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The U.S. Supreme Court today (June 28, 2010) handed down its highly-anticipated opinion in the case of Bilski v. Kappos, Case No. 08-964.  The Supreme Court affirmed the decision of the Court of Appeals for the Federal Circuit and held that the subject matter of Mr. Bilski’s patent application was not patentable subject matter. However, in ruling against Mr ...

If you are a U.S. business with international operations, here are four questions you should consider: Does your company have more than two foreign subsidiaries, at least one of which is profitable? Do you have a profitable foreign subsidiary that guarantees any U.S. debt? Are you considering the purchase of a company located outside the U.S.? Does your U.S ...

President Obama has renewed his proposal to cut over $40 billion in tax breaks for oil, gas and coal producers over the next decade in an attempt to spend more for alternate energy and conservation. The $3.8 trillion budget proposal represents a 29% increase in renewable energy funds in 2013, as compared to 2012 ...

Managing General Agent (“MGA”) Agreements are unique and can be exceedingly complex. They often include detailed underwriting guidelines and strict limits on an MGA’s authority. After all, an MGA is authorized to bind an insurer on substantial risks often with little direct supervision by the insurer. While no two MGA Agreements are the same, all must incorporate certain required provisions. The NAIC has promulgated the Managing General Agents’ Act (NAIC Model No ...

Insurers are well aware of the typical bad faith scenario in third-party claims. Counsel for a claimant sends a demand for policy limits to the insurer in the hope that the insurer does not accept within a time limit specified in the demand ...

The rapid growth of the hospice industry has attracted the attention of Congress and federal and state healthcare regulatory and enforcement agencies.  The Patient Protection and Affordable Care Act (the “ACA”), signed into law by President Obama on March 23, 2010, included several provisions aimed at hospice providers ...

We are all too familiar with stories of contaminated food and drugs that sicken and even kill consumers.  Given the increasing number of product recalls and their enormous financial impact, it is not surprising the demand for recall insurance has increased exponentially in the middle market. Why has the number of recalls increased so dramatically?  The answer is twofold ...

The access to records clause, sometimes called the inspection or audit clause, is a common fixture in reinsurance agreements and serves an important function.  It enables the reinsurer to track the performance of the agreement and maintain an accurate view of the business ceded.  More specifically, it allows the reinsurer to ensure the cedent is complying with the terms and conditions of the agreement, including timely reporting of losses and calculation of premiums ...

Loose lips sink ships.  They also can sink the protections of the attorney-client privilege.  A case in point is a recent decision from the Southern District of Florida.  Guarantee Insurance Co. v. Heffernan Insurance Brokers, Inc., Case No. 13-23881-CIV (S.D. Fla. June 13, 2014).  In that case, Guarantee Insurance had been sued for the alleged bad faith handling of a worker’s compensation insurance claim ...

As noted in numerous recent publications, captives have been receiving an increased amount of regulatory attention, not just from the domicile states which regulate them, but, more significantly, from national or international bodies.  The NAIC Captives and Special Purpose Vehicles Working Group completed its examination of captives and now two captive related proposals are being considered at the NAIC ...

On October 3, 2014 the Department of Health and Human Services, Office of Inspector General (“OIG”), released a proposed rule to add new safe harbors to the Anti-Kickback Statute (“AKS”) and to amend the definition of “remuneration” in the Civil Monetary Penalties (“CMP”) regulations.  The OIG additionally solicited comments on same which must be submitted no later than 5 pm EST on December 2, 2014 ...

Every day seems to bring word of a new data breach, and given the stakes of these breaches, it would be easy to assume that dealing with the damage they cause would be a top government priority. Unfortunately, a myriad of conflicting state laws, as well as the lack of one over-arching federal law, creates legal and compliance nightmares for companies that these breaches affect. For example, in late February and early March 2014, hackers successfully targeted eBay’s corporate network ...

On July 6, 2015, in response to an executive order signed by President Obama, the U.S. Department of Labor (DOL) published a proposed rule that could significantly impact overtime regulations under the Fair Labor Standards Act (FLSA).  Among other changes, the proposed rule will increase the minimum salary threshold to qualify for the “white collar” exemptions to $50,440 per year, which could affect an estimated 4.6 million workers ...

The Defend Trade Secrets Act of 2016 (DTSA) - arguably the most significant change to U.S. intellectual property laws in the past decade - was signed into law by President Obama on May 11, 2016. The DTSA creates a federal, civil remedy for misappropriation of a trade secret that is related to a product or service used in, or intended for use in, interstate or foreign commerce ...

Brexit, the United Kingdom’s vote to leave the European Union, raises many questions and some are related to intellectual property issues. There are a few anticipated changes to IP rights due to Brexit. Here is a summary of some key issues, and what could happen next. Trademarks and Designs Proceduresfor treatment of EU trademarks will need to be an element of the negotiations for the UK in leaving the EU ...

The Court of Appeals for the Federal Circuit ("CAFC") issued an important ruling today in the ongoing evolution of biosimilar product regulation. In the ruling today, the CAFC in Amgen Inc., Amgen Manufacturing Limited v. Apotex Inc., Apotex Corp. (CAFC Case No. 2016-1308) affirmed the district court ruling and held that the commercial-marketing provision in 42 U.S.C ...

Effective November 1st, new guidelines came into effect for patent applications before the European Patent Office (“EPO”). One significant change affects what the EPO will accept as evidence of transfer of ownership of a patent application, an assignment ...

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 ...

  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 ...

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 ...

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 ...

Notwithstanding the optics of a healthy U.S. economy, beneath the surface there are many U.S. companies and consumers that have become casualties of the “trade war” with China. The first salvo in this trade war was fired in January 2018, and was followed by additional shots later in 2018 as the United States imposed punishing tariffs that affect hundreds of billions of dollars of trade with China and the rest of the world ...

Law360 (May 6, 2019, 7:15 PM EDT) -- A Turkish producer has filed a complaint with the U.S. Court of International Trade over the methodology the U.S. Department of Commerce used to calculate tariffs on its pipe imports, telling the court that Commerce went against its usual practice for determining when the pipes at issue were sold in the U.S. Borusan Mannesmann Boru Sanayi ve Ticaret AS on Friday told the CIT that Commerce’s decision to impose a dumping rate of 5 ...

Patents and technology companies are often intertwined. The story of the startup company patenting its groundbreaking technology is a well-known one. We see this often on the television show "Shark Tank," as investors such as Mark Cuban and Lori Greiner routinely ask whether the founders of a potential investment opportunity have filed for patent protection ...

On September 30, 2020, The Department of Justice (DOJ) announced the results of a sweeping joint healthcare fraud and opioid takedown that resulted in charges against 345 different defendants who were responsible for over $6 billion in government losses involving fraudulent healthcare services and improper billing. This was the largest healthcare fraud enforcement action in the history of the DOJ ...

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