News & Analysis as of

Bayer

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

Your daily dose of financial news - The Brief – 9.14.16

by Robins Kaplan LLP on

Following news of Starboard Value’s plan to shake things up at Perrigo, we have this take from Breakingviews, which suggests that fending off a hostile takeover (as Perrigo did from Mylan) tends to “make fertile turf for an...more

Your daily dose of financial news - The Brief – 9.6.16

by Robins Kaplan LLP on

Dealbook gives us the story of Airgas, where founder Peter McCausland’s reticence to sell (despite serious shareholder pressure) resulted in a $5 billion windfall rather than the all-too-often result of a later sale for...more

Bayer Pharma AG v. Watson Labs., Inc

by Robins Kaplan LLP on

Case Name: Bayer Pharma AG v. Watson Labs., Inc., Civ. No. 12-cv-517 (GMS), 2016 U.S. Dist. LEXIS 55752 (D. Del. Apr. 27, 2016) (Sleet, J.) - Drug Product and Patent(s)-in-Suit: Staxyn® (vardenafil hydrochloride...more

Bayer Pharma AG v. Watson Labs., Inc.

by Robins Kaplan LLP on

Case Name: Bayer Pharma AG v. Watson Labs., Inc., Civ. No. 12-cv-517 (GMS), 2016 U.S. Dist. LEXIS 57888 (D. Del. May 2, 2016) (Sleet, J.) - Drug Product and U.S. Patent(s)-in-Suit: Staxyn® and Levitra® (vardenafil...more

EAB Upholds EPA Cancellation of Flubendiamide Registrations

On July 29, 2016, the Environmental Appeals Board (EAB or Board) issued its Final Decision and Order (Order) upholding the Administrative Law Judge (ALJ) Initial Decision and an earlier order denying Bayer CropScience LP and...more

Intendis GMBH et al. v. Glenmark Pharms. Inc., USA

by Robins Kaplan LLP on

Case Name: Intendis GMBH et al. v. Glenmark Pharms. Inc., USA, 822 F.3d 1355 (Fed. Cir. May 16, 2016) (Circuit Judges Prost, Moore, and Taranto presiding; Opinion by Moore, J.) (Appeal from D. Del., Robinson, J.) - Drug...more

Your daily dose of financial news - The Brief – 7.20.16

by Robins Kaplan LLP on

We’ve heard about VW’s $15 billion settlement to resolve US claims by owners and regulators, but a spate of recent state AG-led actions shows that the fallout from the emissions cheating scandal is far from over. NY, MA, and...more

EPA ALJ Issues Initial Decision in Bayer Flubendiamide Cancellation Proceeding

On Wednesday, June 1, 2016, Administrative Law Judge (ALJ) Susan L. Biro issued an Initial Decision in the matter of Bayer CropScience LP and Nichino America, Inc. (BCS/NAI), U.S. Environmental Protection Agency (EPA) Docket...more

Your daily dose of financial news The Brief – 5.25.16

by Robins Kaplan LLP on

It’s a week of big fat NOs so far, with Tribune emphatically turning down Gannett yesterday and Monsanto doing the same to Bayer and its massive all-cash $62 billion offer...more

Your daily dose of financial news The Brief – 5.23.16

by Robins Kaplan LLP on

We’ve got numbers for Bayer’s unsolicited bid to buy Monsanto—a cash offer of $62 billion, representing a 37% premium on Monsanto’s May 9 closing price...more

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