Is a recession good for innovation? History seems to suggest that it may be and numerous notable inventions have emerged from recessions, for example James Dyson's vacuum came out of the last recession in the 1990s. Innovation is a key priority for the Scottish Government in these difficult times and politicians have described innovation as "essential" to create a more successful Scotland through sustainable economic growth ...
Introduction A plant variety right (PVR) is an IP right which rewards breeders of new plant varieties for their efforts in creating those varieties. The current PVR law dates back to 1975 and is based on the 1961 International Convention for the Protection of New Varieties of Plants. The convention has since been amended several times, most recently and radically in 1991 ...
The new abbreviated regulatory approval pathway for “biosimilar” and “interchangeable” types of biologic drug products was implemented in the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) as part of the Patient Protection and Affordable Care Act of 2010. The details about the use of this pathway were left for further development through Food & Drug Administration (“FDA”) action ...
A March 7, 2013 piece on Morning Edition, the morning news program from National Public Radio, raised a lot of questions. “In A Grain Of Golden Rice, A World Of Controversy Over GMO Foods” told the story of golden rice, a beautiful yellow rice enhanced with beta-carotene, or Vitamin A. This rice was ostensibly developed to be grown in developing countries, where foods high in Vitamin A either are uncommon or are expensive ...
One way to change the law fast is to amend or repeal statutes in budget legislation. That is what the federal government of Canadadid in 2009, 2010 and 2011. Federal programs, staff positions and budgets for environmental science, conservation and protection have been eliminated. That leaves a lot of responsibility with the provinces and territories, and many open questions for industry. This article describes what has happened and identifies what to look out for ...
On 13 June 2013, the Supreme Court of the United States handed down its unanimous decision in the ongoing case of Association for Molecular Pathology et al v Myriad Genetics, Inc. et al 12-398, 569 US __ (2013). This case is the first brought in the US directly challenging the patentability of human genes and for that reason is extremely important to any entity involved in the biotechnology industry which relies on human genetics research as part of innovation strategy ...
Denmark has a large life science sector, including a number of biotech and pharmaceutical companies and research activities. The sector is highly regulated and covered by extensive and complicated statutory requirements, executive orders and ethical standards. Denmark has incorporated most of the EU regulation and Danish law is thus to a large extent in conformity with the general EU regulation and practice of, for example, the European Medicines Agency (‘EMA’) ...
In the innovativeness of its economy, Poland ranks 4th from last in the European Union, but greater support is planned for highly innovative projects that show promise for implementation and commercialisation in Poland. At a session of the Polish Parliament’s Innovation and New Technology Committee on 19 June 2013, the Ministry of Regional Development presented the guidelines for operational programmes Smart Growth 2014–2020 and IT & Telecommunications 2014–2020 ...
On Thursday, November 7, 2013, the United States Food and Drug Administration (FDA) announced measures to definitively eliminate all the artificial trans fats from processed products in the United States. The purpose of the proposal, which is released for public comments for a 60-day period, is to remove trans fats from the “generally recognized as safe” (“GRAS”) category, which would allow these products to be commonly used in food products ...
As in past years, chemical, pharmaceutical and biotechnology patent cases in 2013 offered a combination of the predictable and the unpredictable. On the predictable end of the spectrum, the US Supreme Court offered no surprises ...
Horizon 2020 is the new EU Framework Programme offering more than €70bn funding for Research and Innovation initiatives over the period 2014 to 2020 and covering every stage of the innovation process from research to market uptake. Ivan Waide and Kate Keith, IP & Technology lawyers at A&L Goodbody, take a closer look at the programme, including opportunities available to Northern Ireland businesses and research organisations ...
New technology is most often associated with telecommunications, IT or robotics. Food is seen as a group of products in which innovation is little important, because it is believed that consumers are mostly concerned with prices and quality, but not innovations. However, the dynamic growth in market share of functional foods calls for a critical review of myths that have arisen around R&D projects in the food sector ...
On September 9, 2014, the U.S. Food and Drug Administration (FDA) published the inaugural “Purple Book,” a list of approved or “licensed” biological products, including all biosimilar and interchangeable biological products. The Purple Book is more formally known as “Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations.” The Purple Book is meant, at a fundamental level, to be the biological equivalent of the “Orange Book ...
What Is the Size of the Market and What Are Current Trends in Switzerland? Life Sciences is one of the most dynamic and most rapidly growing sectors in Switzerland with respect to both the industrial and the academic dimension. In 2013, the total financ-ing volume amassed by Swiss biotech companies more than doubled compared to the previous year’s figure, reaching USD 325 million, which amounts to an increase of 112% ...
Are you ready to disclose? All Transfers of Value (ToV) from 2015 must be disclosed publicly via the Irish Pharmaceutical Healthcare Association (IPHA) central reporting system by 1 July 2016. This relates to all ToVs that were made by pharmaceutical companies to Healthcare Providers (HCPs) and Healthcare Organisations (HCOs) in connection with the development and sale of prescription only medicinal products for human use ...
The FDA’s Proposals on the Revision of the Nutrition and Supplement Facts Labels In early 2014, first lady Michelle Obama announced upcoming changes to the FDA’s Nutrition Facts label, and in March 2014, the FDA issued a proposed rule on the revision of Nutrition and Supplement Facts labels “to assist consumers in maintaining healthy dietary practices ...
Important notification of four new guidelines for the compilation of mandatory codes of practice, which are binding in terms of the Mine Health and Safety Act 29 of 1996 (“the MHSA”).Kindly take note that on Friday, 5 February 2016, notices were published in Government Gazette No ...
1. What Is the Size of the Market and What Are Current Trends in Switzerland? Life Sciences is one of the most dynamic and most rapidly growing sectors in Switzerland with respect to both the industrial and the academic dimension. In 2013, the total financing volume amassed by Swiss biotech companies more than doubled compared to the previous year’s figure, reaching USD 325 million, which amounts to an increase of 112% ...
Recently the “guideline for the supervision and regulation of the nutritional composition of foodstuff and its advertisement (“the guideline”) was published by the Undersecretary of Health.The guideline´s main objective is to, “guide the process of supervision and regulation of foodstuff”, taking into consideration the upcoming implementation of Decree No. 13 (June 27, 2016), which modifies the Health Regulations for Food Products ...
Article 81 of the Food Safety Law of the PRC (the “Food Safety Law”), revised in 2015, stipulates that the product formulas for infant formula milk powder shall be registered with the food and drug administration under the State Council ...
Zoetis, the animal health company, has acquired Danish biotech company Scandinavian Micro Biodevices for USD 80 million (approximately DKK 533 million). Plesner assisted Zoetis with the transaction. Zoetis Inc. has acquired Scandinavian Micro Biodevices ApS for the purpose of extending its pipeline of veterinary diagonistics products ...
On October 3rd ALRUD Law Firm Partner Anton Dzhuplin joined a workshop of international Conference “What is happening in pharmaceutical market?”, which took place at “PHARMASTRATEGIES-2017” summit. The conference annually brings together Country managers, CEOs, top-managers of pharmaceutical manufacturers, distributors and retailers, heads of associations, representatives of regulatory authorities, professional and business media ...
Few areas of law have proven more dynamic over the last few years than the interplay between state tort laws and the federal regulation of pharmaceutical drugs and medical devices. During its last two terms, the United States Supreme Court has issued three separate opinions addressing federal preemption of state law claims under the Federal Food, Drug, and Cosmetic Act ...
