Life Sciences

News & Analysis as of

Life sciences patents: method claims – united they stand, divided do they fall?

Patent protection for methods claims can be tricky. Particularly for medical devices, diagnostics and even drugs, methods claims can present dilemmas for enforcement. It can boil down to the key question of "who" – who...more

Where do we go from here? The evolving landscape of molecular diagnostics

"Innovate or die." The adage has been in use for decades, but it holds true today. The world of molecular diagnostics is a rapidly evolving and competitive field. With the advancement in sequencing technologies and the scale...more

Canadian IP law and practice in 2016: reviewing the highlights

As the calendar turns the page from 2016 to 2017, we take the opportunity to review Canadian IP law and practice highlights from the past year....more

Top 5 Patent Red Flags in Life Sciences Due Diligence

Since IP represents 75 to 90% of the value of life science transactions, due diligence is a critical component of the valuation process....more

RxIP Update - 2016 Year in Review

The following are highlights of developments in Canadian life sciences intellectual property and regulatory law in 2016, updating our 2016 mid-year highlights. 1. Substantive patent law developments - Utility and...more

FDA Issues Final Guidance on Postmarket Cybersecurity

Agency establishes a risk-based framework for assessment of postmarket cybersecurity risks for medical devices. On December 28, 2016, FDA issued a final guidance titled “Postmarket Management of Cybersecurity in Medical...more

What the FDA has in store for the food industry in 2017

As Life Sciences Decoded looks forward in 2017, it is clear that FDA-regulated industries have a great deal of change confronting them. Last year, 2016, was a landmark year for the FDA and food regulations, as the agency...more

The Life Sciences Report - Winter 2017

Consumer Digital Health: Market Shift Is Leading to New Opportunities - The newest wave of consumer digital health investment focuses on applications encouraging consumers to change health-related behaviors, shifting...more

Don’t Miss These 2017 J.P. Morgan Healthcare Conference Events in San Francisco

If your work involves life sciences dealmaking, you know it’s the time of year to start firming up your plans for the week of the J.P. Morgan Healthcare Conference. In the last 10 years, the second week of January in San...more

EPO Stays Proceedings Over Patentability Of Plants And Animals

While the U.S. is still sorting out “natural products” jurisprudence under 35 USC § 101, the European Patent Office (EPO) is wrestling with the patentability of plants and animals, and has announced an immediate stay on all...more

November 2016 IPO Market Review

The IPO market cooled in November to produce only a trio of IPOs, the slowest November since the height of the global financial crisis in 2008. The first eleven months of 2016 have produced 91 IPOs—39% below the 150 IPOs over...more

When Time is Money

As the Biologics market is predicted to be a $250 billion market in the next few years, it is not surprising that parties embroiled in biosimilar litigation go to the mat. Both Apotex and Sandoz filed cert petitions this year...more

PTAB Life Sciences Report -- Part IV

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

PTAB Life Sciences Report -- Part III

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

2016 Technology and Life Sciences IPO Report

Wilson Sonsini Goodrich & Rosati’s 2016 Technology and Life Sciences IPO Report presents key data related to the pricing of 49 U.S.- based technology and life sciences issuers between January 1 and December 1, 2016. In a year...more

Is the FSMA a plaintiff’s lawyer’s dream and the food industry’s nightmare?

The Food Safety Modernization Act (FSMA) became law in 2011, signaling a sea change in U.S. food safety regulation and making prevention the cornerstone of safety measures. To achieve its lofty goals, while providing time for...more

FDA Issues Final Guidance on “Emerging Signals”

Guidance addresses industry concerns about premature public notifications. On December 14, 2015, the FDA issued a final guidance titled “Public Notification of Emerging Postmarket Medical Device Signals” (Final...more

Governor Cuomo announces US$650 million life sciences funding initiative

On December 19, 2016, New York Governor Andrew Cuomo announced a US$650 million life sciences initiative aimed at creating an industry and research "cluster" in New York state. The life sciences sector, generally defined as...more

Healthcare & Life Sciences Private Equity Deal Tracker: Bain Capital Acquires Epic Health Services From Webster Capital

Epic Health Services has announced it will be acquired by Bain Capital Private Equity from Webster Capital. Epic Health Services, headquartered in Dallas, is a provider of pediatric skilled nursing, therapy,...more

Guest Post -- The Patient Side of the CRISPR Patent Battle

A contentious patent battle has continued to rage between the Broad Institute at Harvard/MIT and the University of California ("UC"). UC is challenging thirteen patents related to CRISPR gene editing technology that are...more

PTAB Life Sciences Report -- December 2016 #2

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

21st Century Cures: Modernizing Public and Private Research

The 21st Century Cures Act, signed into law by President Obama on December 13, encourages biomedical research investment and facilitates innovation review and approval processes. Through National Institutes of Health (NIH)...more

21st Century Cures Act’s Effect on Pharmaceutical and Biotechnology Industries

The 21st Century Cures Act contains significant new mandates for both the FDA and NIH that affect the pharmaceutical and biotechnology industries and are intended to advance drug research, discovery, approval, and promotion...more

Healthcare & Life Sciences Private Equity Deal Tracker: Linden and DW Healthcare Partners Acquire Edge Systems

Linden Capital Partners and DW Healthcare Partners have announced the joint acquisition of Edge Systems. Edge, based in Signal Hill, Cali., is a developer of equipment and consumable products for non-invasive aesthetic...more

President Obama Signs the 21st Century Cures Act Into Law

The act creates faster, more flexible FDA drug and biologic review, new drug and device approval pathways, increases FDA funding, and reduces EHR administrative burdens. On December 13, 2016, President Obama signed into...more

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