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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

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

Health Insurer Antitrust Claim Against Drug Company Remanded to State Court

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 Looks at ANDA Cases

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

Dr. Reddy’s Laboratories Settles on Eve of Trial – Agrees to Cooperate with Plaintiffs

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

Blog: Litigation Round-Up: Some Recent Drug & Device Settlements, Investigations, Inquiries

Settlements - 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

How Health Care Providers Can Avoid Common Intellectual Property Mistakes

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

Introducing a New Drug Into the Marketplace in the Lifecycle of a Pre-Sales Revenue Biotechnology Venture Destined for IPO Success

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

Guest Post: Myriad -- A Direct and Unexceptional Approach

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

Guest Post: Nature's Indelible Marker - Naturally abundant, stable isotopes have already protected the identity and origin of $1.5...

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

Realizing the Potential of Telemedicine in China, Part 1: Protecting Your IP

This post is the second in Foley’s blogs on China telemedicine and the first in the blog series, “Realizing the Potential of Telemedicine in China,” meant to address top issues facing U.S. companies looking to enter the...more

PGR Report -- The Attack of 35 U.S.C. § 112

Last week, on September 2, 2014, Accord Healthcare, Inc. ("Accord") filed what appears to be the second-ever Post-Grant Review ("PGR") (see Petition). This PGR was for U.S. Patent No. 8,598,219 ("the '219 Patent"), which is...more

Court Report -- Part III: September 2014

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Forest Laboratories LLC et al. v. Sigmapharm Laboratories LLC 1:14-cv-01119; filed September 3, 2014 in the District...more

Intellectual Property and Technology News - Issue 23, Q3 2014

In This Issue: - Substitution Allowed? State Biosimilar Laws Are Evolving - Patent Wars: Can The Energy Industry Avoid Them? - Surviving A Trademark Opposition Challenge: Do You Have A True...more

Australia Upholds Patent Eligibility of Isolated DNA

The Full Federal Court of Australia affirmed that isolated nucleic acids, i.e. whether it be DNA or RNA, are patentable subject matter in Australia. While an appeal to the High Court of Australia may be possible, absent an...more

Federal Circuit Frames Test for Patent-Eligibility

Personalized medicine relies on diagnostics to analyze a patient for individualized therapy and for monitoring a patient’s health status. Some diagnostic tests use natural products, for example gene sequences, either as the...more

Managing IP Risk in the Age of Personalized Medicine

As discussed on Foley’s Health Care Law Today blog, personalized medicine treatment trends and innovations are leading diagnostic and therapeutic companies to form complex arrangements and partnerships with the ultimate goal...more

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