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 ...
Capturing lightning in a bottle: As fast-growing San Francisco concludes its largest rezoning in 10 years, will its novel new urban-planning guidelines for South of Market represent what the city's downtown needs in a fast-moving business, cultural and economic environment? In early December 2018, the San Francisco Board of Supervisors gave final approval of the "Central SOMA Plan," (the Plan) resulting in the largest rezoning of the commercial heart of the city since the renowned Downt
"What are the 'waters of the United States'? As it turns out, defining that statutory phrase—a central component of the Clean Water Act—is a contentious and difficult task." This observation, recently made by Justice Sonia Sotomayor, understates the difficulty in answering what should otherwise be an anodyne question: Does my project require a Clean Water Act permit? At this moment, answers to this question may be far from certain ...
Last week, State Senator Scott Weiner (D-San Francisco) announced new legislation intended to immediately encourage more residential construction in areas near public transit and job centers. Entitled the More Housing, Opportunity, Mobility, Equity and Stability (More HOMES) Act, SB 50 is essentially version 2.0 of SB 827, a similar housing bill proposed by Senator Weiner that failed in committee earlier this year ...
Michigan voters approved Proposal 1 and made Michigan the twelfth U.S. jurisdiction to legalize recreational marijuana. The Michigan Regulation and Taxation of Marihuana Act (MRTMA) went into effect December 6. What has been lost in all the smoke from the past several weeks is how MRTMA impacts the regulation of industrial hemp ...
Institutional Shareholder Services, Inc. (“ISS”) and Glass, Lewis & Co. (“Glass Lewis”) recently released their 2019 proxy voting policy updates. ISS and Glass Lewis are two of the leading proxy advisory services worldwide, and each evaluates and updates their proxy voting policies annually. The key ISS and Glass Lewis updates for the 2019 proxy season are summarized below. ISS ISS published its 2019 Proxy Voting Guidelines Updates on November 19, 2018 ...
The government has approved, by royal decree-law, a legal reform introducing a number of changes to the Retail Trade Law. Royal Decree-Law 20/2018, of December 7, 2018, on urgent measures to foster economic competitiveness in the industrial and trading sectors in Spain, published in the Official State Gazette last Saturday, December 8, amends Retail Trade Law 7/1996, of January 15,1996 ...
Under the Affordable Care Act (“ACA”), large employers (generally those with 50 or more full-time employees or full-time equivalents) must report annually to the IRS information about the health coverage offered to their full-time employees during the prior year using IRS Form 1095-C. The IRS uses the forms to assess whether an employer "shared responsibility" penalty applies. Employers also must provide copies of the forms to their full-time employees ...
Often, board of education members believe what happens in executive session, stays in executive session. However, you and your board’s members, both new and old, are well-served to remember that many issues, including those involving personnel, discussed in executive session are communications that may be subject to discovery in a deposition or other legal proceeding by an affected employee ...
On November 20, 2018, the IRS Criminal Investigation (CI) unit issued a memorandum to IRS Division Commissioners on voluntary disclosure practice following the end of the Offshore Voluntary Disclosure Program (OVDP). How Did We Get Here? For the last 7 years, the IRS maintained a consistent, robust program for taxpayers with exposure to potential criminal liability or substantial civil penalties due to a willful failure to report foreign financial assets ...
The UAE federal government has recently issued a raft of important legislation. The raft addresses and updates areas of law that are key to businesses in the jurisdiction. Amongst this legislation is Federal Decree-Law 14 of 2018 concerning the central bank and the organisation of financial institutions and activities (the New Banking Law) ...
The SEC’s Division of Enforcement recently issued itsannual reportdetailing enforcement activities, statistics, and changes made in the past fiscal year (“FY 2018”). The report discusses several significant developments in the SEC enforcement landscape, including the creation of new task forces, first-of-their kind enforcement actions, and the impact of the Supreme Court’s decision inKokesh v. SEC, 137 S. Ct. 1635 (2017) ...
The large number of vague terms as well as provisions requiring interpretation in the GDPR create significant application issues for companies. However, it becomes even more of a challenge if companies not established in the EU want to review whether the GDPR is applicable to them. Generally speaking, the European legislator set themselves the goal of creating the most extensive territorial scope of the GDPR possible ...
New State Minimum Wage Effective January 1, 2019, the State minimum wage increases to $12.00 per hour for employers with 26 or more employees, and $11.50 per hour for employers with 25 or fewer employees. New Local Minimum Wages Additionally, several California cities and counties have passed their own minimum wage ordinances with a more aggressive schedule of minimum wage increases ...
Educational institutions (“recipient” or “recipient institutions”) have been waiting for the Department of Education to issue formal Title IX regulations after it issued interim guidance in September 2017. This interim guidance rescinded previous Obama-era guidance that called for strict enforcement of Title IX and indicated that new formal guidance would be forthcoming ...
The new anti-money laundering (AML) law of the UAE took effect at the end of October 2018. Containing features recommended by the Financial Action Task Force (FATF), the new law introduces subtle but important changes to the AML landscape in the UAE. The new law was enacted as Federal Decree-Law 20 of 2018. The previous AML law was Federal Law 4 of 2002, as amended by Federal Law 9 of 2014, and the implementing regulations that were promulgated pursuant to Cabinet Resolution 38 of 2014 ...
The enactment of EU Directive 2018/843 on the prevention of the use of the financial system for money laundering or terrorist financing (the "5th AML Directive") has prompted the Luxembourg government to accelerate the final implementation process of EU Directive 2015/849. This Directive prevents the use of the financial system for the purposes of money laundering or terrorist financing (the “4th AML Directive”) ...
In light of the new EU data protection scheme, shaped by the GDPR, Serbia has enacted a new Data Protection Law earlier this year, with its' applicability postponed for 21 August 2019. The new law was long-awaited: it has been 10 years since the existing law was passed, which was even at that moment already outdated (e.g. it recognized only consent in the written form and almost completely restricted data transfers to non-European countries) ...
In a letter to state Medicaid directors on Nov.13, 2018, the Secretary of the U.S. Department of Health and Human Services, Alexander Azar, announced a new demonstration opportunity that will allow states to provide improved care for adults with a serious mental illness (SMI) and children with serious emotional disturbance (SED) ...
As Fast-Growing San Francisco Concludes Its Largest Rezoning in Ten Years, Will Its Novel New Urban Planning Guidelines for South of Market Represent What the City’s Downtown Needs in A Fast-Moving Business, Cultural and Economic Environment? On November 13, 2018, the Board of Supervisors voted to approve the Central SOMA Plan at its first reading. Its final reading and approval, and the Mayor’s signature, is expected in December ...
On November 15, 2018, the Food and Drug Administration (FDA) published a Proposed Rule, which, if finalized, will allow an institutional review board (IRB) to waive or alter certain informed consent requirements if a clinical trial poses minimal risk to human subjects and includes appropriate safeguards to protect the rights, safety, and welfare of those human subjects ...
News of a new federal law on foreign direct investment in the UAE has many people asking: “Does this mean I can now form a new company with majority foreign ownership?” The answer is the same as previously, “No, not yet”. Companies incorporated in the UAE require a minimum of 51 percent UAE ownership. As an exception to this rule, 100 percent foreign ownership is permitted in free zones. The new law may lead to further exceptions in the future ...
The introduction of the e-hailing system had changed the landscape of public transport in Malaysia and, at the same time, intensified the competition in the taxi industry. Whilst the taxi industry was subject to specific regulatory requirements there was previously no express law to regulate the operation of the e-hailing system ...
This case highlights the importance of registering a franchise with the Registrar of Franchises and the consequences of not doing so. In particular, the effect and applicability of section 6(1) of the Franchise Act 1998 (“FA 1998”) are discussed. Facts The subject matter was “Dr. Fong’s Method” of teaching mathematics to students in primary and secondary school, which was developed by Dr. Fong Ho Kheong (“Dr. Fong”). Dr ...
