Resolution number 217/2018 was published in the Brazilian PTO’s Official Bulletin number 2470, and amends Resolution number 80/2013, which refers to the fast-track examination for patent applications related to products, pharmaceutical processes, equipment and materials related to public health, aiming to accelerate patent applications considered strategic to the Brazilian Public Healthcare System ...
The Danish government has now published its life science growth plan, which aims at making Denmark a leading life science nation in Europe. The growth plan is based on the recommendations submitted by the Growth Team for Life Science. Plesner has previously reported on the topic.1 The growth plan contains 36 initiatives in 6 key areas. One of the many initiatives is a pilot scheme for risk sharing in the drug reimbursement system ...
Much has been written about hotel management contracts, their legal nature and their place within the different contractual arrangements available under Spanish law. Nevertheless, in our professional lives we too often encounter contracts that include clauses or use descriptions or definitions that collide head-on with how those contracts should actually be framed ...
On July 11, 2018, then-U.S. Food and Drug Administration Commissioner Scott Gottlieb made a public statement about the agency’s efforts to advance the development of gene therapies.[1] Gottlieb pointed out that the FDA has approved three separate gene therapy products and the agency has issued six scientific guidance documents intended to serve as building blocks of a modern, comprehensive framework for how the FDA can advance the field of gene therapy ...
In recent months a Customs Destination Certificate (CDA, in its Spanish acronym) will be required for medical devices1that do not have a sanitary registration to be imported into Chile. The CDA must be requested and obtained by the importer through the Institute of Public Health’s (ISP, id.) GICONA 2.0 electronic platform, and will require the payment of an official fee corresponding to the service code 4111027, “Customs Destination Certificate, law 18,164” ...
Artificial intelligence technologies are extremely promising in healthcare.1 By examining, cross-referencing and comparing a phenomenal amount of data.2 AI lets researchers work more quickly at a lower cost3 and facilitates doctors’ decision-making with regard to diagnosis, treatment and choice of prescription. The integration of AI into the healthcare field can take various forms:4 Management of electronic medical records (e.g ...
Earlier this year the Danish parliament adopted a new Act to establish a national genome center that will develop and run a nationwide information infrastructure for personalised medicines. The National Genome Center will provide a common infrastructure with capacity for genome sequencing and a national genome data base. Persons within the healthcare sector and patients will receive information on the use of patient treatment ...
Fox News v. TVEyes Shows Fair-Use Defense Remains Risky Business “It seems to me that if there were any logic to our language, trust would be a four letter word ...
In a landmark ruling earlier this year, the United States Supreme Court overturned the ruling of the 3rd Circuit Court of Appeals that upheld the constitutionality of the Professional and Amateur Sports Protection Act (PASPA), the federal statute that effectively prohibits all sports betting in the United States by restricting states (other than a few grandfathered states, including Nevada) from authorizing sports betting ...
Biosimilar developers have been aggressive in filing petitions for inter partesreviews of biologics patents before the Patent Trial and Appeal Board, many ofthem preceding the filing of a marketing application. Such early IPRs are attractiveto biosimilar makers, because they provide a chance to challenge innovator patentsyears before the biosimilar maker files a marketing application with the U.S. Foodand Drug Administration ...
The Department for Digital, Culture, Media and Sport (DCMS) has published the Creative Industries Sector Deal aimed at making the UK the best place in the world for businesses in the creative industries. This is the latest sector deal to flow from the government's Industrial Strategy White Paper after sector deals for life sciences and the automotive industry were announced in late 2017/early 2018, respectively ...
Activists are recasting risk in a way that can only damage industry Last August, a California jury awarded plaintiff Eva Echeverria a total of $417m in compensatory and punitive damages in a lawsuit against Johnson & Johnson (J&J). Her case was that the company should have warned consumers that studies had found an inconclusive correlation between ovarian cancer and talcum powder ...
Can “consent” to use a registered trade mark be considered an abandonment by the owner of the exclusive rights to that registered trade mark in perpetuity? Section 40(1)(dd) of theTrade Mark Act 1976 (“Act”) provides that it is not a trade mark infringement if it is “the use by a person of a trade mark in relation to goods or services to which the registered proprietor or registered userhas at any time expressly or impliedly consented to” [Emph
The Court of Québec released an interesting judgment recently in a case involving civil liability and personal injury.1 Plaintiff, Ms. Bourgault, went to Village Vacances Valcartier (“VVV”) to take part in a snow rafting activity. During a descent, she was twice thrown toward the rear of the inflatable boat. The violent impacts caused her to break a vertebra. She sued VVV for damages arising out of the incident ...
More than two and a half years after the U.S. Food and Drug Administration (FDA) announced that it was reevaluating its regulatory framework for homeopathic products, the FDA released its Draft Guidance on Drug Products Labeled as Homeopathic. The Draft Guidance summarizes the FDA’s current enforcement perspective on homeopathic products and provides a list of the FDA’s enforcement priorities.The bills reawakened a debate about the pros and cons of POHs ...
Although many restaurants are not in states that require food allergens to be declared on menus, the declaration (or labeling) and handling of food allergens is a growing concern for restaurants, due to the significant risks of liability and poor public relations, if handled incorrectly ...
Earlier this year members of Fianna Fáil (the main opposition party to the Government) introduced the Gambling Control Bill 2018 as a Private Members' Bill. The Gambling Control Bill 2018 is largely based on the General Scheme for a Gambling Control Bill which was published by the Irish Government in 2013. The General Scheme was essentially an outline of what was to be included in the Bill once drafted ...
The Minister of State in the Department of Justice and Equality, Mr. David Stanton, has expressed an intention to bring forward the long awaited Gambling Control Bill (the GCB) by the end of 2017. The Government's Legislation Programme for Autumn 2017 notes that work is underway on the GCB. However, there has been no further information on when the draft of the GCB will be published, which is the next substantive step ...
Inter partes review proceedings for biosimilar products are soaring. Biosimilar makers are taking advantage of IPR proceedings to challenge patents protecting some of the world's most important biologic medicines due to the advantages that these proceedings offer: no standing requirement, no presumption of validity, a lower burden of proof and potentially broader claim construction. More than half of the IPR petitions challenging these patents were filed in fiscal 2017 ...
More hotels are imposing mandatory “resort fees” on their guests for amenities, and the amount of those fees is increasing at many of those hotels. Many consumers dislike these fees, even when they appreciate the value of the included amenities. A legal battle is underway over mandatory resort fees ...
The Libel Suit Strikes Back Much has changed since 1972 when reporters Woodward and Bernstein exposed President Nixon of wrongdoing. Through their extraordinary reporting, the public learned of “dirty tricks,” criminal actions and a cover-up led by this country’s leaders inside the White House. All resources available to these reporters including unnamed sources of information provided details that fueled these stories ...
Many of us are aware of the popular myth that ostriches believe burying their heads in the sand will make them invisible to predators. In other words, an “if I can’t see you, you can’t see me” approach. Even though scientists will tell you that this is not true, the approach seems to bear a resemblance to the online behaviour of some humans ...
Earlier this year, Executive Order no 13, which aims to strengthen the fight against illegal gambling in the Philippines, was issued. EO No. 13 mandates relevant law enforcement agencies to coordinate on campaigns against illegal gambling, and clarifies the territorial jurisdiction of government authorities that issue licenses for gambling and online gaming facilities ...
Celebrity chef restaurants, locally inspired food and beverage offerings, communal social spaces, and in-room and hotel-led fitness options–these trends represent a transformation of the traditional hotel model. Amenity preferences, particularly for authentic, one-of-a-kind social experiences, continue to segment the hospitality industry. Many of the large hotel chains have countered with a series of new boutique-style brands that cater to individuality of the customer and locale ...
In recent months, the Senate passed the Act to prohibit and prevent genetic discrimination (Genetic Non-Discrimination Act). This Act also amended the Canada Labour Code and the Canadian Human Rights Act. The new Act aims to regulate the use of genetic tests, namely, tests that analyze the DNA1, RNA2 or chromosomes of a person for predictive or monitoring purposes or for establishing a diagnosis or prognosis, mainly within a contractual framework ...
