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Introducing a New Drug Into the Marketplace in the Lifecycle of a Pre-Sales Revenue Biotechnology Venture Destined for IPO Success

Mindful that this series of articles describes biotech ventures that are ripe for initial public offerings even before launching an income-producing drug product into the commercial market, the paramount objective for all...more

Legislative Update Report No. 2014-19

In This Article: - Federal Government - Alberta - British Columbia - Manitoba - New Brunswick - Newfoundland - Northwest Territories - Nova Scotia - Nunavut - Ontario - Prince Edward...more

Guest Post: Myriad -- A Direct and Unexceptional Approach

Is there a chain of reasoning that leads to the outcome in Myriad more shortly and directly than that outlined by Justice Thomas and without invoking judicial exceptions? It is strongly arguable that this is indeed the case...more

Guest Post: Nature's Indelible Marker - Naturally abundant, stable isotopes have already protected the identity and origin of $1.5...

The pharmaceutical industry is an important segment of the world economy. In 2013, worldwide sales of prescription drugs were over $830 billion. If one adds in over-the-counter medicines and other health-related products...more

Court Report - October 2014

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Shire LLC v. Amerigen Pharmaceuticals Ltd. 1:14-cv-06095; filed October , 2014 in the District Court of New Jersey....more

Realizing the Potential of Telemedicine in China, Part 1: Protecting Your IP

This post is the second in Foley’s blogs on China telemedicine and the first in the blog series, “Realizing the Potential of Telemedicine in China,” meant to address top issues facing U.S. companies looking to enter the...more

Expect Focus - Regulators Are Watching: New Products, New Opportunities, New Risks - Volume III, Summer 2014

In This Issue: - IN THE SPOTLIGHT ..Standard CGL Policy Form Adds Data Breach Coverage Exclusion - LIFE INSURANCE ..Class Claims Against Lincoln National Barred in Section 419 Action – Again ...more

PGR Report -- The Attack of 35 U.S.C. § 112

Last week, on September 2, 2014, Accord Healthcare, Inc. ("Accord") filed what appears to be the second-ever Post-Grant Review ("PGR") (see Petition). This PGR was for U.S. Patent No. 8,598,219 ("the '219 Patent"), which is...more

Court Report -- Part III: September 2014

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Forest Laboratories LLC et al. v. Sigmapharm Laboratories LLC 1:14-cv-01119; filed September 3, 2014 in the District...more

Intellectual Property and Technology News - Issue 23, Q3 2014

In This Issue: - Substitution Allowed? State Biosimilar Laws Are Evolving - Patent Wars: Can The Energy Industry Avoid Them? - Surviving A Trademark Opposition Challenge: Do You Have A True...more

Australia Upholds Patent Eligibility of Isolated DNA

The Full Federal Court of Australia affirmed that isolated nucleic acids, i.e. whether it be DNA or RNA, are patentable subject matter in Australia. While an appeal to the High Court of Australia may be possible, absent an...more

Federal Circuit Frames Test for Patent-Eligibility

Personalized medicine relies on diagnostics to analyze a patient for individualized therapy and for monitoring a patient’s health status. Some diagnostic tests use natural products, for example gene sequences, either as the...more

Managing IP Risk in the Age of Personalized Medicine

As discussed on Foley’s Health Care Law Today blog, personalized medicine treatment trends and innovations are leading diagnostic and therapeutic companies to form complex arrangements and partnerships with the ultimate goal...more

Evolving Healthcare Trends & Patents: Charting a Safe Course for Personalized Medicine

Rapid changes resulting from personalized medicine, including the ability to use individual patient biomarker data to generate a tailored treatment, are transforming healthcare. New business structures are evolving in the...more

Finally, A Biosimilar Application Has Been Accepted By The FDA

In what is thought to be the first application accepted under the new biosimilar pathway created by the Biologics Price Competition and Innovation (BPCI) Act, Sandoz announced last Thursday that the U.S. Food and Drug...more

How is Graphene Currently Used and What is the Hope for the Future? [Video]

In the second video of a three-part series, Fenwick attorney Paul Smith talks about the growing anticipation surrounding this strong, conductive and flexible material. Why the excitement? Simply put, graphene is easy. It’s...more

What is Graphene? Fenwick Patent Attorney Has the Answer [Video]

The technology and life sciences communities alike have been raving about new "wonder material" graphene for the past year. From applications for wearable devices to the creation of lightweight, bendable televisions and...more

Two Tips for Inventors Filing Patent Applications [Video]

The intense patent activity in graphene stems from its enormous technological and commercial potential. But because much of the territory underlying the graphene cross-roads has already been claimed, patenting graphene poses...more

Perspectives - June 2014

In This Issue: - Staying in Compliance While Giving or Receiving Electronic Health Record Systems - When Donations Cross the Line - House Bill 296 Signed into Law to Increase Access to Epinephrine Autoinjectors...more

High Court Will Take Up Standard of Review of Factual Findings in Claim Construction

Teva Pharmaceuticals USA Inc. et al. v. Sandoz Inc. et al. - In a case that will likely determine the standard of review used by the U.S. Court of Appeals for the Federal Circuit over lower court claim constructions,...more

Beginning the Patent Process

The second step in bringing your medical device to market is to understand whether you can protect your invention. This article is part two of a series that presents the three big issues in intellectual property: Do...more

The Life Sciences Report - Spring 2014

In this issue: - A New Accelerator Takes Digital Health Start-Ups to the Next Level - The Return of the MedTech IPO Market - Is There a Deal in Your Future? A Guide to Navigating Antitrust Waters -...more

Patent-Eligibility of Stem Cells Under New USPTO "Myriad-Mayo" Guidance

In March, the U.S. Patent and Trademark Office (USPTO) implemented new procedures to address whether inventions that relate in whole or in part to laws of nature and naturally occurring products are patent-eligibility in...more

Personalized Medicine and Patent Eligibility under 35 U.S.C. § 101

Double-digit growth is predicted for the molecular diagnostic market in the next several years, driven in part by an increased demand for personalized medicine—medical decisions and therapeutic products tailored to address...more

Legal and Ethical Risks of Healthcare Businesses in China

Recent disputes and controversies involving Chinese subsidiaries of foreign pharmaceutical companies have sounded warning bells on legal and ethical issues regarding participation in China’s rapidly growing and evolving...more

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