Chicago IP Attorney & Lawyer : R. David Donoghue : Chicago IP Litigation Blog

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.

* Click here for more on this case and related cases.

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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.

* Click here for more on this case and related cases.

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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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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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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.

The Court then made detailed, initial claim construction rulings and, based upon them, found a substantial likelihood of infringement.  The Court also considered Sandoz's invalidity arguments, but held that Sandoz had not proved a likelihood of success regarding its invalidity arguments.  The Court also held that the balance of hardships tipped in Abbott's favor because allowing Sandoz's generic product to remain in the market would necessarily take market share from Abbott.

In addition to its preliminary injunction stopping future product sales, the Court also required that Sandoz recall all of its existing product, so long as an adequate bond was set.

*  You can read more about the Federal Circuit decision in which the Federal Circuit overturned the Court's grant of a PI in a related case in the Blog's archives.  You can also read another take on this case at the Orange Book Blog.

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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 and against the applications' claims) to the USPTO, both of which were material to the claims, was both inequitable conduct and fraud.  The studies were conducted during the pendency of one application and prior to two others.  Additionally, three of the named inventors co-authored a journal article detailing the results.  And during her deposition, prosecution counsel admitted being aware of the studies during prosecution of the applications.  The Court held that the evidence warranted in camera review of selected documents from plaintiff's privilege log to determine whether there was evidence of intent.  But after its review, the Court found no direct evidence of intent to defraud the USPTO.  The Court noted that "[n]one of the documents . . . contained a 'smoking gun' or anything close to it."  Furthermore, while intent can be inferred based upon circumstantial evidence, there most be more evidence than failure to disclose to support the inference. 

* You can see more on this case, in particular, various preliminary injunction opinions here and here.

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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. 

The Federal Circuit, applying Seventh Circuit law, held that preliminary injunctions would be given preclusive effect only in the "rare instances" that the injunction raised an "insuperable obstacle" to plaintiff's success on the merits.  Because the Court did not find an insuperable obstacle to Abbott's success on the merits, the denial of a preliminary injunction against Teva had no preclusive effect in this case.  As a result, the Federal Circuit upheld the Northern District's preliminary injunction.

The Federal Circuit's reasoning appears to square with Judge Coar's reasoning in the Sandoz case.  In Sandoz, the Court held that preliminary relief holdings have no preclusive effect because they are made on an incomplete record, "inherently tentative" and based upon only "an estimate of the likelihood of success."  Despite the fact that the Federal Circuit's denial of the preliminary injunction lacked preclusive effect, however, the Court ultimately refused to reach a holding inconsistent with the Federal Circuit's without a "substantial showing" on a more complete record.  So, although the Court denied the TRO, it appeared to remain open to a preliminary injunction based upon a more complete record.

You can find more on the Federal Circuit's Andrx case at Patently-O and the Patent Docs.

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