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

Brian Higgins's Maryland IP Law Blog post about the progeny of In re Seagate, 497 F.3d 1360 (Fed. Cir. 2007), inspired me to do follow up posts identifying Northern District cases discussing recent major IP decisions -- click here for my post on injunctions after eBay Inc. v. MercExchange, L.L.C., 126 S.Ct. 1837, 164 L.Ed.2d 641 (2006).  There have been a number of obviousness decisions in the Northern District since KSR Int’l Co. v. Teleflex Inc., __ U.S. __, 127 S.Ct. 1727 (2007).  Here they are:*

• Abbott Labs. v. Sandoz, Inc., No. 05 C 5373, 2007 WL 1549498 (N.D. Ill. May 24, 2007) (Coar, J.). -- Holding that the Court's pre-KSR analysis need not be reconsidered in light of KSR because an element was missing from the prior art, regardless of what standard was used.
  
• Herman Miller, Inc. v. Teknion Corp., No. 05 C 2761, 2007 WL 2230042 (N.D. Ill. Jul. 30, 2007) (Gettleman, J.). -- Noting that, in light of KSR, plaintiff issued a statement of non-liability and certain patents were removed from the suit.
  

• Lexion Medical, LLC v. Northgate Techs., Inc., No. 04 C 5705, Slip Op. (N.D. Ill. Jun. 8, 2007). -- Holding that the pre-KSR jury's decision would not have changed if given a KSR obviousness instruction.

These opinions suggest that KSR is not changing obviousness law in the Northern District much.  I suspect that is not true.  Once we have a larger sample of cases, including more where the initial analysis was not done pre-KSR, we will see more patents held invalid based upon obviousness.

*  A brief note on methodology:  this was not a thorough study and does not include cases that granted or denied injunctions without discussion.  For a more complete list of post-KSR decisions nationwide, go to the Fire of Genius.

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Brian Higgins at the Maryland IP Law Blog posted an analysis of significant willfulness decisions post-In re Seagate, 497 F.3d 1360 (Fed. Cir. 2007) -- click here for the post and click here for a subsequent post discussing Se-Kure Controls, Inc. v. Diam USA, Inc., No. 06 C 4857, 2008 WL 169029 (N.D. Ill. Jan. 17, 2008) (Cox, Mag. J.).  Of the eleven decisions Higgins identified, three were Northern District decisions and one was a Federal Circuit decision analyzing a Northern District case.  Here are my posts on the Northern District decisions:

• Abbott Labs. v. Sandoz, Inc., No. 05 C 5373, 2007 WL 4287503 (N.D. Ill. Dec. 4, 2007) (Coar, J.).
  
• Se-Kure Controls, Inc v. Diam USA, Inc.
  
• Trading Techs. Int’l, Inc. v. eSpeed, Inc., No. 04 C 5312, Slip Op. (N.D. Ill. Jan. 3, 2007) (Moran, Sen. J.).
  

As you can infer from the relatively small number of cases identified by Higgins, there remains a lot of law to be written about Seagate before the standard is well settled.  I suspect that within 18-24 months there will be a relatively large body of law, including numerous Federal Circuit decisions exploring the new standard's outlines.  Until then, patent litigants will face a degree of uncertainty regarding willfulness.  Of course, defendants will generally be glad to have some uncertainty in exchange for plaintiffs's higher willfulness hurdle.

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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.

* 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 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. 07 C 1721, Slip op. (N.D. Ill. May 3, 2007) (Anderson, J.).

Judge Anderson denied plaintiffs'  motion for a preliminary injunction to prevent defendants Sandoz, Inc. ("Sandoz") and Teva Pharmaceutical Industries, Ltd. ("Teva") from selling a generic version of plaintiff Abbott Laboratories' ("Abbott") antibiotic cefdinir, which it markets using the name Omnicef.  Plaintiffs' original patent, U.S. Patent No. 4,559,334 (the "'334 patent"), covering a form of cefdinir expired on Sunday, May 6, 2007 at 10:59 p.m. CDT.  Plaintiffs' second patent, U.S. Patent No. 4,935,507 (the "'507 patent"), covering a crystalline cefdinir, does not expire until December 4, 2011.  Plaintiffs argued that Sandoz's and Teva's respective formulations of cefdinir (the "accused products"), which the parties agree can be classified as cefdinir monohydrate, infringed the '507 patent and, therefore, sales of the accused products should be enjoined.  The Court, with agreement of the parties, adopted a prior claim construction from Judge Payne of the E.D. Virginia for purposes of the PI determination.  Using Judge Payne's construction, the Court held that the accused products did not likely infringe the '507 patent.  First, cefdinir monohydrate only displayed four of the seven peaks in an x-ray diffraction pattern that the '507 patent identified as indicative of crystalline cefdinir within the +/-.1 degree margin of error that the Court determined was the proper construction of the '507 patent's "about" qualifier.  Second, the Court held that "trace" amounts of crystalline cefdinir that were allegedly in the accused products in addition to the cefdinir monohydrate did not likely amount to literal infringement.

The Court also held that plaintiffs had not shown a likelihood of proving infringement pursuant to the doctrine of equivalents.  First, the Court discounted plaintiffs' expert's allegation of equivalents because he did not support his opinions with "empirical or substantive evidence."  Second, the Court denied plaintiffs' argument that Sandoz's and Teva's statements that the accused products were bioequivalent to crystalline cefdinir in their ANDAs was proof of infringement.  The court noted that if bioequivalency were infringement, there could never be generics during a patent's life.

Because Sandoz's ANDA was previously approved by the U.S. Food & Drug Administration (the "FDA"), the Court's ruling meant that Sandoz was free to sell its generic beginning Sunday, May 6 at 11:00 p.m. CDT.  Teva's ANDA had not been approved, however, so it must wait until the FDA acts upon its ANDA.  You can find the Chicago Tribune's brief coverage of the decision in last weekend's Midwest Briefs.

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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 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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Abbott Labs. v. Sandoz, Inc., No. 05 C 5373, 2006 WL 3718025 (N.D. Ill. Dec. 15, 2006) (Coar, J.).

Judge Coar denied plaintiff's, Abbott Laboratories ("Abbott"), motion for a temporary restraining order ("TRO") to prevent defendant, Sandoz, Inc. ("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 had entered a TRO and, ultimately, a preliminary injunction preventing another party, Teva Pharmaceuticals ("Teva"), from selling a generic version of plaintiff's patented extended release antibiotic, but the Federal Circuit vacated the preliminary injunction.  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. 

In the instant case, Sandoz argued that the Federal Circuit's prior ruling that there was a question regarding the validity of the claims-at-issue precluded any preliminary injunctive relief.  The Court held that rulings on preliminary relief 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 that ruling, however, the Court noted that "the practical effect of [the Federal Circuit's] holding still militates towards the denial of the TRO in the instant case."  The Court 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 appears to have kept an open mind about a preliminary injunction based upon a more complete record.

*For another take on this case, check out the Orange Book Blog.

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