason for Caraco seeking a DJ on the second patent was because they wanted to trigger the 180 days, so that Ivax won't delay market entry.

But isn't that precisely the same reason Apotex is bringing the DJ against Janssen, i.e. in order to trigger Teva's 180 days? So where's the difference?

Finally, your point about "burning" Teva's 180 days is entirely unclear. If you mean that Teva's 180 days would be burned to the extent it's triggered before the expiry of the '663 - well here the court denied DJ even after the '663 expiry AND also in the Caraco case there was surely a chance that only the second patent would be struck and not the first - whereby Ivax's 180 days would be burned.

There can be differences of opinions, but an "opinion" needs to make sense. This opinion doesn't.

Dear Josh:

They don't make it easy, do they?

Turning to your comment, you say that Caraco needed to invalidate only the asserted patent for Ivax to begin marketing, and then you say they needed to invalidate both to trigger Ivax's 180-day exclusivity. But if Ivax could begin marketing if only one (the asserted) patent was invalidated, wouldn't marketing start the 180-day period for Ivax? So then was the Caraco court incorrect when it said:

"Only by obtaining a judgment of noninfringement on BOTH the '712 and '941 patents can Caraco trigger Ivax's 180-day exclusivity period, which currently prevents the FDA from approving Caraco's ANDA."

What am I missing?

1. If the first patent is invalidated Ivax can be begin marketing anytime they want - They can delay market entry (despite being granted market entry) and they wouldn't forfeit the 180 days. Only when they begin marketing would the 180 days start to run. Thus Caraco would be subject to Ivax's discretion as to when the 180 would start running.

2. On the other hand, if BOTH patents were invalidated then the 180 days would start running immediately upon court judgement.

Thus, Caraco wanted BOTH patents struck, because they didn't want the start of the 180 days to depend upon Ivax's willingness to begin marketing.

Bottom line, the DJ on the second patent was to trigger Ivax's 180 days. There is no distinction over this case.

[I have a gut feeling that Moore lacks familiarity with the intricate structe of the H-W act. The lack of clarity in this opinion attests to that]

Dear Josh:

Sometimes I think Judge Moore isn't alone.

Maybe this panel agrees with Judge Friedman who dissented in Caraco that the case was wrongly decided. This opinion could be a way for Judges Michel and Rader to set up a conflict in CAFC jurisprudence that would justify en banc review, either in this case or a future one. In which case, having Judge Moore write the opinion is pretty clever.

Thanks for the comment string. It made the piece better.

Kevin,

DJs after MedImmune, and Hatch-Waxman patent issues relating to the filing ANDAs, are each headache enough. The combination of the two, as in Janssen and Caraco, requires an Extra Stength dose of Excedrin. The conclusion in the Janssen cases seems right to me, even in view of Caraco. As I read Janssen, basically Apotex shot itself in the foot by stipulating to the validity, infringement and enforceability of the '633 patent. So even if Apotex was able to clear the other 2 patents (the '425 and '587 patents) out its way, they still wouldn't be able to move forward on their generic product launch because the '663 patent was still in the way, and no longer challengeable by Apotex because of their stipulation. Did I get it right?

Dear EG:

I think Apotex did shoot themselves in the foot, but Josh's point (which is persuasive to me) is that if Caraco should be able to leap the jurisdictional hurdle (i.e., NOT on the merits) then Apotex should as well. I think the equities are different (in Caraco the panel seemed concerned about generic market entry delay by an invalid patent versus the apparent duplicity of Apotex stipulating to the validity of the '663 patent and then trying to trigger Teva's 180 days before the '663 patent expired).

The only counter I can think of is that here there was no remedy for Apotex even if they had invalidated the two unasserted patents. There was just a harm against Teva that would work to Apotex's advantage.

But the case isn't a paragon of judicial clarity.

Thanks for the comment.

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