News & Analysis as of

AstraZeneca

Rx IP Update - April 2018

by Smart & Biggar on

Standing Committee on Health proposes National Pharmacare program, modifications to prescription and generic drug pricing - While common among member countries of the Organisation for Economic Co-operation and Development...more

No Section 8 Liability for Valid and Infringed Patent in NEXIUM Proceeding

by Smart & Biggar on

What happens when a patentee is unsuccessful in a prohibition application under the Patented Medicines (Notice of Compliance) (PMNOC) Regulations against a generic entrant, but subsequently prevails in an infringement action...more

Accounting of profits offers significant benefits to patent owners

by Smart & Biggar on

The Canadian “accounting of profits” remedy for patent infringement, which is not available in the U.S., provides a potentially significant opportunity for companies with Canadian IP rights. Recent court decisions have...more

Top 10 Highlights of Canadian IP Law and Practice in 2017

by Smart & Biggar on

2017 was a year of significant developments to Canadian IP law and practice, with important court decisions and numerous legislative amendments. We have taken the opportunity to review the top 10 highlights from the past...more

Rx IP Update - 2017 Highlights in Canadian Life Sciences IP

by Smart & Biggar on

The year 2017 was one of the most significant years for Canadian Life Sciences IP and Regulatory Law in Canada’s history. The year saw major developments in patent linkage, patent term, and substantive patent issues. As we...more

Courts Continue To Grapple With Leave As A Reasonable Accommodation Under ADA

by Pierce Atwood LLP on

When is it safe to terminate an employee who has exhausted (or is ineligible for) Family Medical Leave Act (FMLA) leave, but who is unable to return to work? This question continues to confound employers, and has been the...more

Rx IP Update - October 2017

by Smart & Biggar on

Pfizer obtains orders of prohibition on polymorphic form patent - On September 22, the Federal Court, in a pair of decisions, granted Orders of prohibition under the Patented Medicines (Notice of Compliance) Regulations...more

Update on AstraZeneca SCC and developments on “overpromising” under grounds other than utility

by Smart & Biggar on

SCC Update. On October 23, 2017, the Supreme Court of Canada dismissed Apotex’s motion to amend the Supreme Court of Canada’s judgment in AstraZeneca Canada Inc v Apotex Inc, 2017 SCC 36 (reported here, relating to...more

Federal Court of Appeal Applies Supreme Court’s Utility Test to SPRYCEL Patent

by Smart & Biggar on

In its first decision to consider the Supreme Court of Canada’s landmark decision in AstraZeneca Canada Inc v Apotex Inc, 2017 SCC 36 [Esomeprazole](see our article here) on the utility requirement, the Federal Court of...more

AstraZeneca succeeds in omeprazole patent infringement profits case

by Smart & Biggar on

The Federal Court has issued its Public Judgment and Reasons concerning the financial compensation to be paid to AstraZeneca as a result of Apotex’s infringement of the omeprazole formulation patent (AstraZeneca’s LOSEC) in...more

Mylan Pharm. v. AstraZeneca AB (PTAB 2017)

The Patent Trial and Appeal Board of the U.S. Patent and Trademark Office recently issued a Final Written Decision in an inter partes review styled Mylan Pharm. v. AstraZeneca AB affirming the patentability of all challenged...more

Rx IP Update - August 2017

by Smart & Biggar on

Gilead prevails in SOVALDI appeal - The Federal Court of Appeal recently affirmed a trial decision relating to two competing patents over Gilead’s SOVALDI (sofosbuvir). In the trial decision, as previously reported, the...more

Rx IP Update - July 2017

by Smart & Biggar on

Supreme Court of Canada strikes down "promise doctrine", upholds AstraZeneca’s NEXIUM patent as useful - As previously reported, on June 30, 2017, the Supreme Court of Canada granted AstraZeneca’s appeal in the NEXIUM...more

Supreme Court of Canada Promises New Utility Test for Patents

What does “useful”, one of the basic requirements for the patentability of an invention, mean in Canadian patent law? On June 30, 2017, in AstraZeneca Canada Inc. v. Apotex Inc. (AstraZeneca), the Supreme Court of Canada...more

Court Construes “Hydrate” to Require Crystalline Form Following Battle of the Experts

by McDermott Will & Emery on

Addressing the issue of the proper construction of claims to a trihydrate compound, the US District Court for the District of New Jersey concluded that a person of ordinary skill in the art (POSA) would understand “hydrate”...more

Procure and Enforce—Canada's Highest Court Hands IP Owners Two Wins in Three Days

by Bennett Jones LLP on

The Supreme Court of Canada has issued two IP decisions in the span of three days—both of which spell victory for IP rights-holders. One case confirms the availability of a novel form of worldwide injunction where a non-party...more

A broken promise – The Supreme Court of Canada reverses Canada's "promise of the patent" doctrine

by DLA Piper on

The Supreme Court of Canada (or SCC) has dealt a significant blow to the “promise of the patent” doctrine—a controversial judge-made approach to the question of patent utility in Canada that has been heavily criticized over...more

Supreme Court of Canada strikes down "promise doctrine", upholds AstraZeneca’s NEXIUM patent as useful

by Smart & Biggar on

The Supreme Court of Canada today delivered an important and highly anticipated decision, AstraZeneca Canada Inc v Apotex Inc (2017 SCC 36), by rejecting the “promise doctrine” and clarifying the requirement for patent...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

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

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