Life Sciences

News & Analysis as of

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

Anti-Bullying Hurdles for the Life Sciences

First Decision for the Fair Work Commission's Anti-Bullying Regime - The Fair Work Commission’s (FWC) Anti-Bullying Regime opened its doors on 1 January 2014. The new Anti-Bullying Regime got off to a leisurely start...more

Five Things You Should Know About the USPTO Patent Subject Matter Eligibility Guidelines

The new USPTO patent subject matter eligibility guidelines set forth a detailed analytical framework for evaluating whether claims satisfy the patent subject matter eligibility requirement of 35 USC § 101. If you are an...more

Patent Profile: VM Institute of Research Receives Patent for Method of Treating Triple Negative Breast Cancer

The U.S. Patent and Trademark Office recently issued U.S. Patent No. 8,642,270, which is entitled "Prognostic biomarkers to predict overall survival and metastatic disease in patients with triple negative breast cancer." The...more

D.C. Circuit Court of Appeals Upholds FDA Oversight of Autologous Stem Cell Therapeutics

A company that developed a stem cell-based therapy for treating diseases and conditions was found to be in violation of the federal Food, Drug, and Cosmetic Act for failing to seek approval for its product. Cellular and...more

Business Litigation Report -- February 2014

In This Issue - Firm News: ..Kathleen Sullivan Featured in December 2013 The American Lawyer Cover Story ..Quinn Emanuel Named to BTI’s 2014 “Client Service A-Team” Honor Roll Main Article: ..Overview...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

February 2014: Life Sciences Litigation Update

Can the FDA Be Held Liable in a Private Lawsuit for Failure to Prevent Recent Drug Shortages? In Carik et al. v. United States Dep’t of Health & Human Servs. et al., CV 12-272, __ F. Supp. 2d __, 2013 WL 6189313 (D.D.C. Nov....more

Patent Profile: Patent Issued for Method of Differentiating Pancreatic Cancer from Benign Pancreatic Disease

The U.S. Patent and Trademark Office recently issued U.S. Patent No. 8,632,983, which is entitled "Biomarkers for pancreatic cancer and diagnostic methods." The '983 patent, which is assigned to the Van Andel Research...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

Privacy And Data Security For Life Sciences And Health Care Companies

Pepper Hamilton Health Care-Life Sciences Webinar - The explosion of mobile technology and Web applications linking patients with doctors, pharmacies and medical devices is undergoing scrutiny by the FDA, FTC, HHS and...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

"Health Care and Life Sciences: Affordable Care Act Rollout to Impact M&A and Enforcement Activity"

Health care and life sciences companies face a variety of issues in 2014, including further difficulties with the Affordable Care Act (ACA) rollout because of legal and logistical challenges, the potential dampening 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

Institut Pasteur v. Focarino (Fed. Cir. 2013)

Last month, the Federal Circuit dismissed an appeal by Institut Pasteur of a determination by the Board of Patent Appeals and Interferences affirming the rejection of claim 14 of U.S. Patent No. 7,309,605 in an inter partes...more

Patent Profile: Duke University and Cognosci Receive Patent for Methods of Diagnosing Cancer

Last week, the U.S. Patent and Trademark Office issued U.S. Patent No. 8,623,601, which is entitled "Methods of diagnosing cancer." The '601 patent, which is assigned to Duke University and Cognosci, Inc. (out of the...more

Institut Pasteur Obtains Reversal of USPTO Board Decision of Obviousness of Eukaryotic Site-Directed Mutagenesis Methods

In Institut Pasteur v. Focarino, the Federal Circuit found that the obviousness determination by the USPTO Board of Patent Appeals and Interferences was not supported by substantial evidence, and rested on an “erroneous...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

Life Sciences MVP: Morrison & Foerster's David Doyle

Morrison & Foerster LLP partner David C. Doyle has successfully fought for generic drug companies’ access to markets years before competitors’ exclusivity runs out, including Sandoz Inc.’s bid to invalidate Teva...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

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