Beginning on 1 January 2014, French pharmacists are now legally permitted to substitute a biosimilar for the prescribed (reference) biological medicine as long as the prescribing physician has not marked the prescription as “non-substitutable.” According to the new law, substitution is allowed only when initiating a course of treatment, and if the biosimilar belongs to the same group as the prescribed product, known as a “similar biologic group.” The criteria for inclusion in a “similar biologic group” have yet to be defined by the French healthcare authority (ANSM).
Companies known as “non-practicing entities” (NPEs), patent assertion entities (PAEs) or, more colorfully, patent trolls do not produce patented products or services, but instead are created specifically to own patents and seek licensing fees. Lawsuits brought by NPEs are increasingly pervasive and costly. This article provides a roadmap that will allow corporate counsel to analyze and address the demands of a patent troll.
Resolving trademark registration disputes through the US Patent and Trademark Office’s Trademark Trial and Appeal Board (TTAB) can be a painstaking process. Although counsel have been slow to adopt them, better, more efficient methods exist. Read this article to learn about other options, including the Accelerated Case Resolution (ACR) procedure.
This case law is an order granting in part and denying in part Plaintiffs' motion for spoliation and discovery abuse sanctions.
Panelists are expected to address a number of patent prosecution issues that in-house counsel continue to struggle with, either when dealing with their own outside patent counsel or addressing these issues directly on their own. These issues include: strategies for filing a U.S.-based application or Patent Cooperation Treaty at the outset; proper claim construction; nuances for filing under the AIA and any changes they have seen in prosecution under the America Invents Act; and practical tips for foreign filing strategies, etc. Exercises in claim construction and foreign filing considerations (e.g., a road map to key countries, and why or why not a company should seek protection outside the United States in Europe, Asia, South America) are expected.
After a 40-year history of negotiations, it is expected that the Unified Patent Court (UPC) will soon become a reality in Europe. The UPC will have jurisdiction for litigation relating to the new Unitary Patent and the European Patent granted by the European Patent Office. Attend this session to hear the latest on this groundbreaking development, and its implications for obtaining and defending patents in Europe.
Bringing a drug to market requires an extraordinary investment. In-house counsel at biotech and pharmaceutical companies routinely face the challenge of developing an IP strategy that maximizes an investment’s return. This is especially difficult when the market for approval of a drug is relatively small. This article provides an overview of the regulatory frameworks for orphan drugs in the United States and other developed and emerging markets.
This InfoPAK is not a comprehensive analysis of Intellectual Property licensing, but rather, it is a discussion of the best practices and recent developments in intellectual property licensing. The core of this InfoPAK touches on issues that are fundamental to the granting of rights, as well as the assets covered by most intellectual property licenses.
This brief overview (QuickCounsel) touches on those issues that are fundamental to most patent licenses and should at least be considered in the context of a patent license negotiation.
The purpose of this disclosure form is to permit evaluation of your invention, to determine whether the invention is patentable and to establish whether commercial development is feasible.