On June 13, 2013, in the highly anticipated decision for Ass’n for Molecular Pathology v. Myriad Genetics, Inc., the Supreme Court shed some light on the future of genetic patenting to companies and scientists working in the personalized medicine and genetics industry. The personalized medicine industry seeks to revolutionize patient care by using genetic sequencing and testing to predict disease likelihood, severity, progression, and/or treatment response ...
Can a patent be infringed even if the patented product is not manufactured, assembled, or even used? Indeed, such infringement is possible. In fact, this is known as the theory of inducement of infringement. Naturally, acts of ?inducement? must meet certain conditions before inducement of infringement can be found. The Federal Court of Appeal recently clarified these conditions ...
On Dec. 22, 2020, the U.S. Food and Drug Administration (FDA) issued warning letters to five companies for violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) related to the sale of cannabidiol (CBD) products.[i] CBD is the primary non-psychotropic compound in Cannabis sativa plant. The FDA stated the companies who were served warning letters illegally marketed CBD products for the treatment or prevention of medical conditions, including COVID-19 ...
MP Dr Liam Fox provided his support to a draft bill recently placed before parliament focusing on individuals with Down’s Syndrome. He has been working on the bill with a Down’s Syndrome Association in Portsmouth. If the draft bill passes through parliament and receives royal assent, the Down’s Syndrome Act will come into force. Its focus is on improving provision for those with Down’s Syndrome which includes education, health, social care and employment ...
In recent years, the Department of Justice, the FDA and the FBI have stepped up enforcement of the Food Drug and Cosmetic Act’s (FDCA) drug importation, distribution and misbranding requirements particularly with respect to high-priced and difficult-to-obtain drugs used in cancer treatment. Recently, these efforts suffered an unexpected setback in the Sixth Circuit following the United States’ decision to abandon its prosecution against an East Tennessee Oncologist and his wife ...
“It is a treasured value in humanity … that no parent would want her child to grow up thinking that she (the child was) a mistake." - Justice Choo Han Teck In 2010, a Chinese woman, trying to conceive a child with her Caucasian husband, underwent an in vitro fertilisation (“IVF”) procedure at a clinic. Like the previous time she bore a child through IVF at that clinic in 2006, no third party’s gametes were meant to be used ...
The Chilean Institute of Industrial Property (INAPI) has recently announced the possibility to apply to a program for fast-tracking patent’s and utility model’s applications, provided that said applications relate to technical solutions capable of impacting the environment positively ...
Due to the active spread of coronavirus infection COVID-2019, the Russian authorities, at both the federal and regional levels, are taking significant measures to ensure the self-isolation of citizens. These measures include increasing the liability for violation of measures for preventing the spread of coronavirus infection, which caused adoption of a number of legislative acts. 1 ...
Dinsmore employment law attorney Alyson St. Pierre authored an article for The Indiana Lawyer regarding a recent Indiana law that does not automatically grant religious exemptions from COVID-19 vaccinations and instead allows employers to investigate the validity of religious exemption requests. An excerpt is below ...
We are increasingly being asked: “Is it more likely that individuals rather than companies will be prosecuted under the new Health and Safety Offences Act 2008?”. The new Act, which came into force in January 2009, did not introduce any further duties on either organisations or individuals, but it did dramatically increase the penalties that can be imposed for breaches of existing health and safety legislation ...
Sixteen years since the enactment of Law No. 7 of 1996 regarding Food (“the 1996 Food Law”), the Government issued the new Food Law (ie Law No. 18 of 2012) (“Food Law”) on 18 October 2012, two days after World Food Day. The Food Law replaces The 1996 Food Law. The Food Law covers three significant areas which were not governed by the 1996 Food Law, ie imports of food; the halal requirement; and the establishment of a new non-ministerial agency in-charge of food matters ...
Referring to Newsletter Issue No. 12 in relation to the Health Bill, the new Health Law No. 36 of 2009 was finally issued on 13 October 2009. Under the Health Law, mothers must breastfeed their babies exclusively from birth until 6 months old. It is expected that family members, the Government, Regional Governments and communities will support lactating mothers by providing time and space for them to breastfeed their babies in work places and public areas ...
A new regulation has been issued by the Minister of Health, namely Regulation of the Ministry of Health No. 1010/MENKES/PER/XI/2008 regarding the Registration of Medicines (“Regulation 1010/2008”). Regulation 1010/2008 revokes previous Ministry of Health Regulation No. 949/Menkes/Per/VI/2000. Under Regulation 1010/2008, a medicine to be distributed in Indonesia must first be registered before a Distribution License (Izin Edar) can be applied for ...
On 30 January 2020, the World Health Organization (WHO) declared that the outbreak of novel coronavirus or COVID-19 constituted a Public Health Emergency of International Concern (PHEIC). The COVID-19 is a respiratory illness caused by a new coronavirus which first originated in Wuhan, Hubei Province, China, the death toll from which has reportedly surpassed 1,000 on mainland China, while confirmed infections have passed 40,000 globally ...
Under Regulation No. 122/M-IND/PER/12/2014 on Delegation of Authority to Grant Industrial Business Licenses to the Head of the Capital Investment Coordinating Board, the MOT has delegated its authority to issue certain licenses to BKPM. Business licenses delegated consist: 1. Industrial Business License and/or Expansion Licenses as follows: a. alcoholic beverages industry; b. valuable paper industry; c. weapons and ammunition industry; d ...
The Head of the National Agency for Food and Drug Control (BPOM) has issued Regulation No. 11 of 2014 on The Procedure for the Certification of Good Manufacturing Practices, ensuring compliance with the applicable standards for processed food. Regulation 11 has been in force since 5 August 2014 ...
The government’s recently announced low-carbon industrial sector strategy, supported by over £1 billion in funding to cut emissions from industry and public buildings, if nothing else, shows great ambition but does it also deliver the wherewithal to achieve those objectives? It builds on the proposals in the Energy White Paper which themselves expanded upon the Ten Point Plan for a Green Industrial Revolution announced by Prime Minister in November last year ...
A new change in the Italian regulation of the industrial design has been recently introduced by section 8, paragraph 10, of Law Decree no. 70 of May 13, 2011 (“First urgent provisions for the economy”), aimed at restricting the temporary protection granted to industrial design works under copyright law under section 239 of the Industrial Property Code (Legislative Decree no. 30 of February 10, 2005, as amended by Legislative Decree no ...
In Industrial Tribunal case number 3642/CCG, the applicant claimed that he had been subjected to discrimination, lack of equal pay, a breach of the grievance procedure under the collective agreement, lack of payment of a performance bonus and constructive dismissal. Firstly considering discrimination, the applicant argued that he was not allowed to avail himself of a career break to work with a company operating in the financial services industry ...
The U.S. Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) released an interim final rule on October 29, 2020, delaying the implementation of the information blocking rule under the 21st Century Cures Act (Information Blocking Rule) ...
The U.S. Environmental Protection Agency has announced its temporary policy regarding environmental enforcement activities during the COVID-19 pandemic. The policy is retroactive to March 13, 2020, and will apply for the foreseeable future, until seven days after EPA gives notice that the policy will terminate. The policy applies to actions for which EPA has federal enforcement authority ...
The manufacturer of the official facemask for the Brazilian Football Confederation filed a court action against an e-commerce company, accusing it of offering similar items allegedly manufactured by third parties. The manufacturer of the official facemask for the men’s and women’s teams of the Brazilian Football Confederation (CBF) filed a court action against an e-commerce company, accusing it of offering similar items allegedly manufactured by third parties ...
The COVID-19 pandemic has exposed the difficulties in reacting at European level to a major health crisis and the intention of the European Commission is to respond more effectively to future problems in the area of health. As a result, it is currently conducting an initial assessment of possible legislative changes in the area of medicinal products for human use ...
As corporate policyholders continue to submit claims to their insurers for business interruption and related losses sustained from the COVID-19 pandemic, insurers appear to be denying such claims routinely where the policies at issue contain exclusionary language specific to viruses — whether in stand-alone virus exclusions or other types of exclusions ...
