News & Analysis as of

Novartis

California Supreme Court Recognizes “Innovator Liability”

Last week, the California Supreme Court in T.H. v. Novartis Pharmaceuticals Corp., became the first state high court to recognize the doctrine of “innovator liability,” unanimously holding that brand-name prescription drug...more

Addendum to the Worst Prescription Drug/Medical Device Decisions of 2017

by Reed Smith on

Sometimes it happens.  For eleven years, we have published our annual “worst of” the year post on the Thursday before Christmas and our annual “best of” the year post on the Thursday before New Year’s....more

Breaking News: TH v. Novartis – California Supreme Court Recognizes New Tort Duties as Traditional Limits Slide into the Sea

by Reed Smith on

We posted our 2017 “Worst 10 decisions” list a day too soon, because the California Supreme Court issued its anticipated decision in TH v. Novartis, No. S233898, slip op. (Cal. Dec. 22, 2017) today, and if it is not the worst...more

More on Venue -- Plexxikon v. Novartis Pharmaceutical Corp. (N.D. Cal. 2017)

The sequel to the original summer blockbuster movie, Jaws, had as a tagline "Just when you thought it was safe to go back in the water." This sentiment can describe much of U.S. patent law over the last decade and a half,...more

Your Daily Dose of Financial News

by Robins Kaplan LLP on

Swiss pharma giant Novartis has issued a $3.9 billion cash bid to buy Advanced Accelerator Applications, a French company [and spinoff of the organization in charge of the Large Hadron Collider] known for producing...more

Sandoz Pushes Back Pegfilgrastim U.S. Resubmission Target Date

by Goodwin on

Novartis recently released its Q2 2017 financials, which included updates on various biosimilar products in its subsidiary Sandoz’s pipeline. Pegfligrastim - As we previously reported last July, the FDA last year...more

Update on Regulatory Compliance in the Global Health Care Industry

by Baker Ober Health Law on

A comprehensive understanding of the constantly evolving layers that make up federal anti-corruption statutes, sanctions regulations and export control restrictions is imperative for both the pharmaceutical and health care...more

No Due Process Violation in PTAB’s Treatment of References

by McDermott Will & Emery on

Addressing issues of procedural due process and obviousness, the US Court of Appeals for the Federal Circuit affirmed a Patent Trial and Appeal Board (PTAB) decision to invalidate a patent in an inter partes review (IPR),...more

District Court Ruling on Obviousness Does Not Bind PTAB

by McDermott Will & Emery on

Addressing issues of motivation to combine and whether the Patent Trial and Appeal Board (PTAB) is bound by district court decisions of obviousness, the US Court of Appeals for the Federal Circuit found that the PTAB is not...more

PTAB Life Sciences Report -- Part II - May 2017

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents. Argentum Pharmaceuticals LLC. v. Alcon Research, Ltd. PTAB Petition: IPR2017-01053; filed...more

PTAB Life Sciences Report - May 2017 #2

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents. Mylan Pharmaceuticals, Inc. v. Cosmo Technologies Ltd. PTAB Petition: IPR2017-01034; filed...more

Novartis Pharms. Corp. v. Breckenridge Pharm., Inc.

by Robins Kaplan LLP on

Case Name: Novartis Pharms. Corp. v. Breckenridge Pharm., Inc., Civ. Nos. 14-1043-RGA, 14-1196-RGA, 14-1289-RGA, 2017 U.S. Dist. LEXIS 46595 (D. Del. Mar. 28, 2017) (Andrews, J.)....more

South Korea Fines Prominent Pharmaceutical Manufacturer in Latest Anti-Corruption Enforcement Efforts

by Ropes & Gray LLP on

In a sign that South Korea is ramping up its anti-corruption enforcement efforts, Korean authorities announced on April 27 that they plan to levy a $48 million fine against Swiss pharmaceutical giant Novartis International AG...more

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

by Knobbe Martens on

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

by Knobbe Martens on

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

by Knobbe Martens on

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

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