Intellectual Property Health

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Health Alert (Australia) - January 25, 2016

In This Issue: -Judgments; Legislation; and Reports -Excerpt from Judgments Commonwealth. Fair Work Commission 15 January 2016 - Lawrence v Calvary Home Care Services Ltd [2016] FWC 175 This...more

Representatives Send Letter to HHS and NIH Seeking Response to Pharmaceutical Costs

In a letter sent earlier this month to Secretary Sylvia Mathews Burwell of the U.S. Department of Health & Human Services and Director Francis S. Collins of the National Institutes of Health, fifty members of the U.S. House...more

Webinar PowerPoint Slides: Medical Apps and Devices: The Convergence of FDA, FTC, and State and Federal Regulations

These are the PowerPoint slides from this webinar: Years ago, if someone told you that computers would replace doctors for medical treatment, you would have laughed. While we have yet to reach this paradigm, mobile medical...more

Medical Apps and Devices: The Convergence of FDA, FTC, and State and Federal Regulations [Video]

Years ago, if someone told you that computers would replace doctors for medical treatment, you would have laughed. While we have yet to reach this paradigm, mobile medical applications and devices have come to the forefront...more

International News: Focus on Tax - Issue 3, 2015

The breadth of the articles contained in our Focus on Tax this issue demonstrates the perennial importance of this topic to global businesses and international high net worth individuals. We examine topics ranging from...more

Amgen v Apotex - 180-Day Advance Notice of Biosimilar Marketing is Mandatory

The Federal Circuit in July said in its Amgen-Sandoz decision that declining to share information under the biosimilars pathway “patent dance” made the 180-day advance-notice provision mandatory; however, it left open the...more

Life Sciences Spotlight - Asia Pacific - Issue 6, 2015

Trends and developments in cyber security and data protection: Why pharma and life sciences companies should take action. Pharmaceutical and life sciences companies are increasingly the target of cyber-attacks and...more

Abbott Secures Preliminary Injunction in Gray Market Case

On November 6, 2015, Abbott Laboratories and its diabetes care units secured a preliminary injunction against multiple pharmacies, distributors and associated individuals engaged in the sale of gray market Abbott FreeStyle...more

The Give and Take of the 2015 Library of Congress Sec. 1201 Copyright Exemptions

I used to love working on cars. As a teenager I had a 1972 Karmann Ghia, which I could repair, MacGyver-like, with rubber bands, tinfoil, and sticks of chewing gum. But as automotive technology advanced, the prospect of...more

Magistrate Recommends Granting Motion To Intervene

Hospital seeks to intervene in order to press its claim of ownership of patent and certain related patent applications. The court finds that the four elements required to be proven in order to intervene are met. The motion...more

Employment Law This Week: Wellness Programs, Arbitration Agreements, Class Action Waivers, Non-Competes [Video]

We invite you to view Employment Law This Week - a weekly rundown of the latest news in the field, brought to you by Epstein Becker Green. We look at the latest trends, important court decisions, and new developments that...more

Litigation Alert: Federal Circuit’s Ariosa Decision, Good Chance for Rehearing En Banc

In June of this year, the Federal Circuit panel in Ariosa Diagnostics, Inc. v. Sequenom, Inc. invalidated a patent on the grounds of patent-ineligible subject matter. 788 F.3d 1371 (Fed. Cir. 2015). While the case is one of...more

Three Pressing Challenges for Personalized Medicine

Personalized medicine can be described as the science of targeted therapies. Advances in diagnostic and molecular medicine have made it possible to more precisely identify alternative treatment options for patients based on...more

3D Printing Partnership: 3D Medical Limited to Acquire Mach7 Technologies

3D Medical Limited (ASX: 3DM) recently announced that it has entered into a binding Heads of Agreement (HOA) to purchase 100% of shares issued in Mach7 Technologies. According to the agreement, 3D Medical will issue 460...more

NuVasive Receives First-Ever 510(k) Clearance for a Cervical Corpectomy Cage

Spinal device specialist NuVasive recently received section 501(k) FDA clearance for its X-Core Mini Cervical Expandable VBR System, a titanium vertebral-body replacement device used in the cervical spine to replace vertebral...more

Employment Law This Week – Episode 2 [Video]

We invite you to view Employment Law This Week - a weekly rundown of the latest news in the field, brought to you by Epstein Becker Green. We look at the latest trends, important court decisions, and new developments that...more

A Split Decision Remains Split; No en banc Review of Amgen v. Sandoz

On October 16, 2015, the Court of Appeals for the Federal Circuit (“Federal Circuit”) opted not to rehear its previously issued split decision in the court’s first analysis of the Biologics Price Competition and Innovation...more

Hospira Moves to Dismiss Amgen’s BPCIA Claims in Epogen Biosimilars Suit

Last month, Amgen sued Hospira in Delaware under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) over Hospira’s proposed biosimilar version of Amgen’s Epogen (epoetin alfa). In addition to claims for...more

Trans-Pacific Partnership: Compromise on Biologics Exclusivity Unclear

Earlier this month, a final agreement was reached on the Trans-Pacific Partnership that could provide for as little as five years of exclusivity for biologics. In recent months, it was reported that the biologics exclusivity...more

Amendments in Kazakhstan’s medicinal products registration system: new hope for rights holders

In January and June 2015 Kazakhstan’s legislation was amended in order to protect the interests of developers of new pharmaceuticals and apparatus used in healthcare....more

Health Alert (Australia) - October 12, 2015

In This Issue: - Judgments; Legislation; and Reports. - Excerpt from Judgments: Australia. High Court 7 October 2015 - D'Arcy v Myriad Genetics Inc [2015] HCA 35 The High Court has unanimously...more

Physiology/Medicine Nobels Awarded for Discoveries of “Natural Products”

In re Roslin Institute, a Fed. Cir. panel consisting of Judges Dyk, Moore and Wallach ruled that methods of isolating cffDNA were not patent eligible. Judge Dyk, writing for the panel endorsed the “markedly different”...more

Expect Focus – International, Summer 2015

In This Issue: - TTIP’s Impact on U.S. and EU Trade Relations - Proposed Innovation Box Legislation - Justice Department Recovers Nearly $6 Billion From False Claims Act Cases in 2014 - Rules...more

PTO Releases Report on Confirmatory Genetic Diagnostic Testing

More than three years after the June 15, 2012 deadline for providing it, the U.S. Patent and Trademark Office has issued its report on so-called "second opinion" genetic diagnostic testing, mandated by Section 27 of the...more

High Court of Australia determines isolated BRCA1 gene not patentable in Australia

The High Court of Australia has unanimously overturned previous decisions from lower courts and has held that certain claims to Myriad's patent for isolated BRCA1 nucleic acid molecules are not patentable in Australia...more

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