News & Analysis as of

Apotex

Federal Court Dismisses CFAA Claims Against Former Executive, Allows CFAA and DTSA Claims Against Competitor in Pharmaceuticals...

by Seyfarth Shaw LLP on

A recent decision from the Eastern District of Pennsylvania reinforces the importance of the timing of purported misconduct in alleged violations of the Computer Fraud and Abuse Act (CFAA) and Defend Trade Secrets Act (DTSA)....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

Additional Discovery of Clinical Trial Data in Inter Partes Review

by BakerHostetler on

In Apotex, Inc. et al. v. Novartis AG (IPR 2017-00854, paper 47 dated Feb. 5, 2018), petitioner Apotex sought, and was granted, discovery of a Phase III clinical trial protocol from patent owner Novartis. The patent at...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

Apotex Released from Infringement Finding After Claim Construction Appeal

by McDermott Will & Emery on

The US Court of Appeals for the Federal Circuit found that the US District Court for the District of Delaware erred in its claim construction and consequently vacated the ruling that Apotex’s proposed abbreviated new drug...more

Rx IP Update - January 2018

by Smart & Biggar on

Apotex granted damages from contract research organization for delayed FDA approval of two products - Appeal of summary dismissal under PMNOC Regulations: dismissal order stayed...more

Apotex granted damages from contract research organization for delayed FDA approval of two products

by Smart & Biggar on

On December 22, 2017, Patillo J. of the Ontario Super Court of Justice held that Apotex was entitled to $11,303,131.80, plus pre-judgment interest, for losses flowing from delays in the US Food and Drug Administration (FDA)’s...more

2017 – It was biotech and pharma who kept the Australian legal system busy

by FPA Patent Attorneys on

2016 saw the Australian legal system deal with the questions that ranged from defining a human being to defining an inventor. 2017 proved to be just as interesting, and just as informative for patentees and applicants as to...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

Federal Circuit Issues Mandate in Amgen v. Apotex

by Goodwin on

As we previously reported, last month a Federal Circuit panel affirmed the district court’s judgment that Apotex’s pegfilgrastim and filgrastim biosimilar candidates do not infringe Amgen’s protein refolding method...more

Rx IP Update - December 2017

by Smart & Biggar on

PMPRB News - PMPRB releases scoping paper relating to proposed amended Regulations - As previously reported, on December 2, 2017, Canada’s Governor-in-Council published proposed Regulations Amending the Patented...more

IPR Updates

by Goodwin on

Below are recent updates in biosimilar-related IPR proceedings: GENERAL BIOLOGICS PATENTS - On December 1, 2017, the Board granted institution of four IPRs on Celltrion’s petitions (IPR2017-01373 and IPR2017-01374) and...more

Federal Circuit Affirms Apotex Bench Trial Win in Neulasta Biosimilar Suit

On November 13, The Federal Circuit issued a decision affirming a district court judgment that Apotex did not infringe Amgen’s recombinant protein patent in its abbreviated Biologics License Applications referencing Amgen’s...more

Federal Circuit Provides Guidance on Probative Value of “Patent Dance” Letters and aBLA Parameters in an Infringement Analysis

by Fish & Richardson on

On November 13th, in an opinion drafted by Judge Taranto, the Federal Circuit affirmed the Southern District Court of Florida’s judgment that Apotex’s biosimilar versions of Neulasta® and Neupogen® do not infringe Amgen’s...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

Pfizer obtains orders of prohibition on polymorphic form patent

by Smart & Biggar on

On September 22, the Federal Court, in a pair of decisions, granted Orders of prohibition under the Patented Medicines (Notice of Compliance) Regulations preventing Apotex and Teva from marketing their generic...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

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

Fresh From the Bench: Precedential Patent Cases From the Federal Circuit

The Circuit issued only one precedential patent case this week, reversing a determination of obviousness as to a Millennium Pharmaceutical patent covering its blockbuster cancer drug Velcade®, thus extending the life of...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

PILLOW TALK: A Threat to Trade Secrets?

It turns out that, even in romantic relationships, some things are best kept secret. On July 7, 2017, Teva Pharmaceuticals USA, Inc. filed a complaint in the Eastern District of Pennsylvania alleging that a former executive...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

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

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