Biaxin XL

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Abbott Labs. v. Sandoz, Inc., No. 05 C 5373, 2007 WL 4287503 (N.D. Ill. Dec. 4, 2007) (Coar, J.).*
Judge Coar granted defendant Sandoz’s Fed. R. Civ. P. 12(b)(6) motion to dismiss or in the alternative Fed. R. Civ. P. 12(c) motion for judgment on the pleadings, dismissing plaintiff Abbott’s willfulness claims Abbott alleged that Sandoz willfully infringed Abbott’s patent related to an extended release antibiotic (clarithromycin, an erythromycin derivative which Abbott markets as Biaxin XL). At the time Sandoz entered the market with its generic version of Biaxin XL, the Federal Circuit had issued an opinion based upon an interlocutory appeal of a temporary restraining order, which included statements that Abbott’s patent was susceptible to invalidity and unenforceability argument. The Court held that Sandoz’s reliance on that opinion, regardless of the limited record it was based upon or its non-final nature was objectively reasonable, well above the In re Seagate objective recklessness standard.
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Continue Reading Reliance Upon Fed. Cir.’s Cursory Potential Invalidity Statements Avoids Willfulness

Abbott Labs. v. Sandoz, Inc., No. 05 C 5373, 2007 WL 4287501 (N.D. Ill. Dec. 4, 2007) (Coar, J.).*
Judge Coar construed the claims of plaintiff Abbott’s patent related to an extended release antibiotic (clarithromycin, an erythromycin derivative which Abbott markets as Biaxin XL), denied defendant Sandoz’s motion for summary judgment of noninfringement and granted Abbott summary judgment regarding anticipation, obviousness and inequitable conduct. Of particular interest, the Court held that the use of Markush group language – “selected from the group consisting of” – in the specification did not necessarily limit the construction of claim terms. The Court also noted that materiality of a reference in an inequitable conduct analysis was determined from the perspective of a reasonable examiner, not the patentee.
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Continue Reading Markush Language in Specification Does Not Limit Claims

Abbott Laboratories and Andrx Pharmaceuticals have settled their Northern District patent litigation over Andrx’s efforts to sell a generic version of Abbott’s extended release antibiotic Biaxin XL, Case No.05 C 1490 (discussed at length in the Blog’s archives). According to IP Law360 (subscription required), the settlement includes an agreement that Andrx will not market a generic version of Biaxin XL for, presumably, the remainder of Abbott’s patent term.
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Continue Reading Abbott & Andrx Settle Biaxin Litigation

Abbott Labs. v. Sandoz, Inc., No. 05 C 5373, 2007 WL 1549498 (N.D. Ill. May 24, 2007) (Coar, J.).
Judge Coar denied defendant Sandoz, Inc.’s (“Sandoz”) motion to stay the Court’s preliminary injunction pending appeal to the Federal Circuit pursuant to Fed. R. Civ. P. 62(c). The Court previously granted plaintiff Abbott’s motion for a preliminary injunction (you can read more about that decision and related cases in the Blog’s archives). The PI enjoined defendant Sandoz from selling a generic version of Abbott’s patented extended release antibiotic (clarithromycin, an erythromycin derivative which Abbott markets as Biaxin XL). Sandoz argued that the PI should be stayed pending appeal because of conflicting Federal Circuit law regarding the Court’s claim construction and because of the Supreme Court’s KSR decision.
First, Sandoz argued that two different Federal Circuit panels had issued differing rulings construing the claims at issue. Judge Coar rejected this argument because the construction relied upon in the PI ruling was the Federal Circuit’s second, broader claim construction. The Court explained that the “only rational assumption” was that the second panel was aware of the constructions in the first, but relied upon something different in the record or identified a fact missed by the first panel. Further, the Court predicted that the Federal Circuit would not retreat from its second opinion to its first, prior opinion.
Second, the Court held that the KSR decision did not change its analysis of Sandoz’s likelihood of success on its obviousness argument. The Court provided a detailed explanation of KSR and its reasoning, but differentiated the current case because the Court held that one of the limitations in the Abbott claims did not exist in Sandoz’s cited combination of prior art references. Because the references did not disclose one of the elements of the claims, whether or not the Court used a strict application of the Federal Circuit’s teaching, suggestion or motivation test did not change the outcome of its analysis. Both the Federal Circuit’s and the Supreme Court’s standards required that all elements be disclosed by the combined prior art references.
Finally, the Court held that Sandoz had not provided sufficient evidence that it would be irreparably harmed. Sandoz argued that if it could not enter the market at the same time as other generics, which are not subject to PI’s, pharmacists would be reluctant to later restock their shelves with Sandoz’s generic version of the drug. But the Court reasoned that the lure of generics is their prices, not their brand recognition, so Sandoz should have no trouble re-entering the market at a later date should it prevail.
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Continue Reading Neither Federal Circuit Split Nor KSR Warranted Stay of a Preliminary Injunction Pending Appeal

Abbott Labs. v. Sandoz, Inc., No. 05 C 5373, 2006 WL 1141635 (N.D. Ill. Apr. 16, 2007) (Coar, J.).

Judge Coar granted plaintiff Abbott’s motion for a preliminary injunction, after having previously denied it a TRO.*  The PI enjoined defendant Sandoz from selling a generic version of Abbott’s patented extended release antibiotic (clarithromycin, an erythromycin derivative which Abbott markets as Biaxin XL).  The Court held that Sandoz had shown a substantial likelihood of materiality and Abbott’s intent to deceive the PTO  based upon Abbott’s failure to disclose certain taste perversion data during prosecution.  But because Abbott abandoned the claims to which the taste perversion data was relevant of its own accord, the Court did not find the patent preliminarily unenforceable.  The Court explained its reasoning as follows:

Redemption is one of the core principles of the American ethos.  Thus in addition to being contrary to the spirit of Scribbs, Kimberly-Clark and the Code of Federal Regulation, it seems wholly inequitable to hold a patent to be invalid for fraudulent conduct in the prosecution of a claim that was withdrawn before actual prosecution had even begun.

Continue Reading Preliminary Injunction Granted Despite Likely Inequitable Conduct Because Likely-Tainted Claims Were Voluntarily Withdrawn From Prosecution

Abbott Labs. v. Andrx Pharms., Inc., No. 05 C 1490, 2007 WL 551551 (N.D. Ill. Feb. 20, 2007) (Brown, Mag. J.).*

The Court denied defendant’s motion to compel production of attorney-client privileged documents pursuant to the crime-fraud exception.  Defendant argued that plaintiff’s failure to disclose full results from two studies with conflicting results (for…

Abbott Labs. v. Andrx Pharm., Inc., No. 06-1101, __ F.3d __ (Fed. Cir. 2007).

While this is not a Northern District case, it is relevant to the Blog because it is an appeal of a Northern District case and because it confirms Judge Coar’s ruling (discussed here) that a preliminary injunction holding lacked preclusive effect in the related case Abbott Labs. v. Sandoz, Inc., No. 05 C 5373, 2006 WL 3718025 (N.D. Ill. Dec. 15, 2006).  In this patent dispute plaintiff, Abbott Laboratories ("Abbott"), alleged that defendant’s, Andrx Pharmacueticals ("Andrx") sale of a generic form of Abbott’s patented extended release antibiotic (clarithromycin, an erythromycin derivative) which Abbott markets as Biaxin XL.  The Northern District held that Abbott had established a likelihood of success on the merits of its infringement claim and that Andrx had not established a likelihood that the patent would be held invalid.  As a result of those holdings, the Northern District issued a preliminary injunction.  In its appeal, Andrx argued that Abbott was precluded from obtaining a preliminary injunction because the Federal Circuit overturned a previous Northern District preliminary injunction for Abbott against another generic antibiotic producer Teva Pharmaceuticals ("Teva").  In that case, the Federal Circuit held that Teva raised a substantial question as to the validity of the claims at issue, sufficient to call Abbott’s likelihood of success on the merits into question.  Continue Reading Federal Circuit Agrees With the Northern District: Preliminary Injunction Holdings Are Not Preclusive