Firm: All
Practice Industry: Healthcare & Pharmaceuticals, Technology
Region: All
Country/ State: All
Tag: All

On May 4, 2017, the en banc Federal Circuit heard oral arguments in Wi-Fi One, LLC v. Broadcom Corp., Appeal 2015-1944 (Fed. Cir. Sept. 16, 2016) to consider whether the findings of the Patent Trial & Appeals Board (“PTAB”) regarding 35 U.S.C. § 315(b), which governs the timeliness of filing a petition for inter partes review (“IPR”), are subject to judicial review on appeal ...

Disruption. Possibly the most overused word in today's global lexicon, it refers to the upheaval that is created when a new business (these days, usually founded by a smart alec entrepreneur) uproots an established method of delivering a product or service. Think Spotify, a music-streaming business that has sounded the death knell of CDs. It has, as its most vocal opponent, pop star Taylor Swift, who felt that it did not adequately value her art ...

Heuking | April 2017

  EnerDry holds numerous patents based on inventions by its founder and CEO Arne Sloth Jensen, including European Patent EP 1 070 223 B1. This patent relates to steam dryers with a specific type of cyclone, which substantially improves the capacity and efficiency of steam dryers ...

Haynes and Boone, LLP | April 2017

On Wednesday, April 26, 2017, the Supreme Court heard oral argument in Sandoz Inc. v. Amgen Inc. et al., a landmark case that many hope will provide clarity and guidance for consumers and the pharmaceutical industry on the regulatory approval pathway for biosimilar drugs under the Biologics Price Competition and Innovation Act of 2009 (“BPCIA” or “Biosimilars Act”) ...

Dispute is heating up over IRS’s attempts to get personal information about users of Bitcoin and other virtual currencies. Last November, the Internal Revenue Service (“IRS”) filed a petition in the United States District Court for the Northern District of California. It sought the court’s permission to serve a “John Doe” summons on Coinbase, Inc., a virtual currency exchanger in San Francisco ...

Cybersecurity is one of the most critical challenges facing our nation and our economy. U.S. regulators on both the state and federal level are working to keep pace with the challenges and risks posed by cybercrime. On March 1, 2017, the New York State Department of Financial Services (DFS) issued a new cybersecurity regulation designed to protect financial institutions, their information technology systems, and their customers from cybercrime1 ...

ENSafrica | March 2017

In addition to registering their trade marks with the Companies and Intellectual Property Commission (“CIPC”), brand owners should ensure that their trade marks are protected online. One way of doing this is by registering a domain name. What is a Domain Name?A domain name allows a party to establish its identity on the internet. It assists internet users to easily identify brand owners on the internet and to access their sites on the web ...

Lavery Lawyers | March 2017

Can computers learn and reason? If so, what are the limitations of the tasks that they can be given? These questions have been the subject of countless debate as far back as 1937, when Alan Turing published his work on computable numbers1. Many researchers have devoted themselves to developing methods that would allow computers to interact more easily with human beings and integrate processes used to learn from the situations encountered ...

Waller | March 2017

Most people probably associate cyber-crime with issues of national security—what with Russia dominating so much space in the headlines, lately. However, cybersecurity breaches can have a palpable and damaging effect on everyday individuals, due to how often they’re tied to corporate security breaches involving highly sensitive personal information like credit card numbers, social security numbers, and contact information ...

Hanson Bridgett LLP | March 2017

Upon reconsideration in Gerard v. Orange Coast Memorial Medical Center, Case No. G048039 (March 21, 2017) (Gerard II), the Fourth Appellate District decided that IWC Wage Order 5 is valid and that healthcare employees may waive one of their two required meal periods on shifts longer than 8 hours ...

Haynes and Boone, LLP | March 2017

As of March 14, 2017, the recently enacted Consumer Review Fairness Act (the “Act”)1 will prohibit “gag clauses” – contract provisions that prohibit or restrict a consumer's ability to write negative reviews of products and services. While enforcement by the Federal Trade Commission (“FTC”) and state attorneys general is set to begin on December 14, 2017, businesses should act now to ensure compliance ...

The September 23, 2013 deadline for covered entities, business associates and their subcontractors to implement the new HIPAA rules is approaching quickly. In case you missed it, on January 25, 2013, the U.S. Department of Health and Human Services issued an omnibus final rule modifying the Health Insurance Portability and Accountability Act of 1996 ...

It is undeniable that technology and globalization are changing the way lawyers practice law.  Technology has not just made people, places, and things much more accessible to us – it has impacted the way we store information and documents, the way we communicate with and advise clients, how we conduct investigations, and how we participate in discovery ...

by Eric E. Kinder President Bush signed the ADA Amendments Act into law. The ADAAA significantly increases the scope of the Americans with Disabilities Act of 1990 as it has been interpreted by federal courts by overturning several United States Supreme Court decisions regarding the Act. According to the Congressional Committees that oversaw the passage of the ADAAA, these amendments will restore the original Congressional intent behind the ADA ...

The Treasury Department has announced further extensions for medium-sized and large-sized employers for compliance with the “employer mandate” of the Affordable Care Act (“ACA”). The employer mandate requires employers with a threshold level of employees to provide affordable health insurance to 95% of their full-time employees. Under the ACA, a full-time employee is defined as any employee who works on average 30 or more hours per week ...

   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 ...

The Patient Protection and Affordable Care Act ("ACA") has significantly changed the healthcare industry in the United States.  Among the many changes is the new requirement that healthcare providers must provide all "Food and Drug Administration approved contraceptive methods, sterilization procedures, and patient education counseling for all women with reproductive capacity."77 Fed. Reg. 8725 (Feb. 15, 2012); see 42 U.S.C. 300gg-13(a)(4), 45 C.F.R. § 147.130(a)(1)(iv) ...

Dispute is heating up over IRS’s attempts to get personal information about users of Bitcoin and other virtual currencies. Last November, the Internal Revenue Service (“IRS”) filed a petition in the United States District Court for the Northern District of California. It sought the court’s permission to serve a “John Doe” summons on Coinbase, Inc., a virtual currency exchanger in San Francisco ...

Waller | February 2017

In one of the first concrete developments related to the Affordable Care Act (ACA) changes following Dr Thomas E Price’s approval as Secretary of the Department of Health and Human Services (HHS), a Notice of Proposed Rule making was recently released by HHS. The recent release by HHS stated a goal of helping to stabilize the individual and small group marketplaces established by the ACA ...

Waller | February 2017

External pressures, such as lower reimbursement rates and an overall shift in policy by the Centers for Medicare and Medicaid Services (CMS) and state Medicaid agencies have put significant financial and operational pressure on skilled nursing and other senior living operators in the United States ...

Haynes and Boone, LLP | February 2017

  View the February 2017 Health Law Vitals Newsletter PDF. Final Guidance Sheds Light on Medical Device Reporting Requirements In November 2016, the U.S. Food and Drug Administration issued a final guidance on medical device reporting for manufacturers ("Final MDR Guidance") ...

Waller | February 2017

Membership substitution transactions are the most common form of business combination transaction in the nonprofit hospital industry. They are also widely misunderstood and the source of many mistakes. Many large 501(c)(3)s have become more acquisitive as a result of economic pressures of the ACA. Nonprofit health systems have been getting much better at participating in and winning competitive sale processes, resulting in an increased use of this business combination form. http://www ...

Haynes and Boone, LLP | February 2017

Just weeks into the new Administration, perhaps the only certain thing is that there will be uncertainty as the Administration makes its mark and works to fulfill campaign promises. Meanwhile, restaurant chains and food companies are trying to allocate resources to best address business priorities and hot legal issues ...

Waller | January 2017

The impacts of the Americans with Disabilities Act loom largest in the public consciousness in the form of handicap-accessible parking spaces and entrance ramps — accommodations for physical access to public premises. But under the law, it also appears that businesses must make sure their websites and mobile apps are ADA-compliant. Derek Edwards is a partner at Waller Lansden Dortch & Davis, where he specializes in financial services litigation ...

Atsumi & Sakai | January 2017

Summary Amendments to Japan’s Act on Protection of Personal Information (“APPI”) (“Amendments”) were passed by the Diet on 3rd September 2015; some provisions, mainly those establishing and governing the Personal Information Protection Commission (“Commission”), are in force, and it has now been announced that the remaining provisions will be implemented on 30th May 2017 (“Implementation Date”), though regulations and guidelines setting out

dots