News & Analysis as of

Pfizer

Your Daily Dose of Financial News

by Robins Kaplan LLP on

The Peltz/P&G drama continues, with the company suggesting that Trian has lost its bid for a Board seat and the fund arguing that it disagrees with the company’s counting of the ballots....more

No Comment: Temporary Anti-Inversion Regulation Rejected Under Administrative Procedure Act

On Friday, September 29, 2017, the Federal court for the Western District of Texas struck down the temporary anti-inversion regulation issued under Sec. 7874, which has been charged with preventing the planned $160 billion...more

Following Biosimilar Trial, Jury Awards Amgen $70 Million for Pfizer’s Pre-Approval Infringement of Now-Expired EPO Patent

In one of the first Biologics Price Competition and Innovation Act (BPCIA) litigations to reach trial, a jury on Friday awarded Amgen $70 million in damages for Pfizer’s infringement of one of Amgen’s expired patents...more

Funding Arrangements in Private Litigation Are Private Matters—Not to Be Scrutinized by the Federal Court or the Defendant

by Bennett Jones LLP on

Equip: IP Litigation Case of the Week - The cost of litigation can be a non-starter for an intellectual property owner with a strong infringement case. Litigation funding enterprises can help where the cost of litigation...more

Pfizer and Flynn Pharma fined €101 million for charging the UK health service excessive prices for Phenytoin sodium capsules, an...

by Dechert LLP on

The UK Competition and Markets Authority (“CMA”) recently published its infringement decision of 7 December 2016 that imposed a fine on Pfizer and Flynn Pharma (“Flynn”) for abusing their respective dominant positions by...more

Pfizer Sues J&J, Alleges Anticompetitive Practices in Connection with Remicade®

by Goodwin on

Today, Pfizer filed an antitrust lawsuit against Johnson & Johnson (J&J) in the U.S. District Court for the Eastern District of Pennsylvania alleging that J&J has engaged in an anticompetitive scheme to protect its Remicade®...more

Recent IPR Updates

by Goodwin on

The PTAB has been a busy place for biologics patents in the past few weeks. Here are some of the highlights...more

Amgen/Allergan and Pfizer Present Positive Phase 3 Data For Two Investigational Trastuzumab Biosimilars

by Goodwin on

At the European Society for Medical Oncology (“ESMO”) 2017 Congress, which was held over the past several days in Madrid, Spain, companies presented Phase 3 clinical data regarding two investigational biosimilars of...more

Excessive Pricing in Generic Drug Markets

by Ropes & Gray LLP on

EU and UK antitrust laws make it illegal for dominant firms to charge unfair or excessive prices. These laws have most often been applied in markets that feature high barriers to entry or expansion, which enable a dominant...more

Anti-Corruption Risks and Drug and Device Companies

by Michael Volkov on

For years, the Justice Department and the Securities and Exchange Commission touted the FCPA “sweep” of the pharmaceutical and medical device industries. With good reason, DOJ and the SEC turned the drug and medical device...more

Hospira Finds Mixed Results in Instituting IPRs Against Genentech Patents for Herceptin®

by Knobbe Martens on

Hospira (owned by Pfizer) filed five IPR petitions against Genentech patents that Genentech asserted were directed to Herpceptin® (trastuzumab). The PTAB has now instituted IPRs in three of the five petitions and denied the...more

Genentech to Defend 3 of 4 Herceptin® Patents Challenged by Hospira

by Jones Day on

At least 19 IPRs have been filed against seven of Genentech’s patents covering its blockbuster antibody drug Herceptin® (trastuzumab). On July 27, 2017, the PTAB instituted IPRs filed by Hospira, Inc. (a subsidiary of Pfizer)...more

Q2 Earnings Round-Up

by Goodwin on

Below are some highlights from second quarter earnings reports recently released by biologics and biosimilar companies. ..Coherus reported that it has cash and cash equivalents of $118.3 million as of June 30, 2017 and...more

Money’s big for Big Pharma — in settlements, lobbying, and product prices

Even as drug makers are settling or scrambling to resolve disputes with regulators over dubious ways they peddle products, Big Pharma is busting records for its spending to lobby lawmakers on skyrocketing prices, easing...more

Bevacizumab Biosimilar Update

by Goodwin on

There has been some recent activity regarding proposed biosimilars to Roche’s Avastin (bevacizumab). Avastin is indicated for the treatment of various types of cancers, including colorectal, lung, and kidney cancer....more

PTAB Life Sciences Report - July 2017 #3

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents. Pfizer, Inc. v. Biogen, Inc. PTAB Petition: IPR2017-01115; filed March 24, 2017....more

Pfizer Takes Aim at Herceptin® Patent at the PTAB

by Fish & Richardson on

Pfizer has shown its muscle in the biosimilars field, purchasing Hospira in 2015 and launching the second biosimilar on the U.S. market, Inflectra® (infliximab), a biosimilar of Johnson & Johnson’s Remicade®. Pfizer is now...more

The Travails of the First U.S. EPO Biosimilar

Pfizer’s proposed biosimilar of Amgen’s Epogen® and Johnson & Johnson’s Procrit® (epoetin alfa) is poised to be the first erythropoietin (EPO) biosimilar in the U.S. FDA staff recommended approval of Pfizer’s product as a...more

What Is Actual Knowledge? Third Circuit to Weigh in on Post-Escobar Materiality Question

by Pepper Hamilton LLP on

One year after the Supreme Court changed the False Claims Act landscape, FCA litigants continue to grapple with the “demanding” materiality standard set forth in Universal Health Services v. United States ex rel Escobar. Now...more

Pfizer Files Two Petitions for IPR of Genentech’s Trastuzumab Patent

by Goodwin on

Pfizer has filed two petitions for IPR of U.S. Patent 8,591,897, owned by Genentech: IPR2017-01726 and IPR2017-01727. According to the petitions, the ‘897 patent is directed to methods for treating patients with...more

Federal Court reaffirms and reissues section 8 venlafaxine judgments overturned by the Court of Appeal for hearsay

by Smart & Biggar on

As previously reported, in 2016 the Federal Court of Appeal set aside a decision of the Federal Court awarding Teva close to $125 million in damages under section 8 of the Patented Medicines (Notice of Compliance) Regulations...more

Pfizer Gets Second CRL On Proposed Epoetin Alfa Biosimilar

by Goodwin on

According to a Pfizer press release, the FDA has issued a second Complete Response Letter (CRL) to Pfizer in connection with the company’s aBLA for Retacrit, a proposed biosimilar of Epogen® and Procrit® (epoetin alpha)....more

Consolidated Cholesterol Drug Cases Lack Critical Mass for CAFA Jurisdiction

by Carlton Fields on

The Central District of California district court recently weighed in on the limits of mass action jurisdiction under the Class Action Fairness Act (CAFA). The matter began as various individual state court actions alleging...more

Biosimilars Update -- Pfizer's Proposed Epogen®/Procrit® Biosimilar Recommended for Approval

On May 25, 2017, the FDA's Oncologic Drug Advisory Committee recommended approval of biologics license application ("BLA") 125545 submitted by Hospira Inc., a Pfizer company, for Retacrit, a proposed biosimilar to Amgen...more

Pfizer files two IPR petitions on Genentech’s Patent Directed to Methods of Making Humanized Antibodies

by Goodwin on

Pfizer, Inc. has filed two petitions (IPR2017-01488 and IPR2017-01489) challenging claims of U.S. Patent No. 6,407,213 (“the’213 patent”). According to the petitions, the ’213 patent is directed to methods of making humanized...more

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