Life Sciences

News & Analysis as of

Federal Circuit: A Biosimilar Applicant Must Provide Notice of Intent to Market a Biosimilar Product, No Exceptions

On July 5, 2016, in Amgen v. Apotex (No. 2016-1308), the Federal Circuit again held that a biosimilar applicant must provide its biologic competitor with 180 days’ notice of intent to commercially market a biosimilar product....more

Healthcare & Life Sciences Private Equity Deal Tracker: Warburg Pincus to Acquire Stake in Hygenia

Warburg Pincus has announced it will invest in Hygenia. Warburg Pincus, headquartered in New York, is a PE firm that takes a long-term perspective and invest in businesses at all stages of development. It invests...more

PTO Provides Additional Guidance on Patent Eligibility of Life-Sciences Method Claims

On July 14, 2016, the PTO sent a memorandum to the examining corps regarding the recent rulings in Rapid Litigation Management Ltd. v. Cellzdirect, Inc., Appeal No. 2015-1570 (Fed. Cir. July 5, 2016), and Ariosa Diagnostics,...more

Healthcare & Life Sciences Private Equity Deal Tracker: Thoma Bravo to Acquire Healthcare IT Security Company Imprivata for $544...

Thoma Bravo has announced it will acquire Imprivata for approximately $544 million. Thoma Bravo, with offices in Chicago and San Francisco, is a PE firm that invests with a particular focus on application and...more

USPTO Patent Eligibility Guidance In View Of CellzDirect And Sequenom

On July 14, 2016, the USPTO issued a Memorandum to the Patent Examining Corps on patent eligibility in view of recent court decisions. The July 2016 Memorandum extracts more guidance for assessing patent eligibility from the...more

European Life Sciences Review: Issue 3

Welcome to the third issue of our European Life Sciences Review that covers some of the most critical developments in the pharmaceutical and medical technology sectors in the last month and is produced by our life sciences...more

Method For Preserving Hepatocytes Patent-Eligible, Despite Use Of Newly-Discovered Natural Cell Characteristics

Rapid Litigation Management, Inc. v. CellzDirect, Inc., No. 2015-1570 (Fed. Cir. July 5, 2016) - The Federal Circuit recently held that a patent covering a process for producing a preparation of frozen liver cells...more

New EU Rules for Medical Devices

After four years of negotiations, European lawmakers agreed on June 15 on a new EU Medical Devices Regulation (MDR). The MDR is the equivalent to the FDA’s CDRH regulations in the United States and essentially specifies...more

Federal Circuit Offers Path Through Section 101 Thicket for Biotech Method Patents

In its July 5, 2016 decision in Rapid Litigation Management Ltd and In Vitro, Inc. v. CellzDirect, Inc. and Invitrogen Corp., the Federal Circuit held that patent claims directed to an improved method of cryopreserving...more

Medtronic Acquires HeartWare for $1.1 Billion

Medtronic PLC has announced it has agreed to acquire HeartWare International Inc. for $1.1 billion in cash. According to the press release, the acquisition will expand Medtronic’s portfolio of diagnostic tools and treatments...more

Federal Circuit’s Recent Primer on Patent-Eligibility

A method of producing a desired population of multi-cryopreserved hepatocytes was held to be patent-eligible because the challenged claims did not recite a judicial exception. Rapid Litig. v. CellzDirect, Inc.., 2015-1570...more

Calling All Robot Enthusiasts: The White House Wants Your Input

White House issues an RFI on the legal and governance implications of artificial intelligence. On June 27, the US Office of Science and Technology Policy (OSTP) issued a Request For Information on Artificial Intelligence...more

Lessons learned from "Health Tech Innovators" conference

Allen & Overy was delighted to be involved in the recent London Technology Week event called “Health Tech Innovators”. ?Organised by Tech London Advocates, MedCity and DigitalHealth.London, the event brought together...more

Healthcare & Life Sciences Private Equity Deal Tracker: RoundTable Healthcare Partners Completes Acquisition of Symmetry Surgical

RoundTable Healthcare Partners has announced it has closed on its acquisition of Symmetry Surgical. RoundTable is an operating-oriented firm focused exclusively on the healthcare industry. The company, based in Lake...more

Political Risk Coverage Expanding to Life Science Needs; Opportunities for Surplus Lines Insurers Likely to Follow

The insurance industry is beginning to see the emergence of new kinds of coverage to protect life science companies from contingencies traditionally not covered by political risk policies. Political risk coverage is often...more

NuVasive Acquires Biotronic NeuroNetwork for $98 Million

NuVasive, Inc., has announced it has agreed to acquire Biotronic NeuroNetwork for $98 million cash. According to the press release, the acquisition more than doubles NuVasive’s footprint in the neurophysiology business across...more

Carry on as Before: Supreme Court Refuses Sequenom’s Petition

To the surprise of many, including myself, the Supreme Court denied Sequenom’s petition for writ of certiorari (“Petition”). Sequenom asked the Court whether the inventive concept required under the Mayo/Myriad framework can...more

Supreme Court Denies Sequenom’s Cert Petition, Leaving the Federal Circuit’s Interpretation of the Mayo/Alice Patent Eligibility...

The Supreme Court today denied Sequenom Inc.’s petition for writ of certiorari, in which Sequenom asked the Court to review a decision of the Federal Circuit invalidating its patent on a breakthrough prenatal diagnostic...more

Biosimilars: Supreme Court Calls for Solicitor General’s Views in Amgen v. Sandoz

On Monday, June 20, 2016, the Supreme Court deferred a decision on the certiorari petitions filed by both parties from the Federal Circuit’s decision in Amgen v. Sandoz, 794 F.3d 1347 (2015), and instead called for the views...more

AGG Food and Drug Newsletter - June 2016

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

Healthcare & Life Sciences Private Equity Deal Tracker: Bain Capital to Acquire Majority Stake in Navicure

Bain Capital Private Equity will acquire a majority stake in Navicure, according to a Navicure press release....more

The Life Sciences Report - Summer 2016

The Future of Innovation in Medtech: An Industry in Search of Growth While Facing Pressures to Consolidate in a Post-ACA World - In the Affordable Care Act (ACA) era, the healthcare industry has witnessed significant...more

Femto-Sec Tech, Inc. v. Lensar, Inc. (C.D. Cal. 2016)

Patent Having Claims That Apply Law of Nature Is Patent-Eligible - On June 8, 2016, the U.S. District Court for the Central District of California issued an order denying a motion to dismiss, and found that U.S. Patent...more

May 2016 IPO Market Review

The IPO market in May produced 15 IPOs, doubling the count for the first five months of 2016 to 30 IPOs. Gross proceeds for the month were $3.56 billion, buoyed by a pair of billion-dollar IPOs, the first such sized offerings...more

Subject Matter Eligibility Guidance -- Example on Screening for Gene Alterations

Last month, the U.S. Patent and Trademark Office issued further guidance for determining subject matter eligibility under 35 U.S.C. § 101. In addition to a memorandum on subject matter eligibility determinations that was...more

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