General Business Intellectual Property Health

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Legal and Ethical Risks of Healthcare Businesses in China

Recent disputes and controversies involving Chinese subsidiaries of foreign pharmaceutical companies have sounded warning bells on legal and ethical issues regarding participation in China’s rapidly growing and evolving...more

FDA Draft Guidance Proposes Change to Combination Product Exclusivity Policy

New market exclusivity opportunities emerge for pharmaceutical companies. In draft guidance released by the Food and Drug Administration (FDA or the Agency) on February 24, 2014, the Agency proposed changes to its...more

TransCardiac's State Court Complaint Avoids Raising Federal Question

Judge Totenberg remanded the case brought by TransCardiac Therapeutics, Inc. (“TransCardiac”), against Ajit Yoganathan, Ph.D, Jorge H. Jiminez, Ph.D., Vinod H. Thourani, M.D., Emory University, Georgia Tech Research...more

FDA Intends to Grant Five Years of Market Exclusivity to Fixed-Dose Combination Drugs Containing One New Drug Substance

Fixed-dose combination drug products are becoming increasingly important in the treatment of patients with diabetes, cardiovascular disease, and infectious disease. Within the last two decades, the U.S. Food and Drug...more

Here's One Good Way to Anticipate Top Business & Legal Trends in 2014

If the past is prologue, what better way to consider the interests, needs, and concerns of business leaders and consumers in the new year than to look at what captured their attention in 2013? And so...more

IMS Study Shows Pro-Competitive Effects of Reverse Payment Settlement Agreements in ANDA Litigation

Earlier this month, the Generic Pharmaceutical Association (GPhA) held a press conference to announce the release of a study of the effects of reverse settlement payment agreements in ANDA litigation. ...more

Intellectual Property Topics for Mobile-Device Healthcare and Medical Information Technology

Developers seeking to innovate using wireless terminals, information networks and devices, as well as users seeking to exploit new innovations, generate proprietary rights that may need to be perfected, and which might be...more

The Life Sciences Report - Spring 2013

In this issue: - Best Patent Practices Under the America Invents Act - CMS Issues Final Rule for Implementing Sunshine Act - New IP Litigation Team a Boon for Firm's Life Sciences and Technology...more

Rubin v. General Hospital Corp. (Fed. Cir. 2013)

On March 28, the Federal Circuit in Rubin v. General Hospital Corp. affirmed judgment by the District Court for the District of Massachusetts dismissing the suit brought by Drs. Berish Rubin and Sylvia Anderson against The...more

WLF Submits Comments on Abbott's Citizen Petition on Biosimilars

Last April, Abbott Laboratories filed a Citizen Petition with the U.S. Food and Drug Administration, asking the agency to refrain from accepting biosimilar applications under the Biologics Price Competition and Innovation Act...more

The Legal Framework on Commercial Franchise of In-home Care Business

To conclude a little bit on some of the most concerned questions from investors in the franchise regulatory environment, I will, in this article, introduce the legal system in China on commercial franchise, what are the...more

Mandelbaum Salsburg Fall 2012 Newsletter

Mandelbaum Salsburg's Fall 2012 Newsletter containing helpful information for businesses and individuals. Table of Contents: Why Every Employer Needs a Social Media Policy A Business’s Obligations Under The Identity...more

SOPA Moves to House Committee with Modifications

Scott & Scott, LLP attorney, Keli Johson, says a copyright owner's remedies in enforcing his or her copyright will be directly impacted if the Stop Online Privacy Act (SOPA) is enacted. Foreign websites hosting copyrighted...more

Newsletter Pharma

Case law in pharmaceuticals: trademarks, patents and regulatory issue...more

Harvard Medical School Revises Conflicts of Interest Policy for Faculty Relationships with Industry

The life science industry has had a long and mutually rewarding relationship with Harvard Medical School (HMS). HMS faculty members have founded life science companies, served as advisors and directors to life science...more

Creative Royalty Structures for Life Science Companies

In any major license or partnering transaction, rarely is the royalty as simple as a single percentage on all net sales. The royalty provisions will include structures such as tier royalties, sublicense royalties, know-how...more

Joint Ownership: Shortcut to Trouble?

Life science companies are constantly entering into collaborations or other agreements with third parties in which new intellectual property may be created, whether it is a full-fledged partnership with a large pharmaceutical...more

Patent Opposition in India: Recent Trends

Therefore, as may be seen, the two-stage patent opposition process has particularly affected the pharmaceutical industry, as the patent applicants are now vulnerable to multiple pre-grant oppositions filed by competitors, or...more

Importance of Patents for Start-ups, specially in Biotech

A patent is one of the ways by which technological innovations are protected. The most ironical fact about a patent is that although it gives monopoly for a number of years, but in order to gain the monopoly, the invention...more

An Unclear Diagnosis

What constitutes patentable subject matter? The tension between the broad language of 35 U.S.C. Section 101 and the limitations of its scope by the courts is playing out in the context of patent eligibility of process...more

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