Life Sciences Pharmaceutical Industry

News & Analysis as of

Quest Diagnostics and Inserm Launch BRCA Data-Sharing Initiative

Last week, diagnostics services provider Quest Diagnostics and Inserm, the French National Institute of Health and Medical Research institution, announced the launch of BRCA Share, a new datashare initiative that will provide...more

Pfizer’s strategic response to the threat of generic competition upheld by the Federal Court

On 25 February 2015, the Federal Court handed down its much-anticipated judgment in the matter of ACCC v Pfizer Australia Pty Ltd. In dismissing the Australian Competition and Consumer Commission’s (ACCC) allegations, Justice...more

"Insights Conversations: Life Sciences"

A healthy market for M&A activity, particularly cross-border deals, and a strict regulatory environment are the big factors influencing the health and activities of life sciences companies. Skadden partners John T....more

The Patent Office Clarifies the Ban on Patenting Naturally-Derived Drugs and Other Products

Since the very beginning of America’s revolutionary patent system, inventors in the life sciences have been granted patents for discovering and purifying natural products. It was taken as a given that a purified natural...more

Celltrion Healthcare Co. v. Kennedy Trust for Rhematology Research (S.D.N.Y. 2014); Hospira Inc. v. Janssen Biotech Inc. (S.D.N.Y....

Earlier this month, Judge Paul Crotty, U.S. District Court Judge for the Southern District of New York handed down rulings in two separate cases related to the biosimilars law (the Biologics Price Competition and Innovation...more

Sophisticated Hackers Target Insider Information

A security consulting firm has discovered a sophisticated hacking campaign that has targeted more than 100 public companies, investment banks and law firms. In a report released December 1, cybersecurity firm FireEye...more

A CEE Change Is Coming

Earlier this month, U.S. Customs and Border Protection (Customs) announced that it plans to expand its first three Centers of Excellence and Expertise (CEEs) over the next 12 months to cover their entire industries. Included...more

More of the Same: Recently Released FDA Social Media Guidance for the Life Sciences Industry

On June 17, 2014, the U.S. Food and Drug Administration ("FDA") continued to outline its expectations for pharmaceutical and medical device manufacturer use of social media platforms to promote manufacturers' products in two...more

Inside M&A - Summer 2014

“Commercially Reasonable Efforts” Diligence Obligations in Life Science M&A" - More than 80 percent of all deals in the pharmaceutical, medical device and biotech industries include an earnout structure that provides...more

FDA Plays Catch Up in the Digital Age

Part of JD Supra's series on innovation and the law. A look at how, as pharmaceutical manufacturers increasingly turn to social media to exchange information, laws and regulations that are decades old struggle to keep pace...more

Update on Myriad Appeal and Announcing a Public Forum on the USPTO 101 Guidelines

Myriad has appealed the district court decision that denied its motion for a preliminary injunction against Ambry Genetics Corp. According to a report in Bloomberg BNA Life Sciences Law & Industry Report™, on April 14, 2014,...more

IPR Update -- The First Biotech IPR Decisions

Earlier this month, on March 6, 2014, the Patent Trial and Appeal Board ("Board") issued three related inter partes review opinions, marking the first set of opinions related to either the Biotech or Pharmaceutical industry. ...more

Using Contingent Consideration to Bridge the Value Gap in Acquisitions of Publicly Traded Life Science Companies

M&A activity remains in the doldrums as we enter 2014. According to FactSet Mergerstat, in 2013, 446 transactions were announced involving a U.S. buyer or target in the life sciences sector, as compared to 527 in 2012. Many...more

No Patent for You

Patent eligibility restrictions hit life sciences and tech - After years of issuing rulings limiting what can be patented, the Supreme Court turned its attention squarely toward patent eligibility in the life sciences...more

Court Report - Part II: February 03, 2014

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Novartis Pharmaceuticals Corp. et al. v. Noven Pharmaceuticals Inc. et al. 1:14-cv-00111; filed January 30, 2014 in the...more

Court Report - February 02, 2014

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Eli Lilly and Company v. Glenmark Generics Inc., USA. 1:14-cv-00104; filed January 23, 2013 in the Southern District of...more

More Q&A from Webinar on Top Patent Law Stories of 2013

On Tuesday, we presented a live webinar on the "Top Patent Law Stories of 2013." The webinar covered ten of the fourteen stories that made it onto Patent Docs seventh annual list of top biotech/pharma patent stories. Posts...more

Top Stories of 2013: #7 to #10

Reflecting upon the events of the past twelve months, Patent Docs presents its seventh annual list of top biotech/pharma patent stories. For 2013, we identified fourteen stories that were covered on Patent Docs last year...more

The Danger of Self-Colliding Divisional Applications in the EPO

Last week I had the honor of speaking at the 27th Annual Pharmaceutical/Chemical Patent Practice Update put on by the New Jersey Intellectual Property Law Association’s Chemical Practice Committee. The entire program was...more

For the Common Good

For-profits and nonprofits in life sciences team up - Nonprofit groups are actively supporting research to solve tough medical challenges. Life sciences and pharma companies are eager to accelerate product development....more

Court Report -- December 15, 2013

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Pfizer Inc. et al. v. Hetero USA Inc. et al. 1:13-cv-02021; filed December 11, 2013 in the District Court of...more

United States BioPharma Patents - Quick Tips and News - Nov/Dec 2013

A. Three Tips for Overcoming U.S. Obviousness Rejections - 1) Argue no PFO first: Always argue down existence of an Examiner-asserted presumption of prima facie obviousness (PFO), before going on to second-step...more

The Regulation of Follow-on Biologics

What is new in the world of follow-on biologics? Manthei: Congress enacted the Biologics Price Competition and Innovation Act of 2009 to provide an alternative to the submission of a Biologics License Application for...more

Court Report -- December 08, 2013

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Astrazeneca AB et al. v. Aurobindo Pharma Ltd. et al. 3:13-cv-07298; filed December 3, 2013 in the District Court of New...more

The Life Sciences Report - Fall 2013

In this issue: - How to Expedite Examination of a Patent Application - The FDA Releases Final Guidance for Mobile Medical Applications - Creating Value in the Medtech Industry Using a Gender Lens -...more

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