Intellectual Property Health

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In Non-precedential Case, Third Circuit Affirms Fracking Trade Secrets Trump Physician’s Right to Know, Absent Actual Harm

Fracking in Pennsylvania continues to create work for the courts. On March 16, 2015, in a non-precedential opinion in Rodriguez v. Secretary of Pennsylvania Environmental Protection of PA et al., the Third Circuit issued a...more

Trademarks in Cuba, Successful Whistleblowers, Big Data, Health Care Encryption, Jury Instruction Tips [Expect Focus – Vol. 1,...

IN THE SPOTLIGHT · Is your Company Ready to Comply with Encryption of Individually Identifiable Health Information? LIFE INSURANCE · STOLI Schemers Must Make Good on Damages Caused · At the State Level, Is a Fixed-Index...more

FDA Regulatory and Compliance Monthly Recap – March 2015

In This Issue: - FDA issues guidance on meetings between agency and sponsors to promote consistency and effectiveness - FDA approves Novartis’ Zarxio as the first biosimilar in the U.S., clearing the drug for...more

PATIENT PRIVACY IN AN ERA OF SOCIAL MEDIA [Video]

The rise of social media has introduced new opportunities and new legal challenges for companies in the health care industry. Attorneys Seth Northrop and Sharon Roberg-Perez discuss the legal issues faced by care providers,...more

Insurance Recovery Law - April 2015

Legal Issues Not Proper Expert Testimony - Why it matters: As a good reminder concerning the boundaries for admissibility of expert opinions, a federal court in Texas recently granted a policyholder’s motion to strike an...more

N.D. Cal Interprets the Biological Price Competition Act

Amgen Inc., et al. v. Sandoz Inc., et al., No. 14-cv-04741RS - On March 19, the Northern District of California became the first court to interpret two key provisions of the Biological Price Competition Act: whether...more

Biosimilars in the US: still at the starting line?

Congress enacted the Biologics Price Competition and Innovation Act (BPCIA) in 2009 to create a framework for the introduction of biosimilar and interchangeable drugs into the US market. Like the predecessor Hatch-Waxman Act,...more

FDA Approves Biosimilar Agent Zarxio: Dawn of a New Era in Pharmaceutical Therapy and Product Liability Law

The FDA's approval on March 6, 2015, of Sandoz's Zarxio (filgrastim-sndz) is a momentous occasion for pharmaceutical therapy and product liability law in the United States. Catching up with Europe (where Sandoz's identical...more

Court Report - March 2015 #3

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Otsuka Pharmaceutical Co., Ltd. v. Sandoz Inc. et al. 1:15-cv-01716; filed March 9, 2015 in the District Court of New...more

FDA Approves First US Biosimilar but Court Action Could Delay Market Entry

On March 6, 2015, the U.S. FDA announced that it had approved Zarxio, making Sandoz the first company ever to obtain approval of a biosimilar product in the U.S. The FDA deemed Zarxio to be biosimilar to Amgen’s Neupogen...more

Mayo Clinic and Gentag, Inc. To Develop Wireless Sensors for Treatment of Obesity and Diabetes

Mayo Clinic and Gentag, Inc. have reached a joint intellectual property (IP) agreement to develop wearable biosensors designed to fight obesity and diabetes.  According to the press release, the agreement will allow certain...more

Guest Post: $2.6 Billion Per Drug: Is Your Patent Portfolio Strong Enough to Protect Your Investment?

Late last year, the Tufts Center for the Study of Drug Development (CSDD) released a number that would cause jaws to drop all around the healthcare world.  The estimated cost for developing a new drug was an astounding $2.558...more

TAKETEN and TAKE10! Can Coexist Without Confusion - In Re St. Helena Hospital

The U. S. Court of Appeals for the Federal Circuit reversed the Trademark Trial and Appeal Board’s (the Board) decision, concluding that the trademark TAKETEN used for a residential health improvement program can co-exist...more

Employees vs. Independent Contractors: The Consequences of Misclassification

The distinction between independent contractors and employees carries more burdens, consequences, and decisions than ever before. In addition to the tax consequences, there are health care compliance consequences, workers’...more

Orange Book Patent Listing and Patent Certifications: Key Provisions in FDA’s Proposed Regulations Implementing the Medicare...

On February 6, 2015, the United States Food and Drug Administration (FDA) issued long-awaited proposed regulations to implement portions of the Medicare Modernization Act of 2003 (MMA). Consisting of almost one hundred pages...more

Clinical Trial Data: Shared Resource or Private Property?

In a recently released report titled “Sharing Clinical Data – Maximizing Benefits, Minimizing Risks,” the U.S. Institute of Medicine (IOM) has called for more clinical trial data transparency. Historically, participant-level...more

Can Digital Healthcare Innovation Be Patented? Eligibility of Digital Healthcare Technologies Under the New USPTO Eligibility...

Digital healthcare, the confluence of digital technology with medical and other biological fields, has become an ever-increasing presence in our daily lives. Ideas that seemed nearly impossible just a few years ago (such as...more

Nothin’ from Nothin’ Leaves Nothin’

Axiom Worldwide Inc. v. Excite Medical Corp. et al. - The U.S. Court of Appeals for the Eleventh Circuit affirmed a district court’s $1.32 million judgment in favor of a medical device maker, ruling that it never owned...more

ODAC Committee Votes to License Sandoz’s Zarxio®

As noted in our previous client alert, FDA Accepts First Biosimilar Application Filed under Section 351(k) of the Public Health Service Act, Sandoz Inc. (“Sandoz”) filed the first biosimilar application under the Biologics...more

Preliminary Injunction Order in Actavis Casts a Skeptical Eye Toward the “Hard Switch”

Last week, we briefly reported on the injunction granted by the U.S. District Court for the Southern District of New York in the New York Attorney General’s “product hopping” suit against Actavis and its subsidiary, Forest...more

News from Abroad: Research Exemptions and Active Ingredient Manufacture

After a series of papers, reports and consultations on the scope of the research exemptions to patent infringement stretching over 10 years, section 60 of the Patents Act 1977 was finally amended on 1 October 2014 by the...more

Another Patent Challenge for Personalized Medicine

The U.S. Supreme Court’s recent trilogy of patent-eligibility decisions (Prometheus, Myriad and Alice) have called into question the validity of many U.S. patents on diagnostic medical methods. Nevertheless, legal battles...more

Intellectual Property Issues for Health Care Providers - November 2014

In This Presentation: - Introduction - Intellectual Property (IP) Basics - IP Strategy - IP Encountered by Health Care Providers - Securing Ownership of IP Assets -...more

Intellectual Property Law Issues for Health Care Providers  [Video]

Whether they are aware of it or not, health care providers create, purchase and use a variety of intellectual property daily in the course of operating their businesses, sometimes leading to issues involving patents,...more

Comments Sought by December 19th on the FDA's Proposed Criteria for "First Generic" Applications

This morning, the Food and Drug Administration (FDA) opened a public docket and requested comments on its proposed criteria for expedited review of "first generic" Abbreviated New Drug Applications (ANDAs). The comment period...more

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