News & Analysis as of

Novartis

Issue Four: PTAB Trial Tracker

by Goodwin on

Parallel District Court and PTAB Proceedings - In Douglas Dynamics, LLC v. Meyer Prods. LLC, No. 3:14-cv0886-JDP (W.D. Wis. April 18, 2017), the district court for the Western District of Wisconsin drew a clear line...more

Novartis’ Gilenya Patent Invalidated as Obvious

On April 12, 2017, the Federal Circuit affirmed the determination by the US Patent and Trademark Office (USPTO), Patent Trial and Appeal Board (Board) that the claims of U.S. Patent No. 8,324,283 (“the ’283 patent”) were...more

No Nexus For Novartis Gilenya Patent

by Foley & Lardner LLP on

In Novartis AG v. Torrent Pharmaceuticals Ltd., the Federal Circuit affirmed the decision of the USPTO Patent Trial and Appeal Board (PTAB) invalidating all claims of U.S. Patent 8,324,283, which is one of four Orange...more

PTAB Life Sciences Report -- Part II - April 2017#2

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents. Actavis Laboratories FL, Inc. et al. v Janssen Oncology, Inc. PTAB Petition: IPR2017-00853;...more

Novartis AG v. Torrent Pharmaceuticals Ltd. (Fed. Cir. 2017)

Can a prior art reference that does not contain a teaching sufficient enough to allow it to be used in an obviousness combination nevertheless be used as a background reference for evidence of motivation to combine? ...more

Fed Circ Affirms Conflicting Invalidity Determinations from District Court and PTAB

by Jones Day on

As we have previously discussed on this blog, when considering an issue of patentability such as definiteness under section 112, the PTAB and a district court may properly reach opposite conclusions. In Tinnus Enterprises LLC...more

Federal Circuit Affirms PTAB’s Obviousness Holding for Novartis’s Dementia Drug Patents

The Federal Circuit affirmed the PTAB’s final written decisions holding that claims directed to Novartis’s dementia drug compositions containing Exelon were obvious in Novartis AG v. Noven Pharm. Inc., No. 2016-1679 (Fed....more

PTAB Life Sciences Report -- Part I - April 2017#2

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents. Reckitt Benckiser LLC v. Ansell Healthcare Products LLC - PTAB Petition: IPR2017-00063; filed...more

Federal Circuit Affirms Obviousness of Novartis’s Patent for Multiple Sclerosis Drug

The Federal Circuit affirmed the PTAB’s final written decision holding that claims directed to Novartis’s multiple sclerosis drug Gilenya were obvious in Novartis AG v. Torrent Pharmaceuticals. Ltd., No. 2016-1352 (Fed. Cir....more

Just Because the Board Didn’t Say It, Doesn’t Mean that the Board Didn’t Think It

In Novartis AG v. Torrent Pharmaceuticals Limited, [2016-1352] (April 12, 2017), the Federal Circuit affirmed the PTAB’s determination that the challenged claims of U.S. Patent No. 8,324,283, and Novartis’ proposed substitute...more

Courts' Findings of No Invalidity Are Not Binding on the Patent Office in Inter Partes Reviews

The US Circuit Court for the Federal Circuit issued an important decision last week regarding the interplay of court litigation and inter partes reviews (IPRs) at the US Patent and Trademark Appeals Board (PTAB) on the issue...more

Novartis AG v. Noven Pharmaceuticals Inc. (Fed. Cir. 2017)

In inter partes review proceedings, is the U.S. Patent and Trademark Office's Patent Trial and Appeal Board required to take into account a final district court determination of non-obviousness of the same claims based on the...more

Novartis and Sandoz Withdraw Zioxtenzo (pegfilgrastim) European Application

by Goodwin on

The EMA announced on January 27 that Novartis and Sandoz have withdrawn their marketing application for their pegfilgrastim biosimilar (Zioxtenzo). The application was withdrawn after the Committee for Medicinal Products for...more

Biosimilar Updates: Epoetin, Rituximab, Adalimumab

by Goodwin on

Over the past week or so, several biologic and biosimilar companies have issued their year-end earnings reports. Below are some highlights on the biosimilar front...more

Facility Inspections Delay Sandoz's Filing For Humira Biosimilar in US

by Goodwin on

Yesterday, during its Q4 2016 earnings call, Novartis CMO Vasant Narasimhan told investors that its subsidiary Sandoz had delayed filing its aBLA for a biosimilar of Humira® (adalimumab), which originally had been planned for...more

Shearman & Sterling’s Recent Trends and Patterns in the Enforcement of the Foreign Corrupt Practices Act (FCPA)/FCPA Digest -...

by Shearman & Sterling LLP on

Shearman & Sterling’s bi-annual Trends & Patterns in FCPA Enforcement report provides insightful analysis of recent enforcement trends and patterns in the US, the UK and elsewhere, as well as helpful guidance on emerging best...more

Sandoz: Etanercept biosimilar switch has no impact on safety and efficacy

by Goodwin on

Novartis announced on Friday that the EGALITY study, analyzing the clinical safety and efficacy of Sandoz’s etanercept biosimilar, was published in the British Journal of Dermatology. The 52-week EGALITY study involved...more

Novartis AG v. Ezra Ventures, LLC

by Robins Kaplan LLP on

Case Name: Novartis AG v. Ezra Ventures, LLC, Civ. No. 15-0150-LPS, 2016 U.S. Dist. LEXIS 129502 (D. Del. Sept. 22, 2016) (Stark, J.) - Drug Product and Patent(s)-in-Suit: Gilenya® (fingolimod); U.S. Patent No. 5,604,229...more

Approval of Sandoz’s Pegfilgrastim Biosimilar May Be Delayed until at Least 2018

by Goodwin on

As we previously reported, in July the FDA issued a complete response rejecting Sandoz’s aBLA for a biosimilar of Neulasta® (pegfilgrastim). Novartis, Sandoz’s parent, indicated that that Sandoz was “working with the agency...more

Big Pharma, undeterred, racks up a half-billion dollars in regulator penalties

Big Pharma’s dubious hype of its sometimes risky products marched on last week, with the industry racking up a half-billion in regulator penalties and settlements but no seeming end to its questionable strategies and...more

First Circuit Affirms Stringent Rule 9(b) Particularity Requirement in False Claims Act Cases

by Ropes & Gray LLP on

On June 17, 2016, the First Circuit issued an opinion addressing, among other things, the particularity requirement that applies in False Claims Act (“FCA”) cases where the defendants are not alleged to have directly...more

Court Report - September 2016

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Horizon Therapeutics, Inc. v. Lupin Ltd. et al. 1:16-cv-04438; filed July 21, 2016 in the District Court of New Jersey...more

Biosimilars Development Updates

by Goodwin on

According to a press release, Novartis AG has contracted Jacobs Engineering Group Inc. to provide engineering, procurement, and construction management services to expand monoclonal antibody (mAb) production capacity by 70%...more

Headlines from Mid-Year FCPA Enforcement Review

by Michael Volkov on

Just to add my voice to the cottage industry surrounding FCPA enforcement and compliance, I wanted to take a deep breath and offer some observations on FCPA enforcement in 2016. There are a few significant headlines...more

CMS Posts Open Payment Data – $7.52 Billion in 2015

by Tucker Arensberg, P.C. on

CMS published the 2015 Open Payment Data on June 30, 2015. CMS has presented tables in its press release showing the highest paid specialties and highest paying companies. ...more

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