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Federal Circuit Clarifies Law of Obviousness-Type Double Patenting: Patent Term Extension and Patent Term Due to URAA Are Safe from Gilead v. Natco
Patterson Belknap Webb & Tyler LLP, December 2019

In two decisions on Friday, the Federal Circuit clarified the law of obviousness-type double patenting (ODP) and provided certainty to biopharma patent owners.  In Novartis AG v. Ezra Ventures LLC, the court held that ODP does not invalidate an otherwise valid patent term extension (PTE) granted under 35 U.S.C. § 156 (extending the term of a pharmaceutical patent to compensate for regulatory delays).  And in Novartis Pharmaceuticals Corp. v. Breckenridge Pharmaceutical Inc...

The Potential Impact of Blockchain and Smart Contracts on the Chilean Telecommunication
Carey, October 2019

Although blockchain and smart contracts are young, still-evolving and need to be tested and improved, they are already promising a revolution in different areas of the economy, and this is not unfounded; both could bring huge improvements across many areas. Imagine being able to get a mortgage, buy an apartment and get the relevant records immediately registered under your name with no need to make legal reviews of these transactions in just one click...

From Footfall to Clicks - The Experts Talk Retail Risk
Shoosmiths LLP, September 2019

Over the last few years, news that some of the nation's most iconic retail stores have closed has become more frequent. Yesterday, Poundworld entered administration. Last week, House of Fraser announced it would be closing 31 stores, many of which are in some the UK's largest cities. It is no secret that many retailers have been adversely affected by the shopping habits of consumers, ever since the advent of a new pastime - buying online...

New Pharmacist's Guidelines for Advertisement in Brazil
Veirano Advogados, January 2019

The Federal Council of Pharmacy published Resolution No. 658/2018 to regulate publicity, advertisement and announcement of activities related to the pharmaceutical profession. Such include any disclosure arising or promoted by pharmacists, regardless of the means of communication...

Mentoring at Shepherd and Wedderburn
Shepherd and Wedderburn LLP, January 2019

Shepherd and Wedderburn, as a collection of individuals and as a business, has put diversity and inclusivity at the heart its organisational culture and values. The business case for fostering diversity and inclusivity in the workplace is compelling...

Dispute Between Two Popular Ride-Sharing Companies in Brazil Reinforces That Comparative Advertising is Not Illegal
Veirano Advogados, January 2019

The dispute between ride sharing companies Uber and 99 is increasingly fierce. Now the main stage is Rio de Janeiro. In May 2018, Uber filed a lawsuit against 99 in the city, claiming misleading advertising. Less than two months ago, 99 began an aggressive discount campaign in the city to promote the 99Pop service in Rio, competing directly with Uber...

Indonesian Equity Crowdfunding Regulation
Makarim & Taira S., January 2019

The Financial Services Authority (“OJK”) issued OJK Regulation No. 37/POJK.04/2018, on 31 December 2018 on equity crowdfunding services (the“Crowdfunding Services”) which allow offers of shares for sale by an issuerdirectly to investors through an open information technology system (“POJK37/2018”). POJK 37/2018 applies to offers of shares through a Crowdfunding ServicesProvider’s system...

Directors to Get Better Protection From Fraud
Shoosmiths LLP, January 2019

The UK government has announced changes to legislation to reduce the risk of fraud, violence or intimidation faced by company directors as a result of having their residential addresses on the public record. For a number of years, directors have been able to keep their residential address details private by making use of a separate service address, often the company's registered office...

Transfer Pricing Update In Panama
Morgan & Morgan, January 2019

The regulation of Transfer Pricing is one of the mechanisms through which the Directorate General of Revenue (DGI) seeks to avoid the erosion of the tax base. In Panama, it is regulated in the Fiscal Code in its Chapter IX from Article 762-A to 762-Ñ. The obligation on the issue of Transfer Pricing and specifically with the study is generated since the 2011 period...

Recent Changes to EPA Coal Ash Regulations - Regulatory and Insurance Coverage Implications
Haynes and Boone, LLP, January 2019

A new rule promulgated by the U.S. Environmental Protection Agency (“EPA”) governing the disposal of coal combustion residuals, also known as CCR or coal ash, raises the risk for civil claims and the need for insurance to cover them.1 The rule, which takes effect Aug. 29, 2018, revises regulations issued in 2015 and has the stated intent of providing utilities and states “more flexibility in how CCR is managed...

Hong Kong Court Orders Director to Personally Pay Litigation Costs
Deacons, January 2019

It appears that Big Island Construction (HK) Limited (BIC) and Wu Yi have had a long drawn out battle since 2005, with numerous judgments reported, starting from the District Court and going all the way up to  the Court of Final Appeal...

People over Wind and Peter Sweetman v Coillte
A&L Goodbody, January 2019

In case C-323/17 People Over Wind and Peter Sweetman v Coillte, the Court of Justice of the European Union (CJEU) ruled that mitigation measures could not be taken into account at the screening stage of an appropriate assessment. Facts This case focused on proposed works that were necessary to lay a cable connecting a wind farm to the electricity grid and the potential effects that this would have on two special areas of conservation...

The Advocate: Risks to the Energy Sector Posted by Climate Change Litigation
Haynes and Boone, LLP, January 2019

Fossil fuels are under attack in the legislative, regulatory, and judicial arenas, and in the market place—driven by environmental concerns, especially global warming and associated climate change. The Sierra Club, for example, has launched a “Beyond Dirty Fuels Initiative,” seeking to “push back against the construction of dirty fossil fuel infrastructure that would lock America into decades more of climate-polluting oil and gas production...

Securing Indemnification and Additional Insurance Coverage Requires Careful Drafting
Lowenstein Sandler LLP, January 2019

Insurance plays a prominent role in all real estate transactions. Stakeholders generally understand that insurance policies must be secured for the leasehold to address property damage and liability claims. However, stakeholders often do not pay attention to the precise contract language used to establish the insurance requirements and address how the waterfall of available insurance coverage will flow...

Pathways to Success ACO Model
Dykema, January 2019

The U.S. Centers for Medicare and Medicaid Services (CMS) issued a final rule redesigning the Medicare Accountable Care Organization (ACO) program via a new Pathways to Success ACO model. [1]See83 FR 67816 (Dec. 31, 2018). CMS stated five goals for this redesign: ACO Accountability, Competition, Engagement, Integrity, and Quality...

Conviction for Failing to Keep Significant Controllers Register on the Increase
Deacons, January 2019

On 7 January 2019, the Companies Registry announced that twelve Hong Kong companies were prosecuted for, among other things, failing to keep the significant controllers register at their registered offices, and the companies were fined...

Disconnecting from Work: A New Reality
Garrigues, January 2019

Employers must develop in-house policies laying down the right of employees to disconnect from work, with special emphasis on remote working using digital tools. Recent legislation — Organic Law 3/2018, of December 5, 2018 — not only brings Spanish law on the protection of personal data up-to-date, but also includes a section regulating the protection of citizens’ digital rights...

Medicare Coverage for Ambulance Services – Physician Certification Will Not Be Enough
Dykema, January 2019

A physician certification for Medicare coverage for ambulance services is not the final word. An ambulance service also must demonstrate the beneficiary’s condition and establish medical necessity when transporting the Medicare beneficiary...

U.S. Department of Labor Issues Proposed Rule on Association Health Plans
Morris, Manning & Martin, LLP, January 2019

On January 5, 2018, the U.S. Department of Labor (“DOL”) published a much-anticipated proposed rule that would make it easier for groups or associations of employers to band together to form association health plans (“AHPs”).[1]  The proposed rule comes in response to an executive order issued by the White House in October 2017 directing the DOL to consider issuing such a rule...

Bona Fide Prescriber-Patient Relationship Requirement for Controlled Substance Prescribing Effective January 4, 2019
Dykema, January 2019

Bona Fide Relationship Requirement Law. Public Act 247 of 2107, MCL § 333.7303a(2), requires that except as provided in exceptions detailed in administrative rules, a prescriber must be in a bona fide prescriber-patient relationship with a patient before prescribing a schedule 2-5 controlled substance (“CS”)...

It's Still Gray: The 2018 Farm Bill and the Legality of CBD Under Federal Law
Haynes and Boone, LLP, January 2019

President Trump recently signed the Agriculture Improvement Act of 2018 (also known as the 2018 Farm Bill) and the cannabis industry quickly and widely celebrated passage as clearing the way to sell products containing cannabidiol (better known as CBD). But is it really? As one might expect, this lawyer’s answer is that “it depends.” CBD has become known for its purported health benefits in relation to a wide range of conditions...

If You Have Suggestions for Improving the HIPAA Privacy or Security Rule, Now Is the Time to Speak Up
Dykema, January 2019

On December 14, 2018, the U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) published a Request for Information (RFI) about ways to modify the HIPAA Privacy and Security Rules[1]to promote the transition of the health care industry to a value-based Medicare payment model and improve care coordination for patients. See “Request for Information on Modifying HIPAA Rules to Improve Coordinated Care,” 83 FR 64302 Page:64302-64310...

Posting Workers to Poland? Learn About Your Duties Before the Polish Authorities
Wardynski & Partners, January 2019

The Act on Posting of Employees for Performance of Services of 10 June 2016, implementing the Posting of Workers Directive (96/71/EC) and the Enforcement Directive (2014/67/EU), imposes anumber of obligations on foreign employers posting their employees to Poland which may prove difficult to implement in practice...

Best Practices For Sellers in The Evolving DSO Marketplace
Dykema, January 2019

The tsunami of consolidation activity in the dental services industry has created remarkable financial opportunities for dentists and investors. Primarily, these opportunities play out in the form of Dental Services Organizations formed by entrepreneurial dentists and/or private financial interests through the acquisition of established, profitable practices...

Law No. 21,121 Amends Rules Relating to Corruption and Other Crimes, Incorporates New Criminal Conducts, and Expands Criminal Liability of Legal Entities
Carey, January 2019

Law No. 21,121 (the “Law”), which came into force on November 20, 2018, amends the Criminal Code, Law No. 20,393 on Criminal Liability of Legal Entities, and Law No. 19,913 on Money Laundering, in connection with various criminal conducts relating to corruption and conflicts of interest. The following is a summary of the main aspects of the Law: 1.Domestic Passive and Active Bribery...

The Healthcare Industry: A Look Back. A Look Ahead.
Waller, January 2019

While buzzwords like consolidation and price transparency continue to dominate headlines, major players throughout the healthcare ecosystem are working tirelessly behind the scenes to deploy creative and complex service methods that leverage a smarter, more holistic approach to care. The goal? Control escalating costs and deliver tangible value to patients – all while maintaining a healthy balance sheet...

Ireland In a No Brexit Deal Scenario - What Measures is The EU Proposing For Financial Services, Air Transport, Road Haulage and Customs?
A&L Goodbody, January 2019

Background The UK invoked the exit procedure under Article 50 of the Treaty on European Union in March 2017. Unless the UK's decision is withdrawn or the period is extended, this will become effective in a little over 80 days...

Data protection in the application process
Heuking Kühn Lüer Wojtek, January 2019

Under its Article 88(1), the GDPR allows Member States to draw up their own rules for the area of employee data protection. Germany has taken advantage of this option with Section 26 of the Federal Data Protection Act (BDSG). The first sentence of Section 26(1) already applies while the decision to establish an employment relationship is made and hence it needs to be taken into account early in the application process...

Changes to Rules on Occupational Safety and Health in Mining Activities
Veirano Advogados, January 2019

On December 19th, 2018, the Ministry of Labor published Ordinance No. 1,085/2018, for the purpose of amending Regulation No. 22 ("NR-22"), which regulates aspects related to the mining sector occupational safety and health. The reformed NR-22 therefore brings changes to the sections regarding the Disposal of Tailings, Wastes and Products and the Emergency Response Plan, within the framework of the National Policy on Dams Safety ("PNSB")...

Year in Review: Top Insurance Cases of 2018
Hunton Andrews Kurth LLP, January 2019

2018 was a busy year for courts deciding insurance coverage disputes. Many of those decisions will shape the coverage landscape for years to come. Policyholders enjoyed their fair share of the wins, including substantial victories in areas involving social engineering to disgorgement of corporate gain. We take this opportunity to reflect on some of the year’s most notable coverage decisions...

Overview: The Evolving Dynamics of IP
Simonsen Vogt Wiig AS, January 2019

To protect and stimulate creators to increase innovation and encourage entrepreneurship, Norwegian authorities are changing the law. In 2018 we received several proposals towards strengthening the rights of those who create new ideas or build their business on intellectual property. Looking back at 2018, we see a year in which the Norwegian intellectual property (IP) legislation has been in movement. Technology is developing fast, and so must the law protecting technology...

Michigan Changes Medical Marihuana Licensing Process to Facilitate Investment, Provide Path for Publicly Traded Companies
Dykema, December 2018

As one of the final acts of its 99th Legislative Session, the Michigan Legislature passed amendments to the Medical Marihuana Facilities Licensing Act (MMFLA), as well as changes to the Marihuana Tracking Act. These amendments were signed by outgoing Governor Rick Snyder on December 28, 2018, with the MMFLA amendments effective January 1. The Tracking Act amendments took effect immediately...

Overview: Expect Increase in Private M&A Transactions in 2019
Simonsen Vogt Wiig AS, December 2018

Despite a positive and active start in H12018 with high M&A activity in the Norwegian market, the total number of completed deals in Norway in 2018 will be significantly lower than in 2017. YTD it has been registered 248 completed deals in Norway compared to 346 in 2017 (full year)...

Unlicensed Michigan Medical Marihuana Facilities Must Close December 31
Dykema, December 2018

CLOSE OR BE DENIED! In a major year-end development, the Michigan Court of Claims today dismissed the last of the cases that allowed unlicensed Michigan medical marihuana facilities to operate...

Overview: Technology Trends and Software Liability
Simonsen Vogt Wiig AS, December 2018

Software is becoming the main part of an increasingly amount of products set on the market; a trend which will become more and more evident in the years to come. This fact challenges the legal landscape and interpretation of product liability laws, and contract makers must pay attention to potential new risks imposed on the parties. If a product causes damages to a third party, complex questions may arise with respect to liability and the chain of causation...

CMS Continues to Enhance Oversight of Accrediting Organizations
Dykema, December 2018

The U.S. Centers for Medicare and Medicaid Services (CMS) has once again stepped up its oversight of Accrediting Organizations (AOs).[1] On December 18, 2018, CMS issued a Request for Information (RFI) seeking to determine whether AOs have a conflict of interest between their governmental contract and their private business. See “Medicare Program: Accrediting Organizations Conflict of Interest and Consulting Services; Request for Information,” 83 FR 65331...

Overview: Implementation of PSD2 in Norway
Simonsen Vogt Wiig AS, December 2018

PSD2 came into effect in the European Union on January 13, 2018. PSD2 is important as it aims to further harmonise the EU payments market and break the banks' de facto monopoly on the provision of payment services and the use of their customer data. Below is a review of developments to date as they relate to transposing PSD2 into Norwegian law, including an update on the most recent developments...

Michigan Passes New Industrial Hemp Law, Sets Up Statutory Conflict
Dykema, December 2018

On the last day of the legislative session, the Michigan Legislature passed House Bills 6330, 6331, and 6380 to create the Industrial Hemp Research and Development Act (IHRDA). If signed by the Governor, IHRDA will require the registration of industrial hemp growers and processors as a prerequisite to grow or sell industrial hemp. Oversight authority is given to the Michigan Department of Agriculture and Rural Development (MDARD)...

Pro League Adopts Action Plan Clarifying the Role of Football Agents and Increasing the Transparency in Belgian Football
ALTIUS/Tiberghien, December 2018

An expert panel of the Pro League (the organization representing the interests of all professional Belgian football clubs) appointed by the latter and presided by Belgian minister of State, Melchior Wathelet, was consulted on the role of football agents within the current Belgian football landscape. The panel was asked to formulate recommendations and ‘best practice’-proposals to the Pro League...

New Owner Through Foreclosure Must Perfect Title to Property Before Serving a Three-Day Notice to Quit to Tenant
Dykema, December 2018

In December of 2018, the California Supreme Court issued its ruling in Dr Leevil, LLC vs Westlake Health Care Ctr, No S241324, 2018 LEXIS 9546 that an owner acquiring title to real property under a power of sale contained in a deed of trust must perfect titlebeforeserving the three-day written notice to quit required by California Code of Civil Procedure section 1161a(b). Westlake Village Property, L.P., owned real property in Thousand Oaks...

China Encourages Share Repurchase by Revising the Company Law
Deacons, December 2018

On 26 October 2018, the Standing Committee of the National People's Congress approved a decision to revise the Company Law of the People’s Republic of China (Revision), with the aim of supplementing and improving the existing share repurchase regime. We have set out a brief introduction to this Revision below. Background It has only been five years since the last revision to the Company Law of the People’s Republic of China (Company Law)...

A New Year’s Resolution for Illinois Employers: Update Policies and Procedures to Comply with New Law Requiring Broad Expense Reimbursement Duties
Dykema, December 2018

Beginning on January 1, 2019, Illinois employers will—for the first time—have to reimburse employees for “all necessary expenditures or losses incurred by the employee within the employee’s scope of employment and directly related to services performed for the employer...

Broader Protection from Discrimination and Harassment on The Horizon
Deacons, December 2018

The Discrimination Legislation (Miscellaneous Amendments) Bill 2018 (Bill) was gazetted on 30 November 2018...

Federal Penal Code Amendments
Afridi & Angell, December 2018

In the latest development in an eventful year, Federal Decree-Law 24 of 2018 introduces amendments to the Federal Penal Code, originally enacted as Federal Law 3 of 1987. The amendments are designed to make the Penal Code consistent with other recent federal legislation and current federal enforcement policies. Only ten provisions of the statute have been affected, out of the more than 400 total articles contained in the statute...

Community Banks Disappointed with Federal Regulators’ Proposed Community Bank Leverage Ratio
Dykema, December 2018

One of the key provisions of the Dodd-Frank Act rollback law signed by President Trump on May 24, 2018, hasn’t met its early promise for U.S. community banks. Recently proposed rules to implement simplified capital requirements have fallen short of the industry’s expectations when the bank deregulation law was enacted in May...

Online Retail Sector Increasingly Targeted by the Competition Authorities
Simonsen Vogt Wiig AS, December 2018

The online retail sector has seen a considerable increase in intervention by the competition authorities both on a national level and in Brussels. Most recently, in December 2018, the European Commission fined the clothing company Guess € 39.8 million for applying online sales and advertising restrictions...

Tax Planning for the End of 2018 and Beginning of 2019
Dykema, December 2018

Before 2018 comes to a close, it may be worthwhile to review the state of your tax, estate, and charitable giving plans. Along with the typical end-of-year considerations, this year it is crucial also to pay careful attention to the effects of the 2017 tax act (P.L. 115-97, signed into law on December 22, 2017, and informally called the “Tax Cuts and Jobs Act of 2017,” herein the “2017 Tax Act”) that altered many longstanding rules and assumptions...

Covered by the Clean Water Act and WOTUS? Maybe Not Anymore.
Schwabe, Williamson & Wyatt, December 2018

In December of 2018, the U.S. Environmental Protection Agency (EPA) and Army Corps of Engineers (Corps) released their much-anticipated draft proposed rule to re-write the definition of “waters of the United States” (WOTUS) (“2018 Rule”). The definition of WOTUS establishes the scope of agency jurisdiction over waters and wetlands under the Clean Water Act (CWA)...

Bringing Back Discretion: DOJ Announces Revisions to Current Policy Concerning Corporate Misconduct
Dykema, December 2018

In 2015, the Department of Justice (“DOJ”) announced a more aggressive stance requiring individual accountability in civil and criminal investigations of corporate misconduct...

Hong Kong Court Holds That Claim in Tort Was Not Affected by Arbitration Clause
Deacons, December 2018

“Arbitration agreement” is defined under section 19 of the Arbitration Ordinance (Cap 609) as an agreement by the parties to submit to arbitration all or certain disputes which have arisen or which may arise between them in respect of a defined legal relationship, whether contractual or not. Disputes submitted to arbitration may involve contractual claims and non-contractual claims, such as tortious claims...

 

 

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