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Drug Labels Can Provide The “Specific Intent” Required For Inducement Of Infringement

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Pharma-pills-multiple-colors-and-bottlesIn DSU Medical Corp. v. JMS Co., 471 F.3d 1293, 1306 (Fed. Cir. 2006) (en banc in relevant part), the Federal Circuit held that inducement of infringement under section 271(b) requires a “specific intent” to infringe. A general intent to encourage direct infringement will not establish a successful inducement claim. But the court failed to provide any guidance on establishing the requisite intent. In pharmaceutical cases, however, specific intent may be established by the wording of a drug label, particularly in Hatch-Waxman cases.

Inducement is particularly relevant in pharmaceutical litigation as method-of-use claims are infringed under section 271(b). Conventional principles of induced infringement apply in determining infringement under the Hatch-Waxman Act. See Warner- Lambert Co. v. Apotex Corp., 316 F.3d 1348, 1365 (Fed. Cir. 2003). First, the inducer must have knowledge of the asserted patent. See Global-Tech Appliances, Inc. v. SEB S.A., 131 S. Ct. 2060, 2070 (2011). In Hatch-Waxman actions, this knowledge is easily proven by reference to the Orange Book. Moreover, the filing of a paragraph IV certification undoubtedly shows that a generic manufacturer had actual knowledge of any patents that claim the proposed method-of-use. See, e.g., Bone Care Int’l, L.L.C. v. Roxane Labs., Inc., 2012 WL 2126896 (D. Del. June 11, 2012). Therefore, once direct infringement is established, a plaintiff must only prove that the generic manufacturer had the specific intent to induce infringement. Such intent may be inferred from evidence of a sales force, advertisements in medical journals, direct marketing to doctors, or funded research or meetings on the claimed method. See Warner-Lambert Co. v. Apotex Corp., 2001 WL 1104618, at *3 (N.D. Ill. Sept. 14, 2001), aff’d, 316 F.3d 1348 (Fed. Cir. 2003). Continue Reading »

A slippery slope? Schlumberger v. Rutherford and implications for future abuse of the Texas Anti-SLAPP statute in trade secret litigation.

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Two-business-people-meeting-in-an-isolated-placeSometimes, the cure is as bad as (or even worse than) the disease. When it comes to Anti-SLAPP statutes, that has, at times, seemed to be the case. Such statutes are intended to quickly defeat meritless suits filed to stifle free speech and thwart legitimate filings with courts and government agencies (“SLAPP” stands for “strategic lawsuits against public participation”). Indeed, they have often proven useful in facilitating the early dismissal of litigation before the commencement of costly fact discovery. But, because they amount essentially to a pre-discovery summary judgment and may result in significant awards of fees and costs to the defendant, Anti-SLAPP statutes have also been misused as a tool to cut off legitimate claims before they can be fully and fairly litigated. Some Ninth Circuit judges have recently voiced their view that the federal courts in their circuit made a serious mistake in applying the California statute in federal cases, given how incompatible many of its more harsh procedures are with the Federal Rules of Civil Procedure.   See Makaeff v. Trump University, 715 F.3d 254 (9th Cir. 2013)  And now, in Texas, which only enacted its Anti-SLAPP statute[1] in 2011, a trial court has recently issued a ruling with troubling implications for future Anti-SLAPP counterattacks by defendants in trade secrets cases. Continue Reading »

The Third Circuit extends Octane Fitness’s “exceptional” test to Lanham Act cases

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Fair Winds Sailing, Inc. v. Dempster, __ F.3d __ (3d Cir. Sept. 4, 2014) (FUENTES, Rendell, Greenaway Jr.) (No. 11-cv-00055, D.V.I. (Gomez, J.))

The Third Circuit has loosened the standard for obtaining attorney fees in trademark cases. For over twenty years the Third Circuit utilized a two-step test that required a finding of culpability before assessing attorney fees in trademark suits. That test no longer applies. The appellate court has ruled that the lower threshold for fee-shifting in patent cases set out in Octane Fitness applies equally to Lanham Act actions. Continue Reading »

Inventor’s Affirmative Misrepresentations Nearly Rose To Level Of Misconduct That Supports Inequitable Conduct Finding Without Need To Prove But-For Materiality

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Apotex, Inc. v. UCB. Inc., __ F.3d __ (Fed. Cir. Aug. 15, 2014) (REYNA, Wallach, Hughes) (No. 2013-1674, S.D. Fla. (Middlebrooks, J.)) (2 of 5 stars)

Fed Cir affirms district court’s judgment that Apotex’s U.S. Patent 6,767,556 (“the ’556 patent”) is unenforceable due to inventor’s inequitable conduct. Continue Reading »

Infringement Analysis Under §271(e) Focuses On The Product That Is Likely To Be Sold Following ANDA Approval, Not

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Ferring B.V. v. Watson Labs, Inc. et al.,__ F.3d __ (Fed. Cir, Aug. 22, 2014) (LOURIE, Dyk, Reyna) (D. Nev. Jones) (2 of 5 stars)

Fed Cir affirmed non-obviousness but reversed infringement finding, and vacated the injunction and order preventing FDA approval of a generic product until patent expiration.  This is a companion appeal to Ferring, B.V. v. Apotex, Inc., involving the same patents but a different ANDA defendant.  Continue Reading »

If ANDA is Silent on Infringement, then Infringement is Assessed Based on the Product Likely to Be Sold; Courts Have Discretion to Consider Post-Trial ANDA Amendments

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Ferring B.V. v. Apotex, Inc. et al.,__ F.3d __ (Fed. Cir, Aug. 22, 2014) (Lourie, DYK, Reyna) (D. Nev.: Jones) (3 of 5 stars)

Fed Cir affirmed dismissal of Ferring’s Hatch-Waxman infringement claim as moot after Apotex’s amendment to its ANDA rendered it non-infringing.

The patents covered an extended-release drug and required that less than “about 70%” of the active ingredient dissolve after 45 minutes.  Apotex filed an ANDA in 2010 that did not specify the dissolution rate but amended it in 2014 to require at least 75% dissolution at 45 minutes.  The district court found that, although the 2010 ANDA infringed because its silence on the dissolution rate meant Apotex “could” sell an infringing product, the 2014 amended ANDA no longer infringed and thus dismissed the claim as moot.  Continue Reading »

Double-Patenting May Apply Whenever Two Patents Have Different Expiration Dates; Later-Expiring Patent to a Species Was Invalid Where Earlier-Expiring Patent Disclosed Small Genus and the Utility Claimed in the Later Patent

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AbbVie Inc. v. The Mathilda & Terence Kennedy Inst. of Rheumatology Trust, ___ F.3d ___ (Fed. Cir. Aug. 21, 2014) (DYK, Wallach, Chen) (S.D.N.Y.: Crotty) (2 of 5 stars)

Fed Cir affirms invalidity based on obviousness-type double patenting.  Kennedy obtained two related patents covering treatment methods for rheumatoid arthritis by co-administering two drugs. The later patent claimed a species of the genus covered by the first, earlier-expiring patent.  Continue Reading »

District Court Properly Clarified Claim Construction Post-Verdict to Require Method Steps Be Performed In a Particular Order to Avoid Rendering One Step Superfluous

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mFormation Techs., Inc. v. Research in Motion Ltd., ___ F.3d ___ (Fed. Cir. Aug. 22, 2014) (PROST, Schall, Hughes) (N.D. Cal.: Chen and Ware) (2 of 5 stars)

Fed Cir affirms JMOL of non-infringement. The patent covers a method remotely managing an electronic device that required “establishing a connection between the wireless device and the server” and “transmitting” information “from the server to the wireless device.” The district court, in granting JMOL, clarified that the “establishing” step had to be complete before transmission began, while the accused products did not. Continue Reading »