Gibbons Law Alert

Gibbons Law Alert

Author: Charles H. Chevalier

Supreme Court Will Not Review Bar for Proving Inequitable Conduct

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Posted in Patent

On October 24, 2013

We have previously reported on the Federal Circuit’s en banc decision in Therasense, Inc. v. Becton Dickinson & Co., 649 F.3d 1276 (Fed. Cir. 2011) issued on May 25, 2011. In that decision, the Federal Circuit heightened the standard required to show that a patent holder committed inequitable conduct during the prosecution of the patent at issue. Prior to Therasense, an accused infringer asserting inequitable conduct as a defense had to show that the withheld information or false statements were material and the patent applicant intended to deceive the USPTO. Materiality and intent were analyzed on a sliding scale, where intent could be inferred if the withheld information was considered highly material.

ANDA Product Controls Infringement Analysis In Hatch-Waxman Framework

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Posted in Patent

On October 3, 2013

Last week, the Federal Circuit, in Sunovion Pharm. v. Teva Pharm. USA, et al., addressed the appropriate infringement analysis in the context of Hatch-Waxman (aka “ANDA”) litigation. It held: Although no traditional patent infringement [occurs] until a patented product is made, used, or sold, under the Hatch-Waxman framework, the filing of an ANDA itself constitutes a technical infringement for jurisdictional purposes. But the ultimate infringement question is determined by traditional patent law principles and, if a product that an ANDA applicant is asking the FDA to approve for sale falls within the scope of an issued patent, a judgment of infringement must necessarily ensue.

Cancellation of Claims by USPTO During Reexam is Binding in Pending District Court Infringement Litigation

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Posted in Patent

On August 26, 2013

Last month, the Federal Circuit addressed the question of “whether, under the reexamination statute, the cancellation of claims by the PTO is binding in pending district court infringement litigation.” Fresenius USA, Inc. v. Baxter Int’l, Inc., 2013 U.S. App. LEXIS 13484, at *13 (Fed. Cir. July 2, 2013). The Federal Circuit interpreted the reexamination statute to have a binding effect on concurrent litigation, and thus terminated a pending litigation where the same patent claims were cancelled during reexamination. Id. at *43. Accordingly here, the Federal Circuit held that the PTO’s invalidity decisions trump the prior district court ruling.

Resuscitating Therasense? CD Cal Court Finds Inequitable Conduct by Patentee

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Posted in Patent

On August 14, 2013

IP practitioners have witnessed the dearth of inequitable conduct findings in the wake of Therasense, Inc. v. Becton, Dickinson & Co., 649 F.3d 1276 (Fed. Cir. 2011). There, the Federal Circuit reiterated en banc that to establish unenforceability for inequitable conduct before the United States Patent and Trademark Office (“PTO”), a party must prove by clear and convincing evidence that (1) information material to patentability was withheld from the PTO, or material misinformation was provided to the PTO, and that such act was done (2) with the intent to deceive or mislead. A few months ago, we reported on a case that continued to signal the death knell of this formerly ubiquitous defense, and thus begging the present question: is inequitable conduct even alive anymore? Of course it is.

Epic and Limelight File Petitions for Certiorari in Induced Infringement Matters

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Posted in Patent

On January 28, 2013

We previously reported on the Federal Circuit’s twin en banc decisions in Akamai Techs., Inc. v. Limelight Networks, Inc. and McKesson Techs. Inc. v. Epic Sys. Corp., 692 F.3d 1301 (Fed. Cir. 2012). These rulings dramatically altered the enforceability of method patent claims by relaxing the rules for proving liability in induced infringement cases. As anticipated, both Epic Systems (“Epic”), and Limelight Networks (“Limelight”) filed separate petitions for certiorari.

U.S. Supreme Court Will Not Review Lead Compound Test for Obviousness Analysis

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Posted in Pharmaceuticals

On January 15, 2013

On Monday, the Supreme Court denied the petition for writ of certiorari filed by Apotex seeking review of the Federal Circuit’s May 7, 2012, ruling that affirmed the District Court of New Jersey’s judgment that Otsuka’s patents covering its blockbuster drug Abilify© are valid and not obvious. In that ruling, the Federal Circuit found no error in the District Court’s application of the so-called lead compound test; an analytical framework in chemical art cases that seeks — in an obviousness inquiry under 35 U.S.C. § 103 — to determine whether a POSA (“person of ordinary skill in the art”) would select the proffered prior art as a “lead compound.” Specifically, in a lead compound analysis, the Court will consider: the hypothetical person of skill in the art’s identification of a lead compound, structural differences between the proposed lead compound and the claimed invention, motivation or teachings in the prior art to make the necessary changes to arrive at the claimed invention, and whether the person of skill in the art would have a reasonable expectation of success in making such structural changes.

Tim Tebow Time in the Trademark Office . . . .

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Posted in Trademarks

On October 24, 2012

The U.S. Patent and Trademark Office (“PTO”) recently published for opposition the mark TIM TEBOW. The applicant for the mark in these various goods and services is XV Enterprises LLC of Denver, Colorado, who has indicated that Tim Tebow, the two-time Heisman Trophy winner and New York Jets quarterback (formerly with the Denver Broncos), has consented to the applications.

CAFC Reverses Inequitable Conduct Finding: Outside The Box Innovations v. Travel Caddy

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Posted in Patent

On October 9, 2012

The Federal Circuit recently reversed the Northern District of Georgia’s judgment of unenforceability based on inequitable conduct, in Outside The Box Innovations, LLC v. Travel Caddy, Inc. Other aspects of the decision are outside the scope of this blog. In reversing, and citing last year’s en banc decision in Therasense, Inc. v. Becton, Dickinson & Co., 649 F.3d 1276 (Fed. Cir. 2011), the CAFC reiterated that to establish unenforceability based on inequitable conduct before the United States Patent and Trademark Office (“PTO”), a party must prove by clear and convincing evidence that (1) information material to patentability was withheld from the PTO, or material misinformation was provided to the PTO, and that such act was done (2) with the intent to deceive or mislead.

FTC Petitions for Certiorari in Reverse Payments Dispute

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Posted in Patent

On October 5, 2012

As we anticipated, the Federal Trade Commission (“FTC”) filed a petition for certiorari yesterday with the Supreme Court in FTC v. Watson Pharmaceuticals, Inc. In that case, the Eleventh Circuit upheld reverse payments (payments made by branded pharmaceutical patent holders to generic challengers to postpone market entry under the scope-of-the-patent approach, i.e., as long as the anti-competitive effects fall within the scope of the exclusionary potential of the patent, absent sham litigation or fraud), as lawful. The Second and Federal Circuits follow that approach. In contrast, the Third Circuit has held that such payments are presumptively anti-competitive under the “quick look rule of reason analysis” that may be rebutted by showing that the payments was for something other than delay or that the payment has a competitive benefit, and thereby increases competition.

Will the Supreme Court Weigh in on Reverse Payments in ANDA Cases — Revisited

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Posted in Patent

On September 28, 2012

We have written previously on numerous developments concerning reverse payments in Hatch-Waxman litigation settlements (i.e., payments made by branded pharmaceutical patent holders to generic challengers to postpone market entry of proposed generic products). Earlier this month, we reported that Merck & Co. had filed a petition for a Writ of Certiorari seeking to challenge the Third Circuit’s decision in In re K-Dur Antitrust Litig. holding that reverse payments are prima facie evidence of an antitrust violation.

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