Perla: LegalTech Startups Can't Fix BigLaw's Cyber-Security Problems
Competitor or Collaborator? What UpCounsel's Growth Means for BigLaw
Polsinelli Podcasts - Hedge Funds Now Using IPR Challenges
MacEwen on BigLaw's 'Hollow Middle', Shaky Vereins & Dentons in China
Special Report: The Hot-ish Swag at LegalTech New York 2015
Is the Patent Litigation Boom Coming to an End?
What is Bitcoin 2.0?
Will 2015 Bring New Regulations for Bitcoin Users?
Waldman: Stop Immunizing Websites That Allow Harassment
A Moment of Simple Justice - Snitching Ain't Easy
Data Privacy: The Next Frontier of Corporate Compliance
What are the Implications of Alice v. CLS?
After SoundCloud & Wunderlist: How Berlin plans to grow its startup scene
Diversity and Technology in Focus for Morgan Lewis's Incoming Chair
Diversity and Technology in Focus for Morgan Lewis's Incoming Chair
PREVENTING AND RESPONDING TO DATA BREACHES IN AN ERA OF CYBER INSECURITY
What Does the Supreme Court Ruling in Alice v. CLS Mean to a Software Entrepreneur?
A Moment of Simple Justice - Revenge Porn
Why Cyber Security?
How Fenwick Partners Caught the Tech Wave
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
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
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
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
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. 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
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
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
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
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
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
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
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
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
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
In This Presentation:
- Intellectual Property (IP) Basics
- IP Strategy
- IP Encountered by Health Care Providers
- Securing Ownership of IP Assets
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
Over the last several years, several health insurers have brought antitrust claims against drug companies, contending that they were overcharged for drugs as a result of agreements reached by the drug companies in the...more
Lex Machina, a commercial venture spinning out of the "quantitative statistics" trend in patent scholarship popularized by Mark Lemley, Kimberly Moore, David Schwartz, and others, has released a Report on ANDA litigation that...more
Much has happened since our last post on the Nexium “pay for delay” class action lawsuit. Jury selection began in the District of Massachusetts on Monday, October 20, 2014. The day prior, one of the generic drug makers, Dr....more
Pharmaceutical company Organon Inc. agreed to pay $31 million to settle federal and state allegations that it underpaid Medicaid drug rebates, provided kickbacks to nursing home pharmacy companies,...more
Intellectual property can be some of the most valuable assets any business, including a health care provider (“Provider”) has. Adequately protecting this intellectual property can increase the value of the Provider’s business...more
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
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
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
Find a Science, Computers & Technology Author »
Back to Top