News & Analysis as of

Pfizer

FDA Approves Ixifi® (infliximab-qbtx), Third Biosimilar of Remicade® in U.S.

by Goodwin on

The FDA announced that it has approved Pfizer’s Ixifi® (infliximab-qbtx) as a biosimilar to Remicade®. Ixifi® is indicated for the treatment of most of the same conditions as its reference product: Crohn’s disease, pediatric...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

Pfizer Accuses J&J of Anticompetitive Business Practices over Remicade Biosimilar

by Knobbe Martens on

In a recent development with the ongoing complex litigation involving Janssen Biotech’s arthritis biologic medicine Remicade (infliximab) and Celltrion’s biosimilar, Celltrion’s partner Pfizer has filed a suit against...more

The Herceptin® Battle Moves into the District Court

by Fish & Richardson on

On November 17, 2017, Genentech filed suit against Pfizer in the District of Delaware, alleging that Pfizer’s biosimilar of Herceptin® infringes forty Genentech patents covering Herceptin® and its methods of use and...more

Genentech Files Complaint Against Pfizer Regarding Herceptin

by Goodwin on

Genentech filed a complaint last Friday in the District of Delaware against Pfizer for infringement of 40 patents under the BPCIA regarding PF-05280014, Pfizer’s biosimilar of Herceptin® (trastuzumab). According to the...more

IPR Updates

by Goodwin on

Here are some updates since our last IPR update: HUMIRA - On November 6, 2017, Sandoz filed an IPR Petition challenging AbbVie’s U.S. Patent No. 9,187,559 (IPR2018-00156). ...more

Pfizer Inc. v. Mylan Pharms. Inc.

by Robins Kaplan LLP on

Case Name: Pfizer Inc. v. Mylan Pharms. Inc., No. 15-79-GMS, 2017 U.S. Dist. LEXIS 125634 (D. Del. Aug. 9 2017) (Sleet, J.). Drug Product and Patent(s)-in-Suit: Toviaz® (fesoterodine fumarate extended-release tablets);...more

PTAB Life Sciences Report - November 2017

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 and Genentech, Inc. PTAB Petition: IPR2017-02126; filed October 6,...more

Pfizer and Celltrion Healthcare Reveal New Data For infliximab biosimilar Inflectra®

by Goodwin on

Last year we reported the FDA approval and then U.S. launch of Inflectra®, a biosimilar of Remicade® (infliximab). This week, Pfizer and Celltrion Healthcare have reported that the results of a Phase 3 study of Inflectra...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

PTAB Life Sciences Report - October 2017

About the PTAB Life Sciences Report:  Each month we will report on developments at the PTAB involving life sciences patents. Sun Pharmaceuticals Industries, Ltd. v. Novartis AG - PTAB Petition: IPR2017-01929; filed...more

Texas Federal District Court Invalidates IRS Regulations Limiting Inversion Transactions

by Shearman & Sterling LLP on

On September 29, 2017, the United States District Court for the Western District of Texas granted summary judgment in favor of the U.S. Chamber of Commerce and Texas Association of Business, holding that the Internal Revenue...more

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

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