Life Sciences

News & Analysis as of

Corporate Governance Features: for Silicon Valley and San Francisco Bay Area Public Companies

Orrick has unveiled an unprecedented new study examining the corporate governance structures of the largest public companies in the Bay Area, including tech industry leaders. The comprehensive study reviewed the 153...more

Europe: Combatting illegal pharma trade

We are delighted to announce the launch of our Combatting illegal pharma trade enforcement guide. This publication is a pharmaceutical industry-specific brochure which complements our suite of brand and trademark protection...more

A Startup Attorney’s Tips to Advance Private Company Diversity

One of the biggest contributors to a lack of corporate diversity is the size of a company. And the problems are often traceable to the company’s leanest, earliest days. One of my key messages to clients is that it’s never too...more

Novartis Secures FDA Approval for Breast Cancer Drug Kisqali

On March 13, 2017, the use of Novartis cell cycle inhibitor Kisqali® (ribociclib, LEE011) in combination with an aromatase inhibitor was approved by the U.S. Food and Drug Administration as a first-line treatment for...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: IPR2017-00510; filed December 20,...more

Seven Key Questions in Understanding the Current Regulatory State of HCT/Ps

Despite regulations, litigation, and significant draft guidance, the future of regulation of HCT/Ps remains up in the air. Learn what you need to know quickly with these seven questions and answers....more

PTAB Life Sciences Report -- March 2017 Part III

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

2016 – a year at a glance

What is a human? When is your best method not good enough? When is an inventor not an inventor? What happens when your patent application fails to deliver on its promise? These are just a few of the questions that the...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

"Trends in Corporate Integrity Agreements Reflect New HHS OIG Guidance on Use of Exclusion Authority"

2016 was a year of change for the Department of Health and Human Service's Office of Inspector General's (OIG) approach to corporate integrity agreements (CIA). The OIG began to use its new model CIA format and applied its...more

Gender Diversity Survey - 2016 Proxy Season Results

The Fenwick & West Gender Diversity Survey provides unique insight into women’s participation at the most senior levels of public technology and life sciences companies in the Silicon Valley 150 Index (SV 150) and the large...more

Business Litigation Report - February 2017

French Anti-Corruption Law Reform - Despite signing the OECD anti-corruption Convention in 1997, France has long been perceived as lacking necessary tools for domestic and international anti-corruption enforcement,...more

PTAB Life Sciences Report -- Part I - March 2017

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents. McKesson Corp. v. My Health, Inc. - PTAB Petition: IPR2017-00312; filed November 29,...more

Dechert survey: Developments in securities fraud class actions against U.S. life sciences companies

Life sciences companies continued to be popular targets of securities fraud class action lawsuits filed in 2016, and prudent life sciences companies should take heed of the results of this year’s decisions. In 2016,...more

Combatting illegal pharma trade: Combatting black and grey markets for the pharmaceutical industry

Focus I: International black market trade - Among the industries that suffer most from black and grey market activities, the pharmaceutical sector sadly holds one of the top positions. The World Health Organization (WHO)...more

Preparing Biotech Patent Applications - Ten Strategies for Success

Obtaining issued patents in the biotechnology space can be a challenge. Here is a list of ten patent strategies we recommend for biotechnology innovators to increase their odds of obtaining valuable intellectual property...more

Chemistry & Nanotechnology Developments to Watch in 2017

As cases and outcomes make their way into the news this year, we will be watching the following developments closely and sharing them with the IP community....more

February 2017: Life Sciences Litigation Update

Recently Amended FDA Rules Can Affect Settlements in Pharmaceutical Litigations. After more than thirteen years of bureaucratic analysis and rulemaking, the U.S. Food and Drug Administration recently implemented its new rules...more

Relocation of the EU Medicines Agency - The Netherlands: Tulips & EMA, a Gouda combination

The EMA is looking for a new home. According to the Dutch Minister of Foreign Affairs and the Minister of Health, Welfare and Sports' formal bid, this home is where the heart of the Netherlands is. It might not have the food,...more

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

As former Chief Judge Giles Rich proclaimed, “The name of the game is the claim.” In Part II of “Myriad, Mayo, Chakrabarty, Oh My: Strategies for Life Sciences Diagnostics”, we will look at claiming strategies. Often...more

Editing the future: A brief introduction to CRISPR

For those with an interest in life sciences, the rise to prominence of CRISPR has been impossible to ignore. It seems a day does not go by without the discovery of a new application for the technology or a new variant of one...more

Supreme Court Limits Foreign Reach of the U.S. Patent Act

The supply from the United States of a single component of an invention, for assembly of the invention abroad, is not patent infringement under Section 271(f)(1) of the Patent Act. This is according to a unanimous ruling this...more

Florida Supreme Court Rejects More Rigorous Expert Testimony Standard

The federal court system and 36 states have adopted the so-called Daubert standard in place of the Frye standard when it comes to qualifying expert witnesses under the rules of evidence. In 2013, the Florida Legislature...more

French Legal and Regulatory Update - January 2017

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 January 2017. 1. Audovisual...more

PTAB Ruling on CRISPR: No Interference

On Wednesday, February 15, 2017, the Patent Trial and Appeal Board (“PTAB”) ruled in favor of the Broad Institute of MIT and Harvard in a closely watched patent fight with UC Berkeley over the breakthrough CRISPR...more

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