By Andrew Williams --
Last week, in Teva Pharma. Indus. Ltd. v. AstraZeneca Pharma. LP, the Federal Circuit reiterated that, in the context of 35 U.S.C. § 102(g), "[t]o establish prior invention, the party asserting it must prove that it appreciated what it had made." The complication is, however, how do you define what the invention is? This is because the invention is not necessarily what is claimed -- "'[t]he invention is not the language of the [claim] but the subject matter thereby defined'"(citing Dow Chemical Co. v. Astro-Valcour, Inc., 267 F.3d 1334 (Fed. Cir. 2001)). Therefore, in this case, because AstraZeneca "appreciated" that it had a formulation with a stable compound (the defined invention), and it knew what the components of the formulation were, it conceived and reduced to practice a stabilized pharmaceutical composition of rosuvastatin (a statin) before Teva's date of invention, even though AstraZeneca did not appreciate the stabilizing property of one of the components, which was a limitation found in Teva's claims.
The technology at issue in this case involved statin formulations, which are inherently unstable and as a result need to be stabilized to be medically viable. Teva discovered that, among other things, amido-group containing polymeric compounds ("AGCP compound") can be used to stabilize statins, and obtained a patent (RE39,502) with the following representative claim:
1. A stabilized pharmaceutical composition for the treatment of dyslipidemia, comprising
an active component consisting essentially of one or more compounds selected from the group consisting of (i) an HMG-CoA reductase inhibiting ring-opened 7-substituted-3,5-dihydroxyheptafloic acid or a pharmaceutically acceptable acid salt thereof, and (ii) an HMG-CoA reductase inhibiting ring-opened 7-substituted-3,5-dihydroxyheptenoic acid or a pharmaceutically acceptable acid salt thereof, and
a stabilizing effective amount of at least one amido-group containing polymeric compound or at least one amino-group containing polymeric compound, or combination thereof, wherein said stabilized pharmaceutical composition does not contain a stabilizing effective amount of another stabilizer or a combination of other stabilizers.
(emphasis as found in the opinion). Teva's earliest effective filing date was April 10, 2000, and the earliest date that it alleges it could establish conception and reduction to practice was December 1, 1999. Teva sued AstraZeneca for infringement in October 2008 for the stabilized statin (rosuvastatin calcium) formation that it was marketing for the treatment of dyslipidemia. The relevant facts were uncontested, and AstraZeneca conceded infringement for the limited purpose of advancing its summary judgment motion (AstraZeneca appears to have been able to challenge infringement because its formulation contained a second stabilizer, tribasic calcium). The facts related to AstraZeneca's prior invention allegation included: (1) AstraZeneca had manufactured a 10,000-unit batch of the formulation with the same ingredients as its commercial drug in mid-1999, (2) it had made additional batches in the summer and fall of 1999, (3) it had disclosed the ingredients and quantities for the formulation that match all commercial drug dosage strengths, and (4) it included crospovidone, an AGCP-compound, as a disintegrant, but did not understand that it had a stabilizing effect on the statin. As a result, the sole legal question for the Court was whether AstraZeneca conceived and reduced to practice the claimed invention before Teva.
It is clear that prior invention in the context of 102(g) requires a showing that the challenging party (1) reduced its invention to practice first, or (2) was the first to conceive and then exercised due diligence in reducing the invention to practice. In order to conceive, the inventor needs a specific and settled idea, a particular solution to a problem at hand. Reduction to practice, on the other hand, requires that the inventor constructed an embodiment that met all of the claim limitations, and determined that it would work for its intended purpose. However, the inventor need not understand precisely how the invention worked. There is another requirement that is relevant in the chemical and biotech arts -- conception of something reduced to practice requires more than an unrecognized accidental creation, but instead, the inventor must appreciate what he has invented. In other words, "'a party who first reduced to practice, but who 'fail[ed] to recognize that he had produced a new form [of matter] . . . is indicative that he never conceived the invention''" (quoting Dow at 1341 (quoting Heard v. Burton, 333 F.2d 239, 243 (C.C.P.A. 1964)).
Teva argued that because AstraZeneca did not appreciate that crospovidone was a stabilizing agent, it could not have appreciated the invention of a formulation with "a stabilizing effective amount" of an AGCP. The lower court, however, held that all AstraZeneca had to appreciate was the stabilization of its overall pharmaceutical composition that contained crospovidone. On appeal, Teva complained that the District Court implicitly construed the claims to encompass stabilized statin formations that contained AGCP, without taking into account that AGCP had to act as a stabilizer. However, the Federal Circuit pointed out, while quoting William Shakespeare, that AstraZeneca was not required to appreciate the invention in the same terms as those recited by the claims ("[T]hat which we call a rose [b]y any other name would smell as sweet."). Therefore, because AstraZeneca appreciated that the statin in its formulation was stable, and because it appreciated what the components of the formation were, it appreciated the invention.
On its face, this outcome appears to be inequitable. After all, reducing Teva's claim to "a stabilized [statin-containing] pharmaceutical composition" appears to ignore the rest of the claim, including Teva's alleged inventive contribution. In fact, the panel questioned both sides during the hearing as to whether Teva should be entitled to this patent because it provided the public with something that it didn't have before the filing of the application -- the knowledge that AGCPs can act as stabilizing agent for statins. Nevertheless, this line of reasoning has its limits, in part because Teva did not claim the use of AGCPs as stabilizing agents in this patent. Instead, Teva claimed a composition that used such stabilizing agents. The important thing to consider is that AstraZeneca was using its composition (the same one that Teva alleged infringed) before Teva's elucidation of the mechanism of action of AGCPs. And, it is still true that, that which infringes after, anticipates before, even if the use before was without the benefit of the knowledge as to why it worked. Teva should not be allowed to now take this composition out of the public domain just because it discovered why the composition was so successful -- specifically, because it determined the inherent stabilizing effect that crospovidone has on statins. This case does have the flavor of inherent anticipation. The panel was very clear in its opinion and during the hearing that the concept of inherency was not implicated in this case or its decision. However, one cannot help think that this outcome smells a lot like inherency jurisprudence. Perhaps this rose just has a different name.
Teva Pharmaceutical Industries Ltd. v. AstraZeneca Pharmaceuticals LP (Fed. Cir. 2011)
Panel: Chief Judge Rader and Circuit Judges Linn and Dyk
Opinion by Circuit Judge Linn
Why didn't this case implicate 102(a), in which case it would fall squarely within the CAFC's inherent anticipation jurisprudence?
Posted by: Confused | December 08, 2011 at 12:31 AM
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
Posted by: Andrew Williams | December 08, 2011 at 08:35 AM
"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)?
Posted by: EG | December 08, 2011 at 08:53 AM
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
Posted by: Andrew Williams | December 08, 2011 at 11:57 AM
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?
Posted by: lrozsnyai | December 08, 2011 at 02:12 PM
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
Posted by: Andrew Williams | December 08, 2011 at 02:24 PM
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.
Posted by: lrozsnyai | December 08, 2011 at 03:25 PM
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
Posted by: Andrew Williams | December 08, 2011 at 03:56 PM
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.
Posted by: Not so confused anymore | December 08, 2011 at 04:05 PM
"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.
Posted by: EG | December 08, 2011 at 04:16 PM
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.
Posted by: Most Boring Case of the Year | December 08, 2011 at 05:41 PM
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.
Posted by: J. Demers | December 08, 2011 at 05:44 PM