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A new European Union policy could increase the supply of legitimate pharmaceuticals in developing countries and thereby minimize the problem of counterfeit medicines, but many challenges remain. This paper describes the proposed European legislation and discusses its' potential strengths, weaknesses, opportunities and threats. Ultimately, we consider if the United States should consider similar po
On July 25th 2018, the Court of Justice of the European Union (CJEU) rendered its decision in C-121/17 Teva v Gilead , and thereby delivered yet another judgement on the interpretation of crucial provisions in the Regulation No 469/2009 concerning supplementary protection certificates (SPCs) for medicinal products (the SPC regulation). This time the CJEU attempted to clarify the meaning of article
Excessive pharmaceutical pricing represents one of the most contentious issues in legal and political discourse and has recently gained renewed attention by courts, competition authorities and political forces on both sides of the Atlantic. Balancing the public demand for affordable and accessible health-care with the need for sufficient incentives and a sustainable innovation system in the field
Using large-scale whole-genome sequencing, Dewan et al. identify pathogenic HTT repeat expansions in patients diagnosed with FTD/ALS neurodegenerative disorders. Autopsies confirm the TDP-43 pathology expected in FTD/ALS and show polyglutamine inclusions within the frontal cortices but no striatal degeneration. These data broaden the phenotype resulting from HTT repeat expansions.
Most university biobanks begin like other university research projects, i.e. with an idea conceived by an individual researcher in pursuit of his/her own research interests, publications, funding and career. Some biobanks, however, come to have scientific value that goes beyond the projects that were initially responsible for the collection of the samples and data they contain. Such value may deri
As the Broad Institute faces a formidable task in defending its revoked CRISPR patent claims in a pending appeal at the EPO, European academics Jakob Wested, Timo Minssen, and Esther van Zimmeren are wondering whether some of the issues might be referred to the Enlarged Board of Appeal.
Follow-on pharmaceutical innovation occurring after the initial discovery of a drug active ingredient plays an important, but at times underappreciated, role in providing innovative solutions to compelling medical needs. Examples of follow-on innovation include new forms of a drug with improved safety-efficacy profiles, new formulations and dosages providing improved patient outcomes, and new meth
The revocation of Broad Institute’s patent EP2771468, marks the latest major development in a series of patent battles over the revolutionary and highly lucrative CRISPR- Cas 9 technology (and other gene editing technologies) in the US and Europe. While this is the first EPO decision in an opposition procedure concerning the Broad patent portfolio, the outcome may have implications for other relat
Abstract: Despite an avalanche of recent court decisions on the European system for supplementary protection certificates (SPCs), the issue of third party SPC applications - also known as “SPC squatting” – has never been sufficiently clarified. Considering the ambiguous stipulations in the SPC Regulations, as well as the practical and theoretical significance of this issue, the lack of judicial gu
In accordance with the concept of the book and the assigned scope of the contribution, this chapter describes the European law with respect to the patent-eligibility of isolated DNA sequences. This chapter will further include a brief comparison with recent developments from the US and Australia. It will, however, not focus on the important debates regarding the patent-eligibility of other biologi
Research and innovation are key pillars of the EU’s strategy to create sustainable growth and prosperity in Europe. Research infrastructures (RIs) are central instruments to implement this strategy. They bring together a wide diversity of expertise and interests to look for solutions to many of the problems society is facing today. To facilitate the creation and operation of such RIs, the EU adopt
Many areas of pharmaceutical legislation in the European Union (EU) are harmonised in order to promote the internal market and protect public health. Ideally, harmonisation leads to less fragmented regulation and cross-border complexities. This study, however, focuses on an increasingly harmonised legislative area that is subject to increases in requirements and complexities: the distribution of m
This opinion argues that carefully drafted IPR-policies could be used to protect the substantial investments made by biobanks in the collection of HBM and data while at the same time allowing scientists to share information and to seek IPRs on downstream inventions resulting from the use of such collections. We also recognize that the feasibility of IPR-policies depends on the specific types, set-
Intellectual property rights (IPRs) represent a key concern for researchers and industry in basically all (high-tech) sectors. IPRs regularly figure prominently in scientific journals and at scientific conferences and lead to dedicated workshops to increase the awareness and “IPR savviness” of scientists. In 2015, Biotechnology Journal published a report from an expert meeting on “Synthetic Biolog
Osteoporosis-related fractures are undertreated, due in part to misinformation about recommended approaches to patient care and discrepancies among treatment guidelines. To help bridge this gap and improve patient outcomes, the American Society for Bone and Mineral Research assembled a multistakeholder coalition to develop clinical recommendations for the optimal prevention of secondary fractuream
On June 13, 2013, the U.S. Supreme Court decided the Myriad gene patent case. In a unanimous judgment the Court held that patent claims directed to isolated genomic DNA are identical to the naturally occurring sequence and thus unpatentable “products of nature”. This decision affects all isolated"products of nature", including genes, gene fragments, and other naturally occurring nucleotide sequenc
