In re Metoprolol Succinate Patent Litigation (Fed. Cir. 2007).

Astra holds the patent on Toprol-XL (Metoprolol succinate) and sued several generic ANDA filers. On summary judgment, a Missouri Federal court held Astra’s patent invalid for improper obvious-type double patenting and unenforceable. Astra appealed for inequitable conduct during prosecution.

Double-Patenting: A later patent claim will be invalid for obviousness-type double patenting if it is not patentably distinct from an earlier claim from a commonly-owned patent. This analysis involves construction of both sets of patent claims.

[T]he critical inquiry remains whether the claims in the [prior] application define an obvious variation of the invention claimed in the … patent [at issue].

Normally, obviousness-type double patenting is avoided by filing a terminal disclaimer. Here, however, a secret inventorship and ownership dispute prevented such action.

Invalidity affirmed.

Inequitable Conduct: On summary judgment, the district court also found the patent unenforceable based on Astra’s failure to notify the PTO of the inventorship dispute during prosecution.  Inequitable conduct, however, is rarely found on summary judgment. Here, the CAFC saw potential holes in proof of intent — finding that the “district court erred in equating the presence of an incentive with an intent to deceive on summary judgment.”

Dissent: Judge Schall dissented

Comments

[Obviousness-type patent attorney]

Oh what a tangled web we weave. I have never much liked the historical development of the obviousness-type double doctrine, and this case helps point to why.

Lejus has a patent that claims a composition that contains metoprolol succinate. Astra has a patent, effectively a CIP of the Lejus patent, that claims metoprolol succinate per se. If the Astra patent weren't a CIP of the Lejus patent, and were merely filed later, then the Astra claim would be dead as anticipated by the Lejus patent. But since Astra's patent is a CIP of the Lejus patent (assuming the claim on metoprolol succinate was sufficiently supported by the original Lejus application), we can't make a novelty rejection. So the majority says, well, it would have been obvious to to modify the claimed composition of claim 8 of the Lejus patent by removing the coatings and leaving just the active ingredient. Hmm. Doing that would make the composition of Lejus' claim 8 inoperable for its intended use, which is classic teaching away from a given modification. So it's hard to accept the majority's stated reasoning.

But let's suppose the majority has phrased it differently: if you have a composition containing an active ingredient, then the active ingredient itself is obvious in view thereof. That statement makes more sense. The active will still be active all by itself, and will still be useful, even if packaged in a different formulation, or in combination with something else. And it avoids the majority's contorted discussion (which I suppose it had to make due to counsel's arguments) about a combination not making a subcombination obvious, which seems to me somewhat out of place here (though perhaps appropriate with respect to machines).

The real difficulty, only briefly discussed at the end of the dissent, is two-fold: (a) the two patents are owned by different entities, which, in the words of earlier CCPA case law, could lead to "vexatious litigation" (neither opinion discussed this), and (b) under the screwy old 17-years-from-issue regime, the two patents will expire at different times. If metoprolol succinate was sufficiently disclosed by the original disclosure, then the later expiration of the '154 patent would effectively extend the time the public is enjoined from using this compound. That ain't fair.

Let's suppose that the order of grant to the two patents was reversed. Would Lejus' composition claim be an obvious variant of Astra's claim on metoprolol succinate? Maybe, maybe not. There are plenty of valid patents out there on pharmaceutical compositions, which claim a composition containing a known active ingredient. But this hypothetical points out that what was nettlesome here was that the composition claim issued before, and would expire before, the claim on the active.

So a terminal disclaimer should have been filed, not necessarily because the compound per se was obvious in view of the composition (at least not obvious according to the reasoning stated by the majority), but because the PTO's policy, backed by CCPA case law, is that we want potential infringers to have to deal with one address, and we want the two patents to the same inventors, and in this case arising from the same application, expiring at the same time.

I think from a strict legal reasoning perspective, the dissent got it right. But I think from a policy perspective the majority reached the right result, albeit through skewed reasoning. Reading both the majority and the dissent try to state their reasoning in terms of obviousness-type double patenting doctrine was just tortuous.

[Luke Ueda-Sarson]

"Obviousness-type patent attorney" wrote:

a fine post. I haven't the time to read the decision right now, but I certainly shall given interesting your analysis.

Regards, Luke