News & Analysis as of

AstraZeneca

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

AstraZeneca AB v. Aurobindo Pharma Ltd.

by Robins Kaplan LLP on

Case Name: AstraZeneca AB v. Aurobindo Pharma Ltd., 14-664-GMS, 2017 U.S. Dist. LEXIS 14647 (D. Del. Feb. 2, 2017) (Sleet, J.). Drug Product and Patent(s)-in-Suit: Onglyza® (saxagliptin) and Kombiglyze™ XR (saxaglibtin...more

PTAB Life Sciences Report -- Part III

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents. InnoPharma Licensing, LLC v AstraZeneca AB - PTAB Petition: IPR2017-00900; filed February 17,...more

PTAB Life Sciences Report -- Part III

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents. Complex Innovations, LLC. v. AstraZeneca AB - PTAB Petition: IPR2017-00631; filed January 9,...more

Rx IP Update - February 2017

by Smart & Biggar on

Federal Court of Appeal rules on non-infringing alternatives and apportionment as defences to an accounting of profits from patent infringement - On February 2, 2017, the Federal Court of Appeal released a...more

Apotex’s Infringement of AstraZeneca’s Omeprazole Formulation Patent Upheld

by Smart & Biggar on

The Federal Court of Appeal, in a unanimous decision released on January 12, 2017 (2017 FCA 9), has affirmed the validity of AstraZeneca’s Patent No. 1,292,693. The patent covered AstraZeneca’s successful product, LOSEC, for...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

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

No legal advice privilege over lawyers' notes of interviews with employees

by Allen & Overy LLP on

Astex Therapeutics Limited v Astrazeneca AB [2016] EWHC 2759 (Ch), 8 November 2016 - In-house and external lawyers' attendance notes of conversations with employees of a client company who are not directly involved in...more

Rx IP Update - November 2016

by Smart & Biggar on

Federal Court of Appeal opines on the framework for analyzing obviousness-type double-patenting - On November 4, 2016, the Federal Court of Appeal dismissed Apotex’s appeal in Apotex Inc v Eli Lilly Canada Inc, 2016 FCA...more

Two reverse-payment appeals to watch

It has been over three years since the Supreme Court’s Actavis decision. Since then, numerous putative class actions alleging harm to competition as a result of “reverse-payment” settlements have flooded the courts. The...more

PTAB Life Sciences Report - October 2016

About the PTAB Life Sciences Report: Each month we will report on recent developments at the PTAB involving life sciences patents. Argentum Pharmaceuticals LLC. v. Janssen Oncology, Inc. - PTAB Petition: ...more

The Supreme Court of Canada’s Fall Term: the Internet Court?

by Bennett Jones LLP on

The Supreme Court of Canada’s Fall term, which began on October 3rd, could probably be labelled the “internet term”, with major cases involving both Google and Facebook. The Court will also be hearing a number of other cases...more

Subject Matter Jurisdiction Remains in Hatch-Waxman Patent Infringement Action after ANDA Filer Changes from Paragraph IV to...

The District Court of Delaware denied defendant Wockhardt’s motion to dismiss a patent infringement action based on the reasonable inference that plaintiff AstraZeneca may need to assert its patent rights in the future. On...more

Put the Candle Back: the AstraZeneca FCPA Enforcement Action

by Thomas Fox on

I am back from a two-week summer study program at Oxford, run by Michigan State University through its Odyssey to Oxford program. It was a great experience. My class was on The Tudors in film and print so not only did I...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

Lessons Learned from AstraZeneca’s $5.5 Million SEC FCPA Settlement

by Michael Volkov on

Last week, the SEC added another pharmaceutical company to its list of FCPA violators when AstraZeneca agreed to a $5.5 million settlement with the SEC. AZ is now the 25th drug or medical device company to pay an FCPA penalty...more

A Tale of Two Escobars: Federal Courts Begin Grappling with Opposing Views of “Materiality”

by BakerHostetler on

On June 16, 2016, the U.S. Supreme Court issued a highly anticipated opinion in Universal Health Services, Inc. v. U.S. ex rel. Escobar, which for the first time expressly recognized implied certification as a viable theory...more

Archigen Biotech seeks FDA Approval for Rituximab Phase I Clinical Trials

by Goodwin on

The Korea Herald reports that Archigen Biotech, a joint venture between AstraZeneca UK and Samsung BioLogics, has applied for FDA approval to begin Phase I clinical trials for its rituximab biosimilar, SAIT101. ...more

Deal Watch: AstraZeneca and LEO Pharma collaborate on skin drugs tralokinumab and brodalumab

by Goodwin on

AstraZeneca announced today that it has entered licensing agreements with LEO Pharma to develop and commercialize tralokinumab, a biologic that has completed a Phase IIb trial for atopic dermatitis, and brodalumab, which is...more

IP World Tour: Snapshots of Overseas IP Protection

by WilmerHale on

No matter where you look in the world, it’s a certainty that a dispute is ongoing over someone’s intellectual property (IP). The theft of ideas is nothing new, but just as important to those investing abroad is knowledge of...more

TPPs Fail to Put Their Money Where Their (Litigation) Mouth Is and Lose

by Reed Smith on

In third party payor litigation over prescription medical products, we have often marveled at the causation arguments that plaintiffs have offered and the willingness of some courts to accept collective proof over what really...more

Timing Is Everything – Meeting the One-Year Filing Deadline for IPR - Lannett Holdings Inc. v. AstraZeneca AB

by McDermott Will & Emery on

Addressing the one-year time bar for filing an inter partes review (IPR) petition, the Patent Trial and Appeal Board (PTAB or Board) found petitioner’s arguments regarding proper service and jurisdiction unpersuasive and...more

Supreme Court Hearing May Resolve Critical Questions in Canadian Patent Law

The Supreme Court of Canada (SCC) recently granted AstraZeneca Canada Inc. et al. (AstraZeneca) leave to appeal from the Federal Court of Appeal’s decision upholding the invalidity of AstraZeneca’s Nexium patent. This appeal...more

Federal Circuit Finds Personal Jurisdiction Based On Plans To Market ANDA Product

by Foley & Lardner LLP on

In Acorda Therapeutics Inc. v. Mylan Pharmaceuticals Inc., the Federal Circuit held that the filing of an Abbreviated New Drug Application (ANDA) and intentions to market the product across the United States–including in the...more

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