Pfizer

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FDA Regulatory and Compliance Monthly Recap — January 2016

OPDP enforcement reaches record low in 2015 as drugmakers face uncertainty in digital marketing - Enforcement by the OPDP has fallen notably since 2010. The decline has been attributed, in part, to the agency's slow...more

Pfizer v. Lee: A Patent Term Adjustment Double Standard?

In Pfizer v. Lee (No. 2015-1265, January 22, 2016), the Federal Circuit upheld the U.S. Patent and Trademark Office’s (USPTO) determination that the toll period for A-type patent term adjustment (PTA) delay stops upon the...more

Federal Circuit Holds a Defective Restriction Requirement Ends Patent Term Adjustment

In Pfizer v. Lee, the Court of Appeals for the Federal Circuit held that a “defective” restriction requirement was sufficient to stop the period of patent term adjustment granted when the U.S. Patent and Trademark Office...more

Incomplete Restriction Requirement Stops Clock For Patent Term Adjustment

In Pfizer v. Lee, the Federal Circuit affirmed the decision of the U.S. District Court for the Eastern District of Virginia that upheld the USPTO’s Patent Term Adjustment (PTA) calculation that stopped the clock running...more

Canadian Court Nixes Class Action for Patent Abuse

The decision relates to an application to certify a proposed class action, commenced by a representative plaintiff, Britton Low, against various Pfizer companies, alleging that Pfizer unlawfully abused the patent system with...more

IRS Continues Focus on Corporate Inversions

The Internal Revenue Service (IRS) continues its focus on perceived abuses in corporate inversion transactions. On November 19, the IRS released Notice 2015-79, which places new limitations on the ability of a U.S....more

Life Sciences Spotlight - Asia Pacific - Issue 6, 2015

Trends and developments in cyber security and data protection: Why pharma and life sciences companies should take action. Pharmaceutical and life sciences companies are increasingly the target of cyber-attacks and...more

Enbrel Biosimilar in Europe and US

On November 19, 2015, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion, recommending marketing authorization of Benepali, the first biosimilar of Enbrel...more

Federal Judge Remands Viagra Case to State Court

In February 2015, sixteen plaintiffs sued Pfizer, the maker of Viagra, alleging that their ingestion of Viagra between 1998 and 2013 caused them to develop melanoma. Plaintiffs asserted the following cause of actions: breach...more

Your daily dose of financial news The Brief – 11.25.15

A groundbreaking move by Calpers—California’s state pension fund—to disclose how much money it’s made from and paid to private equity funds ($24.2 billion and $3.4 billion, respectively, since 1990) may help pave the way for...more

Your daily dose of financial news The Brief – 11.24.15

The Pfizer/Allergan deal continues to dominate the financial world, with Pfizer’s CEO defending the merger and Washington searching for ways to reform the corporate tax code and prevent future tax-motivated corporate...more

Your daily dose of financial news The Brief – 11.23.15

Clocking in at an as-promised $150 billion, the Pfizer/Allergan merger is a done deal, marking one of the biggest ever takeovers in the health care industry. As mentioned here last week, the deal finalization comes on the...more

Pfizer Inc. v. Alkem Labs. Ltd.

Case Name: Pfizer Inc. v. Alkem Labs. Ltd., Civ. No. 13-1110-GMS, 2015 U.S. Dist. LEXIS 94327 (D. Del. July 21, 2015) (Sleet, J.) - Drug Product and Patent(s)-in-Suit: Toviaz® (fesoterodine); U.S. Patents Nos. 7,384,980...more

DOJ Fraud Section Retains Hui Chen as Compliance Counsel Expert

Chen brings important industry experience to the role. The Department of Justice (DOJ) Fraud Section has retained Hui Chen as a “full-time compliance expert.” Ms. Chen comes to the position with compliance counseling...more

Another No Show For Personal Jurisdiction In The Show Me State

We have previously expressed our surprise that personal jurisdiction has so quickly become such an effective bulwark against the forum abuse that we call litigation tourism. Our surprise is modest, mind you, since the recent...more

When a Divisional Is Not a Divisional: No Section 121 Safe Harbor for Reissue Patentee Who Retroactively Omitted New Matter - G.D....

Addressing the “safe harbor” provision under 35 U.S.C. § 121, the U.S. Court of Appeals for the Federal Circuit upheld a district court ruling that a reissue patent was invalid for obviousness-type double patenting. G.D....more

Pharmaceutical IP and Competition Law in Australia: Overview

Conditions and legislation Australian patent law is governed by the Patents act 1990 (Cth) (Patents Act). The Patents Act provides for the grant of two main types of patents in Australia: - Standard, which is...more

Federal Circuit Strikes Final Blow to Celebrex Patent

In 2008, the Federal Circuit determined that claims 1-4 and 11-17 of U.S. Patent No. 5,760,068 were invalid for obviousness-type double patenting (OTDP) over a related parent patent, in part because the ‘068 patent was filed...more

G.D. Searle LLC v. Lupin Pharmaceuticals, Inc. (Fed. Cir. 2015)

Over seven years ago, the Federal Circuit delivered a mixed ruling against Pfizer in litigation against Teva) relating to the pain medication Celebrex® (celocoxib) (where "celocoxib" is...more

Pfizer Wins First Zoloft Birth Defect Trial in Missouri

A jury trial was wrapped up recently after lasting a little more than a week in state court in St. Louis after the jury found in favor of Pfizer. The lawsuit alleged that Logyn Pesante, an eleven year old boy from California,...more

Pfizer’s strategic response to the threat of generic competition upheld by the Federal Court

On 25 February 2015, the Federal Court handed down its much-anticipated judgment in the matter of ACCC v Pfizer Australia Pty Ltd. In dismissing the Australian Competition and Consumer Commission’s (ACCC) allegations, Justice...more

Pfizer Inc. v. Mylan Pharms. Inc.

Case Name: Pfizer Inc. v. Mylan Pharms. Inc., Civ. No. 10-528-GMS, 2014 U.S. Dist. LEXIS 150283 (D. Del. Oct. 22, 2014) (Sleet, J.) (When a POSA would have to undertake significant guesswork to vary the parameters of...more

Court Report - February 2015 #4

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Novartis Vaccines and Diagnostics, Inc. et al. v. Pfizer, Inc. 2:15-cv-01283; filed February 18, 2015 in the District...more

Court Report - February 2015

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Otsuka Pharmaceutical Co. Ltd. v. Apotex Inc. et al. 1:15-cv-00109; filed January 29, 2015 in the District Court of...more

Viagra Ad Campaign Targets Women Amid Melanoma Risk

Viagra is so popular that it is a frequent target of counterfeiters. Here, a U.S. Customs and Border Patrol agent displays seized goods. Viagra (sildenafil) has featured prominently in the news over the past few months...more

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