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Health Alert (Australia) - September 28, 2015

In This Issue: -Judgments; Legislation; and Reports In This Issue: -Judgments; Legislation; and Reports Australia Federal Court Alphapharm Pty Ltd v H Lundbeck A/S [2015] FCAFC...more

Acumed Sues Skeletal Dynamics For Patent Infringement

Acumed LLC recently sued Skeletal Dynamics LLC in the United States District Court for the District of Oregon. Acumed’s complaint alleges that Skeletal Dynamics’s REDUCT Headless Compression Screw infringes one of Acumed’s...more

Health Alert (Australia) - September 14, 2015

In This Issue: -Judgments; Legislation; and Reports -Excerpt from Judgments New South Wales (NSW) 9 September 2015 - Idameneo (No 123) Pty Ltd v Auzcare Pty Ltd [2015] NSWSC...more

3D Printing of Medical Devices: When a Novel Technology Meets Traditional Legal Principles

This white paper – 3D Printing of Medical Devices: When a Novel Technology Meets Traditional Legal Principles – explores the legal ramifications and risks of the rapidly increasing use of 3D printing of medical devices. 3D...more

Inevitable Disclosure Doctrine Held Inapplicable To Failed Business Transaction

An Illinois appellate court recently rejected applying the inevitable disclosure doctrine in a trade secret misappropriation spat arising out of a failed business transaction....more

The United States’ First-Ever Biosimilar Reaches the Market

Today, Sandoz (a Novartis subsidiary) launched the first biosimilar approved under the BPCIA: the cancer drug Zarxio (filgrastim-sndz), which is a biosimilar version of Amgen’s Neupogen. The launch follows the Federal...more

Mechanical Ventilation Innovation Challenge

According to press releases, the American Association for Respiratory Care (AARC) and Edison Nation Medical have partnered to search for innovations for improving the process, outcomes, and comfort for patients requiring...more

Health Alert (Australia) - August 24, 2015

In This Issue: - Judgments; Legislation; and Reports. - Excerpt from Judgements: Victoria 17 August 2015 - Bourke v Coroners Court [2015] VSC...more

Penumbra Files for $115 million IPO

Alameda, California-based medical device company Penumbra, Inc. registered with the Securities and Exchange Commission (SEC) last Friday for an initial public offering (IPO) to raise up to $115 million. The company will be...more

Identifying the likely beneficiaries of an emerging biosimilars market

Financial analysts have predicted that over the next five years, biosimilars will be a $10 billion market, so it is understandable why considerable attention and investment is being made in this space. However, while there is...more

What’s the Secret to Successful Medical Device IP?

Every medtech inventor is looking for the same things—to make a difference for patients, fill an unmet medical need…and maybe, just maybe, become a successful public company or an in-demand acquisition target....more

Bio/Pharma IPR Challenges Nearly Double in 2015

Newly released statistics (2015-06-30 PTAB Statistics) from the USPTO reveal that the number of bio/pharma IPR challenges almost doubled in 2015, even though fiscal year 2015 still has three months to go. Last year, there...more

Federal Circuit Confirms Both New Biosimilar Bring-to-Market Procedural Option and Additional Six-Month Exclusivity Period for...

On July 21, 2015, brand-name biologics companies and companies developing biosimilars received a split in a significant decision with industry-wide ramifications in the high-stakes battle about how and when biosimilar...more

Federal Circuit Amgen Case Clarifies Important Aspects of the Biologics Price Competition and Innovation Act

On July 21, 2015, the U.S. Court of Appeals for the Federal Circuit issued its holding in Amgen Inc. v. Sandoz Inc., 2015-1499 (Fed. Cir. 2015). The Federal Circuit's decision is the latest development in the long-running...more

How an Insufficiently Detailed Provisional Patent Application Can Hurt You

A well-intentioned decision to reduce expenses can result in a poorly written provisional patent application that actually destroys an institution’s future patent rights in an important technology. In today’s world,...more

Attacking Patents on Written Description & Enablement Grounds in Inter Partes Review

Although Inter Partes Review (IPR) is limited to grounds of unpatentability based upon prior art references, it is nevertheless possible to raise issues of written description or enablement by applying intervening prior art...more

The Impact of Ariosa Diagnostics v. Sequenom on the Patent Eligibility of Biomarker Detection Methods

Under the Patent Act, one can patent “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.” Common exceptions to what can be patented include laws of nature,...more

What Constitutes Patentable Subject Matter in Biotechnology? New Federal Circuit Decision Says “Even Less Than You Thought!”

With its recent (June 12, 2015) decision in Ariosa v. Sequenom, the Court of Appeals for the Federal Circuit affirmed the Northern District of California’s broad interpretation of the U.S. Supreme Court’s Prometheus v. Mayo...more

The Life Sciences Report - Spring 2015

In This Issue: - The Rise of Companion Diagnostics in Personalized Medicine: Challenges and Opportunities - Department of Justice Imposes More Than $110 Million in Fines on Medical Device Makers - Life...more

Recent Cases Consider Patent Eligibility Under Mayo/Alice “Two-Step” Test: Invoking Routine and Conventional Elements Is Not...

In a series of cases addressing whether inventions are eligible for patent protection under 35 U.S.C. § 101, the U.S. Supreme Court has adopted a two-step analysis. Two recent decisions by the U.S. Court of Appeals for the...more

The Internet of Things

In this Presentation: - Internet of Things - definition - But what is it all about? - But not just that... - The IoT market in figures... - Beecham Research - view of the World - The Connected...more

The Name Game: AbbVie’s Citizen Petition Regarding Biosimilar Labeling

On June 2, 2015, AbbVie submitted a citizen petition to the FDA arguing against its interim labeling requirements for biosimilar products under the Biologics Price Competition and Innovation Act (“BPCIA”). As of now, the FDA...more

Federal Circuit Finds Revolutionary Non-Invasive Fetal DNA Test Method Unpatentable Under Mayo

On June 12, 2015, in Ariosa Diagnostics, Inc. et. al. v. Sequenom, Inc. et. al., the Court of Appeals for the Federal Circuit invalidated claims in U.S. Patent 6,258,540 directed to methods for detecting paternally inherited...more

Fed Circuit: Sequenom’s Diagnostic Method Claims Invalid Under §101

On June 12, 2015, in Ariosa Diagnostics, Inc. v. Sequenom, Inc., the Federal Circuit affirmed the Northern District of California’s finding that the method claims in U.S. Patent 6,258,540 (‘540 patent) for detecting...more

U.S. Appeals Court Finds Prenatal DNA Test Unpatentable

The United States Court of Appeal for the Federal Circuit in the District of Columbia came down with another blow for the patentability of biotech testing products on Friday, June 12, 2015. The Court affirmed the 2013...more

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