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The Tangential Exception to Prosecution History Estoppel

ELI LILLY AND COMPANY v. HOSPIRA, INC. Before Lourie, Moore, and Taranto. Appeal from the District Court for the Southern District of Indiana. Summary: A narrowing claim amendment does not necessarily surrender all...more

State Sovereign Immunity Does Not Bar an IPR

REGENTS OF THE UNIV. OF MINN. v. LSI CORPORATION - Before Dyk, Wallach, and Hughes. Appeal from the Patent Trial and Appeal Board. Summary: State sovereign immunity does not apply to IPR proceedings asserted against...more

Dr. Falk Pharma GmbH v. Generico, LLC

Federal Circuit Summary - Before Lourie, O’Malley, Reyna. Appeals from the Patent Trial and Appeal Board, United States District Court for the Northern District of West Virginia, and United States District Court for the...more

UC v. Broad Institute: No Interference-In-Fact in CRISPR Genome Editing Applications

Federal Circuit Summary - On September 10, 2018, the Federal Circuit decided Regents of the University of California v. Broad Institute, Inc., affirming the Patent Trial and Appeal Board (PTAB)’s determination of no...more

FDA to Hold Public Hearing on Biosimilar Action Plan

On July 18, 2018, the FDA released a Biosimilar Action Plan that is aimed at promoting competition and affordability across the market for biologics and biosimilar products. The Plan uses four key strategies to accomplish...more

FDA Commissioner Plans to Create a Fast Track Approval Pathway for Certain Gene Therapies

During a speech on May 22, 2018 at the Alliance for Regenerative Medicine's Annual Board Meeting, Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced that the FDA plans to alert companies that “certain...more

D Three Enterprises, LLC v. Sunmodo Corporation

Federal Circuit Summaries - Before Reyna, Clevenger, and Wallach. Appeal from the United States District Court for the District of Colorado - Summary: Even in a simple mechanical case, a narrow disclosure in the...more

Arthrex, Inc. v. Smith & Nephew, Inc.

Federal Circuit Summaries - Before Newman, Dyk, and O’Malley. Appeal from the Patent Trial and Appeal Board. Summary: The PTAB may enter an adverse judgment against a patent owner where, before issuing an institution...more

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

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

California’s Drug Price Transparency Bill

On October 9, 2017, California Governor Jerry Brown signed the new drug price transparency bill SB 17. The new law requires pharmaceutical companies to give 60 days’ notice to state and health insurers if they plan to raise...more

How to Lose an IPR but Amend Your Claims in Reexam and Keep Your Patent

On August 30, 2017, the PTAB issued a Final Written Decision in M & P Golf, LLC (d/b/a Cool Clubs) v. Max Out Golf, LLC, IPR2016-00784, Paper 43 (P.T.A.B August 30, 2017), entering adverse judgement on the original patent...more

Digital Currencies and Blockchain in the Medical Arena

Recently, digital currencies, such as bitcoin, have greatly increased in popularity. Some of this popularity may be attributed to digital currencies’ many purported advantages over traditional currencies, such as that...more

Pharmacyclics Receives FDA Approval for Imbruvica in Treatment for Chronic Graft Versus Host Disease

On August 2, 2017, the U.S. Food and Drug Administration approved the use of Imbruvica® (ibrutinib) for the treatment of adult patients with chronic graft versus host disease (cGVHD) to Pharmacyclics LLC. Imbruvica® is the...more

Janssen and Celltrion: Remicade Biosimilar Patent Dance

Janssen Biotech Inc. and Celltrion Healthcare have taken the next step over Janssen’s blockbuster arthritis biologic medicine Remicade (infliximab) and Celltrion’s biosimilar, as required by the Biologics Price Competition...more

WannaCry Malware and Medical Device Security

The WannaCry virus has infected and frozen computers in many industries around the world. According to a news source report, the virus has extorted doctors and hospital administrators for the keys to unlock and regain access...more

Genentech and Roche Secure FDA Approval of Multiple Sclerosis Drug Ocrevus

On March 28, 2017, the U.S. Food and Drug Administration (FDA) approved the use of Ocrevus (ocrelizumab) in treating multiple sclerosis (MS). Ocrevus is a new biologic and is the first drug approved by the FDA to treat...more

PTAB Grants Rare Motion to Amend

The PTAB issued a Final Written Decision in Amerigen Pharm. Ltd. v. Shire LLC, IPR2015-02009, Paper 38 (P.T.A.B. March 31, 2017) granting a rare motion to amend. The motion canceled all instituted claims and amended a...more

Outsourcing of Services in the Medical Device Industry

As the medical device market continues to grow, the medical device industry has strived to reduce costs through outsourcing. An industry report has found that the global medical device outsourcing market was valued at $33.2...more

Biotechnology Considerations for the Unitary Patent System in Light of Brexit and Other Current Developments

Written by Daniel A. Kamkar and Eric Furman, Ph.D. After the United Kingdom voted to leave the European Union, dubbed “Brexit” by the press, many have called into question whether the UK would ratify the Unitary Patent...more

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