This is a review of the recent publication “Pharmaceutical Innovation, Competition and Patent Law – A Trilateral Perspective”, edited by Max Planck Director Josef Drexl and Finnish scholar Nari Lee (Edward Elgar 2013, 322 p., ISBN 978 0 85793 245 7). In summary, I conclude that the editors, who also contributed with excellent papers, have succeeded very well in the difficult task of structuring, s

While greater incentives and new funding models for antibiotic drug develooment are needed, it is unclear whether a system dependent on endlessly churning out new and ever more expensive medicines will be economically feasible and scientifically possible in the long term. Greater priority should therefore be given to implementing more permanent solutions that are not limited to slowing resistance,

The novel coronavirus (COVID-19) is challenging the world. With no vaccine and limited medical capacity to treat the disease, nonpharmaceutical interventions (NPI) are the main strategy to contain the pandemic. Unprecedented global travel restrictions and stay-at-home orders are causing the most severe disruption of the global economy since World War II. With international travel bans affecting ov

To update the European League Against Rheumatism (EULAR) recommendations for vaccination in adult patients with autoimmune inflammatory rheumatic diseases (AIIRD) published in 2011. Four systematic literature reviews were performed regarding the incidence/prevalence of vaccine-preventable infections among patients with AIIRD; efficacy, immunogenicity and safety of vaccines; effect of anti-rheumati

By Timo Minssen (CeBIL, UCPH), Sara Gerke & Carmel Shachar A recent US lawsuit highlights crucial challenges at the interface of data utility, patient privacy & data misuse The huge prospects of artificial intelligence and machine learning (ML), as well as the increasing trend toward public-private partnerships in biomedical innovation, stress the importance of an effective governance and

On the sixth year anniversary of Mayo (https://www.supremecourt.gov/opinions/11pdf/10-1150.pdf), our empirical study examines the impact of the US Supreme Court decision on patent subject-matter eligibility, patent examination and patent prosecution of biotech related patent applications before the USPTO. To answer our research questions, we developed an empirical methodology designed to elucidate

Importance: Although highly effective disease-modifying therapies for multiple sclerosis (MS) have been associated with an increased risk of infections vs injectable therapies interferon beta and glatiramer acetate (GA), the magnitude of potential risk increase is not well established in real-world populations. Even less is known about infection risk associated with rituximab, which is extensively

In October 2017, the EU Commission announced a consultation on supplementary protection certificates (SPCs) and research exemptions, including Bolar-type provisions. The consultation will provide valuable input for the Commission when preparing an evaluation of the current EU legislation, and any future policy proposals on SPCs and patent exemptions, including the assessment of the impact of diffe

The global epidemic of Alzheimer disease (AD) is worsening, and no approved treatment can revert or arrest progression of this disease. AD pathology is characterized by the accumulation of amyloid-β (Aβ) plaques and tau neurofibrillary tangles in the brain. Genetic data, as well as autopsy and neuroimaging studies in patients with AD, indicate that Aβ plaque deposition precedes cortical tau pathol

In Germany, the UK, the US and the Scandinavian countries there is a distinct difference between direct and indirect (also referred to as contributory) statutory patent infringement. The patent laws that regulate incursions on the exclusive rights of patent holders in these jurisdictions generally distinguish between direct patent infringement on the one hand, which is based on wholly objective cr

In this study we illuminate and discuss the most recent developments in respect of the interpretation of the “industrial application” requirement with respect to gene and protein related inventions in Europe. The analysis will focus on the relevant provisions of the EPC and decisional practice from the European Patent Organisation (“EPO”), particularly decisions from the Technical Board of Appeal