News & Analysis as of

Allergan Inc

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

PTAB Life Sciences Report -- Part I - April 2017

About the PTAB Life Sciences Report:  Each month we will report on developments at the PTAB involving life sciences patents. Merck Sharp & Dohme Corp. v. Genentech, Inc. - PTAB Petition:  IPR2017-00047; filed...more

PTAB Life Sciences Report -- Part II - March 2017

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents....more

Cat Breeders, Fancy Feast, and Gravity: Seventh Circuit Vacates Certification of Classes of Dissatisfied Buyers

by Benesch on

On March 6, 2017, the Seventh Circuit Court of Appeals vacated a district court’s certification of eight separate classes against Allergan and other defendants under an Illinois and Missouri statute. Eike v. Allergan, Inc.,...more

Exchange Act Sections 13(d), 14(d) and 16(a): A New SEC Focus?

by Dorsey & Whitney LLP on

The Exchange Act requires that certain disclosures be made by significant shareholders and those seeking to make a tender offer. Section 13(d), for example, requires those acquiring a stake of 5% or more to make certain...more

Spotlight on Upcoming Oral Arguments - February 2017

In this appeal, the Federal Circuit will determine whether collateral estoppel can bar a party from asserting an infringement claim when, in previous litigation between the parties, a patent in the same family and covering...more

Blog: Allergan Fined for Failure to Disclose Merger Negotiations with Third Parties During Hostile Bid

by Cooley LLP on

At what point do “discussions” with a friendly merger party become “negotiations” that are required to be publicly disclosed under the tender offer rules in response to a hostile bid? In a recent settlement of cease and...more

SEC and Drugmaker Allergan Reach Settlement over M&A Disclosure Violations

by Dechert LLP on

The U.S. Securities and Exchange Commission and drugmaker Allergan settled claims that Allergan failed to disclose negotiations with third parties following the announcement of a hostile tender offer by Valeant and co-bidder...more

SEC Brings Enforcement Action for Disclosure Failures During Merger Talks

The SEC announced that Allergan Inc. had agreed to admit securities law violations and pay a $15 million penalty for disclosure failures in the wake of a hostile takeover bid. The SEC’s order finds that Allergan failed...more

Amgen and Allergan Submit European Application for Avastin® Biosimilar

by Goodwin on

We recently reported that Amgen and Allergan had submitted an abbreviated Biologics License Application to the FDA for ABP 215, a biosimilar to Avastin® (bevacizumab). Today, the companies announced that they have also...more

Amgen and Allergan Submit BLA for Avastin® Biosimilar

by Goodwin on

As we previously reported, Amgen and Allergan are currently collaborating on four oncology biosimilars, including an Avastin® (bevacizumab) biosimilar, ABP 215. Yesterday, the companies announced the submission of a...more

Allergan Sales, LLC v. Sandoz, Inc.

by Robins Kaplan LLP on

Case Name: Allergan Sales, LLC v. Sandoz, Inc., No. 12-cv-207-JRG, 15-cv-347-JRG, 2016 U.S. Dist. LEXIS 135088 (E.D. Tex. Sept. 30, 2016) (Gilstrap, J.) - Drug Product and Patent(s)-in-Suit: Combigan® (brimonidine...more

Purported Public Interest Group Challenges Drug Patent in Qui Tam Action

The intersection of patent law, drug regulations, creative lawyering, and commerce (if not outright greed) has once again arisen in a qui tam suit brought under 31 U.S.C. §§ 3729–3733 (alleging fraud against the U.S....more

Hartig Drug Co. v. Senju Pharmaceutical Co. (3rd Cir. 2016)

Perhaps one of the most influential first year law school classes for the task of learning how to "think like a lawyer" is civil procedure. Particularly when the professor is bold enough to engage students on the intricacies...more

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