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



The '814 patent, which is owned by Defendant-Appellee Aventis Pharmaceuticals Inc., relates to the use of riluzole to treat amyotrophic lateral sclerosis (ALS), otherwise known as Lou Gehrig's disease. Aventis markets riluzole under the trade name RILUTEK.
Seeking approval to market a generic version of riluzole, Plaintiff-Appellant Impax Laboratories, Inc. filed an Abbreviated New Drug Application (ANDA) with the FDA. One year later, Impax filed suit for a declaratory judgment that it did not infringe, induce infringement of, or contribute to the infringement of the '814 patent, and further, that the '814 patent was invalid as anticipated and unenforceable.
After a bench trial, the District Court determined that Impax failed to show that the '814 patent was unenforceable or that claims 1-5 of the '814 patent were anticipated by the '940 patent. Impax appealed that determination to the Federal Circuit, which affirmed-in-part, vacated-in-part, and remanded to the District Court (see
In the second appeal, the Federal Circuit affirmed the District Court's finding of non-enablement, stating that "each component of the claimed invention -- identifying riluzole as a treatment for ALS and devising dosage parameters -- would require undue experimentation based on the teachings of the '940 patent." Because the District Court did not err in finding the '940 patent to be non-enabling, the Federal Circuit also found that the District Court had correctly determined that the '940 patent did not anticipate claims 1-5 of the '814 patent.
The Federal Circuit today affirmed AstraZeneca's latest victory in its long-running battle against generic drug companies who filed ANDAs for its (former) blockbuster drug, Prilosec®. The Court affirmed in toto the decisions of Judge Barbara S. Jones, the District Court judge sitting in the Southern District of New York who has handled the consolidated infringement actions brought by AstraZeneca under 35 U.S.C. § 271(e)(2)(A). The two sets of defendants, Apotex Corp., Apotex, Inc., and Torpharm Inc. on the one hand and Impax Laboratories on the other, were found to infringe the patents in suit, and neither defendant had established that these patents were invalid by clear and convincing evidence.
The Federal Circuit characterized the decision appealed from in this case as the "second wave" of the consolidated, multidistrict litigation involving these patents and various generic company ANDA filers who filed Paragraph IV certifications that AstraZeneca's patents were invalid. The Court had heard and affirmed the first wave decisions in In re Omeprazole Patent Litigation, 86 Fed. App'x. 76 (Fed. Cir. 2003) and
The Federal Circuit affirmed the District Court's interpretation of the statute, saying that the relevant provisions clearly give the District Court the authority to extend a patentee's period of exclusivity for the six-month additional period provided as a reward for performing pediatric testing at the FDA's behest. The CAFC pointed to the express words of the statute, that "the period during which an ANDA may not be approved under section 355(j)(5)(B) 'shall be extended by a period of six months [i.e., the period of pediatric or market exclusivity] after the date the patent expires (including any patent extensions).'" The Federal Circuit also rejected Impax's underlying basis for its argument, that patent expiry removed the District Court's jurisdictional basis under Article III's "case or controversy" requirement. Stating the principle that what is required for a case to be justiciable is "a real and substantial controversy," the CAFC refused to permit patent expiry to be a ground for destroying jurisdiction when there clearly remained a "real and substantial controversy" between the parties (since Impax conceded that, even as they construed the situation, the District Court would have retained its authority if it had rendered its decision before the patents expired). The Federal Circuit also rejected Impax's reliance on
The Federal Circuit today released its opinion in the ongoing dispute between Abbott and Innogenetics over diagnostic tools for classifying hepatitis C virus (HCV) genotypes. Patent Docs
Abbott argued that its product could not infringe the claim because its product constitutes after-arising technology (i.e., it relies on developments that did not exist as of the '704 patent's priority date). Therefore, the Federal Circuit could have used this case as an opportunity to refine the differences between two 2004 cases:
Last month, the Federal Circuit affirmed a District Court's finding on summary judgment that Merck & Co., Inc. had not obtained favorable rulings in two prior proceedings by fraud. The prior proceedings included an infringement suit involving U.S. Patent Nos.
In 1996, Apotex had filed suit against Merck (Apotex I), contending that Merck's process of formulating and producing enalapril tablets (under the brand name Vasotec
In Apotex I and Apotex II, Apotex argued that Merck had suppressed or concealed its practice of the claimed invention, and therefore, that even if Merck had practiced the claimed process before Apotex, Merck's practice of the claimed process infringed Apotex' patents. In Apotex I, the District Court rejected Apotex' argument, finding that Merck had not suppressed or concealed the invention because it had widely distributed a list of ingredients for its enalapril tablets and because a Merck executive had narrated a videotape describing the Merck process during a Canadian trial in 1991. In Apotex II, the Federal Circuit affirmed, determining that the narration of the Merck process in the Canadian trial constituted a public disclosure of the process.
The Federal Circuit today affirmed a District Court finding that ANDA filer Ivax Pharmaceuticals and co-Defendant Cipla had not shown by clear and convincing evidence that Forest Laboratories' patent-in-suit for Lexapro
The case was brought by Forest under 37 U.S.C. § 271(e)(2)(A) upon Ivax's filing of an ANDA for Lexapro
Enantiomer patents can be fitted within at least a portion of this framework. There are typically "market pressures" for producing a more effective drug; in cases where only one of the enantiomers is biologically-active, effectiveness should double. Enantiomers also provide the ultimate in "finite number" of "identified" solutions: namely, two. The question is whether the "solution" - the substantially purified enantiomer - is sufficiently predictable and leads to anticipated success. In the Lexapro
The dissent raises an interesting issue of statutory interpretation. The majority affirmed the scope of the injunction to include Cipla, who was to have produced the drug for distribution by Ivax. Cipla had not supplied Ivax with any infringing drug, however, and its contributions to Ivax's ANDA were limited to information on bioequivalence. Judge Schall in dissent considered Cipla immunized from the District Court's injunction on two grounds: first, that 35 U.S.C. § 271(e)(4)(B) provides for an injunction only against the ANDA filer; and second, that Cipla's activities fell within the scope of 35 U.S.C. § 271(e)(1) under the interpretation of that statute by the Supreme Court in Merck KGaA v. Integra Lifesciences I, Ltd. Although the majority's policy imperative is understandable (without the injunction Cipla could partner with another ANDA filer and challenge the validity of the '712 patent anew), Judge Schall's analysis seems more firmly rooted in the plain language of the statute.
The District Court had already reached this conclusion once, finding that the prior art failed to show that rizulole would be effective for treating ALS. At the time of the Court's initial decision, this finding was probably sufficient to demonstrate that the anticipating reference was not enabled.
In last week's opinion, the District Court found that the anticipating prior art cited by Impax still lacked enablement. While Rasmusson has changed the formal process for evaluating enablement, it probably will have little outcome-determinative effect in most cases. Commentators have long recognized that utility and enablement are related. Though the two doctrines rely on different legal tests, evidence that demonstrates lack of utility will often also demonstrate lack of enablement. But in the context of anticipation, the federal courts have held that enablement, and not utility, is the relevant inquiry for determining whether an anticipating reference precludes patentability.
Unlike earlier incarnations of the dispute, which named several defendants, this case named generic pharmaceutical maker Andrx as the sole alleged infringer. The patent claims at issue recited AstraZeneca's formulation method for omeprazole. This formulation contains an alkaline reacting compound (ARC) to protect acid-sensitive omeprazole during transit through the stomach. The Federal Circuit affirmed the District Court's finding that Andrx infringed, but also affirmed the District Court's determination that AstraZeneca's claims were invalid for being either anticipated or obvious.
The claimed process was directed at the formation of a water-soluble separating layer between the acid-sensitive omeprazole core and the enteric coating, wherein the separating layer was formed in situ by a reaction between the ARC in the core and the enteric coating. As the Federal Circuit explained, "the '281 process produces an omeprazole formulation with three distinct layers, but starts with only two of the three layers," wherein the reaction produced a separating layer comprising a salt form of the enteric coating material. Independent claim 1 recited a minimum ARC concentration in the core required to form the separating layer, and dependent claims recited specific ARC compounds. Significant to the Federal Circuit's decision, the '281 specification contained process parameters (including temperature) not recited in the claims.