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« Mayo Collaborative Services v. Prometheus Laboratories at the Supreme Court: Oral Argument Tomorrow | Main | Plaintiffs File Petition for Certiorari in AMP v. USPTO »

December 07, 2011

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Comments

Why didn't this case implicate 102(a), in which case it would fall squarely within the CAFC's inherent anticipation jurisprudence?

Dear Confused,

That is a good point, and I don’t believe that it was addressed very clearly in the opinion. In fact, the Court stressed that the contents of the formulation were disclosed before Teva’s earliest dates. However, it appears that this disclosure was not a public disclosure (according to other websites that have posted on this case, the briefs of the parties apparently made this clear). As such, AstraZeneca would not have been able to rely on 102(a). To be clear – the Court did not state that inherency was implicated in prior inventorship under 102(g) (in fact, they were pretty it clear that it wasn’t implicated). Nevertheless, I don’t see how the Court could reach the result that it did without the concept of inherency. Thank you for your question, and providing an opportunity to clarify that point.

Andrew

"This case does have the flavor of inherent anticipation."

Kevin,

Whether the panel said so or not, the doctrine of inherency is implicit (pardon the pun) in its opinion. How otherwise can you explain that not recognizing crospovidone (used as a disintegrant by AstraZeneca) could also function as a statin stabilizer was irrelevant to anticipation by AstraZeneca's 1999 formulations under 35 USC 102(g)(2)?

Dear EG,

Thank you for the comment (and I will take it as a compliment that you thought Kevin wrote the post). I agree completely that inherency was inherent in the decision. The interesting thing, however, is that during the oral hearing, if my memory serves correct, one of the parties raised the issue of inherency, and the panel quickly shut them down because the issue in this case was 102(g). Regardless of what they call it, however, it sounds like inherency (thus the Shakespeare quote – if the Federal Circuit can do it, so can I). Thanks again.

Andrew

What about the last limitation of claim 1? AZ's drug also contained tribasic calcium, which is a stabilizer. Shouldn't this limitation have protected Teva and have been included in the court's analysis?

Dear lrozsnyai,

Good catch. However, AstraZeneca conceded infringement for the limited purpose of Summary Judgment, because they apparently thought (correctly) that they could win on the 102(g) argument. The opinion made note of this (and of the additional stabilizer). Presumably, with the tribasic calcium as a stabilizer, AstraZeneca’s prior formulation would not have been a prior invention, and therefore would not have invalidated the claims. Thanks.

Andrew

Andrew, thanks for your explanation.

I am not a litigator, so this tactic is unfamiliar to me: the last limitation in the '502 patent would normally mean that AZ would not infringe, however AZ "concedes" infringement to trigger the "that which infringes if later anticipates if before" rule, thereby invalidating the patent.

This just doesn't sit well with me. How can a party change the application of facts (the relevance of this last limitation) by making a motion in court?

Thanks again.

Dear lrozsnyai,

It does appear to be a legal fiction, but in bringing the suit in the first place, Teva had to allege that the present formulation infringed the claims. I haven’t read the papers from the district court, but I assume AstraZeneca simple said that if Teva’s allegations of infringement are in fact true, then its patent is invalid. Because neither party challenged infringement for the purposes of this summary judgment motion, the court(s) didn’t have to deal with the issue. See Teva. v. AstraZeneca (Fed. Cir. 2011), at 7 (“Because AstraZeneca conceded infringement from the limited purpose of its summary judgment motion, and because Teva maintains the allegation of infringement upon which the suit is based, it is undisputed for the purpose of this appeal that AstraZeneca’s drug is an embodiment within the scope of the asserted claims.”). I hope that helps.

Andrew

Iroznyai, it's not AZ changing facts or their application. It's BOTH parties stipulating to a fact. Teva alleged that AZ infringed; AZ said, Fine, let's assume we infringe as you allege, but we've had this same formulation since before your earliest date, so you still lose. In other words, it's a case of Teva getting hung by its own petard.

"Thank you for the comment (and I will take it as a compliment that you thought Kevin wrote the post)."

Andrew,

Oops, sorry for "misaddressing" my comment (and you should take it as a compliment). With the Christmas holiday and vacation rapidly approaching, I'm blogging at the "speed of light" which is always dangerous for me to do.

No So Confused: "Iroznyai, it's not AZ changing facts or their application. It's BOTH parties stipulating to a fact. Teva alleged that AZ infringed; AZ said, Fine, let's assume we infringe as you allege, but we've had this same formulation since before your earliest date, so you still lose. In other words, it's a case of Teva getting hung by its own petard."

Correct. This is why inherency was not an "issue" and why the panel "shut the patentee down" when it was raised at oral argument. The identity of the prior art formulation and the infringing formulations were stipulated to be identical. The issue before the court was actually extremely narrow and easily addressed under existing law. It's not clear why Teva even bothered appealing except for the usual litigation reasons of bloodletting for the sake of bloodletting.

Note from the Department of Pedantry: You can't get hung by your petard. You can only get hoist. (More Shakespeare, by the way.)

The inherency factor comes into play whenever you invoke "that which infringes after, anticipates before," because that anticpation can certainly be inherent. The court, in this case, didn't need to explore if, how, or when this aspect of 102(a) should be imported into a 102(g) analysis, and wisely left it for another day.

One other observation: the "no other stabilizer" limitation in claim 1 clearly indicates that Teva -- or at least the Examiner -- appreciated that there were novelty issues with this invention.

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