News & Analysis as of

Allergan Inc

Generic Defendants Shed No Tears after Winning Motion to Add Incorrect Inventorship Defense

by McDermott Will & Emery on

The US District Court for the Eastern District of Texas granted defendants' motion to amend their pleadings after the deadline for amending had passed. Allergan v. Teva Pharmaceuticals USA, No. 15-1455-WCB, 2017 WL 1512334...more

Biosimilars Update: Amgen, Allergan, Pfenex, Cinfa

by Goodwin on

Below are regulatory and development updates regarding a number of biosimilar candidates. Today, Amgen and Allergen announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency...more

Allergan, Inc. v. Teva Pharms. USA, Inc.

by Robins Kaplan LLP on

Case Name: Allergan, Inc. v. Teva Pharms. USA, Inc., No. 2:15-CV-1455-WCB, 2017 U.S. Dist. LEXIS 136445 (E.D. Tex. Aug. 25, 2017) (Bryson, C.J.). Drug Product and Patent(s)-in-Suit: Restasis® (cyclosporine); U.S. Patents...more

Allergan Sales, LLC v. Teva Pharms. USA, Inc.

by Robins Kaplan LLP on

Case Name: Allergan Sales, LLC v. Teva Pharms. USA, Inc., Civ. No. 2:15-cv-01471-FRG-RSP, 2017 U.S. Dist. LEXIS 127886 (E.D. Tex. July 25, 2017) (Payne, M.J.). Drug Product and U.S. Patent: Delzicol® (mesalamine); U.S....more

PTAB Permits Amicus Briefing in Connection with the St. Regis Mohawk Tribe’s Motions to Terminate IPRs Based on Tribal Sovereign...

by Goodwin on

In a move that has attracted attention from industry, the judiciary, and Congress, Allergan, Inc. assigned its rights to patents covering its Restasis® dry eye treatment to the St. Regis Mohawk Tribe (“Tribe”) and...more

Missouri Senator Introduces Bill to Abrogate Native American Sovereignty for Inter Partes Review Petitions

by Orrick - IP Landscape on

S.1948 – A bill to abrogate the sovereign immunity of Indian tribes as a defense in inter partes review of patents. Allergan, Inc. and The Saint Regis Mohawk Tribe v. Teva Pharmaceuticals USA, Inc., Mylan Pharmaceuticals,...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

Senators and court complain of ‘anti-competitive’ transfer of patent rights to American Indian tribe

We have previously discussed antitrust implications of pharmaceutical companies’ efforts to maximize patent protection for their drugs. Consumers and generic drug makers, for instance, have alleged antitrust violations based...more

Patents for Billion Dollar Restasis Drug Under Siege

Using an innovative strategy, pharmaceutical company Allergan recently transferred the patents associated with the eye drug, Restasis, to the Saint Regis Mohawk Tribe, in exchange for an exclusive license back. The tribe...more

Court Permits St. Regis Mohawk Tribe to Join Restasis® Litigation, but Nixes Allergan’s Patents

by Goodwin on

Today, Judge Bryson, a Federal Circuit judge sitting by designation in the U.S. District Court for the Eastern District of Texas, Marshall Division, issued an Opinion and Order granting Allergan’s motion to join the St. Regis...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

The Restasis Patents and Tribal Sovereign Immunity: New Developments

by Polsinelli on

The battle between Mylan and Allergan over the six Orange Book patents covering Restasis has taken a next formal step. On Sept. 22, the new patent-owner, the Saint Regis Mohawk Tribe, moved to dismiss Mylan’s requests for...more

Issue Eight: PTAB Trial Tracker

by Goodwin on

A Surprise Move Designed to Shield Patents from IPR - On September 8, 2017, Allergan announced that it had assigned its patents covering Restasis®, a dry eye treatment with a reported $1.4B in sales last year, to the Saint...more

Pharmaceutical Company Seeks to Use Tribal Sovereign Immunity to Avoid Inter Partes Review

by Snell & Wilmer on

Allergan announced on September 8, 2017, that it had transferred its patents covering the drug Restasis to the Saint Regis Mohawk Tribe and will pay the tribe $13.75 million. The tribe is also eligible to receive $15 million...more

Allergan Avails Itself of Sovereign Immunity

The 11th amendment to the Constitution reads: The judicial power of the United States shall not be construed to extend to any suit in law or equity, commenced or prosecuted against one of the United States by citizens of...more

Mohawks To The Rescue? Can You Immunize Patents From PTAB Review By Assigning To A Native American Tribe?

by Pepper Hamilton LLP on

In an unusual move to combat the perceived bias in favor of patent challengers at the U.S. Patent Office’s Patent Trial and Appeal Board (PTAB), the Irish drug company Allergan has decided to warehouse its key patents on the...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

Second Circuit Accepts Appeal of False Claims Act First-To-File Issues

by Farrell Fritz, P.C. on

The Second Circuit recently agreed to accept an interlocutory appeal to decide the question whether a violation of the False Claims Act’s “first-to-file” rule compels dismissal of the complaint or whether it can be cured by...more

Celltrion/Teva and Amgen/Allergan Announce FDA Submissions for Proposed Biosimilars of Herceptin®

by Goodwin on

Yesterday, two groups announced the submission of applications seeking FDA approval of biosimilars of Herceptin® (trastuzumab), which is indicated for the treatment of HER2-positive early breast cancer, adjuvant breast...more

Settling the Discoverability of Settlement Agreements

by McDermott Will & Emery on

Settlement agreement between a co-defendant and plaintiff in a Hatch-Waxman patent litigation matter is discoverable, ruled Judge Bryson in Allergan, Inc. v. Teva Pharmaceuticals, Inc. et al., Case No. 15-1455 (E.D. Tex.,...more

First U.S. Avastin and Herceptin Biosimilars

On Thursday, July 13, 2017, FDA’s Oncological Drugs Advisory Committee (ODAC) unanimously recommended approval of biosimilars of two blockbuster cancer drugs. The first, Amgen and Allergan’s ABP-215, is a proposed biosimilar...more

Ohio sues Big Pharma firms over harms of opioid drug abuse epidemic

With more than 4,000 overdose deaths last year alone and a fifth of its residents having received prescriptions for powerful painkillers, the state of Ohio has sued five Big Pharma companies, accusing them of mispresenting...more

Allergan, Inc. v. Teva Pharms. USA, Inc.

by Robins Kaplan LLP on

Case Name: Allergan, Inc. v. Teva Pharms. USA, Inc., 15-1455-WCB, 2017 U.S. Dist. LEXIS 4545 (E.D. Tex. Jan. 12, 2017) (Bryson, J.). Drug Product and Patent(s)-in-Suit: Restasis® (cyclosporine ophthalmic solution); U.S....more

Allergan Successfully Invalidates Claims Relating to Using Botox to Treat Back Pain

by Jones Day on

Allergan is typically the patent holder in these types of disputes, however, it recently successfully played the role of petitioner in an IPR against 1474791 Ontario Ltd.’s U.S. Patent No. 6,806,251 covering the use of...more

PTAB Life Sciences Report -- Part II - April 2017

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents. Teva Pharmaceuticals USA, Inc. v. Allergan, Inc. - PTAB Petition: IPR2017-00576; filed...more

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