News & Analysis as of

Life Sciences

PTAB Life Sciences Report -- Part II - April 2017#2

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents. Actavis Laboratories FL, Inc. et al. v Janssen Oncology, Inc. PTAB Petition: IPR2017-00853;...more

Is there a legislative fix for biotech patents?

by Morrison & Foerster LLP on

By some accounts, we have entered a golden age for innovation in personalised medicine. Through scientific advancements in the study of genetic coding and molecular analysis, it is now possible to screen an individual for...more

FDA Relents, Grants Premarket Authorization to 23andMe Genetic Diagnostics Test

On April 6th, the U.S. Food and Drug Administration (FDA) continued to loosen the reins on the genetic diagnostic and DNA analysis company 23andMe with regarding to direct-to-consumer (DTC) genetic testing related to...more

French Legal and Regulatory Update – March 2017

by Hogan Lovells on

The Paris office of Hogan Lovells is pleased to provide this English language edition of our monthly e-newsletter, which offers a legal and regulatory update covering France and Europe for March 2017. Please see full...more

PTAB Life Sciences Report -- Part I - April 2017#2

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents. Reckitt Benckiser LLC v. Ansell Healthcare Products LLC - PTAB Petition: IPR2017-00063; filed...more

FDA Cleared First DTC Genetic Tests for Health Risks

by Hogan Lovells on

Last week, the U.S. Food and Drug Administration (FDA) granted marketing authorization for 23andMe’s Personal Genome Service (PGS) Test for 10 diseases or conditions. This was the first FDA authorization for a...more

Healthcare & Life Sciences Private Equity Deal Tracker: KKR to Acquire Angelica Corp.

by McGuireWoods LLP on

Angelica Corp. has announced it has entered into an asset purchase agreement with an affiliate of PE firm KKR. KKR will acquire Angelica’s assets for approximately $125 million plus certain assumed liabilities. Angelica...more

PTAB Life Sciences Report -- Part IV

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents. Smith & Nephew, Inc. v. ConforMIS, Inc. PTAB Petition: IPR2017-00778; filed January 26,...more

The FTC and LabMD’s Legal Battle Gets Personal: First Amendment Claims Against FTC Lawyers Survive

The Federal Trade Commission’s (FTC) sprawling and contentious legal battle with now-defunct medical testing company LabMD recently took an unusual turn when a federal court allowed LabMD (and its former CEO) to proceed with...more

United Medical Instruments Inc. Settles Potential Civil Liability for Alleged Violations of the Iranian Transactions and Sanctions...

by Arnall Golden Gregory LLP on

On February 28, 2017, United Medical Instruments, Inc. (UMI), a California corporation, settled its potential civil liability with the U.S. Department of the Treasury’s Office of Foreign Assets Control (OFAC) in the amount of...more

Right-to-Try or Right to Ask?

by Arnall Golden Gregory LLP on

Recently, the American Society of Clinical Oncology (ASCO), a prominent medical organization, announced that it does not support so called “right-to-try” laws. Right-to-try legislation, which has now gained support in 33...more

Life Sciences Quarterly – Preparing for and Managing a Stock Drop

by Ropes & Gray LLP on

A sharp drop in a company’s stock price frequently results in the filing of one or more securities class actions. 2016 saw the highest number of securities class actions since 2000, with more than 1 in 20 publicly traded...more

Is The Peer Review Crisis A Patent Application Crisis?

by JD Supra Perspectives on

Reproducibility is the cornerstone of peer-reviewed science. A surprisingly high percentage of major studies across various scientific disciplines cannot be reproduced....more

Brexit and Life Sciences Companies

by Arnall Golden Gregory LLP on

The United Kingdom (UK) government served notice on March 29, 2017, under Article 50 of the Treaty on European Union that it intends to withdraw from the European Union (EU). There is no guide to managing a departure under...more

PTAB Life Sciences Report -- Part III

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents. Complex Innovations, LLC. v. AstraZeneca AB - PTAB Petition: IPR2017-00631; filed January 9,...more

[Webinar] Investment Decisions for Investors and Entrepreneurs Considering 505(b)(2) Drug Applications: How to Make Sure Your...

by Robins Kaplan LLP on

Wednesday, April 19, 2017, 1:00 P.M. CST -- Are you an investor or entrepreneur considering 505(b)(2) drug applications? Join Jake Holdreith, Robins Kaplan, and Ken Phelps, Camargo Pharmaceutical Services for a complimentary...more

Myriad, Mayo, Chakrabarty, Oh My: Strategies for Life Sciences Diagnostics – Part III

In Part III of “Myriad, Mayo, Chakrabarty, Oh My: Strategies for Life Sciences Diagnostics”, we consider the use of examiner interviews and how they can assist into obtaining allowable diagnostic claims. An examiner...more

Boom Predicted in Biodegradable Stent Market

Stents, which are typically inserted into a blood vessel in order to expand the vessel to prevent or alleviate a blockage, have traditionally been made from metal mesh and remained in the body permanently (or until later...more

MoFo Biometer, Volume 6, Issue 1

by Morrison & Foerster LLP on

2016 Biometer Shows Strength in Early and Late Stage Deals but Cracks Beneath the Surface - The 2016 BioMeter showed strength at both ends of the drug-development spectrum, with extremely strong results for ...more

Guidebook: Cybersecurity in the Pharma, Biotech, and Medical Devices Industries

by Foley & Lardner LLP on

As a life sciences or medical device company, it is mission critical to protect lab books, drug and clinical test data, product formulas and production processes that underlie your patents, trade secrets and know-how from...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

Trends in Life Sciences: From Data Protection to Drug Pricing

As part of our series on current trends across different industries, we explore current changes taking place in the life sciences field. Privacy & Data Protection - Personal information protection and compliance...more

New Research Shows Potential to Prevent Medical Device-Related Infections

A research team from Trinity College Dublin has recently discovered a way to reduce the incidence of medical device-associated infection resulting from biofilms. The term “biofilms” refers to organized colonies of bacteria...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

Trump's Proposed 2018 Budget Will Double FDA User Fees

by Foley & Lardner LLP on

During his speech last month to a joint session of Congress, President Trump called out the U.S. Food and Drug Administration for its “slow and burdensome approval process.” Those comments came on the heels of Trump’s...more

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