Novartis

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The Pharmacy Industry – 2015 Year In Review

With 2015 coming to a close, we wanted to provide a recap of the major updates impacting the pharmacy industry and what pharmaceutical manufacturers, pharmacy benefit managers (“PBMs”), and pharmacies might expect in 2016. ...more

Novartis Pharmaceuticals Settles $390MM FCA Allegations

Drugmaker Novartis Pharmaceuticals has agreed in principle to pay $390MM (including $20MM in civil forfeitures) to the Department of Justice. This payment, in addition to modification and an extension of Novartis’s existing...more

DOJ and OIG Launch Wave of Aggressive Prosecutions Targeting Entities and Individuals for Illegal Health Care Marketing Practices

In the last few months, the United States Department of Justice (DOJ) and the Office of Inspector General (OIG) have obtained over half a billion dollars in settlements and multiple criminal convictions arising from...more

Novartis Pharm. Corp. v. Zydus Noveltech Inc.

Case Name: Novartis Pharm. Corp. v. Zydus Noveltech Inc., Civ. No. 14-cv-1104-RGA, 2015 U.S. Dist. LEXIS 103708 (D. Del. Aug. 7, 2015) (Andrews, J.) - Drug Product and Patent(s)-in-Suit: Exelon® (rivastigmine); U.S....more

Novartis Pharm. Corp. v. Noven Pharm., Inc.

Case Name: Novartis Pharm. Corp. v. Noven Pharm., Inc., Civ. No. 13-527-RGA, 2015 U.S. Dist. LEXIS 115246 (D. Del. Aug. 31, 2015) (Andrews, J.) - Drug Product and Patents-in-Suit: Exelon® (rivastigmine); U.S. Patent No....more

Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: Novartis AG

Earlier this summer, in Ariosa Diagnostics, Inc. v. Sequenom, Inc., the Federal Circuit affirmed a decision by the District Court for the Northern District of California granting summary judgment of invalidity of the asserted...more

Patent Is Not Invalid for Obviousness or Obviousness-Type Double Patenting

Plaintiff asserted infringement of U.S. Patent No. 6,335,031, which is directed to a pharmaceutical composition containing a compound to rivastigmine. The parties stipulated to infringement if the patent was valid. Defendant...more

Court Report - August 2015

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Millennium Pharmaceuticals Inc. v. Dr. Reddys Laboratories, Ltd. et al. 1:15-cv-00539; filed June 25, 2015 in the District...more

Novartis Pharms. Corp. v. Watson Labs., Inc.

Case Name: Novartis Pharms. Corp. v. Watson Labs., Inc., Fed. Cir. Nos. 2014-1799, -1800, 2015-1061, -1062, -1120, -1121, -1141, 2015 U.S. App. LEXIS 8374 (Fed. Cir. May 21, 2015) (Circuit Judges Lourie, Taranto, and Hughes...more

Court Report - July 2015 #2

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Alcon Research Ltd. v. Akorn Inc. 1:15-cv-00474; filed June 11, 2015 in the District Court of Delaware -...more

Biosimilars Coding & Reimbursement Significance under Medicare Part B

On April 15, 2015, CMS issued a preliminary recommendation for a HCPCS code for Zarxio, the first biosimilar product ever to be approved by the FDA. CMS’s recommendation provides the first indication of how the agency will...more

Court Report - June 2015 #3

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Mayne Pharma International Pty Ltd. v. Merck & Co., Inc., et al. 1:15-cv-00438; filed May 29, 2015 in the District Court...more

Novartis Pharms. Corp. v. Mylan Inc.

Case Name: Novartis Pharms. Corp. v. Mylan Inc., Civ. No. 14-777-RGA, 2015 U.S. Dist. LEXIS 31812 (D. Del. March 16, 2015) (Andrews, J.). Drug Product and Patent(s)-in-Suit: Exelon Patch (rivastigmine); U.S. Patents...more

Notes From The Off-Label Underground

Keeping track of litigation over off-label use/promotion frequently sends us off on tangents. We’ve wandered into abortion cases, securities law cases, criminal cases – even cases brought by criminals....more

United States Patent and Trademark Office Final Patent Term Adjustment Rules

On January 9, 2015, the United States Patent and Trademark Office (USPTO) published its final rules implementing changes to patent term adjustment (PTA), in view of the United States Court of Appeals for the Federal Circuit...more

USPTO Issues Final Rule in View of Novartis v. Lee

Earlier this year, the U.S. Patent and Trademark Office published a final rule in the Federal Register (80 Fed. Reg. 1346) to revise the rules of practice to implement the Federal Circuit's decision in Novartis AG v. Lee. ...more

Court Report - March 2015 #2

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Janssen Biotech, Inc. et al. v. Celltrion Healthcare Co., Ltd. et al. 1:15-cv-10698; filed March 6, 2015 in the District...more

FTC Looks to Accelerate Oncology Drug Growth by Requiring Novartis to Divest Two Protein Inhibitors in Its Clinical Development...

The Federal Trade Commission (“FTC”) on Monday completed its review of Novartis AG’s (“Novartis”) proposed $16 billion acquisition of GlaxoSmithKline’s (“GSK”) oncology drug portfolio with an announced consent decree that...more

Court Report - February 2015 #4

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Novartis Vaccines and Diagnostics, Inc. et al. v. Pfizer, Inc. 2:15-cv-01283; filed February 18, 2015 in the District...more

Court Report - February 2015 #3

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Novartis AG et al. v. Ezra Ventures LLC. 1:15-cv-00150; filed February 11, 2015 in the District Court of Delaware. •...more

Biosimilars Update

Novartis came one step closer to becoming the first company to offer a biosimilar drug for sale in the United States. Last month, an independent panel voted 14-0 to recommend FDA approval of Sandoz’s (Novartis’ generics...more

Court Report - February 2015 #2

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Novartis Pharmaceuticals Corp. et al. v. Roxane Laboratories Inc. 1:15-cv-00128; filed February 5, 2015 in the District...more

A Step Forward in Approving Lower-Cost “Generic” Biologic Drugs

A federal advisory panel has helped clear the path for what may be the first biosimilar biologic drug ever approved in the United States. Interestingly, generics of traditional drugs have been available in the U.S. for...more

The USPTO Giveth and Taketh Away: New PTA Rules Following Novartis v. Lee

On January 9, 2015, the final rules were published regarding patent term adjustment (PTA) following the decision in Novartis AG v. Lee 740 F.3d 593 (Fed. Cir. 2014)....more

Novartis and Qualcomm Form Digital Health Investment Company

Novartis Pharmaceuticals has announced it has formed a joint investment company with Qualcomm Ventures, the venture investment group of Qualcomm....more

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