Despite Obama's lost luster, Winter still holds sway in the W.D. Va.

Late last week, Judge Norman K. Moon of the U.S. District Court for the Western District of Virginia, issued a 55-page opinion denying a motion for preliminary injunction in patent litigation regarding a medical device.  See MicroAire Surgical Instruments, LLC v. Arthrex, Inc., case no. 3:09-cv-00078 (W.D. Va. June 3, 2010).

The case involves claims of infringement of a patent acquired by MicroAire from 3M on a carpal tunnel release surgical instrument useful for “probing body cavities and manipulating tissue contained therein under continuous observation.”

Having failed to receive satisfaction from Arthrex in regard to Arthrex’s competing device, MicroAire sued for patent infringement and related torts and moved for a preliminary injunction.

Judge Moon applied the four-part test of Winter v. Natural Resources Defense Council, 129 S.Ct. 365 (2008), endorsed by the Federal Circuit in Titan Tire Corp. v. Case New Holland, Inc., 566 F.3d 1372 (Fed. Cir. 2009), and by the Fourth Circuit in the Real Truth About Obama, Inc. v. FEC, 575 F.3d 342 (4th Cir. 2009).  For more background on Winter and the resulting changes in the Fourth Circuit’s preliminary injunctions law, see this prior post and the articles cited in it.

Astute observers may note at this point that Real Truth has since been vacated by the U.S. Supreme Court and remanded for further consideration in light of the Supreme Court’s controversial Citizen United decision regarding corporate political donations and activity.  See 2010 U.S. LEXIS 3521 (April 26, 2010).  This creates a temporary vacuum, although there appears to be no substantial prospect of anything but Winter filling that vacuum.  Until another Fourth Circuit decision repeating Real Truth’s endorsement of the Winter standard, practitioners should be careful to note the subsequent history of Real Truth when citing that case and should also cite Winter directly and/or a post-Real Truth decision of the district court in which their case is pending (available in both Virginia district courts).

Moving back to Judge Moon’s opinion, the Court labeled the “likelihood of success on the merits” and the “irreparable harm” prongs as central to any preliminary injunctive analysis.  It concluded that MicroAire had not established either one, construing the disputed terms “actuating means” and “essentially perpendicular” in such a way that likely infringement (literally or under the doctrine of equivalents) had not been shown and rejecting the claims of irreparable harm based on loss of goodwill, irreversible price erosion, or general decline in reputation of the surgical procedure at issue.

I could spend many pages relating portions of Judge Moon’s very thorough opinion.  I will leave you, dear reader, to explore what you are most interested in.  Suffice it to say that the analysis addresses how preliminary injunctions apply in the patent context, claim construction, means-plus-function limitations and prosecution disclaimer, the doctrine of equivalents and prosecution history estoppel, irreparable harm with respect to goodwill and the adequacy of damages, and the balancing of the equities as a patent approaches its expiration.

Much ado about too many words

            Hopefully you have already gotten a gift for that special IP litigant in your life this year.  If you’re thinking ahead to a 2010 wish list and have a preliminary injunction in mind, you may have noticed last month’s opinion by U.S. District Judge Henry E. Hudson in PRE Holding, Inc. v. Monaghan Medical Corp., no. 3:09CV458, 2009 U.S. Dist. LEXIS 107222 (E.D. Va. Nov. 17, 2009) (page citations to this opinion are to the version freely available from PACER/ECF).

            Other IP web news sources have questioned whether this opinion raises the bar for a preliminary injunction for patent litigants and whether it is consistent with case law from the U.S. Court of Appeals for the Federal Circuit.  (Federal Circuit law governs the issuance of injunctive relief under 35 U.S.C § 283 because the question “involves substantive matters unique to patent law.”  E.g., Hybritech, Inc. v. Abbott Labs, 849 F.2d 1446, 1451 n.12 (Fed. Cir. 1988).  “[P]urely procedural questions . . . are controlled by the law of the appropriate regional circuit.”  Id.

            In the post below, I conclude that debate over the PRE Holding opinion reflects the difficulties with the preliminary injunction standard and the hazards of not being concise, and that the PRE Holding opinion does not represent a change in the law.

 

            Discussion of federal preliminary injunction law must now begin with two recent United States Supreme Court cases. 

             In Munaf v. Geren, 553 U.S. ___, 128 S.Ct. 2207 (2008), the Supreme Court vacated and remanded decisions on two habeas petitions by detainees, who sought, inter alia, preliminary injunctions to prevent transfer to Iraqi custody.  Regarding the preliminary injunction, the Court “beg[a]n with the basics”:  “A preliminary injunction is an ‘extraordinary and drastic remedy,’” that “is never awarded as of right.  Rather, a party seeking a preliminary injunction must demonstrate, among other things, ‘a likelihood of success on the merits.’”  Id. at 2219.  The Court found fault with the lower court’s failure to apply that standard.  Id. (quoting Omar v. Harvey, 416 F. Supp. 2d 19, 23-24 (D.C. 2006)).  Although the D.C. district court had not relied on the case specifically, it had applied a preliminary injunction test indistinguishable from that adopted by the Fourth Circuit in Blackwelder Furniture Co. v. Seilig Manufacturing Co., 550 F.2d 189 (4th Cir. 1977).  See, e.g., Omar, 416 F. Supp. 2d at 22, 29.

             For more on Blackwelder and the change in the law, along with a discussion of the law in Virginia state court, see this article by Brad Davenport and yours truly in the Spring 2009 Virginia State Bar’s Litigation section news, as well as this brief update in the Fall 2009 issue, noting that the Fourth Circuit later officially put Blackwelder to rest in The Real Truth About Obama, Inc. v. Federal Election Commission et al., 575 F.3d 342, 346 (4th Cir. 2009).

            In Winter v. Natural Resources Defense Council, Inc., 129 S.Ct. 365 (2008), the Supreme Court reversed a Ninth Circuit decision affirming a district court’s grant of a preliminary injunction imposing restrictions on the Navy’s use of active sonar to prevent harm to sea animals.  Citing Munaf and other cases, the Court explained that “A plaintiff seeking a preliminary injunction must establish that he is likely to succeed on the merits, that he is likely to suffer irreparable harm in the absence of preliminary relief, that the balance of equities tips in his favor, and that an injunction is in the public interest.”  Id. at 374 (emphasis added, citations omitted).  As they had done in Munaf, the lower courts in Winter employed a flexible analysis in which a strong showing on one factor allowed a much weaker showing on another – the twist was that the lower courts had concluded there was a strong likelihood of success on the merits, making the “‘possibility’ of irreparable harm” sufficient.  Id. at 375.  The Supreme Court reiterated its “extraordinary remedy” language from Munaf and stated that its “frequently reiterated standard requires plaintiffs seeking preliminary relief to demonstrate that irreparable injury is likely in the absence of an injunction.”  Id. at 375-76.

            With that necessary background, let’s turn to the opinion in PRE Holding.

            After quoting the Winter standard, the Court repeated several points “accentuated” by the U.S. Supreme Court – namely, “that a plaintiff seeking preliminary relief must demonstrate ‘that irreparable harm is likely in the absence of an injunction’” and that “‘injunctive relief [is] an extraordinary remedy that may only be awarded upon a clear showing that the plaintiff is entitled to such relief.’”  PRE Holding at 2 (quoting Winter). 

            The Court then noted that the Federal Circuit had used “likely” in describing what a patent plaintiff need prove for a preliminary injunction prior to Winter, citing Sanofi-Synthelabo v. Apotex, Inc., 470 F.3d 1368, 1374 (Fed. Cir. 2006).  And it quoted Altana Pharma AG v. Teva Pharms. USA, Inc., 566 F.3d 999, 1006 (Fed. Cir. 2009), for the proposition that “if the accused infringer 'raises a substantial question concerning validity, enforceability, or infringement (i.e., asserts a defense that [the movant] cannot show 'lacks substantial merit') that preliminary injunction should not issue.’”  PRE Holding at 2-3.

             After discussing the patents at issue, the Court concluded as follows:  “While the evidence appears to tilt in Plaintiffs' favor, the Court must conclude at this preliminary stage that the evidence, when collectively viewed, still raises a substantial question as to whether the exhalation pathways are sufficiently similar structurally to warrant a finding of infringement….  ‘[b]ecause a preliminary injunction affords, on a temporary basis, the relief that can be granted permanently after trial, the party seeking the preliminary injunction must demonstrate by 'a clear showing' that, among other things, it is likely to succeed on the merits at trial.’  Plaintiffs' evidence fails to meet this standard at this stage.”  Id. at 8 (quoting Real Truth About Obama) (citations omitted).

            What seems to have stirred debate is that the Court quoted Fourth Circuit case law and repeated Winter’s “clear showing” language, which some label as dictum, rather than stating that there needed to be a “reasonable likelihood” of success on the merits (language used in some pre-Winter Federal Circuit cases).

             The first problem is one of wording and clarity.  The standard for preliminary injunctions already contains vast amounts of wiggle room, both because it asks a judge to weigh the “likelihood of success” in litigation and because “the patentee's entitlement to such an injunction is a matter largely within the discretion of the trial court.”  Titan Tire Corp. v. Case New Holland, Inc., 566 F.3d 1372, 1375 (Fed. Cir. 2009). (Thus, a “deferential standard of review” applies, requiring “a showing that ‘the court made a clear error of judgment in weighing relevant factors or exercised its discretion based upon an error of law or clearly erroneous factual findings.’”  Id.

            When you already have a “likelihood” standard, on which discretionary decisions are made, adding additional language – e.g., a “reasonable likelihood,” or a “clear showing” – serves more to obfuscate than anything else.  Making matters less clear by adding words is a problem lawyers routinely confront, and courts are not immune. 

            Indeed, the Federal Circuit itself recently expressed puzzlement at the effect of its own cases’ language.  See Titan Tire Corp. v. Case New Holland, Inc., 566 F.3d 1372, 1376 (Fed. Cir. 2009) (“It is not clear whether the addition of ‘reasonable’ adds anything substantive to the test”).  The Federal Circuit further noted that some commentators have concluded the answer is no.  See id. at 1376 n.2 (quoting the Wright & Miller treatise’s conclusion that, despite the “bewildering variety of formulations of the need for showing some likelihood of success,” “the verbal differences do not seem to reflect substantive disagreement”).

             Moreover, concluding that PRE Holding raises the bar (assuming that one could discern where the bar was before and that it is different now), seems to ignore that the Court was plainly applying its view of both Winter and Federal Circuit law. 

            In PRE Holding, the Court applied the four-factor test from Winter.  On the first factor (“likelihood of success on the merits”), the Court concluded “that the evidence, when collectively viewed, still raises a substantial question as to whether the exhalation pathways are sufficiently similar structurally to warrant a finding of infringement.”  PRE Holding at 8.  That “substantial question” language echoes the Federal Circuit in Altana Pharma AG, 566 F.3d at 1006, which the Court had quoted previously in its opinion. 

            The Federal Circuit has explained what the “substantial question” language means, see Titan Tire 566 F.3d at 1377-79, but as it has stated, the bottom line is that Winter governs in patent infringement cases too.  See id. at 1380 (“Asking whether the challenger has raised a substantial question of invalidity in the manner we have described may be a useful way of initially evaluating the evidence, but the ultimate question regarding the first preliminary injunction factor remains that of the patentee's likelihood of success on the merits.  The Supreme Court has stated that the general rules applicable to injunctions in civil actions apply equally to injunctions in patent cases; there is no room for making the substantial question test a substitute or replacement for the established test for injunctions.”).

             In sum, at least in comparison with precedents like Blackwelder, it is fair to see recent Supreme Court case law as raising the bar.  But PRE Holding, in my mind, does not.  And debating whether the “clear showing” language in Winter is dicta may be little more than an academic exercise.  See, e.g., DaimlerChrysler Corp. v. United States, 361 F.3d 1378, 1385 n.3 (Fed. Cir. 2004) (“even if dicta, we would feel obligated to follow the Supreme Court's explicit and carefully considered statements”) (citing prior Federal Circuit cases).

District Court Departs from the Blackwelder Standard in Denying Preliminary Injunction

On May 7, Judge Spencer, Chief Judge of the Eastern District of Virginia, issued an opinion denying a Motion for a Temporary Restraining Order and a Preliminary Injunction in the third round of the ongoing false advertising battle between baby formula makers PBM Products, based in Gordonsville, Virginia, and industry giant, Mead Johnson. See PBM Products v. Mead Johnson Nutrition Co., Civil Action No. 3:09cv269 (Spencer, J.). In doing so, the Court made clear that it moving away from the longstanding rule for preliminary injunctions in the Fourth Circuit set forth in Blackwelder Furniture Co. v. Seilig Mfg. Co., 550 F.2d 189 (4th Cir. 1977).

Since 2001, PBM, the largest manufacturer of “store brand” or private label infant formulas in the U.S., and Mead Johnson, the maker of Enfamil®, have fought about the falsity of statements made by Mead Johnson about the nutritional value of PBM’s infant formula. The first two suits, in 2001 and 2002, ended with the entry of temporary restraining orders in favor of PBM that directed Mead Johnson to stop making the disputed statements and to retrieve materials it had sent containing those statements.

On April 27, PBM filed a third suit against Mead Johnson, regarding statements by Mead Johnson about two fats, DHA and ARA, in its Enfamil® product which Mead Johnson calls “LIPIL®.” The parties agreed that both companies’ products contained the same levels of DHA and ARA obtained from the same source. Mead Johnson was careful to make sure, however, that it did not make any statements comparing Enfamil®LIPIL® to any other manufacturer’s product. Rather, all of Mead Johnson’s statements just compared Enfamil® without LIPIL® to Enfamil® with LIPIL®. Mead Johnson also included a disclaimer that it was comparing Enfamil®LIPIL® to the prior formulation of the same product without DHA and ARA. Thus, the Court held that the statements were not literally false. Further, PBM did not present evidence of consumer confusion, and so the Court found that there was no evidence that the statements were implicitly misleading. Since PBM failed to prove a likelihood of success on the merits, the Court found that neither the balance of irreparable harm or the public interest favored PBM and so denied PBM’s motion for preliminary relief.

Like almost all decisions regarding preliminary injunctions in the Fourth Circuit, Judge Spencer began by reciting the preliminary injunction standard from Blackwelder. Blackwelder, however, has come under increasing criticism on the grounds that it overemphasizes the balance of irreparable harm and undervalues the importance of the likelihood of success on the merits. Judge Spencer appeared to agree with that criticism, noting that he had previously cautioned against using the Blackwelder test as “contrary to Supreme Court precedent” and citing a recent Supreme Court decision that emphasized that a plaintiff must show a likelihood of success to obtain a preliminary injunction. Munaf v. Geren, 128 S.Ct. 2207, 2219 (2008).

It is likely that litigants and courts in the Fourth Circuit will continue to cite the Blackwelder test as the standard for preliminary injunctions, but decisions such as Munaf, PBM and others make increasingly clear that a plaintiff seeking a preliminary injunction will have difficulty without a strong showing of a likelihood of success on the merits.