Apotex Challenge to ACULAR LS Patent Barred by Res Judicata

Roche Palo Alto and Allergan v. Apotex (Fed. Cir. 2008)

Roche’s patent covers drug formulations for treating eye inflammation and covers products sold as ACULAR and ACULAR LS. The two formulations differ in their proportion of various drugs such as an ammonium preservative and a surfactant.

Hoping to sell generic versions, Apotex filed two ANDAs with the FDA – one for each formulation.  In response, Roche filed two separate infringement actions against Apotex (the ACULAR and ACULAR LS cases respectively). In 2007 the CAFC put a final nail in the ACULAR case by affirming the district court’s holding that the patent was not invalid and not unenforceable (infringement had already been decided).  This appeal involves ACULAR LS.

Reverse Doctrine of Equivalents Remains Dead: In the 1950 Graver Tank opinion, the Supreme Court discussed how the reverse DOE can be used to limit the scope of claim coverage: “where a device is so far changed in principle from a patented article that it performs the same or a similar function in a substantially different way, but nevertheless falls within the literal words of the claim." Although Graver Tank stands as good law, the CAFC has “never affirmed a finding of non-infringement under the reverse doctrine of equivalents.”  Here, the CAFC continued to reject the doctrine of reverse equivalents.

Relying on a technical expert, Apotex argued that its formulation – although covered by the literal claims – operated under a different principle (involving the formation of micelles). The CAFC rejected this argument for several reasons: (1) the principle was derived from expert testimony without relying on the prosecution history which was not entered into evidence in the case; (2) the principle was not required in the specification; and (3) there was no evidence that the examiner relied on the principle in allowing the patent to issue.

Claim Preclusion: Apotex hoped to challenge the patent’s validity a second time — this time with the benefit of the new KSR standards for obviousness. The district court, however, refused a second go-round — finding the claims precluded. In the Ninth Circuit, claim preclusion applies to prevent subsequent litigation where “(1) the same parties … were involved in the prior litigation, (2) the prior litigation involved the same claim or cause of action as the later suit, and (3) the prior litigation was terminated by a final judgment on the merits.”  In patent cases, the second suit is considered the “same claim” when the accused products are “essentially the same.”  The party asserting claim preclusion has the burden of proving that the accused products are essentially the same.

Essentially the Same: On appeal, the CAFC held that analysis of whether two products are essentially the same (for claim preclusion) should focus on the claims. Here, the court affirmed that both the ACULAR and ACULAR LS formulations are essentially the same “because both formulations are encompassed by the [patent] claims.”

“Though the court recognized that there are differences in the concentrations of the ingredients in the ANDA-1 and ANDA-2 formulations, it also realized that all of the concentrations are well within the ranges claimed in the ’493 patent. The fact that they are stabilized by different mechanisms, even if true, is irrelevant because both formulations are encompassed by the claims of the ’493 patent. Thus, any difference in composition between the two formulations is merely colorable and the two formulations are “essentially the same.”

In addition, the CAFC confirmed that there is no “change of law” exception to claim preclusion — what is done is done. Thus, KSR gives no right to re-open closed claims. (*There are of course some exceptions to this role of no exception.).

Notes:

• Claim preclusion is also known as res judicata. The CAFC did not need to reach whether issue preclusion should also apply.
• The CAFC’s claim preclusion jurisprudence appears to be developing a pro-patentee bias. Compare this Roche with the Acumed v. Stryker (a patentee does not lose rights by filing suit against only some of an accused infringer’s products).

Comments

[Malcolm Mooney]

"Reverse Doctrine of Equivalents Remains Dead"

While true at the CAFC, I wonder: has it been successfully employed at the district court level in the past 25 years?

I hope not. But I wouldn't be surprised if it had.

It would be nice if the CAFC would simply kill the reverse doctrine, as obsolete and unnecessary. I can't conceive of an instance where the reverse doctrine would be "needed" to avoid infringement. In every case where the reverse doctrine could be applied, a proper claim construction or invalidation by failure to enable would seem to apply with equal force.

[SF]

"a proper claim construction or invalidation by failure to enable would seem to apply with equal force"

no kidding. courts are more than willing to bend over backwards to bend over unsympathetic, overreaching plaintiffs, either by limiting claim construction to prevent infringement or (more often that in the past) invalidating claims for failing to enable "the full breadth of" their scope, even in arts other than the traditional "unpredictable arts"

[george]

Malcolm,

The CAFC can't "simply kill" the RDOE, as it comes out of S. Ct. cases. The CAFC has gone as far as it can by basically signalling that if the RDOE is all you've got, save yourself the litigation costs and settle.

[TJ]

Indeed, given Westinghouse and Graver Tank, the Federal Circuit may already have pushed the envelope on RDOE a little too far. I would not be surprised if this was the next area that gets certiorari petitions.

[Paul F. Morgan]

A "pro-patentee bias" - by a broader application of "issue preclusion"?

Isn't a "reduced judicial workload bias" just as plausable?

[Also, the facts of this case did not even make it to first base for an application of the RDOE.]

[Malcolm Mooney]

"The CAFC can't "simply kill" the RDOE, as it comes out of S. Ct. cases."

Is the RDOE grounded in the Constitution? Isn't that stuff in Graver Tank mere dicta? If any event, there's been a lot of water under the bridge since 1950.

I think the CAFC can and should declare it dead and then it is dead until the Supreme Court says otherwise, which I don't see happening ... ever.

[e6k]

"I think the CAFC can and should declare it dead and then it is dead until the Supreme Court says otherwise, which I don't see happening ... ever."

From my very limited experience with the SCOTUS it seems that if the Fed Circ were to do such a thing then they'd have their hands free to do just about anything they felt like. The concept of common law would be meaningless, and the problems surrounding 101 would suddenly vanish because all of the "old" cases could simply be declared moot. Of course, if it really is just dicta then perhaps this could happen, but then, it seems well established that it is not mere dicta. It is well established by the fact that courts have been hearing arguments based on the RDOE since the 50's. It seems like it is here to stay to me.

[Lionel Hutz]

I would rather see a the RDoE applied than a Liebel-Flarsheim type invalidation.

[TJ]

Mooney, Graver Tank is arguably dicta, but Westinghouse v. Boyden Power Brake Co., 170 U.S. 537 (1898) is not. And yes a lot has happened since 1898, but the Supreme Court has not taken kindly to suggestions that its patent law precedent expired in 1982 with the Federal Courts Improvement Act. See, e.g., Warner-Jenkinson, Festo, KSR.

[Malcolm Mooney]

"the Supreme Court has not taken kindly to suggestions that its patent law precedent expired in 1982 with the Federal Courts Improvement Act. See, e.g., Warner-Jenkinson, Festo, KSR."

The difference between the doctrines in those cases and the RDOE is that the RDOE is ultrasuperstoopid. In fact, the main reason the Supremes took Festo was to provide momentum for the detoothing of the DOE, which is merely a very silly doctrine. You think they are going to allow their lips to resuscitate the ultrasuperstoopid corpse of the RDOE, just to teach the CAFC a lesson about how awesome their 1898 patent jurisprudence was? I doubt it.

Same with Morse's alleged "signal" claims.

[anonymous]

The Supreme Court's aversion to ultrasuperstoopidity might not be as strong as you think it is.

[Kevin E. Noonan]

Actually, Malcolm, I think the Hilton-Davis and Festo cases mean the exact opposite. The CAFC was going in the direction of detoothing the DOE just fine until Hilton-Davis, when the Supremes said that 1) the DOE is here to stay; 2) there is no rigid formula for applying it; and 3) they are willing to let the CAFC develop case law on how much the doctrine is circumscribed by prosecution history estoppel. When the CAFC came back and said PHE destroys DOE for every amendment for any reason, the Supremes came back and said, YES, PHE is not limited to 102/103 art/amendments/argument, but NO, the estoppel is not to be applied in the draconian manner adopted by the CAFC.

The fact is that the SC, at least this SC, is unwilling to cede any of its prerogatives or precedent, even if dicta, to the CAFC. You may be right that whether they granted cert would depend on the facts of the case, but they have shown no inclination to let the CAFC step on their judicial toes.

[MaxDrei]

To Lionel Hutz: Seen from outside the USA, Liebel brings a dose of common sense. I can imagine why you as a patent lawyer are against it, but is it decisive to society what a patent attorney desires? The idea that you get a scope of monopoly commensurate with what you have enabled is something even a layman (everybody except the patent bar) can grasp. The concept that "a claim means what its skilled technical reader would take it to mean" is another concept graspable beyond the patent bar. Now the RDOI is also a concept, but whether it's graspable beyond the patent bar, I do sometimes wonder. Do we want a clean and simple, coherent patent law in the USA. Or do we not?

[SF]

"The idea that you get a scope of monopoly commensurate with what you have enabled is something even a layman (everybody except the patent bar) can grasp."

We understand enablement. It was the slippery slope that we feared: a process in which courts would (without facts relating to whether inventors tried to create a device without an originally claimed, but later-removed element), note that the specification described an element that is not recited in claim, and then hold the claim didn't enable the full scope of the claim because it read on "element-less" systems.

Liebel would have made much more sense as a written description case (or new matter case for you EPO guys).

[bierbelly]

Well, I, for one, think that the RDOE is cool. It's so arcane, even in the arcane world of patent law. It's kinda like the appendix...we know it exists, but for what purpose?

Years ago I wrote an opinion in which I actually applied the RDOE! Of course, that wasn't the only basis for FTO, but it was interesting to apply the law to the facts to see how the RDOE logic really played out. As you can imagine, it was an extremely rare fact pattern v. patent claims.

[Lionel Hutz]

Max,

By the logic of Liebel-Flarsheim, If I enable an engine and someone adapts my engine (but not even arguably outside the scope of my claims) to an automobile, My claims should be invalidated because I did not enable the use of it with an automobile.

In Liebel-Flarsheim, the defendant's device clearly infringed the claims. The idea that because the defendant managed to adapt them to a new use should not invalidate the claims the Plaintiff obtained.

BTW, I am not saying the Plaintiff should have won, just that the logic in the opinion was terrible

[Lionel Hutz]

Written description would have been a better basis for a decision in LF.

[Malcolm Mooney]

Kevin, that's an interesting perspective and you may be onto something. We'll see how deeply the Supremes care about O'Reilly v. Morse (1853) when they punt on Nuijten.

[Paul F. Morgan]

Various current CAFC panels have come up with more than enough other ways to read patent claims far more narrowly than their literal scope such that it seems hard to imagine any further need for the RDOE?
But is the RDOE still theoretically possible for a patent claim to an invention in one technology that, by unintended accident, reads (if read literally) on a later product in a completely different technology? {However rarely that might ever occur?}