News & Analysis as of

Bayer

Bayer Pharma AG v. Watson Laboratories, Inc. (Fed. Cir. 2017)

The Federal Circuit reversed a finding of non-obviousness on Friday based on clear error by the District Court on factual underpinnings of its obviousness determination, in Bayer Pharma AG v. Watson Laboratories, Inc. Such...more

Federal Circuit Finds Orally Disintegrating Drug Formulation Obvious

In Bayer Pharma AG v. Watson Labs., Inc., No. 2016-2169 (Fed. Cir. Nov. 1, 2017), the Federal Circuit reversed the district court’s conclusion that certain claims of Bayer’s patent covering Staxyn would not have been obvious...more

Expert Testimony on Lack of Motivation Won the Battle, but Lost the War

In BayerPharma AG v. Watson Laboratories, Inc., [2016-2169] (November 1, 2017), the Federal Circuit reversed the district court’s holding that claims 9 and 11 of U.S. Patent No. 8,613,950 would not have been obvious. The...more

Your Daily Dose of Financial News

by Robins Kaplan LLP on

HSBC’s making good on its plans to shift to a focus on Asia by naming John Flint—who spent his first 14 years at the bank in Asia—as its new CEO. Flint will take over from Stuart Gulliver in February....more

Bayer Receives Accelerated Approval for Aliqopa

by Knobbe Martens on

On September 14, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval of Aliqopa to Bayer Healthcare Pharmaceuticals, Inc., for the treatment of relapsed follicular lymphoma. The FDA granted Aliqopa...more

Simpson v. Bayer Healthcare and the “Original Source” Exception: Eighth Circuit’s Interpretation Ups the Ante for Defendants in...

The Eighth Circuit in Simpson v. Bayer Healthcare became the latest circuit court to weigh in on the meaning of the “original source” exception to the False Claims Act’s public disclosure jurisdictional bar. The public...more

Dow Takes its Gene Patents Row with Bayer to the Supreme Court to Avoid the $455 Million Arbitral Award

by Arnall Golden Gregory LLP on

When a company agrees to arbitrate an international patent licensing agreement, the avenues for the appeal of the resulting arbitral award are very limited. Even the invalidity or expiration of the underlying patents may be...more

Pharma advertising in Italy – Online publication of OTC medicinal products list, prices and reimbursability

by Hogan Lovells on

The Court of Milan held in a Judgment recently handed down in the proceedings brought by Bayer S.p.a. against the generic manufacturer DOC Generici S.r.l. that online publication of over-the-counter (OTC) medicinal products...more

Your Daily Dose of Financial News

by Robins Kaplan LLP on

Chevron CEO John Watson is out in a move that leaves the energy giant without a board-confirmed successor and marks the “dramatic shift under way at big oil companies as they adapt to a prolonged period of lower prices...more

Recent $455 Million Payment Reaffirms Certainty of International Arbitral Awards

One of the most often overlooked features of arbitration in the context of international commercial disputes is the certainty provided by a final award. Recently, Dow Agrosciences paid Bayer Cropscience more than $455 million...more

FDA Approves Bayer’s myBETAapp™

by Knobbe Martens on

On May 30, 2017, Bayer announced FDA approval of a supplemental Biologics License Application for Bayer’s myBETAapp™ and BETACONNECT Navigator™. The myBETAapp joins the growing field of medical mobile applications, which the...more

Bayer CropScience AG and Bayer S.A.S. v. Dow Agrosciences LLC (Fed. Cir. 2017)

Last week, in Bayer CropScience AG and Bayer S.A.S. v. Dow Agrosciences LLC, the Federal Circuit determined that the District Court for the District of Delaware did not abuse its discretion in determining that, under the...more

ANDA Update - March 2017 Volume 3, Number 1

by McDermott Will & Emery on

Speculative Evidence of Irreparable Harm Sinks Bayer's Request for Permanent Injunction - Bayer Pharma AG, et al. v. Watson Laboratories, Inc. (D. Del. December 28, 2016) - Applying the eBay factors to Plaintiff...more

Bayer CropScience AG v. Dow Agrosciences LLC (Fed. Cir. 2016)

Earlier this month, in Bayer CropScience AG v. Dow Agrosciences LLC, the Federal Circuit concluded that the District Court for the Eastern District of Virginia correctly confirmed an international arbitration tribunal's award...more

PTAB Denies Institution of IPR Proceedings Against Bayer’s Patent Covering STIVARGA®

by Jones Day on

On February 8, 2017, the PTAB denied Fustibal LLC’s (“Fustibal”) petition to institute inter partes review of U.S. Patent 8,637,553 B2 (“the ’553 patent”) owned by Bayer HealthCare LLC (“Bayer”) (IPR2016-01490). The 553...more

Bayer Pharma AG v. Watson Labs., Inc.

by Robins Kaplan LLP on

Case Name: Bayer Pharma AG v. Watson Labs., Inc., 12-1726-LPS, 2016 U.S. Dist. LEXIS 179103 (D. Del. Dec. 28, 2016) (Stark, J.). Drug Product and Patent(s)-in-Suit: Natazia® (estradiol valerate/estradiol...more

Infringement by equivalence and patentability of intermediates in Italy

by Hogan Lovells on

By decision of December 2nd, 2016, No 24658, Industriale Chimica S.r.l. vs Bayer Pharma AG, the Italian Supreme Court ruled on the infringement by equivalence and on the patentability of intermediates. ...more

Speculation of ANDA Product Launch Before FDA Approval Does Not Warrant Permanent Injunction

by Locke Lord LLP on

On December 28, 2016, Judge Stark of the District of Delaware, despite having previously found infringement, held that plaintiffs Bayer Pharma AG, Bayer Intellectual Property GmbH, and Bayer HealthCare Pharmaceuticals Inc....more

RxIP Update - 2016 Year in Review

by Smart & Biggar on

The following are highlights of developments in Canadian life sciences intellectual property and regulatory law in 2016, updating our 2016 mid-year highlights. 1. Substantive patent law developments - Utility and...more

Bayer Pharma AG v. Watson Labs., Inc.

by Robins Kaplan LLP on

Case Name: Bayer Pharma AG v. Watson Labs., Inc., Case No. 12-1726-LPS, 2016 U.S. Dist. LEXIS 96267 (D. Del. July 18, 2016) - Drug Product and Patent(s)-in-Suit: Natazia® (estradiol valerate / dienogest); U.S. Patent No....more

Supreme Court Punts Again on FCA Claims Specificity

by Holland & Knight LLP on

The U.S. Supreme Court recently denied certiorari in United States ex rel. Walterspiel v. Bayer AG. This case, arising out of the Fourth Circuit, raised yet again the question of how much detail a False Claims Act (FCA)...more

Your daily dose of financial news - The Brief – 9.19.16

by Robins Kaplan LLP on

Gretchen Morgenson and Fair Game have had a few days to reflect on the Bayer/Monsanto deal, and with that little bit of hindsight (and a lot of history), she’s not too sure that Bayer’s stockholders are going to be thrilled...more

Proposed Bayer-Monsanto merger presents a charitable planning opportunity

by Thompson Coburn LLP on

The announcement of the Bayer-Monsanto transaction gives shareholders a great opportunity to think about taxes and charitable planning options. Shareholders have seen a $10-$15/share bump since May, and the current...more

11th Circuit Upholds Award of Summary Judgment in Mirena Lawsuit

In March 2014, Jenna Thurmond sued Bayer in the U.S. District Court for the Northern District of Georgia, alleging that her use of the Mirena contraception system caused her to develop pseudotumor cerebri. Her symptoms...more

Your daily dose of financial news - The Brief – 9.15.16

by Robins Kaplan LLP on

The Committee on Capital Markets Regulation—a nonprofit that represents execs from many of the US’s largest banks—will release a paper today arguing that the Fed illegally sidestepped the APA by adopting “central parts of its...more

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