Life Sciences

News & Analysis as of

News from Abroad: Not One But Two Decisions Fine Tune the Australian Patent Office's Approach to Life Science Technologies

Two recent Australian Patent Office decisions have provided clarity as to the patentability of isolated nucleic acid sequences following the High Court's decision in D'Arcy v Myriad Genetics ('Myriad'). The first decision is...more

FDA Regulatory and Compliance Monthly Recap — November 2016

OPDP issues fifth untitled letter of the year to Supernus for misrepresenting Oxtellar XR in KOL video - In its fifth untitled letter in 2016, the OPDP raised concerns about a Spanish KOL video suggesting Supernus’...more

UK announces intention to ratify the Unified Patent Court Agreement

The UK Government yesterday announced that its plans to ratify the Unified Patent Court Agreement (“UPCA”) will not be derailed by Brexit. The UK Minister of State for Intellectual Property, Baroness Neville Rolfe, made the...more

Post Grant Review: § 112 and Eligibility Issues in Chemical and Life Sciences

Post Grant Review (PGR) petitions are on the rise, and nearly half of all petitions to date have challenged patents in Biotechnology and Organic Chemistry, or Chemical and Materials Engineering technology centers. We have...more

Highlights from McDermott’s 2016 Pharmaceutical/Medtech Dealmaking Symposium

On October 25, 2016, McDermott Will & Emery held its fifth annual Pharmaceutical/Medtech Dealmaking Symposium in Cambridge, Massachusetts. The day consisted of a series of thought-provoking panels with leading dealmakers in...more

Myriad Genetics Announces an Assay that Identifies Patients for Olaparib Treatment

Salt Lake City-based Myriad Genetics, Inc. announced that its BRACAnalysis CDx® test accurately identifies patients with ovarian cancer for a second-line treatment with olaparib. The announcement came as a result of a...more

"Two Court of Chancery Deal Litigation Decisions Provide Helpful Guidance"

Chelsea Therapeutics: Post-Closing Bad Faith Claim a ‘Rare Bird’ in Delaware Absent Allegations of Self-Interestedness or Lack of Independence - In In re Chelsea Therapeutics International LTD Stockholders Litigation,...more

Freedom to Operate and the Use of AIA Review

Freedom to Operate: •Identifying infringement risk •Third party patent (infringement) – claim searching –Timing •Discrete, continuous –Searching •In-house, search agency –Screening/analyzing •Ranking...more

Competition law scrutiny of patent settlements - a new focus in Australia?

Settlement agreements in patent disputes between pharmaceutical companies may soon face greater competition law scrutiny in Australia. The Productivity Commission has put ‘pay for delay’ patent settlements between originator...more

Sanofi & Verily Launch a Diabetes Joint Venture

Sanofi, a French multinational pharmaceutical company, and Verily Life Sciences LLC (formerly Google Life Sciences), Alphabet’s U.S.-based company devoted to the study of life sciences, recently announced the launch of Onduo,...more

Top Takeaways from FDA Draft Guidance on Software as a Medical Device

FDA’s proposed adoption of an IMDRF document raises questions. On October 14, the US Food and Drug Administration (FDA or the Agency) releaseda new draft guidance document, Software as a Medical Device (SaMD): Clinical...more

Healthcare & Life Sciences Private Equity Deal Tracker: ReferWell Completes Financing Round Led by HCCM

ReferWell has announced completion of a private equity financing round led by Health Catalyst Capital Management (HCCM). ReferWell, based in New York, is the developer of a cloud-based referral management platform for...more

Silicon Valley Venture Capital Survey - Third Quarter 2016

We analyzed the terms of 149 venture financings closed in the third quarter of 2016 by companies headquartered in Silicon Valley. Overview of Results - The weakening in venture valuations that began in the second...more

Looking Ahead to a Trump Administration: Health Care and Life Sciences Industry Perspectives

Observers are digesting what the Trump Administration will mean for the health care and life sciences industry. Forecasting is more challenging for this incoming Administration than most given the relatively sparse policy...more

Corporate Governance Survey - 2016 Proxy Season Results

A Comparison of Large Public Companies and Silicon Valley Companies - As outside legal counsel to a wide range of public companies in the technology and life sciences industries, many of which are based in Silicon...more

Preparing for an ACA Rollback: How to Get Paid for Treating the Uninsured - Hospital Industry Viewpoint

Given that Republicans will soon control both Congress and the White House, hospitals may be concerned that expenditures that have helped reduce the ranks of the uninsured will be ratcheted down. However, forward-thinking...more

PTO Schedules s. 101 Roundtables

At 81 Fed. Reg. 71485, The PTO has scheduled two roundtables at the PTO to receive feedback from the IP community, particularly on the Examples that were promulgated in May. The first roundtable will be on November 14th from...more

Guest Post -- The Emergent Microbiome: A Revolution for the Life Sciences -- Part VIII, The Microbiome and Immunotherapy I

Introduction - Cancer immunotherapy or immuno-oncology (I-O) has gone mainstream. You may have heard about these topics in the media. Along with having surgery and radiation therapy, Former President Jimmy Carter was...more

PTAB Life Sciences Report - October 2016

About the PTAB Life Sciences Report: Each month we will report on recent developments at the PTAB involving life sciences patents. Argentum Pharmaceuticals LLC. v. Janssen Oncology, Inc. - PTAB Petition: ...more

Healthcare & Life Sciences Private Equity Deal Tracker: Linden Capital Acquires ProPharma Group, Merical

Linden Capital Partners announced earlier this month that it acquired ProPharma Group and, in a separate transaction, acquired Merical. Linden, based in Chicago, seeks control equity in middle-market companies. A leading...more

Key Takeaways: Fourth Annual Seminar for Pharmaceutical, Biotechnology and Medical Device Companies

On October 5, 2016, Skadden hosted its Fourth Annual Seminar for Pharmaceutical, Biotechnology and Medical Device Companies. The seminar focused on the current and developing challenges facing such companies and included...more

Medical Device Investor Forum - Oct. 27-28 in Irvine, CA - Knobbe Medical

OCTANe, an Orange County-based non-profit life sciences and technology accelerator organization, has announced the agenda for its 11th Annual Medical Device & Investor Forum (MDIF), which will be held on October 27-28, 2016,...more

Life Sciences Spotlight - Asia Pacific Issue 7, 2016

Welcome to the seventh edition of Life Sciences Spotlight, and our very first AusBiotech/Biofest conference edition. We are very pleased to provide updates on a number of developments in the life sciences sector across...more

Don’t Forget About FTC Compliance: Substantiating Claims to Avoid Misleading Consumers

Life sciences companies regularly review their labeling and promotional materials to ensure compliance with Food and Drug Administration requirements. FDA makes its Warning Letters publicly available, and failure to correct...more

Smart Regulations: The Oversight of Artificial Intelligence

The Obama administration's National Science and Technology Council released a report on artificial intelligence (AI) last week that shared findings on the current state of AI and its potential effect on society. The council...more

381 Results
|
View per page
Page: of 16
JD Supra Readers' Choice 2016 Awards

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:

Sign up to create your digest using LinkedIn*

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.

Already signed up? Log in here

*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.
×